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.

Curriculum for this course:
Module 1: Introduction
Overview 45 secs
Course introduction 1 min 31 secs
CFR, ICH and The FDA 1 min 21 secs
Challenges facing the medical device industry 1 min 10 secs
Single user license 58 secs
Course objectives 1 min 09 secs
Module 5: Management Responsibility
Management commitment 1 min 32 secs
Customer focus 1 min 16 secs
Quality policy 1 min 20 secs
Planning 1 min 58 secs
Responsibility and authority 1 min 52 secs
Management representative 1 min 09 secs
Internal communication 1 min 16 secs
Management review – Part 1 1 min 19 secs
Management review – Part 2 1 min 38 secs
Final Assessment

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