![]() While the editions of the standards do not line up when comparing the contents and requirements, the ISO 13485:2016 requirements over ISO 9001:2015 are highlighted in yellow and the relevant ISO 13485:2016 clause number appears with the audit question. You will see questions on the checklist that refer to the standards and for each clause provisions are made for additional questions. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard as you transition from ISO 9001:2015 to include the requirements of ISO 13485:2016. The checklist is based on information from the 5 th edition of the ISO 9001:2015 and from the 3 rd edition of the ISO 13485:2016 International Standards for Quality Management Systems. ISO 13485 PowerPoint Training Materials. ![]() ISO 13485 Online Training Course Listing.ISO 13485 Internal Auditor Training Courses.ISO 13485 Lead Auditor Training Courses.Simple Steps to ISO 13485 Certification Follow our proven and manageable step-by-step process for a successful ISO implementation project.
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