What is minimally required to be included in the assessment plan?
STANDARD: ISO/IEC 17011 · CLAUSE: 7.4.7 · TOPIC: Assessment plan
The goal of the assessment plan (also known as “agenda”) is to enable the assessment team to perform an efficient assessment, and for this the information included must be sufficient for the CAB to be prepared to perform the conformity assessment activities. Normally, this includes CAB’s scope (generic or specific), locations (physical and virtual) and personnel (names and/or functions) as well as a timetable or time schedule of activities to be performed and the persons involved – ISO 19011 can also be used to have additional guidelines.
ABs will be adopting different and varying practices to cover and “record” the risks taken into consideration when preparing for an assessment. What are types of records are acceptable evidence of compliance to this clause of the standard?
It is not possible to provide a prescriptive list of risk factors that impact on the development of an assessment plan. As stated in §7.4.6, ABs need to consider the activities to be covered, and how they will be assessed (e.g. by witnessing), the locations to be assessed and the CAB personnel to be considered. ABs need to take into consideration whether the assessment is an initial assessment or whether the plan is being developed for an accredited CAB which may alter the CAB’s risk profile.
The following will need to be considered: 1- If all risks have been considered, 2- if all risks have been evaluated, 3- whether residual risks remained and why they were deemed acceptable.
What kind of records are required to demonstrate the competence requirements of ISO/IEC 17011:2017 have been met?
STANDARD: ISO/IEC 17011 · CLAUSE: 6.3 · TOPIC: Competence of AB personnel
Records to demonstrate that the competency requirements have been met, include competence matrix/profile per function, records for individuals which may include CV’s, proof of trainings, proof of authorisations, qualifications, evidence of performance monitoring, etc.
Does an assessor need to be observed on-site for each accreditation scheme for which the assessor is authorized?
STANDARD: ISO/IEC 17011 · CLAUSE: 22.214.171.124 · TOPIC: Competence of AB personnel
No. However, if on-site monitoring/observation is not performed for one of the schemes that the assessor is authorised, then some other form of monitoring needs to be done for that accreditation scheme and take into account relevant results of on-site monitoring/observation in other alike schemes, with similar type of requirements.
What is the meaning of “familiarizing technical experts with the relevant requirements and procedures used in the accreditation process” as used in the standard?
STANDARD: ISO/IEC 17011 · CLAUSE: 126.96.36.199 · TOPIC: Competence of AB personnel
This will vary based upon how a technical expert is used by each AB in the accreditation process. The technical expert should be familiar with the relevant information that is applicable to the role they have been assigned for the assessment.
The technical expert is generally responsible for assessing technical competency of the CAB for specific conformity activities and therefore does not need to be trained to the level of an assessor.
The familiarization process of the technical experts could include information sessions (telephonic / workshops/ documented guidance, briefing, videos, …etc.) to give an overview of the relevant accreditation scheme requirements and AB’s procedures, namely use of assessment checklists and documents, their expected role and tasks to perform.
Can roles and responsibilities defined in a job description meet the requirement for the AB to “authorize personnel”?
STANDARD: ISO/IEC 17011 · CLAUSE: 188.8.131.52 c) · TOPIC: Competence of AB personnel
It depends on the documented process of the AB, but this could be a means of authorizing personnel for certain activities if the job description identified the concerned person(s). Other means are also possible.
How can an AB demonstrate competency of the assessment team for procedures/methods developed and validated by the CAB?
STANDARD: ISO/IEC 17011 · CLAUSE: 6.1.3 · TOPIC: Competence of AB personnel
The assessment team must have knowledge of the principles (competence with similar standard methods, technology, technique, relevant technical experience, etc.) of the CAB developed procedures/methods. The assessment team must also have competency to evaluate the validation techniques implemented by the CAB.
How can an accreditation body effectively manage competency for all technical areas of accreditation when the AB itself may not have staff that are technically competent in every area? What approach can be taken and is it acceptable for someone to deem competency when not competent in that area themselves?
STANDARD: ISO/IEC 17011 · CLAUSE: 6.1.3 · TOPIC: Competence of AB personnel / Decision-maker
Demonstration of competence can be done by many ways. The authorization of competence will depend on the documented process and associated records and evidence that the AB requires (interviews with technical peers, feedback from CABs, records of training, years of relevant experience, etc.). An AB may not have staff that will, themselves, be competent in every technical area related to the accreditation schemes they offer. However, the AB must have a documented process to ensure they can evaluate competency by effective means and authorize staff who can evaluate the required evidence to determine competency for specific accreditation activities.