Non-applicable clauses for supplier of component for medical device

I do not have enough information here, but the following requirements can be marked as non-applicable :

• 6.4.2 Contamination control – if it is no necessary to have special control of the work environment during production
• 7.5.2 Cleanliness of the product - if it is no necessary to monitor cleanliness of the product, if it is not sterile
• 7.5.3 Installation activities - if your component does not need installation
• 7.5.4 Service activities – if your comnponent does not need service
• 7.5.5 Particular requirements for sterile medical devices – if your component does not need to be sterile
• 7.5.7 Particular requirements for validation of processes for sterilization and sterile barier systems - if your component does not need to be sterile

Maybe there are some more requirements that can be marked as non-applicable, but for defining that I need more information regarding the product.

For more information regarding the ISO 13485:2016, please see following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

For any other question regarding the ISO 13485:2016, please do not hesitate to ask us.