In Clause 4.1.3 it is stated that if a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates or minimizes such risk. Does this mean that all identified risks need to be eliminated or minimised? What would be an adequate approach for an inspection body to manage identified risks?
The structure and processes used by inspection bodies in the management of impartiality threats varies with the size of, and services provided by, the inspection body. In smaller organisations specific threats may be identified, while in larger organisations threats may be clustered by source or type and treated “generically”. In larger inspection bodies, threats to impartiality may be addressed by multiple systems, with distinct and separate reporting processes. The standard does not nominate or preference techniques in the identification and response to threats to impartiality. Any response to eliminate or minimise a risk will leave a residual risk. The inspection body should be able to demonstrate how it established that the residual risk was acceptable and remains at an acceptable level.
An example of a suitable practice for the review of risks to impartiality would be to combine scheduled periodic reviews with ad-hoc reviews on receipt of advice regarding events potentially impacting the impartiality of the organisation. Such events may include organisational changes, new clients, the launch of new inspection services, new personnel arrangements or changes to scheme or regulatory arrangements.
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 188.8.131.52 to 184.108.40.206. 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.
If accreditation information/certificates are issued by an Accreditation Body to the previous version of an accreditation standard, must the expiration date (if listed) be listed up to but not exceeding the stated transition deadline established by ILAC/IAF?
STANDARD: ISO/IEC 17011 · CLAUSE: 7.8.1 f) · TOPIC: Validity of accreditation information
No, the date listed on the accreditation information/certificate can be the end date of the normal accreditation cycle of the AB, but it is the responsibility of the AB to ensure that all accredited CABs have transitioned by the stated deadline established by ILAC/IAF. If an accredited CAB has not completed the transition by the deadline then the AB must take the appropriate adverse action to ensure it is clear that the accreditation is no longer valid. The AB will also need to ensure that the accreditation information/certificates are updated appropriately when the transition process for the accreditation is completed.