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ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers. ISO 13485 certificate can help you in entering almost any market in the world. It is currently recognized in most major markets (Europe, USA, Canada etc).

While it is based on ISO 9001:2000, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not guarantee compliance with regulatory requirements, but it can facilitate the audit process for those requirements. The ISO 13485 accomplishes a harmonization by writing specific medical device requirements in a generic framework that allows any specific or unique needs of local regulation to be addressed.

13485 dictates that risk management must be thoroughly documented and conducted throughout a product's entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer's management team is charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfill risk-related requirements. While it is not mandatory that a manufacturer be 14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of certification to the latter.

Medical device manufacturers also should realize the importance that risk management bears in a 13485 management system. A lot of places typically look at risk management only at the design and development function and they don't carry it through the entire lifecycle of the product or process