ISO 13485 audit checklist about monitoring and measurement
ISO 13485 audit checklist about monitoring and measurement
Clause 8.2
8.2.1 (Customer satisfaction) Feedback
• How do you obtain information about (customer perception as to) whether Organization has met customer requirements?
• How is this information used?
8.2.2 Internal audit
• Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance)
• Do they determine whether the QMS is effectively implemented and maintained? (Review records)
• Can you show me an audit plan that takes into consideration the importance of the processes and areas to be audited, and the results of previous audits?
• Where are the audit criteria, scope, frequency and methods defined?
• Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial, and that auditors don’t audit their own work?
• Can you show me your internal audit procedure?
• Can you show me the records of internal QMS audits?
• Who ensures that actions are taken to eliminate detected nonconformities and their causes? Are they being taken care of in a timely manner? (verify with records)
• What activities are done to verify the actions taken, and how are the verification results reported?
8.2.3 Monitoring and measurement of processes
• What methods are used to monitor and measure the QMS processes?
• Can you show that they have achieved the desired results?
• When the desired results are not achieved, what actions are taken to ensure that the product meets requirements?
8.2.4 Monitoring and measurement of product
8.2.4.1 General requirements
• What characteristics are checked to verify that product requirements have been met?
• At what stages of the product realization process do monitoring and measuring activities take place?
• Can you show me documented procedures for monitoring and measurement of product?
• How is evidence of conformity with acceptance criteria maintained?
• Can you show me records that indicate who has authorized release of product to the next stage of the process?
• How do you ensure that product is not released until the all requirements have been met?
• If product must be released prior to this, how is it approved?
8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices
• Can you show me records showing the identity of personnel performing inspection or testing?
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