ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.2.2: Review of requirements related to product

The organization reviews product requirements before committing to supply (tender submission, acceptance of a contract or order, acceptance of a change) and ensures product requirements are defined and documented, differences from those previously expressed are resolved, applicable regulatory requirements are met, any user training identified is available or planned, and the organization can meet the defined requirements. Records of the review and resulting actions are maintained. Where the customer provides no documented statement the requirements are confirmed before acceptance. When product requirements change, relevant documents are amended and relevant personnel informed.

Maintained by Gerard BlokdykControl text last updated

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