WHAT IS THIS ALL ABOUT?
The EU Medical Device Regulation (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC) introduced important guidelines for manufacturers. One of these is the implementation of a Quality Management System in accordance with the harmonised standard ISO 13485 by 26 May 2021. What does this mean for manufacturers? How can a company’s use of the System be confirmed?
WHAT IS A QUALITY MANAGEMENT SYSTEM?
A Quality Management System is a set of rules, procedures, records which, by being applied in the day-to-day life of an organisation, will enable it to achieve its quality objectives. The standard for the implementation of the QMS dedicated to medical devices is ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes. This standard specifies the requirements to be met by a company in the following areas: design and development, production, storage and distribution, service and end-of-life and disposal of medical devices.
But what is the difference between implementing a QMS in an organisation and certifying it? The implementation of the QMS itself means that the company operates according to designated standards based on the requirements of established ISO standards, but also the legal requirements to which they are subject. QMS certification is an additional, in most cases voluntary confirmation of the implementation of the system, which is assessed by external certification bodies specialised in this field. After undergoing such an assessment, a positive result results in a certificate being issued by the auditing certification body. Manufacturers of medical devices, depending on the class of products they manufacture, will have to undergo certification or not, according to the new regulation.
MyWam Sp.J., as a manufacturer of Class I medical devices in the form of special wheelchairs for disabled children, is also subject to the above requirements, which means that we have a Quality Management System in place. This means that our products are subject, among other things, to regular quality control based on set standards or a product risk analysis. The QMS itself is subject to regular verification of the effectiveness of the set quality objectives through specified indicators. The implementation of the QMS in accordance with ISO 13485 is confirmed by a company declaration, which, if necessary, we can issue to you after prior CONTACT with us or our business partners.