GHTF Study Group 4 - Auditing Documents
This page contains archived GHTF documents only. Not all documents generated by GHTF are featured in this archive. For a list of final GHTF documents, see the GHTF final documents page.
Technical documents
GHTF code: GHTF/SG4/N30:2010 - Date posted: 27 August 2010
GHTF SG4 - Guidelines for Regulatory Auditing Part2
GHTF code: GHTF/SG4/N83:2010 - Date posted: 27 August 2010
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010
GHTF code: GHTF/SG4/N84:2010 - Date posted: 27 August 2010
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012
GHTF code: GHTF/SG4/N28R4:2008 - Date posted: 27 August 2008
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements
GHTF code: GHTF-SG4-N33 R16 - Date posted: 2 October 2007
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3 Regulatory Audit Reports- October 2007
GHTF code: GHTF/SG4/N30R20:2006 - Date posted: 28 June 2006
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy
GHTF code: SG4(PD1)/N33 R13 - Date posted: 27 June 2006
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports
GHTF code: SG 4 PD N30R16:2005 - Date posted: 15 September 2005
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy - September 2005
GHTF code: GHTF/SG4/N26R1:2001 - Date posted: 13 June 2002
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies
GHTF code: GHTF/SG4/N(99)24R3:2002 - Date posted: 12 May 2002
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)
GHTF code: GHTF-SG4-(00)3 - Date posted: 24 Feburary 2000
GHTF SG4 - Training Requirements for Auditors
GHTF code: GHTF.SG4.(99)14 - Date posted: 29 June 1999
GHTF SG4 - Audit Language Requirements
GHTF code: GHTF.SG4.(99)28 - Date posted: 29 June 1999
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements
Meeting dates and meeting minutes
Date: 10-12 May 2009, Location: Toronto, Canada, Doc code: N93
GHTF SG4 - Meeting Minutes - May 2009 Toronto
Date: 1-3 April 2008, Location: Paris, France, Doc code: N88
GHTF SG4 - Meeting Minutes - April 2008 Paris
Date: 30 September - 2 October 2007, Location: Washington DC, USA, Doc code: SG 4 N 854
GHTF SG4 - Meeting Minutes - September 2007 Washington
Date: 28 June 2006, Location: Lubeck, Germany, Doc code: N/A
GHTF SG4 - Regulatory Auditing 1994-2006 Presentation - June 2006
Date: 26 June 2006, Location: Lubeck, Germany, Doc code: SG 4 N 76
GHTF SG4 - Meeting Minutes - June 2006 Lubeck
Date: 14 February 2006, Location: Taipei, Taiwan, Doc code: GHTF-SG4.N72-2
GHTF SG4 - Meeting Minutes - February 2006 Taipei
Date: 14 Novemeber 2005, Location: Lubeck, Germany, Doc code: GHTF-SG4.N69-2
GHTF SG4 - Meeting Minutes - Novemeber 2005 Lubeck
Date: 12-15 September 2005, Location: Gaithersburg, USA, Doc code: N/A
GHTF SG4 - Auditing Presentation - September 2005 Gaithersburg
Date: 12 September 2005, Location: Maryland, USA, Doc code: SG4 / N 67-2
GHTF SG4 - Meeting Minutes - September 2005 Maryland
Date: 5 May 2005, Location: Boston, USA, Doc code: GHTF-SG4.N65-4
GHTF SG4 - Meeting Minutes - April 2005 Boston
Date: 4 April 2005, Location: Boston, USA, Doc code: GHTF-SG4.N65-3
GHTF SG4 - Meeting Minutes - April 2005 Boston
Date: 27-29 September 2004, Location: Canberra, Australia, Doc code: N63 - 1 d
GHTF SG4 - Meeting Minutes - September 2004 Canberra
Date: 19-21 May 2004, Location: Tokyo, Japan, Doc code: N61-1
GHTF SG4 - Meeting Minutes - May 2004 Tokyo
Date: 2-4 February 2004, Location: Atlanta, USA, Doc code: N59 - 1
GHTF SG4 - Meeting Minutes - February 2004 Atlanta
Date: 22-24 September 2003, Location: Berne, Switzerland, Doc code: N 57 - 1
GHTF SG4 - Meeting Minutes - September 2003 Berne
Date: 10-12 February 2003, Location: Rockville, USA, Doc code: N53-1
GHTF SG4 - Meeting Minutes - February 2003 Rockville
Date: 16-17 September 2002, Location: Lubeck, Germany, Doc code: N52
GHTF SG4 - Meeting Minutes - September 2002 Lubeck
Date: 16-17 September 2002, Location: Lubeck, Germany, Doc code: N52
GHTF SG4 - Auditing Presentation - 16 September 2002 Lubeck
Date: 12-14 May 2002, Location: Singapore, Doc code: N/A
GHTF SG4 - Meeting Minutes - May 2002 Singapore
Date: 6 May 2002, Location: N/A, Doc code: N/A
GHTF SG4 - QSIT Presentation - May 2002 Singapore
Date: 18-20 September 2000, Location: Ottawa, Canada, Doc code: SG4(00)7Rev
GHTF SG4 - Meeting Minutes - September 2000 Ottawa