I completed a Auditor/ Lead Auditor course for ISO 13485 hosted by ASQ and conducted by Stat-A-Matrix. It was 36hrs. I took it to complete the education requirement for RABQSA Provisional Assoc. QMS Auditor so I could start conducting audits (as well as to further my self development). I thought the course I was taking was going to be sufficient for the education requirements under the new competency based scheme , which will last for 4 yrs instead of 3 between recerts under the older qualifications based scheme.
Well while they are one of the best trainers (and it was in my hometown) Stat-a-matrix is classified as a TCC Course. They may have the paperwork in process but they are not yet a TPECS training provider. If they were, when you look on the RABQSA website and do find a trainer, as well as seeing the company is recognized as a trainer for ISO13485, you would also see acknowledgment for giving RABQSA-QM, RABQSA-AU and RABQSA-TL which makes them classified as TPECS Training Provider. Those three courses would also last about 5 days in duration.
So to sum it up, the gap exam is 25 questions, and I was told to take it after applying for certification and the RABQSA folks asked me to go online with a login/pass they gave me. It is a 30 min limit, and you are suggested to have a ISO 9001:2000 on hand. A 100% passing score is needed. A retake is permitted.
This had nothing to do with weather or not I am a CQA in advance, if I already had the RABQSA-QM course done in addition to the Auditor/Lead Auditor for ISO13485 courses (10 days of class total) I think I would have met the knowledge requirement w/o a gap exam requested.
Note that the criteria for Qualification based certification are less stringent.
see email I got from RABQSA staff:
Please be advised TCC and TPECS training can be accepted when applying under Qualification Based Certification.
However, when applying under Competency Based Certification we can only accept TPECS Training. Provisional Auditor Grade falls under our Competency Based Certification. We can still accept the TCC Training Certificate provided that the relevant Knowledge Gap Examination is completed.
RABQSA has developed the knowledge-based competency profile to bridge the ‘gap’ in knowledge competence examination between the Training Provider and Examiner Certification Scheme (TPECS) competencies and the Training Course Certification (TCC) training (e.g., 5-day lead auditor).
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Skids