![]() The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situationsincluding managing the audit process and completing reportingvia hands-on workshops and two competency exams (MD & AU). "About this title" may belong to another edition of this title. Once you understand why to implement 13485, you can follow this checklist of ISO 13485 implementation steps to get started with the project. The ISO 13485:2016 Internal Audit Checklist This checklist is based on the information provided in the release of the ISO 13485:2016 international standard. As an official consultant for the European Union he assists governments in Asia and Eastern Europe in setting up their ISO 9000 accreditation schemes he is a public speaker and contributor of articles at conferences and professional publications and he is an active auditor collaborating with major international registrars. The internal audit checklist will help the organization ensure that its processes and procedures comply with the requirements of ISO 13485. He is a prominent figure in the world of quality and environmental management systems. Kanholm's experience with auditing and certifying management systems dates back to the first European ISO 9000 certifications in the mid-eighties. He is a Registered Lead Assessor licensed by the International Register of Certified Auditors (IRCA), a Lead Auditor under the Registrar Accreditation Board (RAB) Assessor Registration Scheme, and an AIAG certified Lead Auditor. Jack Kanholm holds an Engineering Master of Science degree from the Technical University of Denmark.
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