Understanding The ISO/TS 16949:2002 Standard 

1.2 Application  

        All requirements of this Standard are generic and are intended to be applied to all organizations, regardless of the type, size and product manufactured or supplied.  

        Certain requirements from this Standard may be excluded from your QMS, if they are not applicable due to the nature of your organization and its product 

        You cannot claim conformity to this Standard unless your exclusions: 

Þ      are limited to sub-clauses within Product Realization (clause 7) 

Þ      do not affect your organization’s ability, or responsibility, to provide product that meets your customer and applicable regulatory requirements

        The only permitted exclusions to TS 16949 relate to clause 7.3 where the organization is not responsible for product design and development.  

Key Explanation Points and Tips: 

Þ            The scope of the QMS should be based on the nature of your organization's products and realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements.  

Þ            You must begin with the premise that all requirements of TS 16949 are generic and applicable to your QMS. The only permitted exclusion is from clause 7.3, for product design and development, if your organization is not responsible to any automotive OEM for this activity . If you are not clear whether you are design responsible, contact your customer and get clarification in writing. You must include manufacturing process design and development in the scope of your QMS. 

Þ            Note that if you are exempt from product design and development for automotive clients, but design product for non-automotive customers, you must include 7.3 product design and development in your QMS scope. 

Þ            A clause may be non-applicable in situations where the process exists, but is not currently applicable – e.g. No customer owned tooling exists at the audited site, or there is no written servicing agreement between the customer and your organization. In such cases, plan and document the necessary process controls and implement it when a customer contract requires the use of that process. 

Þ             Your product scope must include all products supplied to customers subscribing to TS 16949 .  

Þ            If you manufacture product for the non-automotive sector, then many of the ISO 9001 and TS 16949 requirements may not be applicable to such products. However, for consistency and overall control, it may be beneficial to apply TS requirements across the board to all products. There are several factors entering this decision. Check with a good consultant or your Certification Body (CB). 

Þ            Your Quality Manual must clearly specify the scope of your QMS.(see clause 4.2.2). Your QMS scope must include –products and services; processes; sites; support functions/locations; any exclusion from the TS 16949 standard with justification; etc. 

Þ            IATF guidance requires that Design and Development activities onsite or remote must undergo surveillance audits at least once within each consecutive 12 month period. Consult with your Certification Body (Registrar) for details.