How should changes to a QMS unrelated to the product be tracked under MDR?

Question

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?

Dr. Oliver Eidel · Accepted Answer

In my case, I don't have a separate SOP for this type of change, but I mention it in the management SOP and keep a record for tracking process changes. Some examples of changes that must be documented include:
• Changes in company activities or scope
• Changes in services offered
• Changes affecting product design
• Changes affecting manufacturing
• Changes in any QMS operational process
• Changes in critical suppliers or subcontractors
• Any change that might impact product safety or efficacy

For each change, we describe and document the impact, criticality, affected documents, and those responsible for change control. This record helps with planning, resource evaluation, and risk assessment related to process changes. Hope this helps.

Answer

In a simple way, I often include tracking of general organizational changes in the document control SOP. It describes how you create and update documents, so adding changes like leadership or address updates is straightforward.

Answer

Section 4.2.4 of ISO 13485 states that changes to documents (including processes) of the QMS should be covered by the document control SOP. However, examples like new CEO or new address are more general organizational changes and usually trigger updates to the relevant documents. Are these the cases the auditor mentioned?

How should changes to a QMS unrelated to the product be tracked under MDR?

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