ISO 14001:2004 Environment Management System

ISO 9000 Document Control System

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The ISO 9000 Document Control Software is developed & designed to control the ISO 9000 Quality Manual, Operating Procedure, Forms & Documents digitally. System will track the all ISO 9000 Documents by ISO Document No. through out the system.

The ISO 9000 Document Control Software Provides:-

• Tracking of Documents
• Efficiency Document Control
• Revision Control
• Multiple File Location
• Centralize Of Document Control
• Security

ISO 9001 Standards Check List

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ISO 9001:2008 include these checklists as follows:

1. ISO 9001 General Requirements

Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?

2. General Documentation Requirements
Does the quality management system documentation include documented procedures and records required ensuring effective operation and control of its processes?

3. Quality Manual
Has a quality manual been established and maintained that includes:

4. Control of Documents
Are documents required for the quality management system controlled?

5. Control of Records
Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?

6. Management Commitment
How has top management demonstrated commitment to the development and improvement of the quality management system?

7. Quality Policy
Organization has top management ensured that the quality policy:

8. System Planning
1. Quality Objectives
a. What are the quality objectives that have been established at relevant functions and levels within the organization?

9. Responsibility, authority and Communication
Responsibility, authority and Communication Audit Checklist
1. Responsibility and authority

10. Resource Management
Resource Management Audit Checklist

1. Provision of resources

11. Planning of Product/Service Realization
Planning of Product/Service Realization Audit Checklist
Is planning of the realization processes consistent with the other requirements of the organization’s quality management system?

12. Management Review
Management Review Audit Checklist
1. General checklist
a) Does the top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?

13. Product review
Determination of Requirements Related to the Product (7.2.1)

14. Design and Development Planning and Design and Development Inputs
What is the design and development planning methodology described in the design procedure?

15. Design and Development Outputs Audit
Are the outputs of the design and/or development process documented in a manner that enables verification against the design and/or development inputs?

16. Design and Development Review Audit
Are systematic reviews of design and/or development conducted at suitable stages?

17. Design and/or Development Verification
Is design and/or development verification performed to ensure the output meets the design and/or development inputs?

18. Design and/or Development Validation
Is design and/or development validation performed to confirm that resulting product is capable of meeting the requirements for the intended use?

19. Control of Design and Development Changes
Are design and/or development changes identified, documented, and controlled?

20. Purchasing Process
Does the organization control its purchasing processes to ensure purchased product conforms to requirements?

21. Purchasing Information
Do purchasing documents contain information describing the product to be purchased?

22. Verification of Purchased Product
Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented?

23. Control of Production and Service
Are the production and service provision planned and carried out under controlled conditions including:

24. Validation of Processes for Production and Service Provision
Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated?

25. Identification and Traceability
Is the product identified by suitable means throughout product realization?

26. Customer Property
How does the organization exercise care with customer property while it is under the
organization’s control or being used by the organization?

27. Preservation of Product
Is conformity of product preserved during internal processing and delivery to the intended destination?

28. Audit Checklist of Control of Measuring and Monitoring Devices
Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements?

29. Customer Satisfaction
Are measurement and monitoring activities needed to assure conformity and achieve improvement been identified and included in the product quality plan?

30. Internal Audit Checklist
Are periodic internal quality audits conducted to determine whether the quality management system has been effectively implemented and maintained?

31. Monitoring and Measurement of Processes
Are suitable methods applied for monitoring and where applicable, measurement of the quality management system processes necessary to meet customer requirements?

32. Monitoring and Measurement of Product
Are product characteristics monitored and measured to verify that product requirements are met?

33. Control of Nonconforming Product Checklist
Is nonconforming product identified and controlled to prevent unintended use or delivery?

34. Analysis of Data
Is appropriate data determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can
be made?

35. Corrective Action
How is corrective action taken to eliminate the cause of nonconformities in order to prevent recurrence?

36 Continual Improvement
Are processes necessary for the continual Improvement of the quality management system planned and managed?

37. Preventive Action
Has the organization determined actions to eliminate the causes of potential nonconformities in order to prevent occurrence?

These checklists also called ISO 9000 audit checklist.

Family Of ISO 14000 Standards

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Family of ISO 14000 include standards as follows:

1. ISO 14001: Environmental management systems—Requirements with guidance for use.

2. ISO 14004: Environmental management systems—General guidelines on principles, systems and support techniques.

3. ISO 14015: Environmental assessment of sites and organizations.

4. ISO 14020: Include series (14020 to 14025) Environmental labels and declarations.

5. ISO 14031: Environmental performance evaluation—Guidelines.

6. ISO 14040: Include series (14040 to 14049), Life Cycle Assessment, LCA, discusses pre-production planning and environment goal setting.

7. ISO 14050: Terms and definitions.

8. ISO 14062: Discusses making improvements to environmental impact goals.

9. ISO 14063: Environmental communication—Guidelines and examples

10. ISO 19011: which specifies one audit protocol for both 14000 and 9000 series standards together.

How to Get an ISO 14001 Accreditation

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If you are someone who is looking into getting an ISO 14001, then you may be wondering exactly why it is that you have to get this accreditation. First, you have to understand that ISO stands for the International Organisation of Standardisation. This is a series of standards that have been developed with a singular level of guidance for all companies to measure up to. The particular 14001 deals with the requirements that you will need to have in order to measure up to the environmental standards that have been set forth by the ISO.

While you do not necessarily have to get the ISO 14001 accreditation to operate your business, it is something you can do to prove to your clients and customers that you are doing your part to help out with the environment. However, you may be confused on how to go about getting this important accreditation, but it is not as difficult to attain as you might think, and most businesses should be able to get the certification within a year of the application. You should know that they will want to make sure that you have been following some form of environmental standards for at least three months prior to your application. To do this you can write an environmental review of your company’s environmental impact as it is in its current operating state. You will then want to make sure that you provide this information when you send off your initial paperwork to begin the overall process.

In order to help prove that your company is doing its part to be environmentally aware you will have to go through an initial audit once the application has been filled out and filed. After the audit has been completed you will get a list of issues that the auditor feels you need to resolve before you can be certified for the ISO 14001. You will need to work on and correct these issues before the second audit is conducted, and they will give you a time period (usually three to six months) when they will return to check on your progress.

When the second audit occurs they will once again assess the overall business and then they will address the issues that were laid out in the previous audit. If everything goes well then your company will have proven that they are doing what they can to meet the standard set forth in ISO 14001, and they will then receive accreditation. However, this is not the end of the process. Even though you are now recognised as having environmentally conscious policies that are congruent with the international standards, you will have to go through periodic audits every three years to make sure that you are still operating correctly. Not only this, but every three months partial aspects of your company will be analysed to see that they are still working within the standards as well. As long as you remain within the compliance terms you will continue to receive your ISO 14001 certification.

Is Green Business Really Environmentally Sustainable ?

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Is Green Business Really Environmentally Sustainable ?

Green Business is about a good management of a range of issues including reduced carbon footprint and good energy management but also including a broader environmental sustainability, within a practical environmental management system. The most effective system is ISO 14001. Many other approaches are less than effective

There is a wide variety of concepts that are understood by some as environmental management systems or EMS and this varies in different industries. The concept has evolved over time. Essentially the name says it all – A system to enable the business owner or manager to manage environmental problems both real and potential.

Owners and managers setting out to have a green business do not always achieve their aim of environmental sustainability and may not even include reduced carbon footprint and good energy management.

Many industry groups have developed industry wide simplistic programs that they call EMS that actually miss the S for system and some really only have a checklist approach that is based on an “average” or “typical” business in that industry. So effectively they also miss much of the environment. Many do not really involve any management either. Some are very superficial in the way that they select the environmental aspects they manage because they have been drawn up to be generic and cut out the need for the business owner to stop and think. In this case it is difficult to understand how any process of continual improvement can result.

One of these programs are as simple as a checklist, or what many involved call a “tick and flick” exercise. These are barely even educational for the business owner and have no ongoing benefits like reduction of costs or legal protection.

Even where the business owners and or managers spend a lot of time filling in forms and communicating with neighbours, there is often a real lack of understanding of how to identify and varied environmental risks in an individual businesses and why these need to be manage. They can easily miss things and even find they are risking legal implications in areas that are not typical and so not covered by the so called system..

An effective management system needs individual businesses to identify and understand what their environmental risks are or may be. These risks need to be managed and there also needs to be a feedback system going into a regularly reviewed system for continual improvement. This can be enhanced with auditing by qualified independent auditors, whether internal or external; although the greatest benefit does come from employing and independent external auditing body such as a certification body.

There were some early ISO 14001 systems that gave the system a bad name because they were based on outdated engineering and military approaches to ISO systems are overly paper heavy and full of jargon. These were not suitable for small business and farms. These systems have given ISO 140001 a bad name in some circles.

Unfortunately many consultants have come from an old style quality management background without any real understanding of or training in the environment. The training to upgrade from quality auditing only involves doing a three day seminar with a minimal assessment by a training organization. Then they audit with a rigid paper based approach and do a serious disservice to both their clients and to the auditing industry.

Small to medium businesses benefit from a simpler approach based on a real understanding of the issues involved and a genuine understanding of risks. Such systems are based on ISO 14001 and have a real emphasis on keeping things simple and minimizing paperwork. These give very real benefits to the businesses involved.

About ISO 14001:2004 Standards

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The ISO 14001 aims to reduce the environmental carbon footprints that many businesses leave behind today because of not taking the right steps to be environmental sustainable. This standard promotes the decrease in the waste of necessary business resources and also reduces the pollution that can sometimes be a by product of a business.

About ISO 14001

The most updated version of the ISO 14001 was released in the year 2004 by the International Organisation of Standardization (ISO), which was attended by members from all the committees from around the world. In order for a company to be awarded the ISO 14001 standard certificate, an external auditor has to audit the company by an audit body that has been accredited by an accreditation body. The certification auditors are required to be accredited by the International Registrar of Certification Auditor and the certification body has to be accredited by the Registrar Accreditation Board in the USA or by the National Accreditation Board in Ireland.

The structure of ISO 14001 is very much like the ISO 9000, which is management standard, so these two standards can be implemented side by side to achieve the best results. As a part of the ISO 14000family, which deals with different aspects of environmental issues, ISO 14001:2004 and ISO 14002 deal with environmental management system (EMS). ISO 14001 gives the requirements for the

EMS and ISO 14002 gives the basic guidelines for EMS.

Environmental Management System with ISO 14001:2004

The EMS, as per the requirements of the ISO 14001, enables the company, may it be of any size, location and income to:

It helps the company improve its environmental strategy and this positively affects their environmental performance.
It helps in identifying and controlling the environmental impact that the activities, services or products of the company might have.
And it helps in carrying out a systematic approach to set environmental targets and objectives, to achieve these and also to demonstrate that they have been achieved.

