What is ISO 13485 and DSTU ISO 13485?
ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes” is an international standard that regulates the creation and implementation of quality management systems in enterprises engaged in the production of medical devices, machinery, and equipment. This standard is generally applied in conjunction with ISO 9001:2015 and the principles of GMP (Good Manufacturing Practice). The Ukrainian analogue of this international standard is DSTU ISO 13485:2018. Its implementation is an obligatory condition for the work on the market for manufacturers of medical products and a necessary condition for the procedure of compliance with the Technical Regulations.
But although the Ukrainian DSTU ISO 13485:2018 is an analogue of the international ISO 13485:2016, its validity applies only to Ukraine. In other countries, the Ukrainian standard has not yet been recognized and accordingly, has no legal force. Therefore, if a company is focused on foreign markets, then it makes sense for it to receive ISO 13485:2016 certification.
Benefits of implementing ISO 13485
The implementation of ISO 13485 or DSTU ISO 13485 allows the manufacturer to evaluate, control and optimize almost all stages of the production of medical devices. This, in turn, helps to identify and eliminate the inefficient use of company resources, ensure effective control over production and product quality and, consequently, enhance its image in the domestic and international markets. While DSTU ISO 13485 certification is a prerequisite for the work of Ukrainian manufacturers of medical products, ISO 13485 certification is not a mandatory procedure. Enterprises decide on their own whether to pass it or not. But for those companies that plan to work in foreign markets, this procedure must be completed. After all, the main advantage of implementing the ISO 13485:2016 quality management system is confirmation of the fact that the manufactured products (medical devices) fully comply with the requirements of the international market.
How to use ISO 13485?
The process of introducing a quality management system for medical devices at the enterprise is a complex and time-consuming process that takes sometimes up to several years. It consists of many stages – and none of them can be ignored, because only exact compliance with the requirements of the ISO 13485:2016 standard can guarantee successful certification. In short, the main stages of the implementation of the ISO 13485:2016 standard can be depicted as follows:
- analysis of the compliance of the company’s work with the requirements of the standard;
- description of processes and development of necessary/missing procedures and documents defined by the standard;
- implementation of a quality management system;
- conducting an internal audit.
It should be noted that if a company already has experience in certification according to ISO 13485:2016, then it will be a little easier to obtainDSTU ISO 13485:2018 certificate of conformity.
How to pass the ISO 13485 certification procedure
IMPROVE MEDICAL is an accredited conformity certification body in accordance with ISO 13485:2016 “Medical devices- Quality management system-Requirements for regulatory purposes”, and DSTU ISO 13485:2018 “Medical devices – Quality management systems – Requirements for regulatory purposes”. Our competence and qualifications of our employees are confirmed by certificates valid both in Ukraine and abroad.
If your company is interested in obtaining a Certificate of Conformity to the Quality System according to ISO 13485:2016 and/or DSTU ISO 13485:2018, you can always contact us to sign agreements both for conducting a preliminary audit and for passing the certification procedure.
.Contact us by phone +38 044 355 50 30 or by e-mail info@improvemed.com.ua and our experts will be happy to help you in your business.
