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| articles:as9100d_oe_requirements-1 [2019/08/17 17:14] – rrandall | articles:as9100d_oe_requirements-1 [2019/08/18 18:42] – rrandall |
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| <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> | <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> |
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| | <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> |
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| <note important>**# 5** \\ When asked "//Is using the process diagram in Figure 2 from clause 0.3.2, in your quality manual for interaction between the processes sufficient?//", 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. 9100-series standards are a process-based standard with requirements to identify the organization’s QMS processes and their interaction. The diagram on page 8 of 9100-series includes the relationships of the 9100-series sections 4 through | <note important>**# 5** \\ When asked "//Is using the process diagram in Figure 2 from clause 0.3.2, in your quality manual for interaction between the processes sufficient?//", 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. 9100-series standards are a process-based standard with requirements to identify the organization’s QMS processes and their interaction. The diagram on page 8 of 9100-series includes the relationships of the 9100-series sections 4 through |
| <note important>**# 12** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the " | <note important>**# 12** \\ 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.//".</note> | [[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> |
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| <note important>**# 12** \\ When asked "//Does clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" mean "maintain documented information”?//", the official response provided in the "[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015]]" stated: //No. 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> | |
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| <note important>**# 14 & 15** \\ There are only 2 requirements in AS9100D for documented "procedures"; "nonconformity control" (8.7.1) & corrective action (10.2.1). These 2 procedures can be (and often are) combined into a single procedure.</note> | <note important>**# 14 & 15** \\ There are only 2 requirements in AS9100D for documented "procedures"; "nonconformity control" (8.7.1) & corrective action (10.2.1). These 2 procedures can be (and often are) combined into a single procedure.</note> |
