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| articles:as9100d_oe_requirements-2 [2019/08/18 11:12] – rrandall | articles:as9100d_oe_requirements-2 [2019/08/18 18:33] – rrandall |
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| <note important>**# 26** \\ AS9100/ISO 9001, sec. "9.3.2 Management Review Inputs" states: \\ The management review shall be planned and carried out taking into consideration: \\ c. information on the performance and effectiveness of the quality management system, including trends in: \\ 2. the __extent to which quality objectives have been met__; \\ \\ When asked "//Is every process established by an organization required to have at least one quality objective?//" (ref. AS9100/ISO 9001sec. 6.2.1), the official response provided in the "[[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]]" (US# 2018-04) stated: // No. (6.2.1 ...shall establish objectives at "relevant" processes...) It may NOT be relevant to set an objective for some processes.//</note> | <note important>**# 26** \\ AS9100/ISO 9001, sec. "9.3.2 Management Review Inputs" states: \\ The management review shall be planned and carried out taking into consideration: \\ c. information on the performance and effectiveness of the quality management system, including trends in: \\ 2. the __extent to which quality objectives have been met__; \\ \\ When asked "//Is every process established by an organization required to have at least one quality objective?//" (ref. AS9100/ISO 9001sec. 6.2.1), the official response provided in the "[[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]]" (US# 2018-04) stated: // No. (6.2.1 ...shall establish objectives at "relevant" processes...) It may NOT be relevant to set an objective for some processes.//</note> |
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| <note important>**# 27** \\ When asked "//Is it a requirement of ISO 9001:2015, Subclause 10.2, to document the root cause analysis?//", 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]]" (RFI# 134) stated: //No. This is because ISO 9001 does not address “root cause analysis”.//</note> | <note important>**# 27** \\ When asked "//If action is taken under section 10.2.1, c) that addresses a cause, but not the "root" cause (e.g., 1 why vs. 5 whys), is a review of the effectiveness of corrective action (part d) required?//", the the official response provided in the "[[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]]" (US# 2019-01) stated: //Yes. Experts agree that the intent of 10.2.1d (review the effectiveness of any corrective action taken) is to ensure that the organization manages nonconformities, and implements corrective action, appropriately. \\ ISO/TS 9002:2016 states in Clause 10.2.1, "The organization should review the effectiveness of any corrective actions by confirming (through evidence) that the actions have been implemented or correction taken and as a result the nonconformities have not recurred."// \\ \\ However, when asked "//Is it a requirement of ISO 9001:2015, Subclause 10.2, to __document__ the root cause analysis?//", 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]]" (RFI# 134) stated: //No. This is because ISO 9001 does not address “root cause analysis”.// </note> |
