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Change management

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Guest user Created:   Feb 22, 2023 Last commented:   Mar 01, 2023

Change management

we are being evaluated as a potential supplier. The customer provided us with an extensive questionnaire.

An entire section is related to change management. From what I understand, the change management as such is not part of ISO 13485.

I believe it is an FDA requirement.

How should I answer the questions related to the change management without losing the trust of the customer?

Or should I just create a new procedure?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Feb 23, 2023

Change management is part of the ISO 13485 covered in requirement 4.1.4. In that requirement is stated that the organization should manage the changes in the quality management system. There is no direct requirement to have a change management procedure, but of course, you can make it. Or, you can elaborate on how you will perform the change management of the quality management system within the Management review procedure. 

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Guest Feb 27, 2023

Good morning, could you please elabore on the link between the change management (in products and processes) info and the Management review procedure? Where should we incorporate for example a revision control system? Thank you.

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Kristina Zvonar Brkić Mar 01, 2023

Any change in the processes and products influence the quality of the product and possibly safety. Therefore, any change directly influences the quality management system. You can elaborate on how will you manage changes in the Management review procedure, but, as I mentioned in the previous answer you can make a separate documented procedure

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Feb 22, 2023

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