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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 Documents page.

For a list of procedural GHTF documents, see the GHTF Procedural Documents page.

GHTF code Document title Date posted Pages
Technical documents
GHTF/SG4/N28R4:2008 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements - DOC (193kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements - PDF (162kb) 27 August 2008 36
GHTF/SG4/N30:2010 GHTF SG4 - Guidelines for Regulatory Auditing Part2 - DOC (253kb) GHTF SG4 - Guidelines for Regulatory Auditing Part2 - PDF (199kb) 27 August 2010 34
GHTF-SG4-N33 R16 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3 Regulatory Audit Reports- October 2007 - DOC (79kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3 Regulatory Audit Reports- October 2007 - PDF (130Kb) 2 October 2007 11
GHTF-SG4-(00)3 GHTF SG4 - Training Requirements for Auditors - DOC (80kb) GHTF SG4 - Training Requirements for Auditors - PDF (44kb) 24 Feburary 2000 6
GHTF/SG4/N30R20:2006 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy - DOC (264kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy - PDf (323kb) 28 June 2006 33
SG4(PD1)/N33 R13 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports - DOC (111kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports - PDF (263kb) 27 June 2006 12
SG 4 PD N30R16:2005 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy - September 2005 - DOC (249kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy - September 2005 - PDF (644kb) 15 September 2005 35
GHTF/SG4/N26R1:2001 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies - DOC (97kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies - PDF (125kb) 13 June 2002 6
GHTF/SG4/N(99)24R3:2002 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) - DOC (61kb) 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) - PDF (61kb) 12 May 2002 6
GHTF.SG4.(99)14 GHTF SG4 - Audit Language Requirements - DOC (57kb) GHTF SG4 - Audit Language Requirements - PDF (35kb) 29 June 1999 2
GHTF.SG4.(99)28 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - DOC (150kb) GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - PDF (128kb) 29 June 1999 31
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GHTF Study Group 4 - Auditing meeting dates and meeting minutes

Date Location Meeting minutes Doc code
10-12 May 2009 Toronto, Canada GHTF SG4 - Meeting Minutes - May 2009 Toronto - DOC (110kb) GHTF SG4 - Meeting Minutes - May 2009 Toronto - PDF (52kb) N93
1-3 April 2008 Paris, France GHTF SG4 - Meeting Minutes - April 2008 Paris - DOC (110kb) GHTF SG4 - Meeting Minutes - April 2008 Paris - PDF (60kb) N88
30 September - 2 October 2007 Washington DC, USA GHTF SG4 - Meeting Minutes - September 2007 Washington - DOC (104kb) GHTF SG4 - Meeting Minutes - September 2007 Washington - PDF (60kb) SG 4 N 854
28 June 2006 Lubeck, Germany GHTF SG4 - Regulatory Auditing 1994-2006 Presentation - June 2006 - PDF (247kb) N/A
26 June 2006 Lubeck, Germany GHTF SG4 - Meeting Minutes - June 2006 Lubeck - DOC (52kb) GHTF SG4 - Meeting Minutes - June 2006 Lubeck - PDF (46kb) SG 4 N 76
14 February 2006 Taipei, Taiwan GHTF SG4 - Meeting Minutes - February 2006 Taipei - DOC (51kb) GHTF SG4 - Meeting Minutes - February 2006 Taipei - PDF (47kb) GHTF-SG4.N72-2
14 Novemeber 2005 Lubeck, Germany GHTF SG4 - Meeting Minutes - Novemeber 2005 Lubeck - DOC (50kb) GHTF SG4 - Meeting Minutes - Novemeber 2005 Lubeck - PDF (41kb) GHTF-SG4.N69-2
12-15 September 2005 Gaithersburg, USA GHTF SG4 - Auditing Presentation - September 2005 Gaithersburg - PDF (1mb) N/A
12 September 2005 Maryland, USA GHTF SG4 - Meeting Minutes - September 2005 Maryland - DOC (50kb) GHTF SG4 - Meeting Minutes - September 2005 Maryland - PDF (40kb) SG4 / N 67-2
5 May 2005 Boston, USA GHTF SG4 - Meeting Minutes - April 2005 Boston - DOC (51kb) GHTF SG4 - Meeting Minutes - April 2005 Boston - PDF (44kb) GHTF-SG4.N65-4
4 April 2005 Boston, USA GHTF SG4 - Meeting Minutes - April 2005 Boston - DOC (47kb) GHTF SG4 - Meeting Minutes - April 2005 Boston - PDF (29kb) GHTF-SG4.N65-3
27-29 September 2004 Canberra, Australia GHTF SG4 - Meeting Minutes - September 2004 Canberra - DOC (47KB) GHTF SG4 - Meeting Minutes - September 2004 Canberra - PDF (281KB) N63 - 1 d
19-21 May 2004 Tokyo, Japan GHTF SG4 - Meeting Minutes - May 2004 Tokyo - DOC (41kb) GHTF SG4 - Meeting Minutes - May 2004 Tokyo - PDF (271kb) N61-1
2-4 February 2004 Atlanta, USA GHTF SG4 - Meeting Minutes - February 2004 Atlanta - DOC (43kb) GHTF SG4 - Meeting Minutes - February 2004 Atlanta - PDF (220kb) N59 - 1
22-24 September 2003 Berne, Switzerland GHTF SG4 - Meeting Minutes - September 2003 Berne - DOC (72kb) GHTF SG4 - Meeting Minutes - September 2003 Berne - PDF (241kb) N 57 - 1
10-12 February 2003 Rockville, USA GHTF SG4 - Meeting Minutes - February 2003 Rockville - DOC (58KB) GHTF SG4 - Meeting Minutes - February 2003 Rockville - PDF (396KB) N53-1
16-17 September 2002 Lubeck, Germany GHTF SG4 - Meeting Minutes - September 2002 Lubeck - DOC (38kb) GHTF SG4 - Meeting Minutes - September 2002 Lubeck - PDF (14kb) GHTF SG4 - Auditing Presentation - 16 September 2002 Lubeck - PDF (147kb) N52
12-14 May 2002 Singapore GHTF SG4 - Meeting Minutes - May 2002 Singapore - DOC (46kb) GHTF SG4 - Meeting Minutes - May 2002 Singapore - PDF (70kb) N/A
6 May 2002 N/A GHTF SG4 - QSIT Presentation - May 2002 Singapore - PDF (207kb) N/A
18-20 September 2000 Ottawa, Canada GHTF SG4 - Meeting Minutes - September 2000 Ottawa - DOC (34kb) GHTF SG4 - Meeting Minutes - September 2000 Ottawa - PDF (115kb) SG4(00)7Rev
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