QMS Certification for Medical Device Manufacturers

ISO 13485

In assessing a quality management system (QMS), international standards and their national alternatives are applied. There are standards that allow assessing the QMS of any company regardless of its business area. For instance, the standards of the ISO 9001 series are widely used. Apart from general standards, there are also industry standards designed to assess the QMS of companies involved in specific lines of activities. ISO 13485 is an example of such industry-specific standard.

ISO 13485 is an international standard designed to assess the QMSs of manufacturers of medical products. GOST ISO 13485 is its national alternative in the Russian Federation.

ISO 13485

Pursuant to Resolution No.46 issued by the Council of the Eurasian Economic Commission on February 12, 2016 setting out rules for registering and reviewing the safety, quality and effectiveness of medical products, QMS implementation and certification for conformity to standard 13485 is a mandatory requirement for manufacturers of medical products.

Manufacturers of medical products get the following advantages by implementing and certifying their QMS
  • The requirement to register medical products is mandatory within the EAEU;
  • Increased trust in the products on the part of consumers and regulators;
  • Ability to participate in tenders and procurement procedures initiated by major customers for whom ISO 13485 certificate is a mandatory requirement or advantage;
  • Ability to build production processes in accordance with the model developed considering the peculiarities of the industry.
Certification stages
1. Application Fill in the application and forward it to the certification body.
2. Assessment Certification services are priced based on the factors referred to below. This stage results in the execution of contract.
3. Document review Stage 1 of the certification process. Detection of violations and assessment of whether the documentation is consistent with the requirements of the standard.
4. Audit Stage 2 of the certification process. Studying the company’s processes and verifying whether the documentation is consistent with the real condition of the company’s management system. The audit results in a report and decision on whether the certificate is to be issued or withheld.
5. Issuing certificate In the event that favorable decision is made, the Customer will be issued a certificate of conformity which will be valid for 3 years.
6. Surveillance audit The 1st and the 2nd surveillance (supervision) audits are conducted annually within the validity term of the certificate.
7. Re-certification The re-certification audit is conducted upon the expiry of the certificate. If favorable decision is made, the Customer will be issued a new certificate of conformity which will be valid for 3 years.
Factors affecting the price of the service:
  • Business area of the company;
  • Number and location of production sites and branches;
  • Headcount.
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