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GHTF Study Group 3 - Quality Systems

This page contains final documents produced by the GHTF Study Group 3. For a list of archived documents, see GHTF Archived Documents.

GHTF code Document title Date posted Pages
Technical documents
GHTF/SG3/N19:2012 GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - DOC (192kb) GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb) 2 November 2012 16
GHTF/SG3/N18:2010 GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - DOC (345kb) GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb) 4 November 2010 26
GHTF/SG3/N17:2008 GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - DOC (300kb) GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb) 11 December 2008 21
SG3 N15R8 GHTF SG3 - Risk Management Principles and Activities within a QMS - May 2005 - PDF (130kb) 20 May 2005 23
GHTF/SG3/N99-10:2004 GHTF SG3 - QMS - Process Validation Guidance - January 2004 - DOC (421kb) GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb) 2 January 2004 N/A
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