WHAT IS ISO 13485 AND DSTU ISO 13485?
ISO 13485:2003 “Medical devices – Quality management systems – Requirements for regulatory purposes” is the international standard, which regulates the creation and implementation of the quality management systems in the enterprises producing medical devices and equipment. That standard is used together with ISO 9001:2008 and GMP principles (good manufacturing practice).
The Ukrainian analog for that international standard is DSTU ISO 13485:2015. Its implementation is an indispensable prerequisite for the work on the market for medical products manufacturers and the necessary condition for conducting of the procedure of compliance with the Regulations. Even though the Ukrainian DSTU ISO 13485:2015 is the analog of the international standard ISO 13485:2003, it is valid only on the Ukrainian territory. In other countries the Ukrainian standard is not acknowledged and, correspondingly, has no legal force. Therefore, if any company is aimed at the external market it makes sense to obtain the ISO 13485:2003 certificate.
ADVANTAGES OF IMPLEMENTATION OF ISO 13485
Implementation of ISO 13485 or DSTU ISO 13485 enables the manufacturer to assess, control and optimize practically all stages of the manufacturing of medical devices. This, in turn, helps to find out and eliminate ineffective use of the company’s resources, ensuring effective control of the production and the quality of the products and, consequently, improve the image in the domestic and international markets.
Should the certification according to DSTU ISO 13485 be a mandatory condition for the work of the Ukrainian manufacturers of medical products, the passing of the certification according to ISO 13485 shall certainly not be a mandatory procedure. Enterprises decide independently to pass or not to pass it. But it is necessary to pass this procedure for companies who plan to operate in the foreign markets.
After all the main advantage of the implementation of the Quality management system ISO 13485:2003 is confirmation of the fact, that the manufactured products (medical devices) fully comply with the requirements of the international market. That same certificate ISO 13485:2003 of the international type opens doors for the Ukrainian manufacturers of the medical products to the foreign markets.
HOW TO IMPLEMENT ISO 13485
The process of the implementation of the Quality management system of medical products in the enterprise is pretty labor-intensive and takes a considerable amount of time – sometimes up to several years. It consists of a number of stages – and none should be ignored, after all only exact compliance with the requirements of the standard ISO 13485:2003 can guarantee successful certification. In short, the main stages of the implementation of the standard ISO 13485:2003 can be represented as follows:
Analysis of conformity of the work of the company to the requirements of the standard;
Description of the processes and working out of the necessary/missing procedures and documents, envisaged by
Implementation of the Quality management system;
Conduct of internal audit.
It’s worth remarking that if the company already has the experience of the certification according to DSTU ISO 13485:2005, it shall be somewhat easier to obtain the conformity certificate ISO 13485:2003.
The procedure of the certification of the enterprise concerning conformity to the Quality management system according to ISO 13485:2003 takes less time than the implementation of the given system by itself. In general, the algorithm of the passing for the certification procedure is as follows:
– Analysis of documentation;
– Audit of the system of the quality;
– Analysis of the results of the audit and issuing of the certificates (in case of positive result).
HOW TO PASS THE CERTIFICATION PROCEDURE ACCORDING TO ISO 13485
The IMPROVE MEDICAL is the accredited conformity assessment body according to DSTU ISO 13485:2005 «Medical products. Quality management systems. Requirements concerning regulation» and ISO 13485:2003/Cor 1:2009 «Medical devices – Quality management systems – Requirements for regulatory purposes». Our competence and skills of our personnel have been confirmed by the certificates valid both in the territory of Ukraine as well as abroad.
If your company is interested in obtaining the Certificate of conformity to the system of quality of DSTU ISO 13485:2015 and/or ISO 13485:2003, you may always apply with us and conclude agreements both to conduct the preliminary audit, and to pass the certification procedure.