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--- articles:iso_9001_objective_evidence_requirements-part_2-records [2023/04/20 14:35] – rrandall
+++ articles:iso_9001_objective_evidence_requirements-part_2-records [2023/05/14 21:37] (current) – rrandall
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 ====== ISO 9001:2015 Objective Evidence Requirements: Part 2 Records ======
+{{keywords>ISO 9001 records}}
+<WRAP button>[[articles:iso_9001_objective_evidence_requirements-part_1-documentation|Return to Part 1]]</WRAP>
 As mentioned in Part 1, ISO 9001:2015 is an incredibly poorly written QMS standard littered with ambiguous/vague requirements that have resulted in subjective interpretations and inconsistent implementation.
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-Some defenders of ISO 9001 (e.g., Consultants, Certification Bodies) have complained that "//ISO 9001 is often criticized for its bureaucracy and paperwork.//". While ISO 9001 requires relatively few records, the above criticism is valid because "bureaucracy" (non-value-added activities) is a relative term (e.g., ISO 9001 requires only a fraction of the bureaucracy that many regulations mandate). The degree of bureaucracy is typically buried in the category of "non-value-added but necessary". The actual degree of bureaucracy is rarely considered UNTIL a company drops its ISO 9001 certification (e.g., due to the loss of customers requiring ISO 9001 certification) and re-categorizes those bureaucratic activities as "non-value-added", and eliminates them.
+Some defenders of ISO 9001 have complained that "//ISO 9001 is often criticized for its bureaucracy and paperwork.//". While ISO 9001 requires relatively few records, this criticism is valid because "bureaucracy" (non-value-added activities) is a relative term (e.g., compared to the bureaucracy mandated by many regulations). The degree of bureaucracy is typically buried in the category of "//non-value-added but necessary//". The actual degree of bureaucracy is rarely considered UNTIL a company drops its ISO 9001 certification (e.g., due to the loss of customers requiring ISO 9001 certification) and re-categorizes those bureaucratic activities as "//non-value-added//", and eliminates them.
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 <WRAP center round important 80%>**# 19** \\ 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. ISO 9001, sec. 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.// \\ \\ A relevant question was asked of the IAQG (responsible for AS9100... which uses ISO 9001:2015 as a "base" tandard), which was: "//Is it the intent of the standard that an organization can have just a top-level requirement(s) that is used to evaluate the effectiveness of the QMS and several individual processes without those processes having specific metrics? For example, OTD of product to the customer of 98% is the top-level metric and the metric used to evaluate the effectiveness of the purchasing process, contract review process, and the manufacturing process with no additional metrics. So if they have met the OTD of 98%, then all processes are deemed as effective.//" (relating to sec. 4.4.1c & g), the IAQG official [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"AS 9100:2016 Series Clarifications"]] responded: "//No. 9100-series standards require the organization to determine if the identified processes are effective and achieving planned results (see clause 4.4.1c). Each process measure should evaluate the effectiveness of that process and be value-added. This is the measure that would be included in Process Effectiveness Assessment Report (PEAR) as the key performance indicator for that process. \\ The 9100-series standards does not mandate a certain number of process measures. Small organizations typically have fewer measures than larger organizations. These small organizations have increased visibility regarding process health due to their size. Regardless, this does not alleviate the need for determining if processes are effective and achieving planned results. The organization can have additional working level measures that may not flow up to top management or management review.//"</WRAP>
-<WRAP center round important 80%>**# 20** \\ 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”.// </WRAP>
+<WRAP center round important 80%>**# 20** \\ 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 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”.// </WRAP>
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