Both quality management systems, favoring different industries, ISO13485 therapeutic devices, TS16949 is the automotive industry; medical device industry is not only the quality, but also emphasize the requirements of local regulations. The automotive industry, on the other hand, emphasizes the special requirements of the customer, especially the requirements of the final OEM. ISO/TS16949, ISO26262 are one of the norms (16949) and standards applicable within the automotive industry.
ISO26262
ISO26262 is an international standard, which is derived from the basic standard for functional safety of electronic, electrical and programmable devices, IEC61508, and is mainly positioned in the automotive industry for specific electrical devices, electronic devices, programmable electronic devices, and other components dedicated to the automotive field, with the aim of improving the international standard for functional safety of automotive electronic and electrical products.
TS16949
TS16949 As one of the two major bases of automobile production, the three major U.S. automobile companies (General Motors, Ford, and Chrysler) began to adopt QS-9000 as their suppliers' unified quality management system standard in 1994; meanwhile, the other production bases, Europe, especially Germany, have issued corresponding quality management system standards. At the same time, another production base, Europe, especially Germany, have issued their own quality management system standards, such as VDA6.1, AVSQ94, EAQF and so on.
Background
Because the U.S. or European automotive parts suppliers at the same time to the major OEMs to provide products, which requires them to meet both the QS-9000, but also to meet the VDA6.1, such as VDA6.1, resulting in the duplication of certification of the various suppliers of the different standards, which is the urgent need to require the introduction of a set of internationally recognized automotive industry quality system standard This is an urgent requirement for the introduction of a set of international quality system standards for the automotive industry to meet the requirements of the major OEMs at the same time, ISO/TS16949:2002 came into being.
Standard
ISO/TS16949 "quality management system - automotive industry production parts and related service parts of the organization to implement the special requirements of ISO9001: 2008" ISO/TS16949: ISO2009 and ISO /TS16949 differences for comparison, we start from a practical point of view, in the background, objectives and significance, content of the three aspects of this quality management system requirements for a brief introduction.
In order to coordinate the international automotive quality system specification, a specialized agency called InternationalAutomotiveTaskForce (IATF) was established by the world's major automobile manufacturers and associations.
The members of the IATF are the following nine OEMs: BMW (BMWGroup), Chrysler (ChryslerLLC), Daimler (DaimlerAG), Fiat (FiatGroupAutomobiles), Ford (Ford Motor Company), General Motors (GeneralMotorsCorporation), and Fiat (FiatGroupAutomobiles). GeneralMotorsCorporation), Peugeot (PSAPeugeotCitroen), Renault (Renault) and Volkswagen (VolkswagenAG).
As well as five national supervisory bodies: the U.S. International Automotive Oversight Board (IAOB), the Italian Automobile Manufacturers' Association (ANFIA), the French Federation of the Vehicle and Equipment Industry (FIEV), the Society of Motor Manufacturers and Traders (SMMT) in the U.K., and the German Association of the Automotive Industry - Quality Management Center (VDA-QMC) make up the group.