May 1, 2012

The Global Harmonization Task Force (GHTF) has proposed establishing a standardized grading system for quality management system (QMS) nonconformities, along with a standardized Regulatory Audit Information Exchange Form to provide more consistent ISO 13485:2003 audit data for use between medical device market regulators.

The GHTF’s proposed Regulatory Audit Information Exchange Form includes three parts. First, a list of nonconformities from a QMS audit report is necessary to explain each nonconformity reported. (The nonconformities included in this list should match those listed in the manufacturer’s original audit report.)

Second, details of a Nonconformity Grading System should be included showing how the manufacturer’s final nonconformity grade was determined.

Third, nonconformities pertaining to country-specific medical device regulatory requirements outside the scope of ISO 13485 should be identified in order to provide regulators with a more complete picture of a particular manager’s general state of compliance.

The GHTF’s proposed Nonconformity Grading System entails a two-step approach: Step 1, involving a Nonconformity Classification Matrix to make initial evaluations, and Step 2, which applies escalation rules in order to determine a final grade.

“Currently, the significance of a nonconformity related to a medical device manufacturer’s Quality Management System (QMS) may vary between regulatory authorities and auditing organizations,” the GHTF proposal states. “All parties will benefit through the use of a standardized and transparent grading system of QMS nonconformities to communicate the findings of a regulatory audit, building the confidence necessary for the potential mutual acceptance of the results of a regulatory audit.”

Even though no current standard QMS regulation exists across medical device markets—even among the GHTF founding members, ISO 13485 is not uniformly required—establishing a single method for evaluating quality system nonconformities could lead to a more effective global regulatory approach to medical device quality systems.


  • Stewart Eisenhart