What to exclude from Procedures and/or Quality Manual?

If you will not design any new products, it means that you are manufacturing already known products, that you can exclude requirement 7.3 Design and development. In our documentation toolkit, you do not need to use folder 09_Procedure_for_Design_and_Development.

If your medical device is not sterile, it means that requirement 7.5.5 Particular requirement for sterile medical devices and 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems. In our documentation toolkit, you do not need to use 12_Procedures_for_Sterile_Medical_Devices. 

Each exclusion must be stated and explained in the Quality manual. For example, requirements 7.5.5 and 7.5.7 are not applicable because our medical devices are not sterile.

On the following link you can find tips on how to write a short quality manual for ISO 13485:

• ISO 13485: How to write a short quality manual https://advisera.com/13485academy/knowledgebase/iso-13485-how-to-write-a-short-quality-manual/