About the Course
Introduction to this course:
This course comprehensively covers Clauses 5 and 6 of the ISO 13485:2016 medical device QMS. Clause 5 details requirements for management responsibility, resource management, and process determination within the quality management system. Clause 6 focuses on planning for the production, installation, and servicing of medical devices.
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 the main responsibilities in Clauses 5 and 6: management commitment, customer focus, quality policy, and planning.
Explain the significance of management commitment in implementing a QMS, emphasizing how it influences the overall effectiveness of the QMS.
Demonstrate how to establish and communicate quality objectives within an organization, ensuring they meet the SMART criteria (Specific, Measurable, Achievable, Relevant, Time-bound).
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: 00:15:11
Course code/version (effective date): L-1410/v1.0 (05/10/2023)
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Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
- Lesson 1: Management and Responsibility: Clauses 5.1 to 5.4.
- Lesson 2: Management and Responsibility: Clauses 5.5 and 5.6
- Lesson 3: Resource Management: Clause 6
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Additional resources
- Mind map: ISO 13485:2016
About the Course
Introduction to this course:
This course comprehensively covers Clauses 5 and 6 of the ISO 13485:2016 medical device QMS. Clause 5 details requirements for management responsibility, resource management, and process determination within the quality management system. Clause 6 focuses on planning for the production, installation, and servicing of medical devices.
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 the main responsibilities in Clauses 5 and 6: management commitment, customer focus, quality policy, and planning.
Explain the significance of management commitment in implementing a QMS, emphasizing how it influences the overall effectiveness of the QMS.
Demonstrate how to establish and communicate quality objectives within an organization, ensuring they meet the SMART criteria (Specific, Measurable, Achievable, Relevant, Time-bound).
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: 00:15:11
Course code/version (effective date): L-1410/v1.0 (05/10/2023)
-
Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
- Lesson 1: Management and Responsibility: Clauses 5.1 to 5.4.
- Lesson 2: Management and Responsibility: Clauses 5.5 and 5.6
- Lesson 3: Resource Management: Clause 6
-
Additional resources
- Mind map: ISO 13485:2016
