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course med DNV Business Assurance
ISO 13485:2016 Internal Auditor Course
Pris pr. deltager
Kursus
13.600,00 DKK
612,00 DKK
I alt ekskl. moms
14.212,00 DKK
25% moms
3.553,00 DKK
I alt inkl. moms
17.765,00 DKK
Se tilgængelighed
About ISO 13485:2016 Internal Auditor Course Content: • ISO 19011:2018 introduction • ISO 13485:2016 introduction and focus on checklists each chapter one day • How to plan and conduct effective audits for ISO 13485 including preparation of checklists • Workshop on Preparation of checklists and presentation Who should attend: The training is for all individuals and organizations who need to perform internal or external audits (supplier audits) within a medical device life-cycle based on ISO 13485:2016. You will learn how to plan and perform audits, how to use the ISO 13485 to prepare checklists and how to report the audit. What will you learn: • Have an understanding of ISO 19011 and its benefits • Have an understanding of the principles and the benefits of ISO 13485 auditing • Have obtained the skills necessary to plan and conduct audits based on ISO 13485 • Be able to plan, prepare, conduct and report on internal audits against ISO 13485 Course Leader: Anette Sjögren, PREVENTIA AB Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Anette is also a member of the new task force for Annex L (high level structure). Language: The training is held in English.
Foredragsholder: DNV Business Assurance
Varighed: minutter
Sprog: Dansk
Tilgængelighed:
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