ISO 13485:2016 Standard Training
ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Estimated to take up to 10-hours to complete, this is a self paced course.
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Zkuste živý kurz virtuálněTarget group
This course is for you if you want to:
- Quickly and efficiently understand the higher level requirements for top management
- Improve your curriculum vitae and career opportunities with qualifications in ISO 13485:2016
- Upgrade your internal auditing expertise from ISO 13485:2003 or ISO 9001:2018 to ISO 13485:2016
- Train top management economically and without the added cost of travel
What will you learn
- Identify the clauses within the standard
- Summarize the high level requirements and intent of this international standard
- Explain the process approach and its relationship to managing an organization
- Explain how the requirements can be interpreted and implemented
Course structure
- Introduction to ISO 13485
- Risk-based thinking
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis, and improvement
Materials Provided
- 365 days of online single-user access (from date of purchase) to the approximately 10 hours of instruction
- Continuous assessment to check knowledge and application of key concepts
- Follow-up to your content questions
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