Health product
ISO 13485
Implementation and internal audit

Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices need to implement an ISO 1348 5 Quality Management System to control, record and evidence the control of their processes. The implementation of ISO 13485 is a requirement of the Regulation (Regulation (EU) 745/2017 MDR and Regulation (EU) 746/2017 on In Vitro Diagnostic Medical Devices (IVDR). deviCE Sistemas adapts the requirements of the ISO 13485 standard to the needs of the company, so that an efficient, useful and user-friendly Quality Management System is developed.

The UNE-EN-ISO 13485 Standard is the reference standard for the development and implementation of a Quality Management System for manufacturers and other actors involved in the life cycle of a Medical Device and an In Vitro Diagnostic Medical Device. ISO 13485. This is a Harmonised European Standard whose purpose is to establish requirements for the fulfilment of regulatory purposes, as specified in its title.

This does not mean that with its implementation, legal compliance is definitively demonstrated, but rather that its implementation is directed towards this compliance.

The fundamental and basic pillar of the ISO 13485 Quality Management System is the management of the risks of the medical device, i.e. the identification and evaluation of the risks of the medical device is the basis that will determine the need for the necessary resources in the organisation for the design, manufacture, preservation, etc. of the device, both at the level of infrastructure and of specially trained people.

Once the characteristics of the product are known based on the requirements established by the client and the regulations, the risk it may have will be determined depending on the production processes and as mentioned above, its own characteristics and form of use.

This graphic establishes the dynamics determined by ISO 13485.

The scope of the ISO 13485 Management System can be the design, development, production, storage, distribution, installation, technical assistance, de-installation and disposal of medical devices, and therefore, the manufacturer or the actor that is going to implement the Standard must clearly establish to which of its processes it will apply. The exact definition of the scope, as well as the determination of exemptions or non-applications, is crucial.

If the company decides to be certified against ISO 13485, the scope of the Quality Management System will be clearly identified in the Certificate. This scope can be extended in subsequent certifications if the company so wishes.

ISO 13485 can be implemented by all the agents involved in the life cycle of the medical device, both agents related to manufacturing or development and service providers, such as sterilisers, warehouse managers, medical device distributors, equipment calibration laboratories, etc.

The ISO 13485 Quality Management System is a system based on the PDCA cycle or Deming Wheel. In other words, once the product(s) to be produced or the services to be provided by the company, their characteristics and requirements are known, the first step is to plan the system itself, determining the processes to be carried out to meet the needs of the company and the product. Together with the processes, the management’s policy of action in this respect will be determined, as well as the specific objectives and the establishment of the necessary resources by the management. Human and infrastructure resources.