17021-1/7.1.2 states: The certification body shall have a process for determining the competence criteria for personnel involved in the management and performance of audits and other certification activities.
Competence criteria shall be determined with regard to the requirements of each type of management system standard or specification, for each technical area, and for each function in the certification process. The output of the process shall be the documented criteria of required knowledge and skills necessary to effectively perform audit and certification tasks to be fulfilled to achieve the intended results.
17021-3 is adding requirements on specific fields of knowledge (not necessarily experience, specific training demands or “competence” as such)
This in mind, we propose the following two case examples:
A) A CB, active in IAF scope 38 states as a qualification/experience basis within the competence profile for its auditors:
- Training with medical knowledge
- Minimum 2 years vocational experience in the field (medical/health sector)
- Training as general practitioner (medical doctor) or
- Training as hospital worker/nurse or
- Training as (health-) care worker
B) Another CB is employing an auditor for 9001 audits in pharmacies, who’s original qualification is documented as “trained office clerk”. The CB has documented as well that this person is fully trained as auditor/lead auditor. Furthermore, according to the CBs records, the auditor has studied various items of pharmacologic literature and has taken part in three individual trainings on “QM in the pharmacy sector”, two of which were held within the CB by a QM-competent pharmacist.
Are those examples acceptable with regard to the competence of auditors under 17021-1/QMS?
September 2024
ISO/IEC 17021-1 requires that competence criteria are determined for personnel involved in the management and performance of audits and other certification activities.
Competence criteria shall be determined for each type of management system standard and, for each technical area. Criteria are required knowledge and skills necessary to effectively perform a management system audit.
Based on the above :
- The competence criteria shall be written in knowledge and skills to be fulfilled, not in qualifications (which are records of having followed a training but without questioning the efficiency of the training for the person)
- The competence criteria shall consider that it is a management system which is audited (and not a product/process or service), that the technical area is a sector field, but not a product, service or profession, A.2.5 (knowledge of client’s business sector) and A.2.6 (knowledge of client products, processes and organization) of ISO/IEC 17021-1 annex A are to be considered in this context.
Both examples are referring to qualification (i.e. previous experience and/or training) and not to knowledge and skills.