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ISO 9001:2015 - Significant Changes (Part 5)

The final instalment of Ian Hannah's first impressions of the proposed changes to ISO 9001.

Risk and Preventive Action

Annex SL text does not include a clause giving specific requirements for "preventive action‟. This is because one of the key purposes of a formal management system is to act as a preventive tool. Consequently, the High Level Structure and Identical text require an assessment of the organization's "external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)" in clause 4.1, and to "determine the risks and opportunities that need to be addressed to: assure the quality management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.‟ in clause 6.1. These two sets of requirements are considered to cover the concept of "preventive action‟, and also to take a wider view that looks at risks and opportunities.