GHTF - ISO/TC 210 Update - Plenary Session Brief

The purpose of this session is to update the general membership of GHTF on the progress made since the Memorandum of Understanding (MOU) between GHTF and ISO/TC 210 was signed at the last GHTF Plenary Session in Bethesda, Maryland (July 1999).

Since the MOU was signed there have been two activities resulting from it. .

1. The Chairman's Advisory Group (CAG) is one of the committees working under ISO/TC 210. The role of the CAG is to assist the ISO/TC 210 Chair as follows:
a) advise on current and emerging strategies, associated issues and trends, and
b) develop plans and strategies for consideration by ISO/TC 210 in order to address emerging issues.
The CAG membership includes all bodies having a liaison link with ISO/TC 210, including GHTF.

The GHTF Chair, Ms. Beth Pieterson, accompanied by Ms. Jocelyn Kula, participated in the CAG meeting during the ISO/TC 210 meeting in Chicago in May 2000. As well as reviewing progress of the work programme with the four ISO/TC 210 Working Group Convenors, the CAG also discussed the ISO/TC 210 business plan which is to be revised soon.

The ISO Technical Management Board requires technical committees to prepare and submit a business plan. ISO/TC 210 has started work on the plan following the CAG meeting in May. Under the MOU, both through liaison with GHTF, and the involvement of the GHTF Chair in the CAG it is intended that GHTF views will be sought in revising the ISO/TC 210 business plan.

2. The International Standard ISO 13485 has application in a number of countries as the basis for the regulatory quality management requirements. The 1994 version of ISO 9001, on which ISO 13485 is based, is being revised and will be published later this year. ISO/TC 210 is responsible for ISO 13485 and must therefore revise ISO 13485 when ISO 9001: 1994 is withdrawn and the new version published. As both ISO/TC 210/WG1 and Study Group 3 have a common interest in the revision of ISO 13485 it was proposed that they could work collaboratively in developing comments on the draft versions of ISO 9001:2000 and the working draft for ISO 13485: 2001. The joint working group has met together on four occasions in the past year.

Robert Allen joined the UK Department of Health in 1976 after working in the UK National Health Service and industry. Currently, he holds the position of Section Head of European Regulatory Affairs 2 (ERA2) with responsibility for medical device clinical investigation reviews, registration of medical devices, and the designation of UK Notified Bodies and Conformity Assessment Bodies. Mr. Allen is also the Chair of GHTF Study Group 4 (Auditing) and Chairman of ISO/TC 210.