ISO 13485 audit checklist about Customer-related processes
ISO 13485 audit checklist about Customer-related processes
Clause 7.2
7.2.1 Determination of requirements related to the product
How does Organization determine each of the following requirements?
• Requirements specified by the customer, including the requirements for delivery and post-delivery activities,
• Requirements not stated by the customer but necessary for specified or intended use, where known,
• Statutory and regulatory requirements related to the product, and
• Any additional requirements determined by the organization.
7.2.2 Review of requirements related to the product
• What kind of review is done to ensure that the organization has the ability to meet requirements before committing to supply product?
• How do you ensure that product requirements are defined, documented, and reviewed before committing to supply product?
• How do you ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product?
• Can you show me records of the product requirement review results and actions resulting from them?
• When customers don’t have documented requirements, how do you confirm their requirements before accepting orders?
• When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes?
7.2.3 Customer communication
What method(s) are used to communicate with customers regarding
• Product information?
• Enquiries, contracts, or order handling, including amendments?
• Feedback, including customer complaints?
• Advisory notices?
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