How does it work?

ISO 14001 does not specify or chalk out a definite level that each business has to reach. If the performance was determined, then it would have to be done for every specific business. But that is not how it works and has a very different approach, like:

The ISO has various standards dealing with environmental issues. ISO 14001 deals with a framework provided for a strategic and holistic approach to the businesses environmental policy, actions and plans.
It gives the general requirements for the EMS.
This also states the reference to the communication requirements for the communication of the environmental management issues between the company, stakeholders, the public and the regulators.
As these standards are not company specific, any and every business can undertake them as long as they are dedicated to the continued and improved environmental performance and they have a commitment to comply with the set norms.

Evolution And Future Challenges Of ISO 14001 Standards

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There has been a clear shift in the profile of users of EMS since the 1990s. Typically, the early adopters of the ISO 14001 Standard were in the heavy industry and manufacturing sectors – companies that had large-scale environmental impacts and experience of using ISO 14001 Standards in management.
There has been a clear shift in theprofile of users of EMS since the1990s. Typically, the early adoptersof the standard were in theheavy industry and manufacturingsectors – companies thathad large-scale environmentalimpacts and experience of usingstandards in management.

However, as environmental issues have increased in importance, organizations in the service and support sectors have adopted EMS as well. The spectrum of EMS users has broadened to areas including zoos, farming, schools and universities, military services, media, ships and airlines.

ISO 14001 certification now reaches cruise ship companies, marine transportation services, container carriers and leading ship classification societies.

Almost all airlines and airports can be expected to be certified within the next ten years. Recreation, holidays, browsing in shopping malls. More and more small- and medium-sized enterprises are discovering the benefits of certification. The myth that ISO 14001 is difficult to implement for small business is de-bunked by the fact that more than 200 German chimney sweeps are certified.

The number of EMS users will continue to grow, particularly as ISO 14001 penetrates more effectively into supply chains.

The real challenge in the future, however, will be how well the ISO 14001 participants deal with the most compelling environmental threats – climate change, resource use, biodiversity loss and legal compliance.

For ISO 14001 to maintain its international currency as a force for environmental protection, it will need to demonstrate that it is able to support action on these areas and remain an effective tool for sustainable consumption and production.

ISO14001: A Deterrent against Environmental Degradation

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Over the last few years, ISO 14001 has gained considerable support of business communities and governments worldwide. Business communities consider it a catalyst which ensures continued business and provides an opportunity to boost trade with customers overseas. Governments look at it as a useful agent to soften the local industry to comply with environmental legislation.

ISO 14001 is being pushed as an agenda, therefore, which will help in lowering environmental impacts that occur because of the manufacturing sector. On the surface, the picture is quite rosy.

For large manufacturers adopting ISO 14001 is quite practical and makes economic sense. The major assumption while formulating the ISO 14001 was that there is no informal manufacturing sector (because of poor representation and inactive role of the developing countries at TC207). Informal sector in Pakistan is a major component of the manufacturing sector and provides useful support to the formal sector. The informal sector exists within the populated areas, making it extremely hard to regulate. Therefore, the environmental impacts due to this sector are quite significant.

ISO 14001 requires the suppliers of a manufacturer to have an Environmental Management System (EMS) in place as well. For a supplier operating from a small facility in a congested area and meager resources, how can s/he be expected to hire a consultant to develop an EMS? In a country which has a significant informal manufacturing sector, high unemployment due to deteriorating economic condition, high inflation, limited resources, weak monitoring agencies and deteriorating infra-structure, with all these constraints, how is it possible for the manufacturing sector to adopt ISO 14001 in it’s true spirit?

Even if a manufacturer adopts the ISO 14001, what is the guarantee that s/he will get business? What is the incentive for the non-exporting manufacturers to adopt ISO 14001? How can the industry be convinced that ISO 14001 is an opportunity not an obstacle? Considering all these factors, this paper will analyze the current status of ISO 14001 adoption in Pakistan, reasons for adoption, deterrents in adoption, and recommendations on how those deterrents can either be removed or minimized, and it’s overall impact on the environment and economy.

Internal Audit In ISO 9001:2008 Standards

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ISO stands for International Organization for Standardization. ISO is a non governmental organization based in Geneva Switzerland which promulgates worldwide commercial and industrial standards. TheISO 9000 is a family of standards set for quality management systems. If a company has the ISO 9001: 2008 certificate, they are said to be ISO 9001:2008 compliant and would have followed a formal procedure of training and auditing to get the certificate.

Courses usually take place in a classroom setting, but some can be conducted online, like the course provided by the Telecom Quality Management System. In general, courses cover customer satisfaction, quality control, quality assurance and ensuring supplier quality. Courses often take the form of lectures and case studies to enable students to understand international standards and follow processes and procedures. Some courses train students on ISO auditing procedures, ISO quality management techniques and ISO certification. The American Society for Quality provides a program which leads to certification.

Companies that produce products, services or software can use ISO 9001 processes to improve their business operations to ensure that the products they produce are of the highest quality. Candidates trained in ISO 9001 standards are able to identify problems, create solutions and therefore implement good quality management practices. Candidates are also able to examine work flow, eliminate waste and maximize performance and effectiveness, ultimately helping to improve operations within the company.

Effective ISO 9001:2008 training prepares students to deal with the issues that can arise due to non conformance with standards. Such issues may include manufacturing errors. The development of quality control mechanisms according to the standards helps to guard against the risk of damaged products being shipped to customers.

Read more on ISO 9001:2008 at http://www.iso9001store.com

ISO 9001 Equipment Maintenance Procedure

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The purpose of this ISO 9001 Standards procedure is to regulate the planning and inspecting maintenance of equipments and machines while implementing process of production industry. The maintenance is to minimize and prevent from unexpected incidents caused by machines influencing the plan and schedule of production.

This procedures include steps as follows:

1. Need of equipment maintenance:

Due to the fact is that maintenance of machines and equipments is very important to the implementation of production industry, so the need of machines maintenance is set up to eliminate and prevent from unexpected incidents by machines and equipments that may affect to the plan and progress of production.

2. Making list of equipments

All machines and equipments that are working are conforming to requirements of production. The maintenance will coordinate with other Heads of departments (HODs) to make a list of each equipment for checking, preparing to replace, or repairing to submit to Technical department for approval.

3. Making a schedule of investigation:

Based on the machines and equipments that are using and depending the capacities and purposes of specialized equipments, the maintenance will make a schedule of investigation accordingly identifying the machines that serve requirements of practical products and give schedule of maintenance periodically or regularly maintained according to frequency of using.

4. Implementation of Investigation:

Based on plan of investigation, the maintenance department will investigate machines and equipment and record clearly:

o The duration of time used
o The duration of time maintained previously
o Trouble shootings earlier.
o Status of machines and equipments.
o Need repairing, replacing or maintenance.

5. Making schedule of maintenance:

After investigation and examination, the maintenance department will review the frequency of using of each machine so as to make a schedule of specific maintenance for each kind of machine and equipment.

o After identifying purpose and the importance of each machine in production, the maintenance department will make a schedule of maintenance for each of equipment as regulated by designers.

6. Material estimate:

Once having schedule of maintenance or repair, the maintenance will inspect to identify the causes leading trouble shootings, make a material estimate request to supply accessories of the equipment that need repairing at definite time. At the same time, there will be supervision and inspection from Head of department where machines or equipments are used.

7. Implementation:

Once having made material estimate and provided, Maintenance Department carry out repair based on the plan of maintenance and approval for repair. After the maintenance is finished, the maintenance will coordinate with the using department to make a report of inspection and evaluating quality of equipment and machines to put into operation and stating clearly about status of equipments that are replaced.

8. Updating files:

When finishing maintenance and repair, the maintenance Dept. will file each of machine whose accessories are repaired and for how long they can work as well as make a file for each machine.

More information on ISO 9001, kindly go to http://www.iso9001store.com

ISO 9000 CERTIFICATION IS AN APPRAISAL TO COMPANY

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During World WarII, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. According to Seddon, “In 1987, the British Government persuaded the International Organization for Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO 9000.”

ISO 9001: 2008 only introduces clarifications to the existing requirements of ISO 9001: 2000 based on eight years of experience of implementing the standard worldwide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001: 2004.. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is deliberately planning the next release as an amendment rather than a formal revision. The difference is that an “amendment” is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-

a set of procedures that cover all key processes in the business;
monitoring processes to ensure they are effective;
keeping adequate records;
checking output for defects, with appropriate and corrective action where necessary;
regularly reviewing individual processes and the quality system itself for effectiveness; and
facilitating continual improvement

ADVANTAGES OF ISO 9000 CERTIFICATION:

It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001: are also sound, according to Wade, and Barnes, who says “ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive.” Barnes also cites a survey by Lloyd’s Register Quality Assurance which indicated that ISO 9001 increased net profit, and another by Deloitte-Touche which reported that the costs of registration were recovered in as less as three months. According to the Providence Business News, implementing ISO often gives the following advantages:

Create a more efficient, effective operation
Increase customer satisfaction and retention
Reduce audits
Enhance marketing
Improve employee motivation, awareness, and morale
Promote international trade
Increases profit
Reduce waste and increases productivity

In today’s service-sector driven economy, more and more companies are using ISO 9000 as a business tool. Through the use of properly stated quality objectives, customer satisfaction surveys and a well-defined continual improvement program companies are using ISO 9000 processes to increase their efficiency and profitability.

Develop Quality Management System Documentation In ISO 9000 Standards

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Develop Quality Management System Documentation In ISO 9000 Standards
Documentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.
Documentation of the quality management system should include:
1. Documented statements of a quality policy and quality objectives,
2. A quality manual,
3. Documented procedures and records required by the standard ISO 9001:2008, and
4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.

Quality documentation is generally prepared in the three levels indicated below that follows. Use ISO 10013:1995 for guidance in quality documentation.

Level A: Quality manual
States the scope of the quality management system, including exclusions and details of their justification; and describes the processes of the quality management system and their interaction. Generally gives an organization profile; presents the organizational relationships and responsibilities of persons whose work affects quality and outlines the main procedures. It may also describe organization’s quality policy and quality objectives.

Level B: Quality management system procedures
Describes the activities of individual departments, how quality is controlled in each department and the checks that are carried out.

Level C: Quality documents (forms, reports, work instructions, etc.)
1. Work instructions describe in detail how specific tasks are performed; include drawing standards, methods of tests, customer’s specifications, etc.
2. Presents forms to be used for recording observations, etc.

ISO 9000 Standards – Document control procedures

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ISO 9000 Standards – Document control procedures
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document
control process is to firstly ensure the appropriate information is available
where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that
may require documented procedures in order to ensure consistency and
predictability. Procedures may not be necessary for each stage in the process.

