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--- articles:iso_9001_objective_evidence_requirements-part_1-documentation [2021/09/29 17:34] – 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:
@@ Line 16: / Line 17: @@
 ^  #  ^  “Maintain” as Documented Information (Documents)  ^  Sec.  ^
 |  1  | //To the extent necessary//, the organization shall:  \\ a. maintain //**documented information**// to support the operation of its processes; \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> |  4.4.2  |
-|  **3**  | The scope of the organization’s quality management system shall be available and be maintained as documented information. |  4.3  |
+|  **2**  | The scope of the organization’s quality management system shall be available and be maintained as documented information. |  4.3  |
-|  **7**  | Quality policy  |  5.2.2.a  |
+|  **3**  | Quality policy  |  5.2.2.a  |
-|  **8**  | Quality objectives  |  6.2.1  |
+|  **4**  | Quality objectives  |  6.2.1  |
-|  10  | The organization shall "determine" and "maintain" //**documented information**// "to the extent necessary:" \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> |  8.1.e  |
+|  5  | The organization shall "determine" and "maintain" //**documented information**// "to the extent necessary:" \\ 1. to have confidence that the processes have been carried out as planned; \\ 2. to demonstrate the conformity of products and services to their requirements; \\ <wrap em>**[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)... NOT the auditor.]**</wrap> |  8.1.e  |
-|  **12**  | 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  |
+|  **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  |
+<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>
-<note tip>**# 3** \\ 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 tip 80%>
+**# 2** \\ The scope of the QMS can be different from the scope of certification.
+</WRAP>
-<note important>**# 3** \\ When asked "//Is it allowable for an organization to claim non-applicability with any sub-clause or sub-paragraph of 9100-series?//", the response contained in the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] stated: \\ //"Yes. Organizations can claim non- applicability even down to a shall statement or portions of a shall statement."// \\ \\ Also, when asked "//Is it required that any non-applicability with a requirement be documented in the scope section of the __Quality Manual__?//", the response contained in the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] stated: \\ //"No. It is required that any non-applicability with a clause or “shall” statement be documented information but does not have to be documented in the scope section of a __Quality Manual__."//</note>
+<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>**# 12** \\ 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>