ISO 13485 audit checklist about purchasing management
ISO 13485 audit checklist about purchasing management
Clause 7.4
7.4.1 Purchasing process
• How do you ensure that purchased product conforms to specified requirements?
• Can you show me a documented procedure for this?
• How do you determine the type and extent of control applied to the supplier and the purchased product?
• How do you evaluate and select suppliers? (based on their ability to supply product in accordance with Organization’s requirements)
• Can you show me the criteria for selection, evaluation and re-evaluation of suppliers?
• Can you show me records of the results of supplier evaluations and any necessary actions? (verify that criteria have been met)
7.4.2 Purchasing information
• Do orders/contracts include requirements for approval of product, procedures, processes and equipment?
• Do require any qualification of supplier personnel? If so, can you show where the requirement is documented?
• Do you have any QMS requirements of your suppliers? If so, can you show me where they are required?
• How does Organization ensure the adequacy of purchasing requirements before communicating them to the supplier?
• Documents and records?
7.4.3 Verification of purchased product
• What inspection or other activities are used to ensure that purchased product meets your purchasing requirements?
• Do you ever perform product verification at the supplier’s site?
• If so, where are the verification arrangements and method of product release identified?
• Can you show me records of onsite verification?
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