How should changes to a QMS unrelated to the product be tracked under MDR?
During a recent MDR audit, a minor non-conformity was issued because changes to our quality management system (QMS) that are not related to the product (such as changes in company leadership or new locations) are not tracked systematically. Changes to the product itself are tracked properly.
Is it necessary to have a separate SOP for tracking these general organizational changes, or is it sufficient to include them in the document control SOP? How have others handled this requirement?
1 comment
A
Anonymous
about 20 hours ago
Did the auditor give a specific requirement reference for this non-conformity?
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