Reducing number of documents for review
How can we reduce the number of documents to be reviewed?
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If I understand your question correctly, you asked how to reduce the number of documents from the ISO 13485:2016 that you need to prepare for your Quality management system.
There are certain points from requirements 6, 7, and 8 that can are not applicable for each manufacturer.
For example, if your medical device is not sterile, then requirements (and all applicable documentation) 7.5.5 Particular requirements for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems are not applicable for you.
If your medical device does not require installation and service, then requirements 7.5.3 Installation activities and 7.5.4 Servicing activities and all applicable documentation is not applicable for your Quality management system, so you do not need to prepare it.
List of mandatory documents for ISO 13485:2016 you can find in the following link:
- List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
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Aug 19, 2020