Every process is likely to require the use of documents or generate documents and it is in the process descriptions that you define the documents that need to be controlled. Any document not referred to in your process descriptions is therefore, by definition, not essential to the achievement of quality and not required to be under control. It is not necessary to identify uncontrolled documents in such cases. If you had no way of tracing documents to a governing process, a means of separating controlled from uncontrolled may well be necessary.

The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures that deal with the controls that apply to all documents. The stages in the process may differ depending on the type of document and organizations involved in its preparation, approval, publication and use. One procedure may cater for all the processes but several may be needed.
The aspects you should cover in your document control procedures, (some
of which are addressed further in this chapter) are as follows
Planning new documents, funding, prior authorization, establishing need
etc.

- Preparation of documents, who prepares them, how they are drafted,
conventions for text, diagrams, forms etc.
- Standards for the format and content of documents, forms and diagrams.
- Document identification conventions.
- Issue notation, draft issues, post approval issues.
- Dating conventions, date of issue, date of approval or date of distribution.
- Document review, who reviews them and what evidence is retained.
- Document approval, who approves them and how approval is denoted.
- Document proving prior to use.
- Printing and publication, who does it and who checks it.
- Distribution of documents, who decides, who does it, who checks it.
- Use of documents, limitations, unauthorized copying and marking.
- Revision of issued documents, requests for revision, who approves the
request, who implements the change.
- Denoting changes, revision marks, reissues, sidelining, underlining.
Amending copies of issued documents, amendment instructions, and
amendment status.
- Indexing documents, listing documents by issue status.
- Document maintenance, keeping them current, periodic review.
- Document accessibility inside and outside normal working hours.
- Document security, unauthorized changes, copying, disposal, computer
viruses, fire and theft.
- Document filing, masters, copies, drafts, and custom binders.
- Document storage, libraries and archive, who controls location, loan
arrangements.
- Document retention and obsolescence.

With electronically stored documentation, the document database may provide many of the above features and may not need to be separately prescribed in your procedures. Only the tasks carried out by personnel need to be defined in your procedures. A help file associated with a document database is as much a documented procedure as a conventional paper based procedure.

ISO 9000 Standards – Document Approval

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ISO 9000 Standards – Document Approval
The ISO 9000 Standards requires that documents be approved for adequacy prior to issue.

Approval prior to issue means that designated authorities have agreed the document before being made available for use. Whilst the term ade-
quacy is a little vague it should be taken as meaning that the document is judged as fit for the intended purpose. In a paper based system, this means approval before the document is distributed. With an electronic system, it means that the documents should be approved before they are published or made available to the user community.

The ISO 9000 Standards document control process needs to define the process by which documents are approved. In some cases it may not be necessary for anyone other than the approval authority to examine the documents. In others it may be necessary to set up a panel of reviewers to solicit their comments before approval is given.
It all depends on whether the approval authority has all the information
needed to make the decision and is therefore ‘competent’. One might think that the CEO could approve any document in the organization but just because a person is the most senior executive does not mean he or she is competent to perform any role in the organization.

Users should be the prime participants in the approval process so that the
resultant documents reflect their needs and are fit for the intended purpose. If the objective is stated in the document, does it fulfil that objective? If it is stated that the document applies to certain equipment, area or activity, does it cover that equipment, area or activity to the depth expected of such a document? One of the difficulties in soliciting comments to documents is that you will gather comment on what you have written but not on what you have omitted. A useful method is to ensure that the procedures requiring the document specify the acceptance criteria so that the reviewers and approvers can check the document against an agreed standard.

To demonstrate documents have been deemed as adequate prior to issue,
you will need to show that the document has been processed through the
prescribed document approval process. Where there is a review panel, a simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the drafting process you may undertake several revisions. You may feel it
necessary to retain these in case of dispute later, but you are not required to do so. You also need to show that the current issue has been reviewed so your comment sheets need to indicate document issue status.

The Challenge Of ISO 14001 Standards

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The Challenge Of ISO 14001 Standards

The building blocks of an environmental management system is an understanding of aspects and impacts.

Implementing ISO 14001 begins with identifying how an organisation’s business activities impact on the

environment.

Many organisations believe they are already aware of the significant aspects and impacts of their operations.

The process of implementing ISO 14001 may uncover significant impacts not previously identified and allows

for a consistent approach to analysis.

Generally this analysis is done department by department or centre by centre.

It is best if it is a team approach that involves the employees who do the activity. An employee’s

familiarity with a task is essential for both the identification of the environmental impacts of business

activities and the determination or implementation of control measures.

An aspect is any element of an organisation’s activities, products or services that can interact with the

environment.

An impact is the change caused to the environment.

Impacts may occur during normal and abnormal operating conditions, such as accidents and emergencies.

Aspects can often be isolated by analysing the inputs and outputs of an activity.

EVALUATION OF IMPACTS

Once the impacts have been determined they have to be evaluated.

Criteria for evaluation include environmental concerns such as the severity of the impact, and business

concerns such as potential regulatory and legal exposure, the probability of the impact occurring, the

cost of changing the impact and effect on public image.

This type of evaluation highlights the significant impacts. These, in turn, determine the significant

aspects. Once the significant aspects have been determined, targets and objectives can be set.

ISO 9000 Softwares

2010-08-29T06:44:00.001-07:00

ISO 9000 Softwares

1. ISO 9000 Software – ISO 9000 Document Control Software

The concept of document control is integral to ISO 9000. Specifically ISO 9001: 2000, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.

For high-tech companies that adhere to ISO 14000 environmental management standards, document control procedures are equally necessary to help them continuously improve their environmental management system.

The ISO 9000 Document Control Software Provides:-

Tracking of Documents- Provides secure tracking of all your ISO 9000 Quality Manual, Operating Procedure & Forms & Documents in any format either in Microsoft Word, Excel, PDF or etc.
Efficiency Document Control- It’s uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.
Revision Control- Tracking of Document revisions, approval & Release Date. Manually Tracking down any revision on the ISO 9000 document activity is difficult . The ISO 9000 Document Control Software will help to keep track the numbers of revision have been carried out, and also maintain the various revision copies of the documents.
Multiple File Location – System will be able to keep track the directories & folder where the original location is saved.
Centralize Of Document Control – Do not worry about the various department is getting the correct edition of the documents, because all documents have been managed by a centralize software. Document reviews are conveniently scheduled and documented.
Security:System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
2. ISO 9000 Software – ISO 9000 Audit Control Software

The ISO 9000 Audit Control Software were designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.

The Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO9001:2000 internal /external audit system.

The ISO 9000 Audit Control Software Provides:-

Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security: System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
http://www.iso9000-software.com

ISO 9000 Standards – Quality Management Principles

2010-08-29T06:43:00.000-07:00

ISO 9000 Standards – Quality Management Principles
A quality management principle is defined by ISO/TC 176 as a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other interested parties. Eight principles have emerged as fundamental to the management of quality.

All the requirements of ISO 9001:2008 are related to one or more of these principles. These principles provide the reasons for the requirements and are thus very important. The quality management principles can be listed as below:

1. Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
The customer focus principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Communication with the customer
b. Care for customer property
c. The determination of customer needs and expectations
d. Appointment of a management representative
e. Management commitment

2. Leadership
Leaders establish unity of purpose and direction for the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
The leadership principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The setting of objectives and policies
b. Planning
c. Internal communication
d. Creating an effective work environment

3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
The involvement of people principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Participation in design reviews
b. Defining objectives, responsibilities and authority
c. Creating an environment in which people are motivated
d. Internal communication
e. Identifying competence needs

4. Process approach
A desired result is achieved more efficiently when related resources and activities are managed as a process.
The process approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The identity of processes
b. Defining process inputs and outputs
c. Providing the infrastructure, information and resources for processes to
function

5. System approach to management
This principle is expressed as follows:
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
The system approach principle is reflected in ISO 9001 through the requirements addressing:
a. Establishing, implementing and maintaining the management system
b. Interconnection, interrelation and sequence of processes
c. The links between processes
d. Establishing measurement processes

6. Continual improvement
This principle is expressed as follows:
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
The continual improvement principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Improvement processes
b. Identifying improvements
c. Reviewing documents and processes for opportunities for improvement

7. Factual approach to decision making
This principle is expressed as follows:
Effective decisions are based on the analysis of data and information.
The factual approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Reviews, measurements and monitoring to obtain facts
b. Control of measuring devices
c. Analysis to obtain facts from information
d. Records for documenting the facts
e. Approvals based on facts

8. Mutually beneficial supplier relationships
This principle is expressed as follows:
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
The mutually beneficial supplier relationships principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Control of suppliers
b. Evaluation of suppliers
c. Analysis and review of supplier data

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

2010-08-29T06:42:00.000-07:00

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

ISO 14001 Standard & Environmental Issues

2010-07-14T05:43:00.001-07:00

ISO 14001 Standard & Environmental Issues

ISO 14001 is a systematic tool that enables an organization in any market sector to focus on their situation, identify the relevant environmental issues and to lessen their impact to their benefit and the environment. It is part of a global response to the recognition that we are damaging the environment in which we all live. The cause and effect of the foremost world environmental issues, which are all due to mankind, are generally too vast and too intangible for us to grasp and so the slightly cliché expression ‘think global, act local’ is very relevant. Once the EMS is implemented and to become registered to ISO 14001, the external auditor will assess your EMS in two separate stages, on site. The first stage to understand your business activities and determine formal readiness for assessment and the second to check practical compliance with ISO 14001. After registration he will return at regular intervals every year to verify continual improvement and regulatory compliance, against your set objectives and your EMS. The external auditor should be seen as a wise friend, not a policeman. He should certainly explain his findings and assist the company to find ISO 14001 registration is not a cure for all environmental problems but I hope I’ve demonstrated that it is a worthwhile, if not essential business initiative that could enable your management to better manage your business, gain commercial advantage and minimize its environmental impact.

How to Get an ISO 14001 Accreditation

2010-07-14T05:42:00.001-07:00

About ISO 14001:2004 Standards

2010-07-14T05:40:00.000-07:00

About ISO 14001

The structure of ISO 14001 is very much like the ISO 9000, which is management standard, so these two standards can be implemented side by side to achieve the best results. As a part of the ISO 14000 family, which deals with different aspects of environmental issues, ISO 14001:2004 and ISO 14002 deal with environmental management system (EMS). ISO 14001 gives the requirements for the

EMS and ISO 14002 gives the basic guidelines for EMS.

Environmental Management System with ISO 14001:2004

The EMS, as per the requirements of the ISO 14001, enables the company, may it be of any size, location and income to:

It helps the company improve its environmental strategy and this positively affects their environmental performance.
It helps in identifying and controlling the environmental impact that the activities, services or products of the company might have.
And it helps in carrying out a systematic approach to set environmental targets and objectives, to achieve these and also to demonstrate that they have been achieved.

