ISO 13485:2016 Certification

ISO 13485:2016 - Medical devices

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about ISO 13485:2016

What is the ISO 13485:2016 Certification?

ISO 13485:2016 is an international standard for quality management systems (QMS) specifically designed for organizations involved in the design, development, production, installation, and servicing of medical devices and related services.

Key elements of ISO 13485:2016 include:

Scope: Quality management system for medical devices and related services.

Terms and Definitions: Clarifies key terminology used within medical device quality management.

Management Responsibility: Top management ensures effectiveness, commitment, and leadership for compliance.

Resource Management: Ensuring adequate resources for efficient quality management system operation.

Product Realization: Planning, designing, developing, and delivering medical devices according to requirements.

Improvement: Continuously enhancing QMS effectiveness through monitoring, analysis, and corrective actions.

What is the goal of ISO 13485:2016?

The primary goal of ISO 13485:2016 is to establish a comprehensive quality management system (QMS) specifically tailored to the requirements of organizations involved in the design, development, production, installation, and servicing of medical devices and related services.

Who needs ISO 13485:2016 Certification?

ISO 13485:2016 is essential for any organization involved in the design, development, production, installation, and servicing of medical devices and related services. This includes: Manufacturers of medical devices, Healthcare facilities, Service providers etc. .