Annex SL – Changes for ISO Standards

The final draft international standard (FDIS) of ISO 9001:2015 has been released in July, and the revised standard is slated for publication in September. Based on Annex SL of the “Consolidated ISO Supplement,” some elements of the standard will be restructured to allow for easier integration of multiple management systems.

Integrated management systems generally refers to integrated processes that result in one management system to implement such as ISO 9001, ISO 14001, and OHSAS 18001.

Annex SL consists of 9 clauses and 3 appendices. This annex has been developed primarily with ISO technical committees who develop management system standards.  The impact of Appendix 2 of Annex SL will be felt by all users of management system standards in the future.

Appendix 2 is in three parts:

* high level structure,

* identical core text,

* common terms and core definitions.

Future management system standards will need to have these elements. In addition, there will be less confusion and inconsistency because common terms will all have the same definition and there will be common requirements across all the management system standards, for example the requirement to establish, implement, maintain and continually improve the management system.

High level structure

The major clause numbers and titles of all management system standards will be identical They are:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement.

All future ISO MSS should be consistent and compatible, and will have the same look and feel. At this time, it is questionable whether ISO 13485 Medical Devices Standard will utilize Annex SL.  We are hoping that this could be the beginning of the end of the conflicts, duplication, and misunderstanding arising from precisely different requirements across the various MSS.

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