How does it work?

The ISO has various standards dealing with environmental issues. ISO 14001 deals with a framework provided for a strategic and holistic approach to the businesses environmental policy, actions and plans.
It gives the general requirements for the EMS.
This also states the reference to the communication requirements for the communication of the environmental management issues between the company, stakeholders, the public and the regulators.
As these standards are not company specific, any and every business can undertake them as long as they are dedicated to the continued and improved environmental performance and they have a commitment to comply with the set norms.

The new edition of ISO 9001 is an amendment and not a revision; in other words, the changes are very small. They are broadly as follows: - the user-f

2010-06-26T21:39:00.000-07:00

ISO 14001 Standard & Environmental Issues

ISO 14001 Standards Environmental Management System

2010-05-22T16:58:00.001-07:00

Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, SMEs can play their part in preserving our natural environment for our next generation.

Both individuals and businesses especially have a social and environmental responsibility to fulfil. With the rapid development in today’s industrialised world, the issue of preserving and managing our environment has become crucial. The increasing awareness of the importance of good environmental management systems is evidenced by the amendments made to the Environmental Quality Act 1974 and other environmental regulations which serve to ensure stricter compliance of environmental standards. Malaysia also adopted the National Environment Policy in 2002 as a means of addressing environmental issues in an integrated manner while more and more companies are striving to attain the MS14001 EMS certification.

WHAT SMEs CAN DO TO SAVE THE ENVIRONMENT
As responsible corporate citizens, SMEs have a major role to play in preserving the environment. For starters, they can help the Government to achieve its recycling goals, by creating mechanisms to facilitate the segregation of recyclable wastes and to ensure that these wastes are sent to the relevant parties instead of being dumped in landfills and illegal dumpsites. Furthermore, SMEs must also ensure that proper waste management systems are in place in conducting their day-to-day businesses.

Below are a few steps that SMEs can take to do their part for the environment:
• Dispose off company wastes properly and responsibly.
• Encourage employees to reuse items where possible, for example, printing on both sides of the paper, etc.
• Practise recycling in the office, by introducing a recycling programme. Among the items that can be recycled are papers, cardboards, glass, aluminium cans and scrap metals.
• Implementing an Environmental Management System (EMS).

WHAT IS AN ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)?
An EMS provides a framework for managing environmental practices that integrates with overall business goals in a systematic way. Various models can be applied to develop, implement and maintain an EMS. One of the more common models used by industries is the model described by the ISO 14001 standard which was developed by the International Organisation for Standardisation (ISO). The ISO 14001 standard EMS model focuses on continuous improvement through an on-going cycle of actions called the continual improvement cycle which incorporates the elements of planning, doing, checking and acting.

An EMS typically begins with a strong environmental policy which describes the organisation’s approach in managing its environmental affairs and reflects its commitment to protect the environment and human well-being. The environmental policy establishes the framework for environmental leadership and serves as a contract between an organisation’s employees and its stakeholders. As such, commitment and strong support from top management is essential in making an EMS a success. Developing the environmental policy also helps to lay the groundwork for the planning phase of the EMS cycle. It is in this stage that active management support is sought, a multi-disciplinary EMS implementation team is formed and an introduction meeting is held to brief employees on the implementation of EMS. On top of that, the scope and budget for the implementation of EMS is also pre-defined. In other words, it is important that management provides all the resources necessary for the successful implementation of EMS.

CURRENT ENVIRONMENTAL PRACTICES
It is evident that some SME has put in place various initiatives to preserve the environment while utilizing resources efficiently. These initiatives include the following:

1. Discouraging open burning in fields and plantation sites while encouraging the composting of felled trees and crops in an environmentally-friendly way which in turn prepares land for replanting by using natural fertilizer;
2. Discouraging the use of chlorofluorocarbons (CFCs) in various industrial, commercial and household appliances; and
3. Encouraging the recycling of resources for example, in the plastic manufacturing industry, materials are being regenerated through the forming process in an effort to reuse biodegradable products in an environmentally-friendly way.

WHAT IS WASTE MANAGEMENT?
Waste management involves collecting, transporting, processing, recycling and disposing waste materials, in an effort to reduce their adverse effects on human health and the environment. Waste materials include solid, liquid or gaseous substances. The implementation of waste management requires careful planning and also adequate financial resources and is the responsibility of all parties involved such as individuals, businesses and corporations, including SMEs.

INCENTIVES FOR ENVIRONMENTAL PROTECTION AND WASTE MANAGEMENT
In an effort to support an enhanced level of environmental pro activity, the government provides a range of fiscal activities which includes the Pioneer Status tax exemption and the Investment Tax Allowance for the manufacture of environmentally-friendly products, the provision and supply of environmentally-friendly services and specific activities which contribute towards the presentation of the environment. The said incentives are available for the following activities:

Storage, treatment and disposal of toxic and hazardous waste
Waste recycling activities which are high-tech in nature for instance, recycling agricultural wastes, chemicals and the production of reconstituted wood-based panel boards or other products
Energy-generating activities using biomass which are renewable and environmentally-friendly. Examples of biomass resources include palm oil mill waste, rice mill waste, sugar cane mill waste, timber/sawmill waste and paper recycling mill waste
Energy conservation services

Accelerated Capital Allowance with a special initial rate of 40% and an annual rate of 20% for total write-off within three years is given to organisations that are waste generators, for their capital expenditure on machinery and equipment incurred, to set up facilities to store, treat and dispose their waste. This incentive is also available to companies undertaking waste recycling activities.

ISO 14001 Template

2010-04-05T05:13:00.000-07:00

ISO 14001 Template

The ISO 14001Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.

The ISO 14001 Template features:-

• Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.
• Professional design and layout.
• It is designed to fulfill the ISO 14001 : 2004 requirements. .
• Easy to read, easy to understand, and easy to implement.
• Easy to audit as it follows the structure of ISO 14001: 2004..
• Includes the required Process Flowchart.

The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process. The ISO 14001 Environmental Management System (EMS) Template are consist of:

a. ISO 14001 EMS Manual Template
The Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative.
ISO 14001 Manual Template Consist of:
• Section 1: General EMS Requirement
• Section 2: Environment Policy – Objectives, Targets & Programmes
• Section 3: EMS Planning
• Section 4: Implementation & Operation
• Section 5: Checking & Monitoring
• Section 6: Management Review

b. ISO 14001 Operating Procedure
The ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation. The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 14001 : 2004.

ISO 14001 Operating Procedures Consist Of:
• Objective & Targets Procedure
• Environmental Management Program Procedure
• Environmental Aspect & Impact Identification & Evaluation Procedure
• Environmental Monitoring & Measuring Procedure
• Legal & Others Requirement & Evaluation Of Compliance Procedure
• Emergency Preparedness & Response Procedure
• Chemical Control Procedure
• Waste Management Procedure
• 5S House Keeping Procedure

c. ISO 14001 Forms
ISO 14001 Forms Consist Of :
• Environmental Non-Conformance Master List
• Environmental Non-Conformance Notice Form
• Environmental Management Program Form
• Environmental Aspect & Impact Identification Form
• Green Environment Internal Audit Master Plan
• Green Environment Plan & Activities Form
• Green Environment Material Purchase Master List
• ISO 14001:2004 Internal Audit Summary Report
• Equipment Monitoring Master List
• Environment Preventive Action Report (PAR) Master List
• Environment Preventive Action Report (PAR) Form.
• Environmental Responsible Form
• EMS Organization Chart.
• Waste Management Schedule Form
• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form

For more information, please visit us at:

http://www.e-wia.com

Evaluation of Compliance In ISO 14001 Standards

2010-01-18T03:08:00.000-08:00

Evaluation of Compliance In ISO 14001 Standards

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdictions approach to allowing a legal privilege for the self-assessment audit.
Evaluation vs. Audit The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

What is ISO 14000 Standards?

2009-12-29T14:59:00.000-08:00

What Is ISO 14000 Standards?

Save The Environment - Implement ISO 14001 Standards

2009-12-26T03:27:00.000-08:00

Save The Environment - Implement ISO 14001 Standards

Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, SMEs can play their part in preserving our natural environment for our next generation.

Both individuals and businesses especially have a social and environmental responsibility to fulfil. With the rapid development in todays industrialised world, the issue of preserving and managing our environment has become crucial. The increasing awareness of the importance of good environmental management systems is evidenced by the amendments made to the Environmental Quality Act 1974 and other environmental regulations which serve to ensure stricter compliance of environmental standards. Malaysia also adopted the National Environment Policy in 2002 as a means of addressing environmental issues in an integrated manner while more and more companies are striving to attain the MS14001 EMS certification.

WHAT SMEs CAN DO TO SAVE THE ENVIRONMENT
As responsible corporate citizens, SMEs have a major role to play in preserving the environment. For starters, they can help the Government to achieve its recycling goals, by creating mechanisms to facilitate the segregation of recyclable wastes and to ensure that these wastes are sent to the relevant parties instead of being dumped in landfills and illegal dumpsites. Furthermore, SMEs must also ensure that proper waste management systems are in place in conducting their day-to-day businesses.

Below are a few steps that SMEs can take to do their part for the environment:
• Dispose off company wastes properly and responsibly.
• Encourage employees to reuse items where possible, for example, printing on both sides of the paper, etc.
• Practise recycling in the office, by introducing a recycling programme. Among the items that can be recycled are papers, cardboards, glass, aluminium cans and scrap metals.
• Implementing an Environmental Management System (EMS).

WHAT IS AN ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)?
An EMS provides a framework for managing environmental practices that integrates with overall business goals in a systematic way. Various models can be applied to develop, implement and maintain an EMS. One of the more common models used by industries is the model described by the ISO 14001 standard which was developed by the International Organisation for Standardisation (ISO). The ISO 14001 standard EMS model focuses on continuous improvement through an on-going cycle of actions called the continual improvement cycle which incorporates the elements of planning, doing, checking and acting.

An EMS typically begins with a strong environmental policy which describes the organisations approach in managing its environmental affairs and reflects its commitment to protect the environment and human well-being. The environmental policy establishes the framework for environmental leadership and serves as a contract between an organisations employees and its stakeholders. As such, commitment and strong support from top management is essential in making an EMS a success. Developing the environmental policy also helps to lay the groundwork for the planning phase of the EMS cycle. It is in this stage that active management support is sought, a multi-disciplinary EMS implementation team is formed and an introduction meeting is held to brief employees on the implementation of EMS. On top of that, the scope and budget for the implementation of EMS is also pre-defined. In other words, it is important that management provides all the resources necessary for the successful implementation of EMS.

