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articles:a_matter_of_risk [2022/06/12 15:13] – [ISO/IEC Directives-Part 1. Annex SL (later changed to Annex L... and then back to Annex SL)] rrandall | articles:a_matter_of_risk [2022/06/12 15:21] – [ISO/IEC Directives-Part 1. Annex SL (later changed to Annex L... and then back to Annex SL)] rrandall |
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This article will discuss two of the most "commonly" used general definitions. | This article will discuss two of the most "commonly" used general definitions. |
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- The "non-traditional" definition is that "risk" can be positive, negative, or both (e.g., for a type of risk involving action-related decisions, such as investment decisions; addressing the consequences of taking some action, as well as __not__ taking that action). This definition appears in [[https://isotc.iso.org/livelink/livelink/fetch/-8921878/8921901/16347356/16347818/2021-05_Annex_SL_Appendix_2.pdf?nodeid=21826538&vernum=-2a|ISO/IEC Directives-Part 1, Annex SL, Appendix 2]]:2022, ISO 9000:2015, ISO 14001:2015, ISO 19011:2018, ISO 31000:2018 & ISO Guide 73:2009) | - The "non-traditional" definition is that "risk" can be positive, negative, or both (e.g., for a type of risk involving action-related decisions, such as investment decisions; addressing the consequences of taking some action, as well as __not__ taking that action). This definition appears in [[https://isotc.iso.org/livelink/livelink/fetch/-8921878/8921901/16347356/16347818/2022-05_Annex_SL_Appendix_2.pdf?nodeid=21826538&vernum=-2a|ISO/IEC Directives-Part 1, Annex SL, Appendix 2]]:2022, ISO 9000:2015, ISO 14001:2015, ISO 19011:2018, ISO 31000:2018 & ISO Guide 73:2009) |
- The "traditional" definition is that "risk" is always "negative" (e.g., for a type of risk involving specific desired outcomes, such as operational processes, projects or designs). This definition appears in ISO 13485:2016, ISO 45001:2018, ISO/IEC Guide 51:2014, along with popular industry standards (e.g., ICH Q9, API Spec Q1 & SAE AS9100C) and government publications (e.g., CNSS Instruction No. 4009 & NIST SP 800-30) | - The "traditional" definition is that "risk" is always "negative" (e.g., for a type of risk involving specific desired outcomes, such as operational processes, projects or designs). This definition appears in ISO 13485:2016, ISO 45001:2018, ISO/IEC Guide 51:2014, along with popular industry standards (e.g., ICH Q9, API Spec Q1 & SAE AS9100C) and government publications (e.g., CNSS Instruction No. 4009 & NIST SP 800-30) |
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<note> | <note> |
The ISO/IEC Directives-Part 1:2019 edition was restructured to (1) rename "Annex SL" to "Annex L" and (2) expand the scope of Annex L to include IEC management system standards (many of whom had been and remain, resistant to adopting the new structure and/or common content). However, the 2022 version has returned to "Annex SL" and no longer includes IEC. It now states: \\ | The ISO/IEC Directives-Part 1:2019 edition was restructured to (1) rename "Annex SL" to "Annex L" and (2) expand the scope of Annex L to include IEC management system standards (who was resistant to adopting the new structure and/or common content). However, the 2022 version has returned to "Annex SL" and no longer includes IEC (S-prefixed annexes only apply to ISO standards, while those without the prefix apply to both ISO and IEC standards). It now states: \\ |
**SL.5 Applicability of this annex** \\ | **SL.5 Applicability of this annex** \\ |
//The procedures in this annex apply to all ISO documents, including TS, PAS and IWA.// | //The procedures in this annex apply to all ISO documents, including TS, PAS and IWA.// |
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated “likelihood” (as defined in ISO Guide 73) of occurrence.</blockquote> | Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated “likelihood” (as defined in ISO Guide 73) of occurrence.</blockquote> |
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<note>While the [[https://isotc.iso.org/livelink/livelink/fetch/-8921878/8921901/16347356/16347818/2021-05_Annex_SL_Appendix_2.pdf?nodeid=21826538&vernum=-2|ISO/IEC Directives-Part 1, Annex SL]]:2022 is titled "Harmonized approach for management system standards" (HA), this is essentially the same as the previous “//High level structure//” (HLS). Interestingly, the actual ISO/IEC Directives-Part 1, Annex SL, Appendix 2]]:2022 is titled "//Harmonized structure for MSS with guidance for use//" (or "HS"). The differences in "ISO/IEC Directives-Part 1, Annex SL, Appendix 2" compared to ISO 9001:2015 are minimal. These differences are described at the end of an article titled [[https://www.quality.org/knowledge/high-level-structure-dead-long-life-harmonised-approach|"The High Level Structure is dead. Long life to the Harmonised Approach?"]].</note> | <note>While the [[https://isotc.iso.org/livelink/livelink/fetch/-8921878/8921901/16347356/16347818/2022-05_Annex_SL_Appendix_2.pdf?nodeid=21826538&vernum=-2|ISO/IEC Directives-Part 1, Annex SL]]:2022 is titled "Harmonized approach for management system standards" (HA), this is essentially the same as the previous “//High level structure//” (HLS). Interestingly, the actual ISO/IEC Directives-Part 1, Annex SL, Appendix 2]]:2022 is titled "//Harmonized structure for MSS with guidance for use//" (or "HS"). The differences in "ISO/IEC Directives-Part 1, Annex SL, Appendix 2" compared to ISO 9001:2015 are minimal. These differences are described at the end of an article titled [[https://www.quality.org/knowledge/high-level-structure-dead-long-life-harmonised-approach|"The High Level Structure is dead. Long life to the Harmonised Approach?"]].</note> |
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