Tag: "Product: ISO 13485 Documentation Toolkit" - Expert Advice Community

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Change controls

I was wondering if you can help me with this question. This is regarding change controls specifically for changes to the quality system procedures such as SOPs and Work Instructions. How would these changes be initiated, reviewed and approved? I noticed there was not a change control form for this and I thought there would have been one in the Procedure for Document and Record Control.
Documents required by MDSAP and FDA in ISO 13485 Documentation Toolkit

1. Do you have in your 13485 & MDR package documents required by MDSAP? If no, where I can get them.

2. The same question about your 13485 & MDR package documents required by FDA?"
Difference between list of internal documents and list of type of records

Looking at the first folder “00”, what is the difference between list of internal documents and list of type of records?