The Global Harmonization Task Force (GHTF) Study Group 3 has released a Proposed Document, “Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange”, dated 18 April 2012. It’s “intended for regulatory authorities and auditing organizations,"with the goal of providing more standardized and transparent audit information to be shared between regulatory agencies worldwide. And of course, as for all GHTF initiatives, the overarching goal is “enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.” Members of the global medical device community hope this leads to greater trust among regulatory agencies, and a reduced number of audits and inspections by them in the future.
But does this proposed document also include elements that might be used by medical device manufacturers themselves? One very powerful element is a “grading system [providing] a common risk based approach.” This improves upon previous categories of major and minor audit nonconformities by providing for five levels.
- Indirect QMS Impact, related to ISO 13485 sections 4.1 through 6.3, versus
- Direct QMS impact, related to sections 6.4 through 8.5, and
- First time occurrence, versus
- Repeat occurrence, and finally
- Escalation, if there is
- no associated documented process or procedure, or
- a nonconforming medical device has been released to the market
In addition to the grading system, there’s a standard reporting format. In addition to ISO 13485 nonconformities, there’s also a provision for documenting country specific regulatory requirements above and beyond the requirements of ISO 13485.
There are multiple examples in the Appendix of the proposed document which are useful for further understanding.
What do you think? Are these elements something your company could use for internal and supplier audits? Will this drive change in common audit practices? In any case, as the GHTF transitions to the International Medical Device Regulators Forum (IMDRF), this is certainly one initiative to monitor closely.
The IAF Initiative for Accredited Certification to ISO 13485 – Medical Devices