T5.C01 – Management System Documentation and Document Control
A course by
Sep/2026
8 lessons
English
Description
Curriculum
Instructor
What you’ll learn
- Understand the general management system requirements and minimum required elements under Clause 8.1
- Structure the documentation hierarchy from quality manual through processes, procedures, and forms
- Apply document control requirements for creation, approval, unique identification, and version control
- Manage document changes and control the retrieval, marking, and retention of obsolete documents
- Plan significant changes to the management system with impact assessment and integrity preservation
- Implement management system changes with proper resourcing, validation, and post-implementation review
Track 5 course, based on Chapter 20 of Quality Management in Clinical Laboratory Demystified by Dr. Taleb Chalab Cham. Self-paced. 8 lessons plus 8 graded quizzes, ~0.7 hours total.
- 1 Section
- 8 Lessons
- 44 Minutes
Expand all sectionsCollapse all sections
- Course ContentAll lessons and their graded quizzes, in order. Self-paced.16
- 1.1Introduction2 Minutes
- 1.2Quiz 0 — Introduction8 Minutes5 Questions
- 1.3Lesson 1. General Management System Requirements7 Minutes
- 1.4Quiz 1 — General Management System Requirements8 Minutes5 Questions
- 1.5Lesson 2. Documentation Hierarchy7 Minutes
- 1.6Quiz 2 — Documentation Hierarchy8 Minutes5 Questions
- 1.7Lesson 3. Document Control: Creation and Approval7 Minutes
- 1.8Quiz 3 — Document Control: Creation and Approval8 Minutes5 Questions
- 1.9Lesson 4. Document Control: Changes and Obsolescence7 Minutes
- 1.10Quiz 4 — Document Control: Changes and Obsolescence8 Minutes5 Questions
- 1.11Lesson 5. Planning for Changes to the Management System7 Minutes
- 1.12Quiz 5 — Planning for Changes to the Management System8 Minutes5 Questions
- 1.13Lesson 6. Implementing Changes6 Minutes
- 1.14Quiz 6 — Implementing Changes8 Minutes5 Questions
- 1.15Lesson 7. Summary2 Minutes
- 1.16Quiz 7 — Summary8 Minutes5 Questions
8 Students5 Courses
Review
$25.00$15.00
100% positive reviews
1 student
8 lessons
Language: English
8 quizzes
Assessments: Yes
Available on the app
Unlimited access forever
Skill level All levels
Courses you might be interested in
Why laboratory quality management exists and how it protects patients What a quality management system is, and the Twelve Quality System Essentials The history of laboratory quality, from Shewhart’s control...
-
8 Lessons
$25.00$15.00
What you’ll learn Understand what qualifies as a quality record and the characteristics of a good record Uniquely identify records and amend them traceably without obscuring the original Store and...
-
8 Lessons
$25.00$15.00
What you’ll learn Identify risks and opportunities for improvement across the total testing process Assess and prioritize risks using severity, likelihood, and detectability scoring Select proportionate risk treatment options and...
-
8 Lessons
$25.00$15.00
What you’ll learn Identify nonconformities from any source and react with immediate containment and escalation Apply root-cause analysis techniques including 5 Whys, Fishbone diagrams, and fault tree analysis Determine whether...
-
8 Lessons
$25.00$15.00
$25.00$15.00