The standard states the time between consecutive on-site assessments shall not exceed two years unless the accreditation body determines that an on-site assessment is not “applicable”. When would an on-site assessment not be applicable? If an on-site assessment can reasonably be conducted under normal conditions, is it “applicable” to be on-site, or does the accreditation body have the ability in all cases to justify the use of other assessment techniques that do not incorporate on-site assessment, and thus exceed the two-year maximum required by the standard?
If an accreditation body implements remote assessment techniques that can achieve the same objectives and outcomes as on-site assessment techniques, can those remote assessment activities be considered equivalent to an on-site assessment?
The expectation from ISO/IEC 17011:2017 is to normally conduct on-site assessments at least every two years during the AB’s assessment programme.
Where it is not possible to do an on-site assessment – e.g. due to force majeure event, health or security crisis, virtual site – then a remote assessment could be applicable. In these cases, the AB must ensure that the same objectives and outcomes are achieved with the remote assessment techniques as with the on-site assessment techniques.
Can an Accreditation Body that is linked to a separate legal entity that provides consulting services have a website with direct hot links to the website of the linked separate entity that provides consulting services and meet the impartiality requirements of ISO/IEC 17011:2017 Section 4.4?
No, if an AB has publicly available in its website (or otherwise) a direct link to a consultancy organization (that is not an accredited CAB and listed as such in its Directory of Accredited CABs) it should be considered as an infringement of clause 4.4.13 of ISO/IEC 17011: 2017.
Can an Accreditation Body that is linked to a separate legal entity that provides consulting services have personnel (internal staff or external contractors) carry out consulting activities for that linked body and meet the impartiality requirements of ISO/IEC 17011:2017 Section 4.4?
No, unless exceptional conditions are met. If the AB’s ‘internal’ staff is providing consulting services, the AB would need to demonstrate simultaneous compliance with several clauses of the standard, namely: – 4.4.4: staff acting objectively, in absence of pressures and disclosing potential conflict of interests; – 4.4.6-9: risk analysis to impartiality, stakeholder consideration of acceptable public perception if AB internal staff provides consultancy, etc.; – 4.4.12.b) and d): effective mechanisms to prevent influence on the outcome of accreditation activities. – 4.4.13: nothing can be said or implied that would suggest that accreditation would be simpler, easier, faster or less expensive if any specified person(s) or consultancy were used;
The analysis of acceptability needs to include a review of the functions that the staff providing consultancy for the ‘Linked Body’ are assigned to do in the AB and the risk arising can differ significantly depending on the tasks performed. It should be noted that the standard forbids any staff providing consultancy to participate in accreditation decision-making.
Regarding clause 4.4.6, note that it may not be sufficient to forbid consulting and assessing to the same customer, to ensure that self-evaluation risks are sufficiently mitigated.
The note to clause 4.4.13 indicates that AB’s personnel can participate as lecturers in training and similar activities, but states that they cannot provide specific solutions to a CAB, so any form of consultancy that includes this would violate the clause.
Can an Accreditation Body that is linked to a separate legal entity that provides consulting services have shared resources (office space, finances, sales, marketing, accounting, human resources, legal counsel, etc.) and meet the impartiality requirements of ISO/IEC 17011:2017 Section 4.4?
The absence of ‘shared resources’ is not required by clause 4.4.12 and is therefore not applicable; however, ‘shared resources’ can be a source of risk to impartiality (Note 1 of 4.4.6) and it should be considered in the risk analysis process covered by clause 4.4.6. The type of resource being shared can introduce additional requirements that should be considered, for example: – sharing office space can infringe confidentiality and public perception requirements; – sharing personnel can violate confidentiality, impartiality, and public perception requirements; – sharing finances can violate confidentiality requirements and allow commercial and financial pressures to appear; – sharing sales or marketing prevents meeting clause 4.4.13.
Can an Accreditation Body that is linked to a separate legal entity that provides consulting services have common owners, or a person who holds a higher position above the managers of both organizations meet the impartiality requirements of ISO/IEC 17011:2017 Section 4.4?
No, unless strict and exceptional conditions are demonstrated to be met: – Because of the common ownership between the AB and the separate legal entity that provides consulting services, then they are deemed to be linked and the AB must fulfil all the conditions in clause 4.4.12 of ISO/IEC 17011:2017; – Regarding the person who holds a higher position at both organizations, this person cannot perform any of the activities listed in clause 5.7 as this would be a violation of §4.4.12 a). Careful consideration must be made to ensure that person is not involved in any of the AB top management activities outlined in clause 5.7 of ISO/IEC 17011:2017.
If an on-site assessment activity is postponed due to the suspension of the CAB, what is deemed acceptable when taking the period between on-site assessments into account (clause 7.9.3 of ISO/IEC 17011:2017)?
Prior to lifting the suspension of the CAB, an AB shall take into account the required two-year maximum allowed between on-site assessments. If the maximum has been exceeded, an on-site assessment shall be conducted to assess the CAB’s continued compliance with the accreditation requirements (including any suspension prerequisites) prior to reinstating the accreditation.
Note: Clause 3.18 of ISO/IEC 17011:2017 defines suspension as temporary restriction.
No, the requirement in clause 7.9.1 of ISO/IEC 17011:2017 states that an accreditation cycle shall not be longer than five years. This is independent of the CAB’s accreditation status.
Note: As stated in IAF COVID-19 FAQ No. 27, due to complications with the COVID-19 pandemic, the assessment can be postponed up to 6 months, and the validity of the accreditation certificate prolonged by the same duration, on the condition that the next accreditation cycle starts from the original end date of the previous cycle.
What is the role of Annex A? Is it informative in the document but normative in interpretation of clause 6.1?
STANDARD: ISO/IEC 17011 · CLAUSE: Annex A · TOPIC: Competence of AB personnel
As stated in the standard, Annex A serves as a summary of the competence requirements found in sections 22.214.171.124 to 126.96.36.199. It is an informative annex that indicates which normative requirements of the standard relate to the identified “Accreditation activities” and “Knowledge and skills” associated with those activities. Annex A, while not normative, indicates which sections of the standard contain the normative requirements associated for the areas indicated in Table A.1.
What is sufficient evidence that risk was considered in the development of an assessment programme for accreditation schemes established prior to the publication of ISO/IEC 17011:2017?
STANDARD: ISO/IEC 17011 · CLAUSE: 7.9.2 & 7.9.3 · TOPIC: Assessment program and accreditation cycle
The first exercise of establishing an assessment program based on risk will probably have to accept assumptions and hypothesis, since previous risk analysis may not have been documented as required by the current version of ISO/IEC 17011.
Must the accreditation decision be made within the maximum 5 years’ assessment cycle?
STANDARD: ISO/IEC 17011 · CLAUSE: 7.9.1 · TOPIC: Assessment program and accreditation cycle
Accreditation cycle begins (according to 7.9.1) at or after the date of decision for granting or decision after the reassessment. Accreditation cycles shall not be longer than 5 years. Clause 7.9.4 requires the reassessment to be completed before the end of the cycle, but the standard does not state that the decision after the reassessment shall be taken before the end of the cycle. Nevertheless clause 7.6.8 requires AB to define time limits for the CAB to respond to the assessment reports and clause 7.7.5 requires AB to take decisions “without undue delay” so it is expected that the decision after the reassessment shall be taken in dates close (but not necessarily before) the end of the cycle.