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articles:re-writing_iso_9001_through_interpretation [2022/05/15 18:17] – [How Could the the "US TC 176 - TG22 - Interpretations" add value?] rrandallarticles:re-writing_iso_9001_through_interpretation [2022/05/15 18:25] (current) – [How Could the the "US TC 176 - TG22 - Interpretations" add value?] rrandall
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 Unfortunately, the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] does a very poor job of providing guidance to assist US-based organizations in developing their own interpretations for requirements left for the organization "to determine"; based upon US socio-political beliefs, economy, laws, regulations, etc. Unfortunately, the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] does a very poor job of providing guidance to assist US-based organizations in developing their own interpretations for requirements left for the organization "to determine"; based upon US socio-political beliefs, economy, laws, regulations, etc.
  
-And, since the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] consists only of non-binding "opinions", they "should" be (and typically are) ignored by ISO 9001 Certification Body (CB) auditors. Therefore, these "interpretations" add no value in supporting arguments for or against a particular interpretation from a CB auditor. +And, since the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] consist only of non-binding "opinions", they "should" be (and typically are) ignored by ISO 9001 Certification Body (CB) auditors. Therefore, these "interpretations" add no value in supporting arguments for or against a particular interpretation from a CB auditor. 
  
 Example 1: Example 1:
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 ===== How Could the the "US TC 176 - TG22 - Interpretations" add value? ===== ===== How Could the the "US TC 176 - TG22 - Interpretations" add value? =====
  
-The [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] should focus on providing guidance to assist US-based organizations in developing their own interpretations for requirements left for the organization "to determine"; based upon US socio-political beliefs, economy, laws, regulations, etc.+The [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] //should// focus on providing guidance to assist US-based organizations in developing their own interpretations for requirements left for the organization "to determine"; based upon US socio-political beliefs, economy, laws, regulations, etc.
  
 A good place to begin would be providing guidance (suggestions) for those instances where ISO 9001 includes the term “the organization shall determine…”... and some of the many other instances where the language suggests that the organization must “determine” what is (or is not) required. A good place to begin would be providing guidance (suggestions) for those instances where ISO 9001 includes the term “the organization shall determine…”... and some of the many other instances where the language suggests that the organization must “determine” what is (or is not) required.
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 ^  Clause  ^  The organization shall determine...  ^  Suggested approach  ^ ^  Clause  ^  The organization shall determine...  ^  Suggested approach  ^
 |  4.1  | external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.  | Address through use of a SWOT analysis.  | |  4.1  | external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.  | Address through use of a SWOT analysis.  |
-|  4.2  | a) the interested parties that are relevant to the quality management system; & b) the requirements of these interested parties that are relevant to the quality management system. |    |+|  4.2  | a) the interested parties that are relevant to the quality management system; & b) the requirements of these interested parties that are relevant to the quality management system. | See [[articles:context_of_the_organization|Context of the Organization... and "Interested Parties"]]  |
 |  4.3  | the boundaries and applicability of the quality management system to establish its scope. |    | |  4.3  | the boundaries and applicability of the quality management system to establish its scope. |    |
 |  4.4.1  | the processes needed for the quality management system and their application throughout the organization...  |    | |  4.4.1  | the processes needed for the quality management system and their application throughout the organization...  |    |