ISO 13485 audit checklist about Planning of product realization
ISO 13485 audit checklist about Planning of product realization
Clause 7.1
1. Where are the processes needed for product realization identified?
2. Is the planning of product realization consistent with the requirements of the other processes of the QMS? (Verify there are no inconsistencies or conflicts between quality system procedures)
3. Where in the product realization process do you determine the quality objectives and requirements for products?
4. When planning for product realization, how do you establish processes, documents, and provide resources specific to the product
5. How do you determine verification, validation, monitoring, inspection and test activities specific to the product, and the criteria for product acceptance?
6. What records exist showing that both the realization processes and the product meet requirements?
7. What are the outputs of product realization planning? Are they in a form suitable for Organization?
8. Documented requirements for risk management?
9. Records?
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