Who is it for?

The ISO 13485 standard is intended for all organisations involved in any way in processes related to medical devices (ranging from plasters to advanced diagnostic equipment). These include entities engaged in:

• the design and development of medical devices,
• the manufacture of medical devices,
• the supply of components for medical devices,
• the storage, packaging and distribution of medical devices,
• the installation and servicing of medical devices,
• the design and development of services related to medical devices,
• the provision of services relating to medical devices (e.g. calibration, sterilisation),
• the disposal of medical devices.

Information about the standard

ISO 13485 is an international quality management system for medical devices. Its guidelines are designed to ensure that such products meet the highest quality standards, and thus comply with applicable legislation and the expectations of end-users.

The implementation of ISO 13485 serves to:

• create a quality management system tailored to the specific nature of the organisation’s activities,
• identify and analyse potential risks associated with its medical devices,
• develop risk minimisation procedures, as well as corrective measures.

The ISO 13485 standard is a standalone standard. However, it can be used in conjunction with the ISO 9001 system, on the basis of which the quality management system for medical devices was developed. The ISO 13485 standard is fully integrated with ISO 9001, but contains requirements specific to medical devices. It also omits certain ISO 9001 guidelines that are not legally necessary in the field of medical devices. Therefore, companies that opt for ISO 13485 certification do not automatically gain proof of compliance with ISO 9001. However, simultaneous certification to both standards is possible.

Benefits of implementation

ISO 13485 certification is recognised worldwide as proof that a company is committed to the safety of medical devices, meets its quality obligations towards its customers, and complies with legal requirements. It serves as a foundation for building the company’s reputation and gaining the trust of business partners and regulatory authorities.

Implementing the ISO 13485 quality management system serves to increase the company’s profitability, minimises risk factors and expands market opportunities. The benefits of applying the ISO 13485 standard include:

• improved quality of products and/or services and work efficiency,
• cost savings resulting from fewer complaints,
• the ability to monitor the medical device supply chain,
• reduction of risks associated with product malfunction,
• the development of transparent processes and proper internal documentation,
• increased competitiveness and a competitive edge in marketing activities,
• better access for the company to domestic and foreign markets.