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--- articles:iso_9001_objective_evidence_requirements-part_1-documentation [2021/09/29 17:36] – rrandall
+++ articles:iso_9001_objective_evidence_requirements-part_1-documentation [2023/05/14 21:35] (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]]</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//.
-AS 9001:2015 is an incredibly poorly written 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  |
-<note tip>**# 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"]]</note>
+<WRAP center round info 80%>
+**# 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.
+</WRAP>
+<WRAP center round info 80%>
+**# 2 thru 4** \\ While ISO 9001 does NOT require a "Quality Manual", it is generally a good idea to do so as a "defensive measure" because: \\ 1. Addressing all of the requirements of ISO 9001:2015 in a "Quality Manual" (at a policy level) the business can argue that it has addressed the more //subjective// requirements (contained throughout ISO 9001:2015) that do not specifically require "objective evidence", and \\ 2. Including references to the sources for the business's interpretations can immediately dismiss many //subjective// interpretations that an auditor may have. \\ \\ Also, a "Quality Manual" can improve efficiency by providing a single source addressing items 2 thru 4 from the above chart.
+</WRAP>
-<note tip>**# 2 thru 4** \\ While ISO 9001 does NOT require a "Quality Manual", it is generally a good idea to do so as a "defensive measure" because: \\ 1. Addressing all of the requirements of ISO 9001:2015 in a "Quality Manual" (at a policy level) the business can argue that it has addressed the more //subjective// requirements (contained throughout ISO 9001:2015) that do not specifically require "objective evidence", and \\ 2. Including references to the sources for the business's interpretations can immediately dismiss many //subjective// interpretations that an auditor may have. \\ \\ Also, a "Quality Manual" can improve efficiency through providing a single source addressing items 2 thru 4 from the above chart.</note>
+<WRAP center round important 80%>
+**# 6** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the "
+[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|Official ISO 9001:2015 Inerpretations from ISO TC/176/SC2]]" stated "No". And explained "//The terms “available” and “maintain” are not synonyms, and the use of “availability” was deliberate. “Available” means “able to be used or obtained, or accessible”, whereas “maintain” means “cause or enable to continue”. The “maintenance” of documented information is not explicitly required by Clause 8.5.1(a), but is addressed by other parts of ISO 9001:2015. Clause 8.5.1 (a) requires the documented information to be “available” so that it can be used, not just “maintained” (i.e. preserved). The documented information that needs to be available under Clause 8.5.1(a) is part of the quality management system documentation, and therefore has to be managed in accordance with Clause 7.5.//".
+</WRAP>
-<note important>**# 6** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the "
+{{page>wiki:pathforward}}
-[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|Official ISO 9001:2015 Inerpretations from ISO TC/176/SC2]]" stated "No". And explained "//The terms “available” and “maintain” are not synonyms, and the use of “availability” was deliberate. “Available” means “able to be used or obtained, or accessible”, whereas “maintain” means “cause or enable to continue”. The “maintenance” of documented information is not explicitly required by Clause 8.5.1(a), but is addressed by other parts of ISO 9001:2015. Clause 8.5.1 (a) requires the documented information to be “available” so that it can be used, not just “maintained” (i.e. preserved). The documented information that needs to be available under Clause 8.5.1(a) is part of the quality management system documentation, and therefore has to be managed in accordance with Clause 7.5.//".</note>