When ISO has a quality management standard revision to release, there is much anticipation—and perhaps a bit of apprehension—among users as to the significance of the changes.

The Annex Revisions

The big 2020 news for many in the standards world revolves around the proposed changes in Annex L (previously known as Annex SL). Although not a quality management standard, Annex L harmonizes more than 40 individual management system standards published by the International Organization for Standardization (ISO). In the simplest of terms, the purpose of Annex L is to standardize standards. With so many standards being established and revised every year, it became important to:

  • Provide a shared structure that unifies common terms and definitions
  • Unify common terms and definitions
  • Unite standards with a shared structure and definitions standards
  • Simplify the compliance process

In 2018, after consulting the developers and users and analyzing different management system standards, it was determined that Annex SL should undergo a revision. The revision involves changes to the annex, including:

  • The content of subclauses 9.3—Non-applicability, and 9.4—Using Appendix 2
  • The high-level structure identical text in Appendix 2
  • The guidance documents for the developers of management system standards, referenced in Appendix 3

Last year, Task Force 14, established under ISO’s Joint Technical Coordination Group, held meetings to discuss the Annex L revision. The main topic of discussion was the method to improve the way risk is addressed in the high-level structure. Task Force 14 also discussed which definition of risk is most appropriate for Annex L and whether the following topics should be addressed in the revision:

  • Management of change
  • Organizational knowledge
  • Incident
  • Conformity and nonconformity, and compliance and noncompliance
  • Emergency preparedness
  • Outsourcing
  • Leadership, governance, and culture

The discussions led to a working draft being reviewed this year. The revised Annex L is scheduled to be published in May 2021.

Outside the Annex

While the development from Annex SL to Annex L is an important one, for others applying specific quality standards, there are revised standards being published this year of equal or greater significance. ASQTV recently covered three upcoming releases:

ISO/FDIS 10018—Quality management—Guidelines for people engagement addresses requirements to have effective involvement of qualified people. Competent staff and teams are crucial to the effective performance of a quality management system. ISO/FDIS 10018 provides guidelines for human factors that influence people involvement and skill. The idea behind the standard is to promote the creation of value and sustainable achievement within the organization.

ISO 14006—Environmental management systems—Guidelines for incorporating ecodesign assists organizations to establish, document, implement, maintain and continually improve their ecodesign management as part of an environmental management system. According to the ISO website, ISO 14006 “is applicable to product-related environmental aspects and activities that an organization can control and those it can influence” but “does not establish specific environmental performance criteria.”

Proficiency testing providers apply ISO 13528—Statistical methods for use in proficiency testing by interlaboratory comparison to design proficiency testing schemes and to analyze the data obtained from those schemes. The standard also provides recommendations on the interpretation of proficiency testing data by participants in such schemes and by accreditation bodies.

This year will see the release of many standards and guidance documents for effectively adopting each boilerplate. Keep your eye on the ISO and other standards websites for updates. You can’t risk missing any important news.