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Tuesday, 30 April 2019

Annex SL 2.0 Work on Revision Started

Annex SL was the major change to management standards which showed the world that it would be better to have all new standards having 10 identical numbered section.  The idea was that it would allow easier integration of systems and provide some form of commonality.   I think it fair to say that Annex SL was not widely acclaimed a success and was partly to blame for the decline in certifications, mainly ISO 9001.

The standards published in 2015 are due for update anyway, so ISO decided that a revision to Annex SL would be in order.  Provisional issue date for Annex SL 2.0 is around 2020.

It is rumoured that the areas most under consideration are:

  • Risks and opportunities
  • Risk-based thinking
  • Levels of risk
  • Definition of opportunities
  • Definition of risk
  • Actions & controls and relationship of objectives to risk.

Many countries were unhappy with the term risks and opportunities which they claim can be misleading as it is not in accordance with ISO 3100.

Apparently the revision is to improve clarity in leadership and governance as well as management of change and risk.  We shall see!!

If the target date is 2020 the we can expect some slippage and will probably see the publication in 2022 along with revised 9001, 14001, and others but apparently not ISO 13485 (Medical Devices) which will continue to go its own way.

No doubt there will be a transition period for organisations to upgrade and there will inevitably be costs involved in additional training and rewriting manuals etc.

Of course, we will be available to help companies make the changes specified, retrain auditors to address the changes and provide assistance as necessary.

We will keep you informed as details emerge.

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