| Both sides previous revisionPrevious revisionNext revision | Previous revision |
| articles:re-writing_iso_9001_through_interpretation [2022/05/15 17:59] – [How Could the the "US TC 176 - TG22 - Interpretations" add value] 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 |
|---|
| So "who" provides interpretation? | So "who" provides interpretation? |
| |
| 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. |
| |
| 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: |
| 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: |
| |
| |
| ===== 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. |
| |
| 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. | 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. |
| ^ Clause ^ The organization shall determine... ^ Suggested "opinion" application ^ | |
| | 4.1 | | | | ^ Clause ^ The organization shall determine... ^ Suggested approach ^ |
| | 4.2 | | | | | 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. | |
| | 4.3 | | | | | 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"]] | |
| | 4.4.1 | | | | | 4.3 | the boundaries and applicability of the quality management system to establish its scope. | | |
| | 6.2.2 | | | | | 4.4.1 | the processes needed for the quality management system and their application throughout the organization... | | |
| | 7.1.1 | | | | | 6.2.2 | ...how to achieve its quality objectives... | | |
| | 7.1.2 | | | | | 7.1.1 | and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. | | |
| | 7.1.3 | | | | | 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. | | |
| | 7.1.4 | | | | | 7.1.3 | provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. | | |
| | 7.1.5.1 | | | | | 7.1.4 | provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. | | |
| | 7.1.5.2 | | | | | 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. | | |
| | 7.1.6 | | | | | 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. | | |
| | 7.2 | | | | | 7.1.6 | the knowledge necessary for the operation of its processes and to achieve conformity of products and services. | | |
| | 7.4 | | | | | 7.2a | the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system; | | |
| | 8.3.3 | | | | | 7.4 | the internal and external communications relevant to the quality management system... | | |
| | 8.4.1 | | | | | 8.3.3 | the requirements essential for the specific types of products and services to be designed and developed. | | |
| | 9.1.1 | | | | | 8.4.1 | the controls to be applied to externally provided processes, products and services when: | | |
| | 9.1.2 | | | | | 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. | | |
| | 10.1 | | | | | 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. | | |
| |
