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What to exclude from Procedures and/or Quality Manual?

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Guest user Created:   Dec 23, 2020 Last commented:   Dec 28, 2020

What to exclude from Procedures and/or Quality Manual?

We will be NOT be designing or making medical devices. We will be molding plastic components that do not require sterilization. What should we exclude from our Procedures and/or Quality Manual?

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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 Dec 28, 2020

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:

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Dec 23, 2020

Dec 28, 2020