28 Jan The IMDRF Quality Grading System

The International Medical Device Regulators Forum (IMDRF) is a group with participants from regulatory bodies in US (FDA), EU, China, and quite a few others.

It’s mission: to establish global regulatory harmonization.

The IMDRF arose after the Global Harmonization Task Force (GHTF) disbanded.  The IMDRF has retained much of the material the GHTF developed, including the nonconformity grading scheme.  The GHTF recognized that not all nonconformities are equal (i.e., risk associated with patient harm -v- regulatory compliance).  The GHTF established a grading system based on the following:

Where indirect impact is anything where clauses 4.1 (General Requirements) – 6.3 (Infrastructure) from ISO 13485 were cited.  These “enablers” do not directly impact patient safety.  Direct impact is when clauses 6.4 (WorkEnvironment) through 8.5 (Improvement) were cited.  Not complying with these have direct impact on medical device safety and performance.

When a nonconformity is repeated in any of the past 2 audits / inspections, the score is incremented.  The paper also establishes an escalation policy where the initial score is incremented if either the required process is completely missing from the QMS or if the product has been released (unless by concession) with the nonconformity.

This scoring mechanism could also be used internally for nonconformities found in testing or internal audits as well as for supplier nonconformities.  The paper also suggests how jurisdiction-specific requirements (i.e., FDA QSR requirements) can be mapped onto the report.  This helps companies better see the broader implications of a particular nonconformity.

The intent is to ensure appropriate (risk-based) focus on the issue.  This approach relies heavily on the individual identifying the nonconformity to assign to the proper ISO clause – which can get a bit tricky at times.  The approach has merit and can help companies ensure they maintain focus on patient safety.

Need guidance?

If this is something you’d consider adopting, contact Realtime at 972-985-9100 – we can help with your Quality System needs.