Currently, CBs are allowed to perform preliminary audit for a given standard or CAS, i.e. an audit performed before any step of certification to evaluate the state of preparedness of a future client to fulfil the requirements of this given standard or CAS, with conditions to accept this practice(only once per client, only gap analysis, no reduction of time of the subsequent audit.)
The standards ISO/IEC 17021-1 or 17065 do not refer to blank audit and we did not find any IAF or EACC decision on this matter.
It is now questioned to extend this possibility of preliminary audit for the revision of a standard or CAS, i.e., during the transition period, the client being already certified by the CB for the previous version of the standard or CAS.
However, this could be considered as a threat for impartiality.
The rationale is as follows : a transition preliminary audit is necessarily performed at a CB’s client (the client is certified for the previous standard/CAS) then it is considered as internal audit and both ISO/IEC 17021-1 (5.2.6) and ISO 17065 (4.2.6.e) forbid the performance on internal audit.
Question 1: shall a transition preliminary audit be considered as an internal audit?
Question 2: If answer to Q1 is no, it means that it is acceptable that accredited CBs realize preliminary audits (which are not in certification process) for their certified clients, to check if they are ready to be audited for the new version of a standard or CAS, when they are certified to the previous version? Are they conditions to have this practice acceptable?
Considering the global subject, we have an additional question referring to the performance of a preliminary audit itself.
Question 3: is preliminary audit in general acceptable? If no, what would be the standard requirement to refer to?
Are any ABs accepting it?
September 2024
It should be noted that the IAF consensus position is related to MS certification, not to product certification.
Answer 1: NO, from definition, a transition preliminary audit it is not an internal audit (first party audit)
Answer 2: YES
Refer to IAF decisions number 10/03/08 and 19/04/01
– 10/03/08 Certification audit process, stage 1 and stage 2
There was consensus in IAF TC
- that more than one stage 1 audit is possible with proper justification
- that pre-audits prior to stage 1 are acceptable as long as impartiality is not compromised , but not appropriate between stage 1 and stage 2
- Pre-audits prior to transition/ migration is acceptable
– 19/04/01Pre-Audit
Additional note to TC Decision 10/03/08 “Pre-audits prior to transition/ migration is acceptable.”
Answer 3: YES, refer to TC decision.
As a general statement it is confirmed that pre-audit cannot be used as a stage 1 audit.
The additional risk to impartiality shall be considered in the CAB’s risk assessment.
For product certification, further considerations may be relevant, e.g. information given in EA-2/20, as well as scheme requirements.