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| articles:re-writing_iso_9001_through_interpretation [2020/01/24 14:50] – [Re-writing ISO 9001:2015... through Interpretation] rrandall | articles: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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| ====== Re-writing ISO 9001:2015... through Interpretation ====== | ====== Re-writing ISO 9001:2015... through Interpretation ====== |
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| ISO 9001:2015 was designed to include many ambiguous/vague requirements because the responsible committee ([[https://www.iso.org/committee/53896.html|ISO TC176/SC2]]) was convinced that in order for the standard to be accepted by a large international user base, it must recognize //cultural relativism//. Cultural relativism is the idea that a person's beliefs, values, and practices should be understood based on that person's own culture, rather than be judged against the criteria of another. (See [[articles:context_of_the_organization|Context of the Organization... and "Interested Parties"]]) | According to [[https://www.merriam-webster.com/dictionary/textualism|Merriam-Webster]], the word "//textualism//" is defined as a "//strict or rigid adherence to a text (such as the text of the Scriptures)//". This word is most often used in the US legal profession and refers to "//a legal philosophy that laws and legal documents (such as the U.S. Constitution) should be interpreted by considering only the words used in the law or document as they are commonly understood//". |
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| Consequently, interpretation of the requirements of ISO 9001:2015 & AS 9100:2016 changes when crossing cultural boundaries. And since culture is most often rooted in socio-political beliefs, economy, laws, regulations, etc., interpretation of the requirements of ISO 9001:2015 & AS 9100:2016 are often "//nation dependent//". | Naturally, many users attempt to interpret ISO 9001 through textualism. But if that is the intent of the committee responsible for crafting ISO 9001, then why is there a need for so many "official" (and unofficial) interpretations? |
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| | ===== Intentional Ambiguity ===== |
| | {{ :articles:the_plain-text.jpg?nolink|}} |
| | ISO 9001:2015 was intentionally crafted to include many ambiguous/vague requirements because the responsible committee ([[https://www.iso.org/committee/53896.html|ISO TC176/SC2]]) was convinced that in order for the standard to be accepted by a large international user base, it must recognize //cultural relativism//. Cultural relativism is the idea that a person's beliefs, values, and practices should be understood based on that person's own culture, rather than be judged against the criteria of another. (See [[articles:context_of_the_organization|Context of the Organization... and "Interested Parties"]]) |
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| | Consequently, interpretation of the requirements of ISO 9001:2015 & AS 9100:2016 changes when crossing cultural boundaries. And since culture is most often rooted in socio-political beliefs, economy, laws, regulations, etc., interpretation of the requirements of ISO 9001:2015 & AS 9100:2016 are often "//nation dependent//". And could even vary by the user organization. |
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| So "who" provides interpretation? | So "who" provides interpretation? |
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| In many cases, it is the organization implementing the standard who also interprets the requirements. The term "//the organization shall determine...//" appears 19 times (ISO 9001, sec. 4.1, 4.2, 4.3, 4.4.1, 6.2.2, 7.1.1, 7.1.2, 7.1.3, 7.1.4, 7.1.5.1, 7.1.5.2, 7.1.6, 7.2, 7.4, 8.3.3, 8.4.1, 9.1.1, 9.1.2 & 10.1)! And there are several other instances where the language //suggests// that the organization must "//determine//" what is (or is not) required. | In many cases, it is the organization implementing the standard who also interprets the requirements. The term "//the organization shall determine...//" appears 19 times (ISO 9001, sec. 4.1, 4.2, 4.3, 4.4.1, 6.2.2, 7.1.1, 7.1.2, 7.1.3, 7.1.4, 7.1.5.1, 7.1.5.2, 7.1.6, 7.2a, 7.4, 8.3.3, 8.4.1, 9.1.1, 9.1.2 & 10.1)! And there are several other instances where the language //suggests// that the organization must "//determine//" what is (or is not) required. |
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| However, there are 2 separate "official" interpretations for ISO 9001:2015... one from ISO, and another from each country (where determined by that country to be necessary), Interpretations from the individual countries are __non-binding__ "opinions". For example: | However, there are 2 separate "official" interpretations for ISO 9001:2015... one from ISO, and another from each country (where determined by that country to be necessary), Interpretations from the individual countries are __non-binding__ "opinions". For example: |
| - [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] (non-binding) | - [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] (non-binding) |
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| While requests for "official" ISO 9001:2015 Interpretations from US TC 176 - TG22 are submitted using a form titled "//Interpretation Request Form//", the TAG 176 – SC2 - TG22 "Standard Operating Procedure" titled "US Guidance for handling requests for interpretation of the requirements of ISO 9001" clearly states in bold text: "//Since the US TAG to ISO TC176 (TAG) does not provide explanations of ISO 9001, responses provided under this procedure are opinions and are not to be offered as an official interpretation.//" | While requests for "official" ISO 9001:2015 Interpretations from US TC 176 - TG22 are submitted using a form titled "//Interpretation Request Form//", the TAG 176 – SC2 - TG22 "Standard Operating Procedure" titled "US Guidance for handling requests for interpretation of the requirements of ISO 9001" clearly states in bold text: "//Since the US TAG to ISO TC176 (TAG) does not provide explanations of ISO 9001, responses provided under this procedure are opinions and are not to be offered as an official interpretation.//" Consequently, the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] is "supposed" to serve as a guidance document providing assistance to US-based organizations in developing their own interpretations based upon US socio-political beliefs, economy, laws, regulations, etc. (hence the reason that it is "non-binding"). |
