ISO 13485:2016
ISO 13485:2016 is a standard for the establishment and maintenance of a quality management system for medical devices. It provides information for design, development, production, additional services of products and uses as criteria for the reliability or capability of the organization.
- Service Scope
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- International Medical device Quality system specification ISO 13485:2016 certification
- Procedure
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Meeting and Discuss direction
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Documentating Medical device quality system
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Preparing and guiding
on-site insepction -
Audit
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Certified ISO 13485
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- Keyword
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- Strengthening for the contents of regulatory requirements
- Strengthening for risk management
- Strengthening for design management
- Strengthening for validation activities
- Strengthening for the cooperative firm management process
- Strengthening for the feedback process
- Strengthening for the content of identification and traceability
- Strengthening for the contents of corrective and preventive measures
- Strengthening for the content of risk-based approaches to quality control systems
- Strengthening for the contents of the management of human resources and sterilized products
- Strengthening for the contents about a risk-based approach of product realization
- Strengthening for the contents about the definition of measurement, analysis, and improvement processes
