ISO 9000/9001/9002
We had provided consulting to many organizations and mostly it is seen that generally people use to indicate the conformance against ISO 9002 standard which in real is just a Model. The complete or full name of the standard is -
ISO 9002:1994 - Quality systems -- Model for quality assurance in production, installation and servicing
Whereas the standard for certification is -
ISO 9001:2008 - Quality management systems -- Requirements
Now whenever you come across anything that says its ISO 9000 or ISO 9002 certified, it would simply mean it is certified against ISO 9001 standard.
ISO 9001
ISO 9001 is a global quality management standard. Use it to establish and to update your organization's quality management system (QMS). It applies to all types of organizations. It doesn't matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world.
ISO 9001:2008 standards replaced the previous ISO 9001:2000 and its objective is to provide Quality Management System that will be of real benefit and help managing business effectively and put in place best practice methodology.
(source: iso.org)
ISO 9001:2008 specifies requirements for a quality management system where an organization -
- needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
ISO 9001:2008 is the latest version in ISO 9000 however there had been some previous versions as well which are as follows -
Evolution of ISO 9000 standards
(source: wikipedia.org)
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.
1987 Version
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:
- ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
- ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
- ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.
1994 Version
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.
2000 Version
ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design and development procedures were required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
2008 Version
ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.
ISO 9001 is supplemented directly by two other standards of the family:
- ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary"
- ISO 9004:2009 "Managing for the sustained success of an organization. A quality management approach"
Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.
Variants of ISO 9000 standards
Since ISO 9001 is generalized and abstract; its parts must be carefully interpreted to make sense within a particular organization. A lot of diverse nature organization have adapted ISO 9001 and have incorporated within the very DNA of the organization. Developing software is not like making cheese or offering counseling services, yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these.
Whereas, over the course of time, various industries felt the need and wanted to standardize their interpretations of the guidelines within their own marketplace. This is to ensure the correct interpretation of the guidelines according to their specific requirements and also to ensure that their assessment is done by more appropriately trained and experienced auditors who understands and have experience of the specific industry. The different industry specific variants of ISO 9000 are -
(source: wikipedia.org)
- The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
- AS9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. Those major manufacturers include AlliedSignal, Allison Engine, Boeing, General Electric Aircraft Engines, Lockheed-Martin, McDonnell Douglas, Northrop Grumman, Pratt & Whitney, Rockwell-Collins, Sikorsky Aircraft, and Sundstrand. The current version is AS9100C.
- PS 9000 * QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000 is now replaced by ISO/TS 16949.
- ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.
- TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 5.0; unlike ISO 9001 or other sector standards, TL 9000 includes standardized product measurements that can be benchmarked. In 1998 QuEST Forum developed the TL 9000 Quality Management System to meet the supply chain quality requirements of the worldwide telecommunications industry.
- ISO 13485:2012 is the medical industry's equivalent of ISO 9001:2008. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Because ISO 13485 is relevant to medical devices manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001:2008 (and vice versa).
- ISO/IEC 90003:2004 provides guidelines for the application of ISO 9001:2000 to computer software.
- ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1 without the Monogram annex.
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