Excellence Beyond Compliance

Appendix B: Addressing the Annex SL Model

As noted in Chapter 1 and again in Chapter 3, the Technical Management Board of ISO published Annex SL in 2012, which included a structure that all future quality management system (QMS) standards would be expected to use. The intent is to make it easier for companies wishing to implement more than one management standard, such as, for example, a company that wants to implement both a quality management standard and an environmental management standard. The intent of Appendix B is to show how a medical device company might address the Annex SL model in two different situations: (1) where the company seeks to address more than one type of management system, such as both quality and environmental; and ...