1. Purpose and scope
This stage sets the frame inside which every later part of the quality management system is built. Before any process is mapped or any procedure written, top management has to answer a few plain questions: why the organisation wants a certified system, which customers and markets expect it, which standards apply, which sites, products and functions fall inside the boundary, and who is accountable for making it work. Answers given loosely here come back later as audit findings, because a certification body tests the system against the scope and policy the organisation itself declared.
The core of the stage is an honest look at the organisation's context. That means the internal and external issues that affect its ability to deliver conforming product, such as the technology it depends on, the concentration of its customers, the stability of its supply base, regulatory change, staff turnover and the maturity of its existing practice. It also means listing the interested parties whose requirements matter, such as customers, regulators, the certification body, suppliers, owners and staff, and recording what each of them needs from the system.
For a semiconductor business that supplies automotive production parts, this stage also starts the customer specific requirements register. Vehicle makers and their tier suppliers publish their own requirements that sit on top of IATF 16949, covering matters such as problem solving formats, change notification, annual requalification, layered process audits and the handling of special characteristics. Knowing which of these apply, at which revision, is a precondition for writing processes that will satisfy them.
Out of scope: the clause by clause gap assessment and the implementation plan, which belong to Gap Assessment & QMS Planning.
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