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Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

Executive summary

Guidance on the development, implementation and maintenance of quality management systems for medical devices (ISO 13485:2003).


This International Standard Technical Report provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. It provides guidance related to quality management systems for a wide variety of medical devices and related services, such as active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices. It does not add to, or otherwise change, the requirements of ISO 13485.

This report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance can be used to better understand the requirements of ISO 13485 and to illustrate the variety of methods and approaches available for meeting the requirements of ISO 13485.

The guidance contained in this report can be useful as background information for those representing quality management system assessors, conformity assessment bodies and regulatory enforcement bodies.

History and related standards

This International Standard includes the following cross-reference:

ISO 9000:2000.

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