1. Purpose and scope
This stage turns the plan into a system that people can follow. The process approach at the heart of ISO 9001 asks the organisation to see its work as a set of linked processes, each with a purpose, an owner, inputs, outputs, resources, measures and risks, rather than as a collection of departments or clauses. The process map shows how the processes connect, and each process description says how the process is run and controlled.
For automotive suppliers, IATF 16949 adds specific processes and documented procedures that must exist, such as those for product safety, the control of changes, the handling of nonconforming product, problem solving, contingency planning, calibration, internal audit and the core tools. The core tools are the shared industry methods published by AIAG and VDA: advanced product quality planning and the control plan, the production part approval process, failure mode and effects analysis, measurement systems analysis and statistical process control. The quality system defines how they are used; each customer program then applies them through the APQP lifecycle.
The stage also sets up document and record control. Every controlled document needs an owner, an approval, a version, a place where the current version is available at the point of use, and a way to keep obsolete versions out of use. Every record needs a retention period, a place to live and a way to be retrieved. Customer engineering documents, such as drawings and specifications, need a review on receipt so their changes reach production on time.
Out of scope: running the processes and building up records, which belongs to Implementation & Records.
12 more sections for registered members.