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The ISO 9000 series of Quality Management System (QMS) standards are generic and applicable to all sectors, which is why there are some elements that some organizations may see as not necessary or that they are not yet fully ready to address. On the other hand, some industry sectors consider that some aspects of the generic standards are not sufficiently detailed for that particular industry. Sector specific standards, based on the ISO 9000 series have therefore been developed that take into consideration characteristics particular to individual sectors. These sector-specific standards have additional requirements for auditors, for certification/ registration bodies and for accreditation bodies.
The development of sector-specific standards and sector schemes has been prompted by the need to respond not only to dissatisfaction raised by customers about parts supplied by suppliers that are registered under the existing ISO 9000 certification/ registration schemes, but also to reinforce assessment activities in industries where quality is critical, while still retaining the generic certification/ registration schemes because of the need to respond to an enormous number of suppliers who do not need to meet these additional requirements.
To give an example, in 1994 the North American automotive industry published QS-9000, which, in addition to the requirements of ISO 9001, has requirements that are particular to the automotive industry. This standard became the forerunner of other sector standards, such as JIS Q 9100 for the aerospace industry, JIS Q 13485 and JIS Q 13488 for medical devices and others. It is important to note, however, that all of these sector-specific standards are based on the ISO 9000 series of standards and are not something entirely different. For example, an automotive component manufacturer wishing to be certified/ registered against QS 9000 will still need to have a quality management system, as for the ISO 9000 series, as well as meeting the additional requirements for the automotive industry.
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In 1994, the North American automotive industry published QS-9000, which includes requirements additional to those of ISO 9001 that are specific to the automotive industry. This was to give automotive manufacturers greater confidence in the quality of components from various suppliers. The following year, an International Automotive Task Force (IATF) was established, with participation from European automotive manufacturers. The IATF pursued improvement of the original QS 9000 standard and built a new structure for accreditation and certification specifically relating to QS 9000. The current (third) edition of the QS 9000 standard was published in 1998.
The International Organization for Standardization (ISO) also published ISO/TS 16949 in March 1999, the outcome of joint efforts with the IATF. The requirements in ISO/TS 16949 are almost identical with QS-9000, but since it also covers the European automotive manufacturers, it can be said to be more international. Since then, ISO/TS16949 has been amended to bring it into line with the new edition of the ISO 9000 series, ISO 9001:2000. The amended version, ISO/TS16949: 2002, was published in March 2002.
The version of QS-9000 that JAB has been referring to for its accreditation of QS 9000 certification/ registration bodies is based on ISO 9001:1994, to which industry specific requirements have been added. With the publication of ISO/TS 16949: 2002 in March 2002, as a standard specific to the automotive industry and in alignment with ISO 9001:2000, and since ISO 9001:1994 ceased to be current as of December 15, 2003, the Automotive Industry Action Group (AIAG) that is the party responsible for the standard decided to "stop certification against QS-9000 as of December 14, 2006".
From this date, accreditation of QS 9000 certification/ registration bodies will continue as before but the reference standard will ISO/TS16949: 2002. There will also be changes to the evaluation and accreditation scheme. Accreditation of QS 9000 certification/ registration bodies that used to be carried out by accreditation body members of IAF will, from December 2003, be undertaken by the International Automotive Oversight Bureau (IAOB) established under the International Automotive Task Force (IATF), which is composed of international automotive manufacturers.
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The aerospace industry used to rely heavily on the standards of the United States Department of Defense, and in many countries industry members applied the US standard MIL-9858A, or equivalent, for quality systems management. In recent years, however, the private sector has made remarkable progress in aerospace technology. The MIL standard structure came into question and MIL-9858A was eventually abolished. Over the same period, many industries adopted ISO 9001 as their chosen quality system standard, including many organizations in the aerospace industry.
The strict requirements of the aerospace industry, however, demanded that ISO 9001 be applied with a number of industry-specific supplementary requirements. Additional supplier requirements were also developed by different organizations within the industry, with the result that the requirements become chaotic.
In order to cope with this situation, industry organizations in Europe and Americas developed and issued a standard common to each area, with additional requirements specific to the aerospace industry. In Americas this was published as SAE AS 9000 and in Europe as AECMA prEN9000-1.
At the Plenary Meeting of the relevant ISO Technical Committee, IISO/TC20, held in Tokyo in 1997, aerospace industry representatives from Europe and Americas proposed that a standard be drafted that would apply specifically to aerospace quality systems. This proposal involved simply adding specific industry requirements to ISO 9001:1994 without changing its original content. Working Group WG11 was set up for this purpose and a final draft was agreed in 1999.
