Certification of management system – 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 ISO 13485:2003 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, ISO 13485:2003 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 ISO 13485:2003 standard applies to the whole management system of an organization manufacturing or supplying medical devices and related services.

Benefits of certification

  • 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 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).

Certification by the accredited certification body

  • 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:
    1. examination of the client”s documentation
    2. 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.

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