This is your opportunity to catch nonconformities before the certification authority does and improve your quality as soon as possible. Last, I'd recommend not making this a "check the box" activity by scheduling audits of various areas using a risk-based approach and allowing enough time for each to do a decent job. This second person would be useful for making sure that you don't audit your own work (as already mentioned by Charley). There are many resources for such classes and, depending on the timeframe needed to do the internal audit, I'm sure you and another person (if not already available) could get such training fairly quickly. You've gotten some good advice already but I might also add that showing competency and obtaining practical methods to audit to ISO 13485:2016 could be built by taking an Internal or Lead Auditor class in the standard. This is my first time taking part in an internal audit so would be very grateful if you could help. Does any one have internal audit plan that can kindly share with me. I would need to run an internal audit for our QMS to ensure its compliance with ISO 13485 requirements. This message was posted by a user wishing to remain anonymous Yes, I attached other information I think is good noting the ISO 13485 is primarily risk based approach. Just in case there is an oversight - always remember to ensure all equipment is calibrated and has up to date calibration certificates to go with them. Ensure all employees are able to present, easily find and talk through in detail as for each department standard. These templates can include forms for documenting customer complaints, non-conformities, corrective and preventive actions, internal audit findings, and management reviews. I'm not sure if the attached will help in anyway but please find attached "some" relevant information I got from LinkedIn posts & for this reason I think they are copyright free to post on this forum.įrom my own experience for internal auditing remember that it's only required to know where every single file is stored / located and not a memory game on knowing e.g. Forms and Checklists: Forms and checklists are used to record data, capture information, and facilitate compliance with ISO 13485 requirements.
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