This draft was referred to the International Aerospace Quality Group (IAQG), which had been established in 1998 with participation from most of the world's manufacturers of aircrafts and engines for aircrafts, in order to facilitate the development of a standard to meet the needs of the industry. The IAQG developed IAQS 9100 based on the original Working Group draft. However, it was agreed that, rather than publishing IAQS 9100 as the only standard common to all in the world, each area should be permitted to have its own version of the standard but with the same content and standard identification number. This resulted in the publication in Americas of SAE AS 9100, in Europe of AECMA EN 9100 and in Japan of SJAC 9100. The Japanese version was published in December 1999 as the standard of the Society of Japanese Aerospace Companies (SJAC).
The Society of Japanese Aerospace Companies, in the expectation that SJAC 9100 would be adopted widely without limiting it as a tool for the private sector only, opted to make it publicly available and proposed that it be published as a JIS standard. This was approved in August 2000 and the standard was published as JIS Q 9100:2000.
The current version is JIS Q 9100:2004 (from the Guide in JIS Q 9100:2004).
Conformity assessment under AS/EN/JIS Q 9100 is being implemented for each sector of IAQG (covering the Americas, Europe, and the Asia-Pacific regions) under monitoring by the Sector Management Structure. This process is based entirely on the scheme for registration of aerospace quality management systems and accreditation of registration bodies which operates under IAF.
In association with this international standard for conformity assessment and registration/certification of quality management systems within the aerospace industry, the IAQG has developed IAQG Procedure 9104, "Requirements for Aerospace Quality Management System Certification/ Registration Programs".
Each IAQG sector (or country) has established a regional (or national) standard based on the fundamental requirements of the international standard for quality systems for the aerospace industry and for its application to relevant regional accreditation bodies and certification/ registration bodies.
In July 2001, JAB commenced accreditation activities based on JIS Q 9100 in Japan, with oversight from the Japan Registration Management Committee (JRMC).
The first registration body was accredited in December 2001. At the time of writing, there is a total of three JIS Q 9100 registration bodies accredited by and registered with JAB.
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It is commonly accepted internationally that, since medical devices relate to the preservation of the life and health of human beings, additional requirements for quality control and quality assurance are needed. In 1996, the ISO developed two new standards relating to the application of the ISO 9000 series of standards to medical devices, with the intention also of ensuring international harmony of quality systems for the manufacture of medical devices:
ISO 13485: 1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001: 1994 and ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002: 1994 were published in December 1996. Based on these two standards, JIS Q 13485 and JIS Q 13488 were published on March 25, 1998 (from the commentary attached to JIS Q 13485:1998 and JIS Q 13488:1998).
As ISO 13485: 1996 and ISO 13488: 1996 were based on the 1994 versions of ISO 9001 and ISO 9002, both standards were revised and integrated to bring them into line with ISO 9001:2000. This revised version was published on July 15, 2003 as:
ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes.
This revision not only updates the contents of the standard from the 1994 version of the ISO 9000 series to ISO 9001: 2000, but also, as its title clearly indicates, places emphasis on its intended use for regulatory purposes in all countries in the world.
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TL 9000 is a quality management system standard for improving the quality of products and services in the industry of telecommunications. The first edition was published in 1999 as the TL 9000 Handbooks. This standard has been developed and is maintained by The QuEST Forum (Quality Excellence for Suppliers of Telecommunications), an organisation founded by communication service providers and telecommunications equipment manufacturers. The QuEST FORUM started its activities mainly in North America and has spread rapidly to become a worldwide body, with members in most Asian and European countries.
The TL 9000 standard specifies requirements over and beyond those of ISO 9001, incorporating requirements from various existing quality standards in the communications industry, such as the old American Belcore Standard. Details are contained in the following two handbooks:
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Quality Management System Requirements Handbook: A telecommunications-specific set of requirements additional to those in ISO 9001, defining in greater detail the requirements for design, development, production, testing, delivery, installation and maintenance of telecommunication products (hardware, software and services) for the purpose of realizing ever higher quality in telecommunications products and services.
This Handbook contains general requirements that are commonly applicable to hardware, software and services, plus requirements that are specific to each of these aspects..
Appendices to this handbook detail the requirements for certification/ registration against TL 9000, including "TL 9000 Accreditation Body Implementation Requirements", "Code of Practice for TL 9000 Registrars" and "Registration Procedures".
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Quality Management System Measurements Handbook: This handbook defines items and measurements for the performance evaluation of products such as hardware return rate, number of software corrective patches, complaints against services, etc. These are the quality control data that suppliers are required to report to The QuEST FORUM.
There is an established system to ensure that these quantified data are controlled uniformly and statistically processed and can be published for use as industry standards.
The requirements contained in booklet (2) are unique even among sector-specific standards.
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Structural Model of TL 9000 Standard
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Registration Scheme and