ISO 9001:2015 vs. 2008 revision. What has changed?

Different parts of the standard have seen different levels of changes. Quality Policy, Leadership, Competence, Training and awareness, Management review, Internal audit and Corrective action had only slight changes, and most of the existing QMS related to these requirements can remain as it was. The second group, which has moderate changes, includes Control of externally provided processes, products and services; Quality objectives and plans for achieving them; Performance evaluation; Document management; Production and service provision; and QMS Scope, and these elements should be revised and updated to be compliant with the new revision of the standard.

There is also a group of new requirements that has to be established and incorporated into the existing QMS from scratch. Risks and opportunities, Context of the organization, and Interested parties are new requirements that need to be met, and they should be implemented with caution because they cast a completely new light on the Quality Management System.

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