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articles:iso_9001_objective_evidence_requirements-part_1-documentation [2023/04/25 03:42] – rrandallarticles:iso_9001_objective_evidence_requirements-part_1-documentation [2023/05/14 21:35] (current) – rrandall
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 ====== ISO 9001 Objective Evidence Requirements: Part 1 Documentation ====== ====== ISO 9001 Objective Evidence Requirements: Part 1 Documentation ======
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 ISO 9001:2015 is an incredibly poorly written "entry-level" QMS standard littered with ambiguous/vague requirements that have resulted in subjective interpretations and inconsistent implementation. This article discusses the minimum "Objective Evidence" actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective //opinion//.  ISO 9001:2015 is an incredibly poorly written "entry-level" QMS standard littered with ambiguous/vague requirements that have resulted in subjective interpretations and inconsistent implementation. This article discusses the minimum "Objective Evidence" actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective //opinion//. 
  
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-**# 2** \\ Guidance from ISO on crafting an acceptable QMS "scope" can be found online in the: [[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/General/APG-Scope2015.pdf|ISO 9001 Auditing Practices Group Guidance on: "Scope of ISO 9001, Scope of Quality Management System (QMS) and Scope of Certification"]]. \\  +**# 2** \\ The scope must define the "Boundaries" of the QMS and justify any "Exclusions" (e.g., processes, product lines, services) to the QMS. Guidance from ISO on crafting an acceptable QMS "scope" can be found online in the: [[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/General/APG-Scope2015.pdf|ISO 9001 Auditing Practices Group Guidance on: "Scope of ISO 9001, Scope of Quality Management System (QMS) and Scope of Certification"]]. \\   
-The scope must define the "boundaries" of the QMS and justify any "Exclusions" (e.g., processes, product lines, services) to the QMS.  +</WRAP> 
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 +**# 2** \\ The scope of the QMS can be different from the scope of certification.
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