Mar 1, 2008

Upcoming changes to QMS auditing requirements have been proposed by Study Group 4 of the Global Harmonization Task Force (GHTF.) These changes may affect your company and you have until 14 MAY 2008 to voice your opinion on them.

GHTF publishes various guidelines to help regulatory agencies and manufacturers interpret standards and guidance documents for quality system processes, and those "guidelines" are followed closely by regulatory authorities. Because these guidelines are not updated frequently, manufacturers should seize the opportunity to comment on the proposed changes.

The changes are being proposed to "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1 General Requirements." A copy of this document can be downloaded from here:

This guideline is intended for use by Notified Bodies, Competent Authorities, regulatory agencies, and consulting firms that conduct regulatory audits of manufacturers, not necessarily for medical device manufacturers. Therefore, it is important for manufacturers to comment on the proposed changes since they are the ones most affected by the audit conduct, process and reporting procedures recommended in this guideline document.

If there are certain aspects of the audit process that your organization would like to see done differently, this is a perfect opportunity to voice your comments.

Significant proposed changes include:

  1. If your auditing organization feels you did not conduct a thorough audit of your supplier, they can audit them for you. This can have a significant impact on "virtual" manufacturers who outsource their manufacturing. Increasingly, Notified Bodies are not satisfied with the control that medical device manufacturers have over their suppliers.
  2. Another proposed change involves third party organizations. Even auditing organizations sometimes outsource the audit of a manufacturer to another auditing organization. What is made clear is that the original auditing organization still has the responsibility for the regulatory compliance of the medical device manufacturer, but the guideline also adds the description of an Observer to the audit process. There have been situations where an Observer is involved with the audit process and the proposed guideline makes clear their roles and responsibilities.

While these proposed changes are important, overall the content of the guideline has changed little. Annexes have been removed, there is more emphasis on language requirements and references to Standards have been updated. Still, they should be reviewed as they may have a direct impact on the quality system of many medical device manufacturers and how they are audited by regulatory agencies.


  • Stewart Eisenhart