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
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-802 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Superb course to help us manage the transition to ISO 13485:2016
The course is easy to follow and aligns exactly with ISO 13485:2016, great job!
An essential course if you are implementing ISO 13485:2016
Related courses:
ISO 13485:2016 – Chapter 1-3: Introduction
ISO 13485:2016 – Chapter 5: Management Responsibility
ISO 13485:2016 – Chapter 6: Resource Management
21 CFR Part 820 Subpart B – Quality System Requirements
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart E – Purchasing Controls
21 CFR Part 820 Subpart F – Identification and Traceability
21 CFR Part 820 Subpart G – Production and Process Controls
21 CFR Part 820 Subpart H – Acceptance Activities
21 CFR Part 820 Subpart I – Nonconforming Products
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