Standard ISO 13485
The CNCps is the certification body of quality systems of medical devices and has the accreditation ENAC 39/C SG-055 in accordance with the standard UNE-EN ISO 17021: “Requirements for the bodies that carry out audits and the certification of quality systems” for the certification of the voluntary standard and UNE-EN ISO 13485: “Quality Management Systems, Requirements for regulatory purposes”. The validity of the accreditation was renewed in November 2021 including the 32 technical areas of products that can be accredited. The scope of this accreditation can be consulted in theENAC's website. With this accreditation, CNCps offers companies the guarantee of their experience, competence, independence, objectivity and impartiality, as well as an appropriate working method based on the application of quality criteria.
Although the UNE-EN ISO 13485 standard is voluntary, the fact that organizations in the health products sector have a certificate of compliance with it is an added value that offers confidence to authorities and customers, both in Spain and beyond our borders.
If you have a quality management system that meets the requirements of the UNE EN ISO 13485 standard, you can apply for certification under ENAC accreditation to the CNCps. The informative documents and forms for the formalization of the application for the certification of this standard and its maintenance are the following:
- 13485 DEX_1 Rev. 4-Information and certification conditions
This brochure provides detailed information on the certification process of the UNE EN ISO 13485 standard, providing an explanation of how to obtain a budget and submit an appropriate application. Before submitting your application, it is recommended that you read this document. - R_DEX_17_ISO 13485_Rev. 1-Agreement CNCps ISO 13485
This agreement establishes the commitments of the action between the CNCps and the requesting company, as well as the economic considerations during the certification that will be signed by both parties. - 13485_PG-FOR-01_Rev. 9-Application 13485
This form collects the information necessary to make the initial certification request for the evaluation of the quality management system, follow-up audit, recertification or any modification of the certification conditions. - DEX_08_Rev. 4-Plan of corrective actions
This form collects the information necessary to submit the corrective action plan to solve the findings of an audit.
