ISO 13485 certification


RABQSA certification and approval

RABQSA is an accreditation schemes for individuals and training organisations.
RABQSA designs, develops, and delivers personnel and training certification into the Management systems-based streams such as ISO 9001, ISO 14001, ISO 13485, ISO/TS 16949 in a similar fashion as IRCA except that IRCA is UK-based and RABQSA US-based. The overall requirements are very similar. They take into account many factors so that you can become an auditor who can be hired by a 3rd party registrar: Knowledge, Skill, Personal Attributes, Qualifications/Education, Work Experience, and Audit Experience. Then there is a periodic surveillance and recertifictaion process.

  • Taking RABQSA approved training courses, which are usually in the form of week long seminars costing in the range of $1800 to $3000,
  • Having Educational Qualifications such as Bachelor Degrees in the area the auditor wants to be qualified for,
  • Having extensive and verifiable Work experience in the industry targeted,
  • Conducting a certain number of audits as an observer, then as a provisional auditor, and then as an auditor. This requires maintaining very accurate logs co-signed by certified auditors and lead Auditors,
  • And maintaining a minimal of Yearly Continuing education (CPD).

  • Application procedures and fees are required to to go through this process. You can download all the RABQSA requirements in details.

    All in all becoming an RABQSA certified Lead Auditor, is very prestigious should you want to work for a Registrar. However, the training is very costly , the application process is very complex and costly, and to move from the initial observer, Provisional Auditor, Auditor and Lead Auditor, is a very lengthy process (it will take years). You will need to know auditors or organisations that will accept to provide you with the auditing experience. Also the yearly renewals or upgrades of your credentials, which require providing verifiable audit logs, CPD, and fees are very burdensome if you do not audit regularly with certified Auditors.

    For conducting internal audits and supplier audits, RABQSA certifications are overkill and very very difficult to achieve AND maintain.


    For this reason, CALISO developed its own approval scheme, which is much more adapted for 1st party (interna audit) and 2nd party (supplier audit) auditor. (non Registrars) Call us, should you need further advice on obtaining adequate training for auditing to the various standards and regulations. the process.  Or contact us by phone 1-800-306-1366 or e-mail: tiout@caliso9000.com should you need more information.