Study Group 3 Work Plan

Quality management system – Medical devices - Guidance on the control of products and services obtained from suppliers.

SG3 / N17

Proposed Document posted on GHTF web site for public comment 2008-04-25.

Comment period ends 2008-09-15.

Comments to be reviewed at Ottawa meeting 2008-10-15

1

January 2009

Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes

SG3 / N18

Development of Working Draft started Feb 2008

1

Q1 2010

Joint SG1 – SG3 activity: Develop GHTF Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer.

SG1(PD)/N055R6

Subgroup of SG1, 2, 3 & 4 members develop Proposed Document

Proposed Document posted on GHTF website 2008-06-18 for public comment.

Comment period ends 2008-12-18.

1

2009

Joint SG3 – SG4 activity : Develop guidance on the auditing of subcontractors

N/A

SG3 and SG4 to begin work Q3 2008

1

2010

Quality Management System – Medical devices - Criteria for characterizing the significance of quality management system deficiencies.

SG3 / N19

Meeting of SG3 regulators held June 2008 to discuss intent of guidance document.

2

2010/ TBD

In collaboration with ISO/TC 210/WG1 examine the possible amendment to ISO 13485:2003 and ISO/TR 14969:2004 as a result of expected amendments to ISO 9001:2000

ISO 13485:20XX

Work on revision expected to commence at TC210’s AGM May 2009

2

Ongoing

Review of work previously performed by GHTF SG3 regarding Quality Plans

SG3 / N20

Work to commence as soon as possible

3

TBD