ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)

Description:

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 4 we will explain documentation requirements, the quality manual, the medical device file, control of documents, control of records and good documentation practices.

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 4: The Quality Management System (QMS)
Documentation requirements – foundation 1 min 35 secs
Documentation requirements – supporting documents 1 min 10 secs
The quality manual 58 mins
Structured to mirror ISO 13485 1 min 12 secs
Graphical representation 1 min 55 secs
The medical device file 1 min 09 secs
The medical device file index 1 min 30 secs
Control of documents 1 min 19 secs
Advantage of numbering documents 1 min 38 secs
Document hierarchy 1 min 42 secs
Approval matrix 1 min 10 secs
Revision history – part 1 50 secs
Revision history – part 2 1 min 21 secs
Release and effective date 1 min 40 secs
Document changes 1 min 38 secs
Revision history – part 3 1 min 27 secs
Administrative changes 1 min 19 secs
Obsolescence of documents 1 min 02 secs
Approved suppler / vendor list 1 min 15 secs
Control of records 1 min 22 secs
HIPAA regulations 1 min 29 secs
Controlled areas 1 min 38 secs
Record retention 1 min 50 secs
Good documentation practices 1 min 40 secs
Signatures and initials – part 1 1 min 01 secs
Signatures and initials – part 2 1 min 08 secs
Date and time format – part 1 1 min 10 secs
Date and time format – part 2 1 min 31 secs
Blue or black pen 50 secs
How to correct documents 1 min 26 secs
Rounding of numbers 1 min 10 secs
Number of pages 1 min 02 secs
Conclusion
Final Assessment
Certification
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