What is ISO 13485:2016? ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers.
The standard details requirements for a quality management system (QMS) that meets both customer requirements and regulations in the European Union (EU), Canada and other major jurisdictions around the world.
Certification to ISO 13485 by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives. In the U.S. the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR).
- Interpret the basic requirements of ISO 13485 as it relates to quality management systems.
- Apply the process approach to managing a company’s quality system, its control and effectiveness.
- Compare ISO 13485 with ISO9001 and the FDA’s QSR requirements with the view of implementing the Standard.
- Consider roles and responsibilities of auditors and management with specific reference to ISO 13485:2016
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