How should changes to organizational details (e.g. CEO, company address) be tracked in a QMS under MDR?

Question

During our recent MDR audit, we received a minor non-conformity because changes to our quality management system (QMS) are not tracked systematically. Product changes are managed, but we lack an SOP for tracking general organizational changes, such as when the CEO changes or when the company opens a new location.
Do you use a separate SOP for tracking these kinds of changes, or do you address them in an existing SOP (such as document control)? How do you ensure compliance in this area?

Answer

In a simple way, I often include this in the document control SOP. It describes how you create and update documents, so adding changes such as new CEO or company location can be handled there. This approach keeps things straightforward and centralizes the control of such organizational updates.

Answer

Changes to documents and processes in the QMS should be covered by the document control SOP, according to section 4.2.4 of ISO 13485. However, general organizational changes like a new CEO or company address usually trigger updates to documents that record these details. Are these the specific cases the auditor mentioned?

Answer

In my case, I don't have a dedicated SOP for these kinds of changes, but I mention them in the management SOP and keep a record for tracking process changes. Some examples include changes in company activities or scope, services offered, product design, manufacturing processes, or critical suppliers. The record should describe the change, its impact, criticality, affected documents, and who is responsible for change control. This helps address planning and risk management when significant changes occur.

Answer

We just decided to add a chapter to our software change management SOP that states we comply with the relevant notified body regulations and will notify them as required. Since our product is stand-alone software, this approach made more sense to us than using the document control SOP for organizational changes like CEO or location updates.

How should changes to organizational details (e.g. CEO, company address) be tracked in a QMS under MDR?

4 Answers

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