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EN ISO 13485:2012 (ISO 13485:2003) - Medical devices

 
Information for download in pdf Information material ISO 13485

EN ISO 13485:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes

The Czech Office for Standards, Metrology and Testing promulgated the standard EN ISO 13485:2003 as harmonized with the European directives 93/42/EEC and 90/385/EEC, 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 13485:2012 standard was elaborated. This standard contains criteria for the whole scope of the medical devices quality management system.

The certificate according to EN ISO 13485:2012 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 13485:2012

  • 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

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Application for certification of the system ISO 13485 in MS WordApplication for certification of ISO 13485
Questionnaire for application of the system ISO 13485 in MS WordQuestionnaire for application of ISO 13485

Technical areas of medical devices

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 ISO 9001
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