Detail kurzu

ISO 13485:2016 Standard Training

EDU Trainings s.r.o.

Popis kurzu

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.
Objectives
By participating in this online course, you will be able to:

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

Obsah kurzu

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
Certifikát Na dotaz.
Hodnocení




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