What is an ISO 13485 Quality Management System?
ISO 13485:2003 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. This is a process-based system and contrasted to the procedure-based system of QSR and ISO 9001.
Manufacturers of Medical Devices are subject to specific legislative fulfilments. Medical Devices intended for diagnostic or therapeutic use, must comply with stringent requirements for safety and effectiveness .The medical device industry throughout the world will move toward adopting the new ISO 13485:2003 as the preferred quality system standard.
Another important aspect of ISO 13485:2003 is the inclusion of risk management throughout the quality system process, thus providing for a risk-based approach for determining a level of rigor when implementing the standards.
ISO 13485 is based on ISO 9001, there are some key differences and additional requirements, in addition to product-specific demands and more stringent documentation requirements. ISO 13485 calls for risk management to be in place for all stages of product realization, training and supervision of staff, project site specs, and prevention of contamination. Clinical evaluation must be carried out as part of design and development evaluation in line with regulatory requirements. The cleanliness of products and contamination control must be considered, as must the status of the product with respect to monitoring and measurement.
In brief, ISO 13485 provides system where the experience, clear point of view and judgement are applied systematically in order to manage the risks related to medical device use. This system was specially developed for medical device manufacturers that use principles based on risk management. For all other participants for example, the ones from the health industry, this standard can be used as informative guidance in the development and maintenance of the system and the risk management processes. This standard manages the risk management processes primarily to patient/user, but also to the operator, other equipment and the environment.
According to the International Standards Organization, from 2004 through 2013 a total of 22,950 ISO 13485 certificates were issued worldwide throughout 93 countries.
What are the benefits of being certified to ISO 13485?