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course med DNV Business Assurance
ISO 13485:2016 Foundation Course
Pris pr. deltager
Kursus
6.800,00 DKK
306,00 DKK
I alt ekskl. moms
7.106,00 DKK
25% moms
1.776,50 DKK
I alt inkl. moms
8.882,50 DKK
Se tilgængelighed
About ISO 13485:2016 Foundation Course Course Objectives This course pack is designed to help you to understand; • Quality/ medical management system • Interpreting the requirements of the ISO 13485 • The benefits of implementation At the end of this course, participants should be able to describe: • Gain detailed knowledge of the Clauses of ISO 13485:2016 • Understanding of important Terms and Definitions • The relationship between ISO 13485:2016 and other quality management standards (e.g. ISO 9001:2015) • The importance of understanding regulatory requirements for the market you serve. Who can attend this course This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, or who simply want to further their knowledge of the ISO 13485 standard. Recommended follow-up courses ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving Course agenda Session 1: Delegate Introduction Background and introduction ISO 13485:2016+Amd 11 Chapter 4 Quality Management System, Chapter 5 Management Responsibility and Chapter 6 Resource Management Session 2 after lunch: Chapters 7 Product Realization and Chapter 8 Measurement, Analysis and Improvement Session 3: Test
Foredragsholder: DNV Business Assurance
Varighed: minutter
Sprog: Dansk
Tilgængelighed:
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