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| And there is a 3rd official "clarifications" (i.e., interpretations) document from IAQG for AS 9100:2016: [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"IAQG AS 9100:2016 Series Clarifications"]]. It states: "//These clarifications are __binding__ where the standard leadership believes a published response is necessary since it has a profound impact upon the use of the standard or when a significant disputes exists.//" | And since AS9100 uses ISO 9001 as a base document (basically ISO 9001 with additional requirements for the aerospace industry) there is a 3rd official "clarifications" (i.e., interpretations) document from IAQG for AS 9100:2016: [[https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf|"IAQG AS 9100:2016 Series Clarifications"]]. It states: "//These clarifications are __binding__ where the standard leadership believes a published response is necessary since it has a profound impact upon the use of the standard or when a significant dispute exists.//" |
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| ===== How ASQ attempted to create a new requirement through Interpretation===== | ==== Do the "US TC 176 - TG22 - Interpretations" add any value? ==== |
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| When reading the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]], these appear fairly typical of what one might expect... with one notable exception. On the third row from the top, we see where the following question was asked (in the "Request" column): "//Does ISO 9001:2015 require internal audits to be process‐based vs. clause/element‐based?//" | In my opinion, the short answer to this question is a resounding "No". |
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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. |
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| | 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. |
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| | Example 1: |
| | When reading the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]], #2017-01 appearing on the second row from the top, asks the following question (in the "Request" column): "//When a consultant who helped to design an organization’s management system audits that system from year to year, is the requirement of 9.2.2.c for objectivity and impartiality of the audit process being met?//" |
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| | In the "Answer" column, we see where the answer was "Yes". |
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| | However, I know of several CBs who issue nonconformities when a consultant audits his own internal audits year after year. So at the very least, someone else would need to audit the effectiveness of the internal audit program. |
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| | Example 2: |
| | When reading the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]], #2017-02 appearing on the third row from the top, asks the following question (in the "Request" column): "//Does ISO 9001:2015 require internal audits to be process‐based vs. clause/element‐based?//" |
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| In the "Answer" column, we see where the answer was originally "No", but changed to "Yes". This in itself is odd. | In the "Answer" column, we see where the answer was originally "No", but changed to "Yes". This in itself is odd. |
| So the reason for the change was the release of ISO 19011:2018... which was merely referenced by ISO 9001:2015‐9.2.2. This doesn't explain how a "//reference//" suddenly became a requirement. | So the reason for the change was the release of ISO 19011:2018... which was merely referenced by ISO 9001:2015‐9.2.2. This doesn't explain how a "//reference//" suddenly became a requirement. |
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| {{ :articles:the_plain-text.jpg?nolink|}} | |
| The actual language of the reference in ISO 9001:2015, sec. 9.2.2 is: | The actual language of the reference in ISO 9001:2015, sec. 9.2.2 is: |
| "//NOTE: See ISO 19011 for guidance.//" | "//NOTE: See ISO 19011 for guidance.//" |
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| The reason that I titled this section "//How ASQ __attempted__ to create a new requirement through Interpretation//" is because, as mentioned earlier, the TAG 176 – SC2 - TG22 “Standard Operating Procedure” titled “US Guidance for handling requests for interpretation of the requirements of ISO 9001” clearly states in bold text: “Since the US TAG to ISO TC176 (TAG) does not provide explanations of ISO 9001, responses provided under this procedure are __opinions__ and are __not to be offered as an official interpretation__.” | ===== How Could the the "US TC 176 - TG22 - Interpretations" add value? ===== |
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| | 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. |
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| | 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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| In other words, the [[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]] __can__ be ignored because it is __non-binding__. | ^ 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. | |
| | | 4.2 | 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. | | |
| | | 4.4.1 | the processes needed for the quality management system and their application throughout the organization... | | |
| | | 6.2.2 | ...how to achieve its quality objectives... | | |
| | | 7.1.1 | and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. | | |
| | | 7.1.2 | and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. | | |
| | | 7.1.3 | provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. | | |
| | | 7.1.4 | provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. | | |
| | | 7.1.5.1 | and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. | | |
| | | 7.1.5.2 | if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. | | |
| | | 7.1.6 | the knowledge necessary for the operation of its processes and to achieve conformity of products and services. | | |
| | | 7.2a | the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system; | | |
| | | 7.4 | the internal and external communications relevant to the quality management system... | | |
| | | 8.3.3 | the requirements essential for the specific types of products and services to be designed and developed. | | |
| | | 8.4.1 | the controls to be applied to externally provided processes, products and services when: | | |
| | | 9.1.1 | a) what needs to be monitored and measured; b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results; c) when the monitoring and measuring shall be performed; d) when the results from monitoring and measurement shall be analysed and evaluated. | | |
| | | 9.1.2 | the methods for obtaining, monitoring and reviewing this information. | | |
| | | 10.1 | and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. | | |
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