ISO 13485:2016

ISO 13485:2016 – Chapter 5: Management Responsibility

The learning objectives for this course are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. Also, to provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards. In module 5 we will discuss management commitment, customer focus, quality policy, planning, responsibility, authority and communication and management review.

CEU Credits: 0.1

Course Code: ELM-803

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Module 1: Introduction

Overview

Course introduction

CFR, ICH and The FDA

Challenges facing the medical device industry

Single user license

Course objectives

Module 5: Management Responsibility

Management commitment

Customer focus

Quality policy

Planning

Responsibility and authority

Management representative

Internal communication

Management review – Part 1

Management review – Part 2

Conclusion

Final Assessment

Certification

Author

Don Rackham

Associate Director QA Asterias Biosciences

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