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 9001:2008 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 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.
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 ?
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.
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:
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:
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.
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
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:-
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:
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.
