About the Course
Introduction to this course:
This course offers a thorough introduction of the ISO 13485:2016 medical device QMS, emphasizing Clauses 1-4 and including Clause 0, covering introduction, scope, normative references, terms, definitions, and quality management systems.
Who should attend:
This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of ISO 13485:2016.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify key terms and definitions in ISO 13485:2016.
Explain the importance of each clause within Clauses 0, and 1-4.
What will I gain:
Participants will gain a solid understanding of the foundational clauses of ISO 13485:2016, enabling them to ensure compliance and improve their organization’s quality management system.
Prerequisites:
No prior knowledge of ISO 13485:2016 is required, but familiarity with general quality management principles is beneficial.
Additional information:
Course duration: 00:23:07
Course code/version (effective date): L-149/v1.0 (08/09/2023)
Course Categories
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Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
- Lesson 1: ISO 13485:2016: Clause 0. Introduction
- Lesson 2: ISO 13485:2016: Clauses 1 to 4
- Reading: How to prepare for QMSR: The QSR and ISO 13485 Harmonization
-
Additional resources
- Mind map: ISO 13485:2016
-
Survey
- Course survey
About the Course
Introduction to this course:
This course offers a thorough introduction of the ISO 13485:2016 medical device QMS, emphasizing Clauses 1-4 and including Clause 0, covering introduction, scope, normative references, terms, definitions, and quality management systems.
Who should attend:
This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of ISO 13485:2016.
Learning Outcomes:
By the end of this lesson, you will be able to:
Identify key terms and definitions in ISO 13485:2016.
Explain the importance of each clause within Clauses 0, and 1-4.
What will I gain:
Participants will gain a solid understanding of the foundational clauses of ISO 13485:2016, enabling them to ensure compliance and improve their organization’s quality management system.
Prerequisites:
No prior knowledge of ISO 13485:2016 is required, but familiarity with general quality management principles is beneficial.
Additional information:
Course duration: 00:23:07
Course code/version (effective date): L-149/v1.0 (08/09/2023)
-
Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
- Lesson 1: ISO 13485:2016: Clause 0. Introduction
- Lesson 2: ISO 13485:2016: Clauses 1 to 4
- Reading: How to prepare for QMSR: The QSR and ISO 13485 Harmonization
-
Additional resources
- Mind map: ISO 13485:2016
-
Survey
- Course survey
