Source: https://learnaboutgmp.com/elearning/iso-134852016-chapter-4-quality-management-system-qms/
Timestamp: 2018-02-22 06:32:21
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ISO 13485:2016 – Chapter 4: The Quality Management System (QMS) - Learnaboutgmp
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)
Home » Library » ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)
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.
CFR, ICH and The FDA
Challenges facing the medical device industry
Module 4: The Quality Management System (QMS)
Documentation requirements – foundation
Documentation requirements – supporting documents
Structured to mirror ISO 13485
The medical device file
The medical device file index
Advantage of numbering documents
Revision history – part 1
Revision history – part 2
Release and effective date
Revision history – part 3
Obsolescence of documents
Approved suppler / vendor list
Signatures and initials – part 1
1 min 01 secs
Signatures and initials – part 2
Date and time format – part 1
Date and time format – part 2
How to correct documents
B.S. in Molecular Biology from SJSU
Results-oriented-quality professional with over twenty years of experience in the life sciences, clinical diagnostics and the pharmaceutical industry. Extensive technical expertise in cellular analysis techniques and methods, and experience in a GMP/GLP environment.
Course code: ELM-802
Superb course to help us manage the transition to ISO 13485:2016
Alan Freeman | Compliance Director
The course is easy to follow and aligns exactly with ISO 13485:2016, great job!
Ralph Padilla | Quality Manager
An essential course if you are implementing ISO 13485:2016
Rochelle Dixon | Senior Manager
ISO 13485:2016 – Chapter 1-3: Introduction
COURSE CODE: ELM-801
21 CFR Part 820 Subpart A – General Provisions
COURSE CODE: ELM-301
21 CFR Part 820 Subpart C – Design Controls
COURSE CODE: ELM-303
21 CFR Part 820 Subpart D – Document Controls
COURSE CODE: ELM-304
21 CFR Part 820 Subpart E – Purchasing Controls
COURSE CODE: ELM-305
21 CFR Part 820 Subpart F – Identification and Traceability
COURSE CODE: ELM-306
21 CFR Part 820 Subpart H – Acceptance Activities
COURSE CODE: ELM-308
21 CFR Part 820 Subpart I – Nonconforming Products
COURSE CODE: ELM-309