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ISO 13485:2016 Clause by Clause Classroom Training
Length of Course
2 Days
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
Level of Difficulty
Beginner (no knowledge at all of the topic).
This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016. The course introduces the concepts needed to understand, develop, and implement a quality management system.
ISO 13485:2016 is an internationally agreed upon set of standard quality management system (QMS) requirements for any company involved in the design, production, installation, servicing and manufacturing of medical devices. ISO 13485:2016 contains 8 clauses as part of its requirements. In this course participants will gain an understanding of the contents of each clause.
On completion of this training, participants will be able to:
- Describe the fundamentals of quality management systems
- Explain the purpose, structure and requirements of ISO 13485
- Apply a process of implementing a quality management system that meets the requirements of ISO 13485
- Prepare for ISO 13485 certification
- Interpret all Clauses of ISO 13485:2016 to accurately address your company’s role in the medical device supply chain.
- Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
- Management representatives
- Implementation team members
- Auditors (internal or external/supply chain).
- Quality managers.
- Regulatory affairs personnel.
- Those involved in the design, production, subcontract manufacturing, importation, distribution, installation, servicing or appointed as authorized representatives in the medical device sector.