SG4 - Archived Documents

Title	Description	Posted Date
SG4/N30R20:2006 [PDF] [Word]	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy	31 August 2006
SG4 (99) 28 [PDF] [Word]	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements	30 December 1999 *Reposted: 30 October 2000
SG4 (99) 14 [PDF] [Word]	Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)	30 December 1999 *Reposted: 30 October 2000
SG4(PD)N33R13:2006 [PDF] [Word]	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports	18 December 2006
SG4(PD) / N30R16 [PDF] [Word]	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy	17 November 2005
SG4-N(99) 24R3 [PDF] [Word]	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)	12 July 2002
SG4-N26R1:2001 [PDF] [Wo rd ]	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies	10 August 2001

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Updated 30 September 2010