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GHTF/SG3/N15R8 FINAL DOCUMENT Title: Implementation of risk management principles and activities within a Quality Management System Authoring Group: GHTF Study Group 3 Endorsed by: The Global Harmonization Task Force Date: May 20, 2005 Abraao Carvalho, GHTF Chair This document was produced by the Global Harmonization Task Force, a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement o f any kind by the Global Harmonization Task Force. Copyright ? 2000 by the Global Harmonization Task Force GHTF Study Group 3 SG3/N15R8 Page 2 of 23 IMPLEMENTATION OF RISK MANAGEMENT PRINCIPLES AND ACTIVITIES WITHIN A QUALITY MANAGEMENT SYSTEM 1. Introduction 1.1. Purpose 1.2. Scope 2. Definitions 3. General 3.1. Documentation 3.2. Communication 4. Management Responsibilities 5. Outsourcing 6. Planning 7. Design and Development 7.1. Design and development planning 7.2. Design and development input 7.3. Design and development outputs 7.4. Design and development review 7.5. Design and development verification 7.6. Design and development validation 7.7. Control of design and development changes 7.8. Design and development transfer 8. Traceability 9. Purchasing Controls and Acceptance Activities 9.1 Purchasing Controls 9.2 Acceptance Activities 10. Production and Process Controls 10.1. Manufacturing, Measuring and Monitoring Equipment 10.2. Work Environment and Personnel 10.3. Process Valida