ISO 14001 Standards – Nonconformance, Corrective and Preventive Action

2009-11-26T15:47:00.000-08:00

ISO 14001 Standards - Nonconformance, Corrective and Preventive Action

ISO 14001:2004 Section 4.5.2, Nonconformance And Corrective Andrequires that organizations establish and maintain procedures that:

Preventive Action,

• Define responsibility and authority for handling and investigating nonconformance

• Take action to mitigate any impacts caused by nonconformance

• Initiate and complete the appropriate corrective and preventive action.

ISO 14001:2004 Section 4.5.2 also states that “…any corrective or preventive action taken to eliminate the causes of actual and potential nonconformances must be appropriate to the magnitude of problems and commensurate with the

environmental impact encountered.”

If any changes in the documented procedures result from any corrective and preventive action, you must implement and record these changes.

Nonconformance refers to any issues that do not meet or comply with the requirements established in the EMS or the ISO 14001 standard. Procedures developed under ISO Section 4.5.2 will provide the mechanism to handle

non-conformances and to ensure steps be taken to prevent a recurrence.

The procedures should include the following key steps:

1. Identify the problem

2. Determine the cause

3. Establish the solution

4. Document the solution

5. Implement the solution

6. Record the documentation and implementation of the solution

7. Communicate the solution.

The History Of ISO 14001 Environmental Management System

2009-11-20T22:44:00.001-08:00

The History Establishment Of ISO 14001 Environmental Management System

Environmental management began in earnest around 1970 as a direct result of environmental catastrophes and governmental reaction to those catastrophes. In many countries, environmental regulations that focus on control of environmentally damaging emissions to air, discharges to water, and disposal of hazardous wastes were instituted in an effort to prevent future environmental catastrophes and to limit toxic releases to the environment. Regulations, however, too often had the effect of placing a ceiling on environmental performance. Many industrial organizations, reacting negatively to governmental environmental regulations that
they view as being based on bad science, adding unnecessary costs, or making them uncompetitive in international markets, have restricted their environmental management efforts to complying with regulations and nothing morIn response, global institutions, recognizing the interconnected problems of persistent environmental degradation, growing economic divisions, and associated poverty and hunger, developed programs to begin to bring economic and social goals into balance with ecological and natural resource preservation. In 1992, the Global Environmental Summit, convened in Rio de Janeiro by the United Nations, brought representatives of 178 nations together to endorse Agenda 21: The Program of Action for Sustainable Development. Agenda 21 details the actions that are necessary on the part of organizations of all kinds if sustainability is to be achieved and collapse of economic, environmental, and social systems is to be avoided.
A second global summit, the World Summit on Sustainable Development (WSSD), was held in Johannesburg in Summer 2002. In tabulating the results since the Rio summit, the WSSD determined that all environmental trends had experienced further degradation and that the only sustainability gains to be reported were progress against infectious diseases, the global literacy rate, and the greater inclusion of women in society’s activities. The significance of Rio is that it marks the time when much of the world realized that we cannot continue on the same path we have been on. The significance of Johannesburg is the realization that, in spite of enormous effort on the part of many institutions, humankind is losing the battle for sustainability.
ISO 14001 is the EMS Specification developed by the international Organization for Standardization (ISO) of Geneva, Switzerland as a part of the ISO 14000 series ofenvironmental management documents. It was issued as both an International and American National Standard in September 1996. The Second Edition of ISO 14001, ISO 14001:2004, was issued as an International Standard on November 15, 2004 and subsequently as an American National Standard.
ISO 14001 establishes a framework for the conduct of environmental management by requiring the organization to define an Environmental Policy and establish sixteen management procedures that support the policy. Many of the ISO 14001 procedures already exist in some form within organizations and only require modification to meet the requirements of ISO 14001. Other procedures have to be added in their entirety. All of the ISO 14001 procedures represent best management practices as defined by a consensus of the representatives of more than 50 national standards bodies and Non-Governmental Organizations (NGOs) who participated in the development of ISO 14001:1996 from early 1993 through July 1, 1995 and in
the development of the Second Edition from early 2002 until mid-2004.

ISO 14001 Standards Audit

2009-11-11T02:19:00.000-08:00

ISO 14001:2004 emphasizes the continuous improvement of an environmental management system (EMS). The standard specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and information about significant environmental aspects. The certification process ensures the conformance of your EMS against the international standard, as well as any organizational specific requirements that have been identified.

The ISO 14001 Standards audit consist of 2 stage registration audit process followed by surveillanceaudits, and ultimately a recertification audit. ISO 14001 Audits include on-site assessments of documents, data, records, activity and personnel. Process audit trails are followed by interviews of personnel responsible for the tasks and reviewing associated activity and records of occurrence. The audit trail will follow interactions between processes as well as the details of the process itself. Following are the stages of the audit process.

Pre-assessmentRegistration Audit – Stage 2Audit Findings• A review of action taken on nonconformities identified during the previous audit• A review of the continued effectiveness of the management system in its entiretyThe continued applicability to the scope of registration

The pre-assessment audit is an optional activity, outside of the registration process, it is highly encourages that any organization to undertake to evaluate the readiness to undergo the two stage registration process. That would optimally occur prior to the stage 1 and 2 audits.

Unlike the Stage 1 and Stage 2 activities you have full discretion as to which areas the preassessment should focus on and for the length of the pre-assessment. This activity allows your organization to become familiar with the audit process and helps prepare your employees for the registration assessment.

The auditor conducting the pre-assessment will typically return to the organization for the assessment. Similar to a ‘true’ audit, the end result of the pre-assessment will be a documented report identifying findings observed during the audit and a closing meeting to discuss the issues.

The pre-assessment activity allows you to correct any issues prior to beginning the registration process.

Assessment

New requirements for certification bodies have changed the registration process. Registration is now conducted in two distinct visits- Stage One and Stage Two- each of which has defined requirements that are outlined below.

Registration Audit – Stage 1

The stage 1 audit, conducted at your facility, is primarily performed for planning and determining the readiness of an organization to undergo a stage 2 registration audit. It also facilitates communicating any needs and expectations to the organization. Activities performed at a stage 1 audit include:

• Conducting a documentation review – This review determines if the organization’s EMS documentation adequately covers all the requirements of the ISO standard

• A review of the aspects and impacts and their significance and an evaluation of the facility(s) site specific conditions

• A review of your organizations non-conformance, preventive and corrective action system • An overview of applicable regulations

• Interviewing your organization’s personnel to assess their general readiness to undertake a stage 2 audit

• Confirming the applicability of the scope of the organization’s EMS

• Obtaining evidence that internal audits and management reviews are being planned and performed

• Providing focus for the planning of the stage 2 audit

If during the stage 1 audit any nonconformities are identified, the auditor will request a corrective action response (see Corrective Action Response).

The objective of the Stage 2 on-site audit is to assess your organizations’ adherence to your own policies, objectives, and procedures and to ascertain conformance to the requirements of the ISO 14001 standard. To accomplish this, the audit will address the implementation of all the elements of the standard. Review of documentation and records to support the implementation is an expected part of the assessment process. If non-conformances or opportunities for improvement are identified they will be documented in a report which will be presented to the organization during the closing meeting. The report will include the auditor’s recommendation regarding registration.

Any deviation from procedures or requirements of the standard will be identified as an audit finding, which will be documented in the audit report. The auditor will draw your attention to non-conformities as they arise so there will be no “surprises” at the closing meeting. Findings are categorized into three categories defined as follows:

• A major non-conformity relates to the absence or total breakdown of a required process or a number of minor non-conformities listed against similar areas. A major non-conformity at the Registration Audit – Stage 2 would defer recommendation for registration until that major has been closed.

• A minor non-conformity is an observed lapse in your systems ability to meet the requirements of the standard or your internal systems, while the overall process remains in tact.

• An observation or opportunity for improvement relates to a matter about which the Auditor is concerned but which cannot be clearly stated as a non-conformity. Observations also indicate trends which may result in a future non-conformity.

Corrective Action Response

ISO 14001 Standards requires corrective action responses from all Registration Audits. Once certification is achieved, dependant upon the extent and nature of the findings, your organization may be required to submit a corrective action plan, detailing your intent to correct the non conformity.

The auditor may also recommend that your organization submit objective evidence to support the to verify closure may be required.

It is recommended that all non-conformities are addressed within your internal corrective action system. Typically, opportunities for improvement would be addressed as preventive actions by your organization.

closure of the finding. In certain circumstances such as a major non conformity an on site activity

Surveillance Audits

Company shall conduct Surveillance Audits on an annual or semi-annual basis. The purpose of the Surveillance Audit is to ensure that the EMS continues to conform to both the organizations’ and the ISO 14001 requirements. Certain processes will be reviewed at each surveillance including:

• Internal audits and management review

• Customer and interested parties communications

• Effectiveness of the management system in achieving defined objectives

• The progress of planned continual improvement activities

• Continuing operational control

• A review of any changes made by the organization which may have impact on the registration

• Use of accreditation and certification body logos provided to the organization upon registration

• objectives, targets and programs

• evaluation of compliance

Re-assessment Audits

The accreditation body requires that a recertification audit be carried out every three years. The purpose of the recertification audit is to confirm the continued conformity and effectiveness of the management system as a whole, and its continued relevance and applicability for the scope of activity.

Recertification audits review the performance of the EMS over the registration period, and include a review of previous surveillance audit records. The recertification audit includes the following:

• The continued relevancy of the organization’s policy and objectives

• The continued effective interaction between the processes of the management system

• A review of internal audits, management reviews, document changes during this certification period

Subscribe For Free ISO 14001 Standards E-Books

2009-11-03T05:38:00.000-08:00

SUMMARY OF CHANGES TO ISO 14001:2004

2009-10-08T08:34:00.000-07:00

SUMMARY OF CHANGES TO ISO 14001:2004
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.

Change In ISO 14001:2004 – Documentation

2009-10-08T08:33:00.000-07:00

Change In ISO 14001:2004 – Documentation
This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:
• the environmental policy,
• objectives and targets,
• a description of the scope of the EMS,
• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records
• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
The revised standard requires documents required by the EMS and the standard to be controlled documents.
Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.

ISO 14001:2004 Evaluation of compliance

2009-10-08T08:32:00.000-07:00

ISO 14001:2004 Evaluation of compliance
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004 includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.

ISO 14001 Standards – Complying with Environmental Laws and Regulations

2009-10-08T08:31:00.001-07:00

One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.

ISO 9001 & ISO 14001 Blog

2009-09-30T06:49:00.000-07:00

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/

ISO 9000 and ISO 14000 in plain language

2009-09-30T05:33:00.000-07:00

Both “ISO 9000” and “ISO 14000” are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management systemconforms to the standard).
ISO 9000 is primarily concerned with “quality management“. In the everyday context, like “beauty”, everyone may have his or her idea of what “quality” is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. “Quality management” means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulationsapplicable to those products or services.
ISO 14000 is primarily concerned with “environmental management”. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products – at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer’s quality requirements. In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization’s activities on the environment (ISO 14000). In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.

