Q1 is about clause 1.4.2
If the client systems are fully integrated, is the EAA approach compulsory to apply or can the CB choose the standard audit approach?
Q2 is about lead auditor competence (clause 1.4.2 c & e, clause 2.1.4, Annex 1 EAA planning session)
Assumption: there are fully integrated QMS and EMS systems. The lead auditor is only qualified for QMS as allowed by MD 11. If the lead auditor will audit MS, fully integrated or not, and audit clauses 4, 5, 6, 9 & 10, how will he be able to audit clauses for 4 and 6 of EMS properly without being not qualified for that system (noted to note ISO/IEC 17021-1:2015 cl 9.2.2.1.2, and also Annex 1 1st part aim)?
Q3 is about audit time for EAA (clause 2.3 b)
Assumption: there are 3 fully integrated systems and the EAA approach will be applied. These are QMS, EMS and OHS MS. Audit time for each system is determined separately. The longest audit is for OHS MS and it is 5 man-days. Then the audit time becomes for the EAA approach as follows:
A = time for OHS MS (5 man-days) B = time for QMS (3 man-days) C = time for EMS (2 man-days)
Audit time (T)= 5+ (50% of 3)+ (50% of 2)= 5 + 1.5 + 1= 7.5 man-days
Is this calculation correct? And there is not any other 20% reduction at most due to integration which is applicable for the standard audit approach. Is this correct?
Q4 is about audit time for EAA (clause 2.3b) related to ISO/TS 22003:2013
Question is for clarification of adding FSMS audit time in an integrated system.
Assumption: there are two fully integrated systems and the EAA approach is going to be applied. These are QMS and FSMS. Audit time is determined for both of systems separately. The longest audit time is for QMS and it is 4 man-days. And FSMS audit time is 2 man-days. Then the audit time becomes for the EAA approach as follows:
A= time for QMS (4 man-days) B= time for FSMS (2 man-days)
Audit time (T)= 4+ (50% of 2)= 5 man-days
However ISO/TS 22003:2013 Annex B defines minimum audit time for ISO 22000 FSMS. When we take 50% of FSMS audit time, we decrease 50% of minimum time. Is it acceptable?
March 2019
A1 The CB can always choose the standard audit approach and even not use IAF MD 11. According to 2.1 of IAF MD 11, they can choose its approach, none of them is compulsory.
A2 According to clause 2.1.3, the audit team must be competent to audit both QMS and EMS, so it is not possible to “only be qualified for QMS”. Although the lead auditor is not qualified for EMS, the team as a whole must be qualified for QMS AND EMS, so it is a matter of distributing areas to be audited. The lead auditor can be only qualified for some of the management systems, but could not audit those MS for which he/she is not qualified.
A3 The calculation is correct.
A4 Yes, it is acceptable, there is no minimum time for the audit of QMS +FSMS together. The level of integration is based on common elements.