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articles:re-writing_iso_9001_through_interpretation [2022/05/15 18:15] – [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 | ||
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So " | So " | ||
- | In many cases, it is the organization implementing the standard who also interprets the requirements. The term "//the organization shall determine...//" | + | In many cases, it is the organization implementing the standard who also interprets the requirements. The term "//the organization shall determine...//" |
However, there are 2 separate " | However, there are 2 separate " | ||
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Unfortunately, | Unfortunately, | ||
- | And, since the [[https:// | + | And, since the [[https:// |
Example 1: | Example 1: | ||
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===== How Could the the "US TC 176 - TG22 - Interpretations" | ===== How Could the the "US TC 176 - TG22 - Interpretations" | ||
- | The [[https:// | + | The [[https:// |
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. | ||
- | ^ Clause | + | ^ Clause |
| 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. | | 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. | ||
- | | 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: |
| 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... | ||
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| 7.1.6 | the knowledge necessary for the operation of its processes and to achieve conformity of products and services. | | | | 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; | | | | 7.2a | 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, including: | + | | 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. | | 8.3.3 | 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: | | | | 8.4.1 | the controls to be applied to externally provided processes, products and services when: | | |