Certification of management system - ISO 13485

iso 13485

Principle of certification according to ISO 13485

The certificate issued by an independent accredited certification body guarantees that the quality management system of a supplier and manufacturer of medical devices has been established, documented, used and maintained in accordance with the requirements of EN ISO 13485:2012 standard.

As more stringent quality management system demands are placed on suppliers and manufacturers of medical devices, ISO 13485/13488:2001 standard has been developed, extending the requirements of ISO 9001 standard (sterilization, technical documentation requirements, traceability, etc.).

In 2003, EN ISO 13485:2012 standard was published as a revised standard, with structure corresponding to ISO 9001:2000 and containing criteria for the whole range of the quality management system for medical devices. The certificate according to EN ISO 13485:2012 standard applies to the whole management system of an organization manufacturing or supplying medical devices and related services.

Benefits of certification

iso 13485
  • Guarantee of production process stability and thus steady and high quality of services and products supplied to customers;
  • Simplifying the process of attestation of conformity to requirements of EU directives and corresponding Government Orders;
  • Attestation of efficiency and effectiveness of the established quality management system by an independent third party;
  • Optimization of costs " reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources savings,
  • Enhancing trust of public and public monitoring bodies in respect of the medical devices manufacturer.

Certification process

The certification process consists of the following basic phases:

  • Processing of documentation
  • Implementation of a QMS
  • Certification by an accredited certification body
    • evaluation and filing of the certification request of the client
    • concluding an agreement on certification audit (certification audit is divided into two steps)
    • appointing a team of auditors
    • preparation of an audit plan
    • verification of facts in the following stages:
      1. examination of client documentation
      2. verification of facts in situ
    • preparation of a report on the results of the certification audit
    • assessment of the audit report by a certification body
    • issuance of the certificate
  • Surveillance Audit
    The surveillance audit is done once a year during the three-year period of validity of the certificate. Based on the result of the surveillance a decision on the verification of validity of the certificate is issued, which is valid until the next surveillance or decision on suspension of the certificate. In the event that there are substantial deviations from the requirements of the standards, the certificate may be revoked in extreme cases.

Certification by the accredited certification body No. 3002

  • Registration of the application
  • Agreement for conducting a certification audit (Note: the certification audit is conducted in two stages)
  • Appointing a team of auditors
  • Preparing an audit plan
  • Audit " verification of facts in the following stages:
    a) examination of the client"s documentation
    b) checking facts on site
  • Elaboration of the Certification Audit Report
  • Assessment of the Audit Report by the Certification Body
  • Issuing the Certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year. One of the following is issued depending on the surveillance findings

  • Decision on confirmation of the certificate validity until the next surveillance;
  • Decision on suspension of the certificate;
  • Decision on withdrawal of the certificate in case of fundamental deviations from requirements of standards.


Fields covered by accreditation

  • Manufacture of chemical substances, preparations and man-made fibres
  • Manufacture of rubber and plastic products
  • Manufacture and repairs of other machines and equipment
  • Production of electrical and optical devices and equipment

If you wish to get ISO 13485 certification, please send us an enquiry.

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