Mark Hammar As an international standard for implementing a QMS, ISO 9001 is maintained by the International Organization for Standardization (ISO), and as such is intended to be usable by any organization, service or manufacturing, in any industry sector. ISO/TS 16949, although also maintained by the ISO group, is intended for use by automotive production and service parts organizations. The additional text originated from the International Automotive Task Force, including membership from Chrysler, Ford Motor Company, General Motors Corp, PSA Peugeot Citroën and Renault. If your company is involved in the automotive industry, or looking at becoming involved, then you may want to include the requirements of ISO/TS 16949 in your quality management system implementation. But, what is the ISO/TS 16949 standard, really?
How is ISO/TS 16949 structured?
ISO/TS 16949, particular requirements for application of ISO 9001:2008 for automotive production and relevant service part organizations, has used the ISO 9001 standard as the foundation for its requirements. ISO/TS 16949 takes the complete ISO 9001 standard requirements (in boxed text) and simply includes additional requirements and notes throughout the document. Due to this, it would be possible to implement a quality management system that is compliant with ISO/TS 16949, with the implementation of certain requirements only applicable to a smaller part of your organization (such as one production line) that is engaged in the automotive industry.
What are the additional requirements?
The first inclusions are in the terms and definitions, where 12 terms used by the automotive industry such as control plan, error proofing and special characteristics are defined. The first added requirements are control of documents specifically for handling customer engineering standard and specifications, and control of records for records required by statutory, regulatory and customer requirements.
The first main addition, although it seems small, is to add responsibility for quality, which demands that non-conforming product be identified to responsible managers for corrective action and that personnel who are responsible for conformity have the authority to stop production to correct problems. The additions to competence, training and awareness includes several requirements on product design skills, identifying training needs, training on the job and employee motivation. Other additions to the overall resource management area include mandates for contingency planning, personnel safety and cleanliness.
As might be expected, the majority of the updates come in section 7 of the standard for product realization. Here is where the standard captures automotive product-specific requirements around such things as acceptance criteria, change control and many specific design approach requirements (such as identifying special characteristics, including manufacturing process design and prototyping). Supplier management requirements, including customer-approved sources and supplier monitoring, are added to the purchasing section of the standard. Probably the greatest number of additions come in the section on control of product and service provision, where requirements on control plans, work instructions, preventive and predictive maintenance and tool management are included, along with some others. Finally, additional requirements on monitoring and measurement equipment control include requirements for measurement system analysis and laboratory requirements.
The final section on measurement, analysis and improvement also received a few additional requirements around the use of statistical tools and concepts, the inclusion of product and manufacturing process audits to the internal audit section, and specific requirements on monitoring and measurement of product and control of non-conforming product. The last additions occur to the corrective action requirements where the introduction of problem solving, error proofing, impact of corrective action and the analysis of rejected product as part of the corrective action system are included.
In addition to the requirements, Annex A on control plans is included to help standardize how these are implemented through organizations accredited to ISO/TS 16949. Something else to note is that the ISO/TS 16949 standard includes only the additional requirements that were agreed upon by all the automotive companies involved. For each company there will be additional written customer requirements that will need to be addressed by the processes, above and beyond those included in ISO/TS 16949.
Some thoughts on application of ISO/TS 16949
It is important to remember that even though it is based on the ISO 9001 standard, and includes all requirements of ISO 9001 within itself, the ISO/TS 16949 standard is written and designed for use in automotive applications and has little application outside the industry. However, as I mentioned earlier, if you have parts of your company that are related to the automotive industry, or you are considering adding such areas to your company, then investigating the feasibility of adding the additional requirements of ISO/TS 16949 to your quality management system might be a good first step. And remember that you can choose to make these additional areas applicable throughout your company if this will be beneficial, or restrict the application to the automotive areas of your company. The decision is up to you.
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