EN ISO 13485:2016 - Medical devices
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EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
The Czech Office for Standards, Metrology and Testing promulgated the standard EN ISO 13485:2016 as harmonized with the European directives 93/42/EEC, 90/385/EEC and 98/79/EC, which permits their use for demonstration of conformity with requirements of the above European directives.
With respect to increased demands on quality management system of medical devices suppliers and manufacturers EN ISO 13485:2016 standard was elaborated. This standard contains criteria for the whole scope of the medical devices quality management system.
The certificate according to EN ISO 13485:2016 standard covers the whole system of management of the organisation manufacturing or supplying medical devices and appropriate services.
Benefits of the quality management system certification according to EN ISO 13485:2016
- Demonstration of commitment to meet legal and regulation requirements
- Guarantee of constancy of a production process and thus of a stable and high quality of services rendered and products supplied to customers
- Demonstration of suitability, efficiency and effectiveness of the implemented quality management system by a third independent party
- Increase in quality of the management system, improvement of the organisation's organisational structure
- Improvement of order and an increase in effectiveness in the entire organisation
- Optimisation of costs - reduction in operating costs, decrease in costs of non-conforming products, savings in raw-materials, energy and other resources
- Increase in confidence of public and state control bodies in manufacturer of medical devices
Offer of CQS services
- Situation audits
- Certification audits (two-stepped), recertification audits
- Audits conducted in the English, German or Russian languages
- CQS certificates and IQNET international certificates
Application for certification
Technical areas of medical devices
License
Criteria for using of certification marks CQS and IQNET in pdf
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