This standard is addressed to medical device manufacturers as well as suppliers and service providers who have to comply not only with international, European or national legal requirements, but also with corresponding requirements of customers. Examples are the Canadian, US or Japanese requirements as well as the European directives concerning medical devices and in vitro diagnostic devices. With a certificate of conformity to ISO 13485 such enterprises document that their management system satisfies the requirements of that standard. ISO 13485 requires significantly more documented procedures and records than ISO 9001 and focusses on patient and user safety.
- Manufacturers of medical devices of risk classes II to IV according to the Canadian Medical Devices Regulations (CMDR) who want to sell their products on the Canadian market.
- Enterprises that want to develop and manufacture medical devices and place them on the market.
- Service providers and other suppliers within the value-added chain.
Requirements of ISO 13485 as compared to ISO 9001
ISO 13485 requires significantly more documented procedures and records than ISO 9001 and focusses on patient and user safety. Specific features of national law, such as the German Medical Devices Act, have to be taken into account. A safety representative and, if applicable, a medical devices consultant have to be named. Requirements are established concerning preventive maintenance, personal/ambient hygiene, and management of special ambient conditions. A risk management procedure according to ISO 14971 has to be introduced. Clinical assessments and/or results of clinical tests are taken into consideration in the validation of the development process. Validations are also required for production and testing software, if such software has an influence on product quality.
An enterprise holding a certificate of conformity to ISO 13485:
- proves compliance with legal requirements,
- minimizes and controls risks,
- contributes to product safety for patients and users,
- emphasizes the competence of the enterprise,
- prevents errors instead of correcting them,
- improves the quality of performance,
- improves customer and employee satisfaction,
- provides transparency and clarity of internal processes, and saves time and costs.