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ISO 13485:2016 Overview
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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 four-hours to complete, this ISO 13485 overview is an overview.
Objectives
By participating in this online course, you will understand:
The high level requirements and intent of this international standard
The methods to managing an organization’s QMS in compliance with ISO 13485:2016
How the requirements can be interpreted/should be implemented within an organization
Objectives
By participating in this online course, you will understand:
The high level requirements and intent of this international standard
The methods to managing an organization’s QMS in compliance with ISO 13485:2016
How the requirements can be interpreted/should be implemented within an organization
Obsah kurzu
General Requirements of ISO 13485:2016Section 4. General and Documentation Requirements
Section 5. Management Responsibility
Section 6. Resource Planning
Section 8. Measurement, Analysis, and Improvement
Materials Provided
365 days of online single-user access (from date of purchase) to the approximately 4 hours of instruction
Continuous assessment to check knowledge and application of key concepts
Follow-up to your content questions
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