Quality management systems of manufacturers of medical devices
The ISO 13485 standard is an international industry standard developed by the International Organization for Standardization (ISO) to facilitate the implementation of harmonized established requirements in quality management systems and to ensure global alignment of appropriate regulatory requirements for medical devices.
The ISO 13485 standard of the current version of 2016 is based on the updated version of the ISO 9001:2015 standard, but the structure of sections of the standards no longer coincides. The standard also includes a number of special requirements for organizations and includes a number of ISO 9001 requirements that are not related to regulatory requirements. With this in mind, organizations whose quality management systems comply with the ISO 13485 standard can no longer claim full compliance with the ISO 9001 standard.
ISO 13485:2016 establishes the QMS requirements that can be applied by an organization involved in one or more stages of the life cycle of a medical device, including the design and development, production, storage and distribution, installation, maintenance and final decommissioning and disposal of medical devices, as well as the design and development or provision of related services (e.g. technical support). The requirements of this Standard may also be used by suppliers or other external parties providing products (e.g. raw materials, components, medical devices, sterilization, calibration, distribution, maintenance services) to such organizations.
The ISO 13485 standard can be used jointly or separately with other management system standards.
The implementation and certification of compliance with the requirements of ISO 13485 allows to increase the company’s competitiveness, demonstrate compliance with international and local legislation in the field of medical devices, enter new sales markets, improve the quality and safety of products, taking into account the risk management system.
Benefits of implementation and certification:
- possibility to export many medical devices to the countries of the customs union and the EU;
- ensuring the economic stability of the organization in the existing market of manufacturers of medical devices and the ability to enter new sales markets;
- high level of harmonization of the standard with other international standards, including ISO 9001 and GMP, which simplifies the creation of integrated management systems;
- systematization of the organization’s activities through the application of a process approach, improving the efficiency of resource management;
- improving the quality of products, as well as their commercial value in terms of greater consumer confidence and, as a result, increasing sales;
- improving the organization’s image, demonstrating commitment to international standards, best practices and product quality, as well as compliance with current legal and regulatory requirements;
- additional advantage of participating in tenders.