Costs Of Setting Up A Quality Management System

2009-09-30T05:32:00.001-07:00

Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

2009-09-30T05:31:00.001-07:00

ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us

ISO 9001 Standards – Documented Procedures

2009-09-30T05:30:00.001-07:00

ISO 9001 Standards – Documented Procedures

The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.
ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:

(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.
Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.
Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.
Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.
Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.
There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.
Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System

2009-09-30T05:29:00.000-07:00

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages

ISO 9001 Standards New Blogs

2009-09-30T05:28:00.000-07:00

Implementing A Quality Management System

2009-09-16T15:42:00.000-07:00

Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 14001:2004 Standards Contents

2009-09-16T15:41:00.000-07:00

ISO 14001:2004 Standards
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

Five Steps to Implementing ISO 14001:2004

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ISO 14001 provides a logical, common-sense approach for
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.

Evaluation Of Compliance Of ISO 14001 EMS

2009-09-04T05:38:00.000-07:00

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.
Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

REQUIREMENTS OF ISO 14001

2009-09-04T05:37:00.000-07:00

REQUIREMENTS OF ISO 14001In order to effectively implement and benefit from an ISO 14001 EMS, it is important tohave an understanding of the standard’s requirements. A quick review of the standardshows that it is structured following the Plan, Do, Check, Improve philosophy of theTotal Quality Management movement, as follows:
PLAN4.2 Policy4.3 Planning
DO4.4 Implementation and Operation
CHECK4.5 Checking and Corrective Action
IMPROVE4.6 Management Review
Within these five elements are 17 sub-elements stating the various requirements.
4.2 Policy
4.3 Planning4.3.1 Environmental Aspects4.3.2 Legal and Other Requirements4.3.3 Objectives and Targets4.4.4 Environmental Management Programs
4.4 Implementation and Operation4.4.1 Structure and Responsibility4.4.2 Training Awareness and Competence4.4.3 Communications4.4.4 EMS Documentation4.4.5 Document Control4.4.6 Operation Control4.4.7 Emergency Planning and Response
4.5 Checking and Corrective Action4.5.1 Monitoring and Measurement4.5.2 Nonconformance, Corrective, and Preventive Action4.5.3 Records4.5.4 EMS Audit
4.6 Management Review
Within these 17 sub-elements are all of the requirements, or “shalls”, necessary toconform to ISO 14001. There is no substitute for reading the standard in terms ofrecognizing the requirements. As a matter of fact, no auditor should embark on an auditwithout having easily available the criteria to which they are doing the audit. However,below we briefly summarize the key points of the sub-elements. This summary is notintended to be a replacement for ISO 14001, and should not be used exclusively as suchduring an audit.
Detailed Section by Section Summary4.2 PolicyISO 14001 requires that the organization have a policy statement to drive the EMS.These tend to be short, one page or less documents, and simply affirm the commitments.There is no expectation that specific details be noted in the policy. For example, thecommitment to pollution prevention can simply be stated saying, “we are committed toprevention of pollution”. The policy must be clearly endorsed by top management andbe available to the public and employees. Although the availability to the public can berather passive; i.e. “is here if they want it”, there is an expectation that the employeeawareness is more proactive. Section 4.2 of ISO 14001 lists the other requirements of thepolicy.
4.3.1 Environmental AspectsThis element requires a procedure that not only identifies the aspects and impacts, butalso provides for determination of significance, and keeping the information up to date.ISO 14001 does not prescribe what aspects should be significant, or even how todetermine significance. However, it is expected the organization will develop aconsistent and verifiable process to do so.
4.3.2 Legal and Other RequirementsThis is a requirement for a procedure that explains how the organization obtainsinformation regarding its legal and other requirements, and makes that informationknown to key functions. This is not the assessment or compliance audit requirement, butrather a more up front determination of requirements.
4.3.3 Objectives and TargetsThere is no requirement for a procedure in this element, only that objectives and targetsbe documented. It does require that certain items be considered in developing theobjectives, such as legal requirements and prevention of pollution. It is sometimeseasiest to develop a procedure anyway for this element to be able to verify theseconsiderations were made.
4.3.4 Environmental Management Programs (EMP)EMPs are the detailed plans and programs explaining how the objectives and targets willbe accomplished. These EMPs usually note responsible personnel, milestones and dates,and measurements of success. Noting monitoring and measurement parameters directlyin the EMP facilitates conforming to 4.5.1 on Monitoring and Measurement discussedbelow.
4.4.1 Structure and ResponsibilityISO 14001 requires that the relevant management and accountability structure be definedin this element. This usually takes the form of an organizational chart. Also, theorganization must denote the Management Representative who is responsible to overseethe EMS and report to management on its operation.
4.4.2 Training Awareness and CompetenceThe key point in this element is that personnel must receive applicable training regardingthe EMS. Specific requirements are itemized in ISO 14001, and include general,company-wide items such as knowing the policy, to more function-specific training onaspects and emergency response. An organization usually responds to this element with atraining matrix, cross-referencing to training materials and records.
4.4.3 CommunicationsProcedures are required for both internal and external communications. Note that ISO14001 only requires procedures, and allows the organization to decide for itself thedegree of openness and disclosure of information. Whatever the decision in terms ofdisclosure, that decision process must be recorded.
4.4.4 EMS DocumentationThis requirement is simply that the organization has documented the system in eitherelectronic or paper form such that it addresses the elements of the standard and providesdirection to related documentation. Not all ISO 14001-required procedures need to bedocumented, as long as the system requirements can be verified.
4.4.5 Document Control.Procedures are required to control documents, such as system procedures and workinstructions, and to ensure that current versions are distributed and obsolete versions areremoved from the system.
4.4.6 Operational ControlThis element is the one which connects the EMS with the organization as a whole. Here,the critical functions related to significant aspects and objectives and targets are identifiedand procedures and work instructions created to ensure proper execution of activities.Requirements for communicating applicable system requirements to contractors are alsoaddressed.
4.4.7 Emergency Planning and ResponseAlthough typically addressed through conventional emergency response plans, thiselement also requires that a process exist for identifying the potential emergencies, inaddition to planning and mitigating them. A linkage to the aspects analysis, whereimpacts are assessed, is appropriate. Emergency incidents include those that may not beregulated, but may still cause significant impact as defined by the organization.
4.5.1 Monitoring and MeasurementProcedures are required describing how the organization will monitor and measure keyparameters of operations. These parameters relate to the significant aspects, objectivesand targets and legal and regulatory compliance. In order to properly manage the system,measurements must be taken of its performance to provide data for action. Responses tothis element usually cross reference to many other specific procedures and workinstructions describing measurement and equipment calibration. It is in this element thatwe find the requirement for what is commonly referred to as a compliance audit.
4.5.2 Nonconformance, Corrective, and Preventive ActionThis element requires procedures for acting on Non-conformances identified in the system,including corrective and preventive action. Non-conformances may be identified throughaudits, monitoring and measurement, and communications. The intent is to correct thesystem flaws. Typically, Corrective Action Report (CAR) forms are the norm, noting thenonconformance, the suggested fix, and closure of the action when completed. Note thatthis requirement does not imply in any way that the party identifying the nonconformancemust be the one to suggest the fix. Instead, it is expected that the system provide for theinformation to be routed to the most appropriate party to address the concern.
4.5.3 RecordsRecords are expected to exist to serve as verification of the system operating. Forexample, records include audit reports and training records. Unlike controlleddocuments, records are “once and done” documents, resulting from the execution of someprocess or procedure. Procedures in this element are required for the maintenance ofrecords.
4.5.4 EMS AuditsISO 14001 requires that the system provide for internal audits. This procedures(s) willinclude methodologies, schedules, and processes to conduct the audits. Interestingly, theEMS audit will in essence, audit the audit process itself!
4.6 Management ReviewThis element requires that periodically, top management will review the EMS to ensure itis operating as planned. If not, resources must be provided for corrective action. Forareas where there are no problems, the expectation is that with time, management willprovide for improvement programs. Usually there is no detailed procedure for thiselement, although records of agendas, attendance, and agreed upon action items aremaintained as verification.

Introduction to ISO Certification

2009-09-04T05:35:00.000-07:00

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Business benefits of ISO 14000

2009-09-04T05:34:00.000-07:00

Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

Requirements for Product Environmental Quality Assurance

2009-09-04T05:33:00.000-07:00

All Mandatory Requirements for Product Environmental Quality Assurance need to be carried out in the following manner1. Establish a system that meets all requirements2. Ensure the system is stable and efficient.3. Document the processes and procedures4. Keep records of the system’s performance.
The assigned management of the supplier shall establish a system to prevent BannedSubstances from being used in the products and packaging.(1) To determine policies and methods for ensuring Product Environment Quality.(2) To assign a person to be in charge of managing Product Environment Quality(“Product Environmental Quality Management Representative”)(3) To establish an organization in managing Product Environment Quality,determine responsibilities, authorities, roles of each department and familiarize allmembers in each department with the importance of Product Environment Quality.(4) To establish a “Cadmium-Free Factory”(5) To review the adequacy and efficiency of the system.
Maintenance of the SystemThe supplier shall maintain the system in a condition to be able to respond to therequests for Product Environment Quality and instruction letters to suppliers),ensure the system is properly functioning.(1) Plan and carry out an internal audit at least once a year.(2) When Non-conforming Products or defects are found in the system, the suppliershall conduct an internal audit immediately.(3) The assigned management for Product Environment Products at the suppliershall revise the system according to the results of the internal audit if necessary.
Documents, Data and RecordsThe supplier should manage documents, verification data related to ProductEnvironment Quality.(1) Keep documents, verification data for three years or longer, if required by law.(2) Provide documents and verification data when requested.(3) Review the documents regularly and keep them updated instructions
Selection of Materials and PartsThe supplier has to comply with the following request when selecting material and parts.(1) “No Use of Banned Substances Allowed” (or equal) must be mentioned in allrelevant documents (specifications, blueprints, purchase orders, etc)(2) Materials must not contain any Banned Substances.(3) Only purchase Designated Raw Materials from Green Partners.

What is ISO 14000?

2009-08-30T05:52:00.000-07:00

ISO 14000 is a series of international standards that have been developed to incorporate environmental aspects into business operations and product standards. ISO 14001 is a specific standard in the series for a management system that incorporates a set of interrelated elements designed to minimize an organization’s impact on the environment. Similar to the ISO 9001 Quality Management System (QMS), ISO 14001 defines the implementation of an Environmental Management System (EMS). In addition, ISO14001 incorporates the QMS ISO 9001 management system philosophy, terminology, and requirement structure, providing system compatibility.
What Does ISO 14001 Require?
Originally issued in 1996 and later revised in 2004, the ISO 14001 EMS standard is intended to address the identification, evaluation, and continual improvement of an organization’s activities, products, or services that interact with the environment. The ISO 14001 methodology is a systematic approach for continually improving environmental management through identification and evaluation of aspects and impacts, development of objectives and measurable targets, implementation of programs, and on-going monitoring and review.

