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--- articles:iso_9001_objective_evidence_requirements-part_1-documentation [2023/02/02 10:32] – rrandall
+++ articles:iso_9001_objective_evidence_requirements-part_1-documentation [2024/08/01 09:06] (current) – rrandall
@@ Line 1: / Line 1: @@
 ====== ISO 9001 Objective Evidence Requirements: Part 1 Documentation ======
+{{keywords>ISO 9001 documentation requirements}}
+<WRAP button>[[articles:iso_9001_objective_evidence_requirements-part_2-records|Go to Part 2 - Required Records]]</WRAP>
+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//.
+The first confusing point to address is which documentation (e.g., procedures) is actually required by ISO 9001:2015.
-The first confusing point to address is which documentation (e.g., procedures) are actually required by ISO 9001:2015.
 ISO 9001:2015, Annex A states:
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 |  **6**  | Controlled conditions shall include, as applicable: \\ a. the __availability__ of //**documented information**// that defines: \\ 1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed; \\ 2. the results to be achieved;  \\ <wrap hi>**[This documented information //may// be provided by the customer (e.g., Drawings)]**</wrap> |  8.5.1.a  |
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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"]]. \\
+</WRAP>
+<WRAP center round tip 80%>
+**# 2** \\ The scope of the QMS can be different from the scope of certification.
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