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2 - THE INFORMED Outlook

These "standards" are in the future of many automotive suppliers, who will need to devote a lot of effort to making the transition, although the benefits of doing it right will benefit their organizations tremendously and make the effort worthwhile. To help you prepare for the coming transition, we will discuss the impact of ISO 9001:2000, in terms of both the structure and the process approach model, and examine approaches to QMS implementation in the transition to TS 16949:2002, with a detailed examination of what we refer to as the Process Review methodology.

ISO 9001:2000's Structure and the Process Approach

ISO 9001:2000's structure is based on five principal components-sections-rather than the 20 clauses in ISO 9001:1994-the "elements" in TS 16949/QS-9000. The new structure is not simply a matter of grouping several elements together into 1 of 5 sections. It involves a significant reorganization of the requirements that brings together some requirements from different elements and breaks up the requirements in some elements and spreads them throughout the 5 sections. Thus, for an organization's QS-9000- based quality system, the new structure is not simply a matter of regrouping procedures

or putting a matrix in front of the procedures manual. It is more of a significant reorganization or a complete rewrite of documentation for companies that wrote their documentation to match the 20 clauses in ISO 9001:1994.

The intent of ISO 9001:2000 was to streamline an organization's processes, avoid the previous compartmentalization of quality system requirements and instill the cross-functional nature of a QMS. This fundamental change will signifi-cantly affect the documentation structure of an organization's QMS. Although ISO 9001:2000 also provides for greater flexibility regarding the need for documented procedures and documentation, you can expect that TS 16949:2002 will "reestablish" some of the documentation requirements in QS-9000/ISO 9001 to suit automotive OEM needs.

At a minimum, the traditional policy-based Quality Manual will need to be rewritten and reoriented. Key changes to TS 16949:2002 are likely to involve the process mapping and process orientation required by ISO 9001:2000. In all probability, the second edition of
ISO/TS 16949:2002 will not prescribe element-based procedures from the first edition. As a result, organizations that have structured their procedures to mimic the QS-9000 elements can expect some major document rework ahead.

TS 16949:2002 will likely require companies to document their product realization process (i.e., the process of creating and producing new products, from concept to delivery to the customer). This process is larger in scope than the current Advanced Product Quality Planning (APQP) process. It also may require organizations to start

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