Understanding the ISO 14001 Standard

2009-08-30T05:51:00.002-07:00

ISO 14001 is an international voluntary standard that specifies the minimum elements for an environmental management system. It was published in 1996 by the International Organization for Standardization and is being taken up by organizations throughout the world at varying speeds.
The above is accepted as true by most people who are aware of the standard. Beyond these simple facts, however, there are many misconceptions about ISO 14001. For instance:
ISO 14001 will be a requirement for all companies.As with ISO 9000, conformance to ISO 14001 may become a condition of doing business in certain countries, regions or markets. This process already has begun in some industrial sectors, such as the automotive and electronics markets. However, there are still a tremendous number of companies in business today that do not conform to ISO 9000, even though that standard is now 13 years old. Thus it is too early to tell how widely ISO 14001 will be required in the future.
Implementing ISO 14001 means getting a registration.Many suppliers choose to demonstrate conformance to ISO 14001 through third-party certification. Some customers may require this. However, the standard itself considers a company’s self-declaration of conformance as an acceptable alternative. Further, some companies simply use the ISO 14001 model for internal purposes as a means to enhance their environmental performance.
ISO 14001 is just paperwork and won’t really help my company.ISO 14001 is like many things in life – you get out of it what you put into it. The way a company implements the standard determines what benefits it receives. Many companies that have implemented ISO 14001 report a variety of benefits, including improved environmental performance, greater operating efficiency, cost reduction, improved employee awareness and enhanced public image, among others.
Implementing ISO 14001 means throwing out our current environmental programs.ISO 14001 criteria specify “what to do,” not “how to do it.” Implementation approaches vary widely. There is no reason to think that your existing approach to environmental management must be put aside to satisfy ISO 14001.

ISO 14001:2004 Document Control System

2009-08-30T05:51:00.001-07:00

Documents required by the environmental management system and by this international standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in 4.5.4 (Control of Records).
The organization shall establish, implement, and maintain a procedure(s) to
a) approve documents for adequacy prior to issue;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revision status of documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and
g) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose. [ISO 14001, 4.4.5]
http://www.iso-consults.com
http://www.e-wia.com

Conducting An Initial Environmental Review For EMS

2009-08-29T15:50:00.000-07:00

Conducting An Initial Environmental Review in ISO 14001 EMS

An initial environmental review covers all the aspects of an EMS. As a result of this review the organization knows its strengths and weaknesses, risks and opportunities regarding the current status of its EMS. The gap between the requirements of the EMS standard and the actual status of the organization shows which aspects the organization should focus its efforts on to improve the system. This leads directly to the development of an environmental management program that should fill the gaps.The Environmental review should focus on three key areas:- Examination of existing environmental management practices and procedures- Identification of significant environmental impacts and their priority- Identification of legal and regulatory requirements1. Examination of Existing Environmental Management Practices andProceduresThe methodology for assessing existing environmental management practices and procedures is proposed here using a questionnaire. The review team fills out this questionnaire by interviewing appropriate people, by analyzing existing documents and procedures dealing with environmental issues and by collecting information about environmental aspects of the organization’s operations, products and services.By conducting the initial environmental review, an organization-specific profile of strengths and weaknesses can be drawn up. Because the score in each EMS area shows the effort needed in terms of financial and human resources,the organization knows where to focus its efforts when building up an EMS and where the largest effort is needed.
2. Identification of Significant Environmental Aspects and their PriorityAn environmental policy requires top management to set priorities regarding environmental aspects. An initial review clearly shows where to set priorities regarding the EMS itself. But, it does not help to set priorities among different environmental problems. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Eenvironmental activism?E often containing many isolated activities, but no clear direction. One way to solve this problem is to develop a so called ?Environmental exposure portfolio?EThe first step of this portfolio analysis is to assess the exposure and therefore the importance of different environmental aspects for an organization’s overall performance.The appropriate perspective and priorities of the environmental policy will differ depending on this preliminary analysis. The analysis should be conducted from the perspective of the stakeholders of the organization, their needs and their importance for the success of the organization. The degree of exposure to different environmental aspects should guide the involvement and perspective of an organization when implementing an EMS. Evaluating exposure to environmental aspects is important, because this exposure is likely to influence the organization’s success sooner or later, either through new legislation, public or consumer perception and behavior or otherwise.The analysis of the expected exposure of an organization to different environmental problems and the weight given to these aspects by various stakeholders enables management to focus on environmental issues that are a high priority to the organization. This is represented in the quadrant in the upper right corner of the environmental exposure portfolio. However, the two quadrants on the left must also be observed, although less vigorously. Issues with low public priority, to which the firm contributes heavily become a problem as soon as the perception of the stakeholders and the public environmental policy changes (the quadrant in the upper left corner of the portfolio). That this can happen very rapidly is obvious, for example from Shell`s ?Brent Spar?Edumping case (detailed information about this case is available from Shell or Greenpeace at their respective WWW-sites). Investments in new production technology, products and services can increase the environmental impact of the organization when not anticipated early enough. In this case, a problem ranked in the lower right corner of the portfolio would shift to the field with the highest priority. Problems ranked in the lower left corner are of no priority. No measures should be taken here.
3. Identification of Legal and Regulatory RequirementsThe identification of legal and regulatory requirements assesses two levels of an organization:- production-related environmental regulations- product- and service-related environmental regulationsThe former addresses the production department while the latter addresses the marketingand R&D departments. Basically, three questions must be answered:- Which are the relevant environmental regulations? (= target)- Is the current situation in the organization known? (= actual)- Does the organization comply with relevant regulations? (=gap)The methodology used here is a questionnaire. To obtain information about environmental regulations the following information sources can be used:- governmental authorities- industry associations- daily newspaper- university publications (law departments)

Evaluation Of Compliance Of ISO 14001 EMS

2009-08-28T06:03:00.000-07:00

Evaluation Of Compliance Of ISO 14001 EMS

2009-08-28T05:54:00.000-07:00

Evaluation Of Compliance Of ISO 14001 EMS

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.
Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

Understanding the ISO 14001 Standard

2009-08-26T17:44:00.000-07:00

The above is accepted as true by most people who are aware of the standard. Beyond these simple facts, however, there are many misconceptions about ISO 14001. For instance:

ISO 14001 will be a requirement for all companies.
As with ISO 9000, conformance to ISO 14001 may become a condition of doing business in certain countries, regions or markets. This process already has begun in some industrial sectors, such as the automotive and electronics markets. However, there are still a tremendous number of companies in business today that do not conform to ISO 9000, even though that standard is now 13 years old. Thus it is too early to tell how widely ISO 14001 will be required in the future.

Implementing ISO 14001 means getting a registration.
Many suppliers choose to demonstrate conformance to ISO 14001 through third-party certification. Some customers may require this. However, the standard itself considers a company’s self-declaration of conformance as an acceptable alternative. Further, some companies simply use the ISO 14001 model for internal purposes as a means to enhance their environmental performance.

ISO 14001 is just paperwork and won’t really help my company.
ISO 14001 is like many things in life – you get out of it what you put into it. The way a company implements the standard determines what benefits it receives. Many companies that have implemented ISO 14001 report a variety of benefits, including improved environmental performance, greater operating efficiency, cost reduction, improved employee awareness and enhanced public image, among others.

Implementing ISO 14001 means throwing out our current environmental programs.
ISO 14001 criteria specify “what to do,” not “how to do it.” Implementation approaches vary widely. There is no reason to think that your existing approach to environmental management must be put aside to satisfy ISO 14001.

Commitment and Environmental Policy

2009-08-24T07:11:00.000-07:00

An environmental policy is a statement of the organization’s overall aims and principles ofaction with respect to the environment, including compliance with all relevant stakeholders. As such, it should be written clearly and concisely to enable a
regulatory requirements. It is a key tool in communicating the environmental priorities of your organization to employees at all levels, as well as to external layperson to understand it, and should be made publicly available. It is up to the organization to decide on environmental priorities based on an initial environmental review, but these choices should be justified in the policy. To be truly effective the policy should regularly be reviewed and revised and incorporated into the organization’s overall corporate policy. The policy statement should set in writing a few achievable quantifiable priorities related to the environmental management system and the significant environmental effects found at the work-site. Furthermore, EMAS requires that the most signifcant environmental effects be mitigated within three years. Some form of improvement must also be accomplished from year-to-year by the organization and must be shown in the annual reports.

Although the formulation of policies and clear priorities is the most important step of
environmental management, this step is often neglected. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Environmental activism?E often containing many isolated activities but no clear direction. For an organization to be a credible and efficient environmental performer and to reap the benefits of being an environmental leader in its markets, the rationale for investing in environmental management must be very clear.

To ensure an organization’s commitment towards a formulated environmental policy, it is
essential that top management is involved in the process of formulating the policy and of setting priorities. Therefore the first step is to get the commitment from the highest level of management. Based on this commitment the organization should then conduct an initial environmental review and draft an environmental policy. This draft should be discussed and approved by the board of directors. Finally, the approved environmental policy statement must be communicated internally and made available to the public.

As the environmental policy establishes an overall sense of direction and sets the principles
of action for an organization, it requires commitment from the highest level of management. Top management should be involved in the development and adoption of an environmental policy.

Getting the commitment from the highest level should be argued on the basis of costs and the implementation of an EMS increases shareholder value it is easier for top
benefits and their impact on shareholder value. If management to commit themselves to approving an environmental policy and to implementing an environmental management system. This commitment includes three basic policy statements:
Continuous improvement in environmental performance
Compliance with environmental regulations

Maintaining public relations regarding environmental issues of the organization, its activities, products and services.

The central focus of the policy should be a commitment to continuous improvement. This

means improvement in the EMS itself and a decrease in environmental impacts caused by an organization’s activities, products and services. It is important for businesses to show improvement over time, both in environmental performance and in organizational commitment to this path.

A commitment to comply with at least local environmental regulations is a minimum
requirement for all of the environmental standards. However, multinationals operating in various environments and facing different laws in each, should think about which laws to abide by and if it is feasible to adopt the same standard worldwide. Generally, laws in newly industrializing countries are lax as compared to industrialized countries. However, given the increase in interest in environmental issues in these industrializing countries and the possible impact of the ISO 14000 series, it may be sound practice to adopt the more stringent laws in worldwide operations, where it is feasible to do so. In addition, the adoption of high standards worldwide can yield other benefits, such as an improved public image or easier technology transfer between different sites.

