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--- articles:as9100d_oe_requirements-1 [2019/08/17 17:15] – rrandall
+++ articles:as9100d_oe_requirements-1 [2019/08/18 18:47] – 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 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>
 <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
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 <note tip>**# 2 thru 8** \\ While AS 9100 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 AS 9100D in a "Quality Manual" (at a policy level) the business can argue that it has addressed the more //subjective// requirements (contained throughout AS 9100D) 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 8 from the above chart.</note>
-<note important>**# 9** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //The 9100-series clause 7.1.5.2 was not intended to force organizations to have the register specifically include the "equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.” The organization is required to have this information for equipment listed on the calibration register but not specifically in the register.// \\ \\ Almost no one identifies the “method” or “acceptance criteria” in their “register” (database)... unless they have a full in-house calibration laboratory. What auditors typically see is: \\ 1. the “method” identified on the calibration certificate (from the calibration/metrology lab). \\ 2. the  “acceptance criteria” either identified in the calibration certificate (from the calibration/metrology lab) OR for the company to have a copy of the calibration “method” that was used (containing the acceptance criteria).  \\ \\ While the company could have the instrument specifications, if those specifications can’t be matched to the actual calibration method used, then there is no way to confirm that was the actual “acceptance criteria” used in performing the calibration.  </note>
+<note important>**# 9** \\ The IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] states: //The 9100-series clause 7.1.5.2 was not intended to force organizations to have the register specifically include the "equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.” The organization is required to have this information for equipment listed on the calibration register but not specifically in the register.//  </note>
+<note tip>**# 9** \\ Consistent with the above "official" interpretation, almost no one identifies the “method” or “acceptance criteria” in their “register” (database)... unless they have a full in-house calibration laboratory. What auditors typically see is: \\ 1. the “method” identified on the calibration certificate (from the calibration/metrology lab). \\ 2. the  “acceptance criteria” either identified in the calibration certificate (from the calibration/metrology lab) OR for the company to have a copy of the calibration “method” that was used (containing the acceptance criteria).  \\ \\ While the company could have the instrument specifications, if those specifications can’t be matched to the actual calibration method used, then there is no way to confirm that was the actual “acceptance criteria” used in performing the calibration.  </note>
 <note important>**# 12** \\ When asked whether clause no. 8.5.1a) of ISO 9001:2015 "availability of documented information" means "maintain documented information”, the "