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ISO 13485. Is it worth to the Medical Device Industry.


Staff member
Super Moderator
While the ISO 13485 is the medical devices QMS - requirements for regulatory purposes., where are the CB’s about regulatory purposes. Is it not the domain of the CB with competency built in its auditors to audit and report the applicable regulatory compliance and such NC thereof? Where is the weightage for the ISO 13485 without any applicable regulatory requirements considered in the assessment? Likewise what is the worth of the CB auditor if he is unable to audit to the applicable regulatory requirements, and the CB who do not assess the regulatory requirements of the client at the time of gathering the company information, and at the stage 1, before each surveillances, and assess it thoroughly.
Had the AB’s more closely interacted with the regulators, and created competency amongst the CB’s and auditors, the ISO 13485 would have seen far better light and worth amongst the regulators. The FDA might have accepted the ISO 13485 for its routine inspection and likewise the rest of the regulatory regions. We would not have had companies going for this ISO 13485 while in reality they stand for only an ISO 9001 scope. The ISO 13485 is reduced to just a glorified ISO 9001, while the intent of the ISO perhaps was different when it came up with the medical devices QMS long time ago.
The net result is that companies who have the ISO 13485 are no more worth than being an ISO 9001. The chances that their medical devices QMS will help them in regulatory inspection are greatly missing. The regulatory inspection authorities too disregard the ISO 13485. They are now searching for solutions forming the IMDRF and the MDSAP in the pilot now until 2016. The ISO 13485 (1996 + 2003) versions have seen nearly 19 years of almost negligible regulatory recognition, still being called the international standard for medical devices QMS. The less said here about the back log the regulators have in their inspection queue, the better.
Now to add more to this wasted 19 years, the delayed new revision is being talked about, while the ISO 9001 has moved into the new revision in 2015, based on the ISO’s high level structure viz:
1. Scope / 2. Normative References / 3. Terms and Definitions / 4. Context of the Organization / 5. Leadership / 6. Planning / 7. Support / 8. Operation / 9. Performance Evaluation / 10. Improvement.
Will the new ISO 13485 follow this,… or lag behind ??
Will it be of any worth to the medical device industry further ? Do we need this new revision at all … ?
It’s very rightly said that when it comes to standards, there are lots to choose from ~~~
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