Companies should guard against going overboard in fulfilling environmental policies. Limits
are in fact set on how far a company has to go to reduce its environmental impacts. Reductions do not have to exceed levels which can be achieved by economically viable application of the best available technology (BAT).

ISO 14000 – Environmental Program Management

2009-08-22T16:09:00.000-07:00

The ISO 14000 series of standards has
received widespread attention, and, like ISO 9000, it is becoming a requirementfor domestic and global organizations.
This document is intended to provide a
baseline understanding of the ISO 14000 standards and to discuss the current status of this important standard.
The International Organization for Geneva, Switzerland, is composed of 92 European Union (EU) to establish universal quality standards. Over time, ISO
Standardization (IOS), headquartered in member countries. Adherance to standards developed by the IOS is voluntary. However, countries and industries may adopt the IOS standards. Until approximately 15 years ago, IOS focused on traditional standards-setting activities. In 1987, IOS published the ISO 9000 series standards that were used with the 9000 became recognized as a positive indicator of quality and a prerequisite to establishing/maintaining business relationships within and outside the European Union.
In the United States, both the American
National Standards Institute and the American Society of Quality Control are privately funded organizations that have adopted ISO 9000, Quality Management, and the ISO 14000 standards.
ISO 14000 is the generic title given to 14040, ISO 14041, and ISO14050 have
the 14000 series of standards. ISO 14001, ISO 14004, ISO 14010, ISO 14011, ISO 14012, ISO 14020, ISO been published as international standards. The ISO 14000 series of standards consists of the following 18 subjects that can be grouped under two major headings:
14001 Specification with Guidance for Use
14004 General Guidelines on Principles,
14010 General Principles of Environmental Auditing
14011 Audit Procedures
14012 Environmental Auditing ? Qualification Criteria
14015 Environmental Site Assessments
14031 Evaluation of Environmental Performance ? Guidelines
14032 Evaluation of Environmental Performance ? Case Studies
14020 Goals and Principles of All Environmental Labeling
14021 Environmental Labels and Declarations ? Terms and Definitions
14024 Environmental Labels and
14025 Type III Labeling
14040 Life Cycle Assessment ? Principles and Framework
14041 Life Cycle Assessment ? Inventory Analysis
14042 Life Cycle Assessment ? ImpactAssessment
14043 Life Cycle Assessment ? Interpretation
14048 Life Cycle Indicator Format
14050 Guide on the Principles of Terminology Work

At the current time, the ISO 14000 as International Standards are referred to
Standards that have not been published as Draft International Standards (DIS). Most DIS are in the final review period before publication. If a particular standard is of interest and is not final, a copy of the DIS may be available for review.

Environmental Aspects (ISO 14001:2004, 4.3.1)

2009-08-13T08:22:00.000-07:00

The requirement of ?4.3.1 of ISO 14001 is to establish and maintain procedures 1) for identifying the environmental aspects of the organization’s activities, products, and services that it can control and those that it can influence and 2) for determining which of those aspects have or can have a significant impact on the environment. Understanding the requirement of this element of ISO 14001 is central to understanding the concept of an environmental management system.
1 .A single manufacturing facility has potentially hundreds of environmental aspects. How far must it go in identifying its environmental aspects to satisfy the terms of the requirement? ISO 14001 specifies that the organization is to identify those aspects that it can control and those that it can influence and that it must also take into account planned or new developments and new or modified activities, products, and services. These stipulations in the requirements, without actually drawing boundaries on how far the organization must go in identifying environmental aspects, at least establish some categories of aspect that must be considered. Beyond this principle, each organization must identify its aspects comprehensively enough so as to not fail to identify a significant aspect or a legal requirement. An objection to comprehensive identification of aspects is that the organization may become so immersed in aspects identification that it loses sight of the end objective of the procedure, which is to determine significance.
2. Significant impact is not a stand-alone term in ?4.3.1.
It is accompanied by the phrase impact on the environment_ and environment_ is a defined term (see definition of environment, ?3.5). Significant aspects, then, are those environmental aspects that have or can have significant impacts on air, water, land, natural resources, flora, fauna, and humans. The organization determines, using its own criteria, what magnitude of impact on these seven environmental receptors constitutes a significant impact. Whether an aspect is regulated is not intended to be a factor in determining significance.
3. Proper execution of the environmental aspects procedure is important, in part, because it lifts environmental management out of the regulatory compliance mode and into the mode of systematically identifying environmental aspects and impacts and considering their consequences for the environment, irrespective of regulation. The organization that rigorously applies the environmental aspects procedure discovers many opportunities to improve environmental performance that regulation does not address, including:
• Use of energy
• Consumption of materials
• Environmental impacts of employee activities
•Environmental impacts of products and by-products post-manufacture, including distribution, use, reuse, and disposal
• Environmental impacts of services
• Unregulated waste streams such as carbon dioxide
Aspects vs. Impacts – Environmental aspects and environmental impacts differ by definition from one another in that an aspect is an element of an organization’s activities, products or services that can interact (emphasis added) with the environment_ while an impact is any change (emphasis added) to the environment_ resulting from an organization’s environmental aspects._ An aspect, then, is a precursor to an impact and an impact occurs when the aspect interacts with and changes the environment.
When identifying its aspects and impacts, the organization may find that there are more than one potential impacts associated with any given aspect. For example, an environmental aspect of a coal-fired power generation facility is stack emissions containing sulfur dioxide, nitrogen oxides, mercury, and carbon. These emissions change the environment and become impacts by contaminating plants, soil, and surface waters; contributing to the formation of ground-level ozone; causing or exacerbating heart and lung disease in humans; entering the aquatic food chain and impairing reproductive, immune, and endocrine systems; and contributing to the increase in atmospheric carbon dioxide leading to global warming. One aspect, stack emissions, then can generate at least five impacts.
Other organizations, applying benefit/cost analyses to their corrective actions, may discover that creation of a beneficial impact provides a greater environmental benefit than elimination of an adverse impact.
The introduction of the beneficial environmental impact concept into the ISO 14001 Terms and Definitions suggests that it was considered by some of the ISO 14001:1996 drafters as a placeholder for the future possibility of offsetting adverse impacts with beneficial and, on balance, achieving an environmentally neutral organization.
Control and Influence – The environmental aspects procedure requires the organization to identify those environmental aspects that it can control and those that it can influence._ Circumstances where control and influence are considered separately can occur where the environmental aspects of products or services are concerned. Some examples illustrate the case:
1. No control, no influence – When an organization manufactures a product, such as lumber, and sells it to a customer that can use the product in any way that it wishes, the organization has no control over the environmental aspects of the product’s use. The customer could use the product benignly as in the manufacture of a table or to damage the environment by burning the lumber and releasing its carbon into the atmosphere. In this case, the organization would not be expected to have either control or influence over the environmental aspects of the product.
2. Control, no influence – When an organization’s environmental aspect is the use of electric power generated from coal, it may be able to control its use of electric power by using less, by buying from a different, less environmentally damaging source, or by generating its own power. Rarely, however, does the organization have influence over the power generator to an extent that it could influence it to reduce the environmental impacts of power production.
3. Influence, no control – When an organization manufactures a product, such as an automobile, which is sold to the customer without restrictions on its use, the organization may be said to have no control over the environmental aspects of the product’s use. The organization may, however, be able to assert influence with the inclusion of owner’s manuals containing instructions for low impact use of the product.
4. Control and influence – When an organization buys a product built to its specifications, it has control over the products’ environmental aspects in the sense that it can determine the environmental aspects of the product. In this case, control also includes influence.
Significant Impacts – ISO 14001 does not provide guidance as to what constitutes a significant impact on the environment_, leaving that determination to the organization.
Many organizations ignore the qualifying phrase, impact on the environment_, and add additional criteria to what they determine to be significant impacts. For example, many organizations decide that aspects that are the subject of regulation, irrespective of impact to the environment, or that can cause damage to business reputation, are significant. Legal requirements, however, are identified in ?4.3.2 and legal requirements and business requirements are specifically considered when the organization establishes its objectives and targets (?4.3.3). Adding criteria that are not relevant to impact on the environment in the determination of significance distorts the outcome of procedures for environmental aspects and objectives and targets by giving these criteria undue weight in the determination of significance. For example, an environmental aspect that is significant only because its disclosure might affect the organization’s reputation is best dealt with in the Public Relations Department rather than as an environmental aspect.
Determination of significance is a yes or no question, not a determination of relative value. It is possible, therefore, that the execution of the environmental aspects procedure will result in the determination that the organization has no significant aspects. While the organization may elect to rank its aspects from most significant to least significant, that does not necessarily mean that any rise to the level of significant impact on the environment.
Where the impact occurs can be material to determination of significance. For example, a coal-fired power plant’s air emissions can interact with the environment; these emissions are clearly environmental aspects. Whether they significantly impact the environment may depend upon where the interaction with the environment occurs.
Part of the importance of establishing significance lies in the fact that the potentially significant environmental impacts become a focus of Objectives and Targets (?4.3.3), Competence (?4.4.2), Operational Controls (?4.4.6), and Monitoring and Measurement (?4.5.1) requirements.
An organization that determines that aspects are significant because of regulation or business reputation increases the amount of work it must do in these areas.
ISO 14001 does not require the organization to establish objectives and targets for each significant environmental aspect. On the one hand, the absence of a requirement to set objectives and targets for all significant aspects gives organizations latitude to conform to the requirements of ISO 14001 while not presently dealing, for example, with the significant environmental aspects of products. On the other, a requirement to establish objectives and targets for all identified significant aspects could easily overwhelm an organization having many significant aspects. Without this latitude, organizations might choose to ignore the existence of significant aspects that they believe are insurmountable or even decide not to implement ISO 14001. As it is, many organizations choose to deny the existence of significant aspects about which they feel they can do nothing.

EMS Documentation

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ISO 14001 Section 4.4.4, EMS Documentation, requires that organizations “. . . establish and maintain information, in paper or electronic form, to: 1. describe the core elements of the management system and their interaction; 2. provide direction to related documentation.”
ISO 14001 Section 4.4.5, Document Control, requires that organizations establish and maintain procedures to control all documents required by ISO 14001. The purpose of these document control procedures is to ensure that organizations create and maintain documents sufficient to implementing an EMS.
The procedure must ensure that:
• EMS documents can be located
• EMS documents are legible, dated (with dates of revisions) and readily identifiable
• EMS documents are maintained in an orderly manner and retained for a specified period
• EMS documents are periodically reviewed, revised as necessary, and approved for adequacy by authorized personnel
• The current versions of relevant documents are available at all locations where they are necessary
• Obsolete documents are promptly removed from all distribution points
• Any obsolete documents retained for legal and/or knowledge preservation purposes must be identified as such.
ISO 14001 Section 4.3.5 also requires that organizations establish procedures and designate responsibilities and
authority regarding the creation and modification of EMS documents.