ISO 13485 is a stand-alone document that is similar in subject to ISO 9001, but with a direct focus regarding the manufacture and design of medical devices. There are a few key differences between the two standards, though. ISO 9001 has requirements for continual improvement of a company’s QMS while ISO 13485 just requires the QMS to be implemented and maintained in an effective manner. Also, the requirement in ISO 9001 for verification of customer satisfaction is not included in ISO 13485.
There are other areas that are required in ISO 13485 that are not mentioned in ISO 9001:
- Management is responsible for the promotion and awareness of regulatory requirements
- There must be controls in place in the workspace to ensure product safety
- Focus on risk management
- Requirements for inspection and traceability
- Requirements for documentation and validation of processes
- Requirements for verification of effectiveness in relation to CAPAs
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