Certification, auditing, verification and training services related to integrated management systems, business processes and system integration

ISO 13485

Standard for medical devices

ISO 13485

ČSN EN ISO 13485 standard was enunciated by Czech office for standards, metrology and testing as a harmonized standard to European standards 93/42/EEC and 90/385/EEC, which makes possible of proving the conformity with requirements from above-cited European standards. Regarding the bigger requirements on the quality management system of producers and suppliers of medical devices the ČSN EN ISO 13485 was developed. ČSN EN ISO 13485 standard contains the criteria for the entire medical devices quality management system.

ČSN EN ISO 13485 certificate applies to the entire management system of an organization which produces and delivers the medical devices and relevant services.

Benefits of ČSN EN ISO 13485 implementation:

  • demonstration of the commitment to observance for legal requirements and law requirements
  • guarantee of the production procedure stability thereby the stable and high quality of provided services and products for customers
  • demonstration of suitability, efficiency and effectiveness of build up quality management system for third party
  • upgrading of management system, company’s organizational structure improvement
  • improvement of an order and increase of efficiency within the company
  • expenses optimization – reduction of operating expenses, decrease of expenses from nonconformity products, savings of raw materials, energy and other resources
  • increase of public and government agencies trust
  • compatibility with the quality management system used in EU countries, faster adaptation of Czech producers to EU requirements