ISO 9001 Section 4: Context of the Organisation
by Jamie Kerrigan, from the Community
This ISO 9001 Section 4 checklist helps organizations assess the context of the organization and establish an effective QMS. It covers 4.1 to 4.4: identifying internal and external issues, understanding interested parties, defining QMS scope, and managing processes. Prompts include reviewing previous audits and NCRs, determining inputs and outputs, sequence and interaction of processes, criteria and methods for control, resource needs, roles and responsibilities, risks and opportunities, performance evaluation, improvement, and maintaining documented information.
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