1. IECEx 02 Audits according to OD 005 Theo Pijpker
Certification Manager KEMA Quality B.V.

2. Topics Why audits? Use of OD 005 under IECEx 02
Benefit of ISO 9001 certification
Audit differences
Multiple production sites
Common NCs
Major/minor NCs
Reporting
Registration of QAR on IECEx website

3. Why audits?
IECEx 02 is an ISO 67 No. 5 product certification system, which requires:
surveillance of the production process/QS
surveillance by testing or inspection of samples from the factory or the open market, or both
Goal: full control of production
every single product must meet the Ex-specifications

4. Use of OD 005
OD 005 specifies the requirements for quality systems used for production sites of the manufacturer
OD 005 is linked to ISO 9001:2000
note: OD 005 must be updated to match with ISO 9001:2008 once it is published
Provides additional requirements related to Ex-equipment
note: informative Annex A and B are considered normative by KEMA
Standard IEC/ISO is being developed by SC31M as future successor of OD 005

5. Benefit of ISO 9001 certification
Good basis for compliance with OD 005
Reduction of IECEx audit frequency from 12 to 18 months (provided that a good ISO 9001 audit has been conducted)
Reduction of actual IECEx audit time

6. Audit differences - 1 Initial audit:
100% audit covering all types of protection and all product groups
100% evidence is collected to support the audit findings
usually 10 to 15 non-conformities; some are major
sometimes additional corrective actions audit required

7. Audit differences - 2 Focus of Follow-up audit:
corrective actions to NCs of previous audit
changes to quality management system
new products
new types of protection
usually 0 to 5 minor non-conformities
usually no additional corrective actions audit required

8. Audit differences - 3 Reassessment audit:
100% audit covering all types of protection and all product groups (identical to initial audit)
evidence is collected as far as it is not already in possession of KEMA
corrective actions to NCs of previous audit
usually 0 to 5 minor non-conformities
usually no additional corrective actions audit required

9. Audit differences?
Difference between initial / follow-up and reassessment audits is merely theoretical
In practice there is often no clear difference between the audits due to changes in products, types op protection, management system, etc.
Only relatively small and stable companies fit more-or-less in the 3 audit type model; large companies with several production sites usually don’t fit in.

10. Multiple production sites
Sites usually operate under the same quality system
Sites differ in product(group) and types of protection
Sites differ in quality level, even within the same quality system
Audit planning determined case-by-case, all production sites are audited at least 1 x 3 years

11. Common NCs Control of documents: not up-to-date
poor traceability between scheduled drawings and related drawings
Evaluation of suppliers:
not evaluated on a regular basis
evaluated on wrong criteria
Control of monitoring and measuring devices
not calibrated (example: go/no go calipers)
used outside calibrated range (example: dielectric strength test equipment)

12. Common NCs Routine tests: method and equipment used no tests conducted
wrong test method (example: even faulty products pass dielectric strength test)
faulty test equipment
Verification of incoming products
poor verification
declaration of conformity missing
Control of Ex m potting material

13. Major / minor NCs
No differentiation between major / minor NCs; instead:
NCs that directly affect the safety level must be solved as soon as possible, evidence of implementation must be provided to KEMA and sometimes a corrective actions audit is conducted to verify correct implementation
other NCs: proposed solution must be provided to KEMA within agreed time, evidence of implementation will be verified during next audit

14. Reporting
Drafting of detailed audit report (QAR) is found quite time-consuming in current IECEx format
KEMA uses an adapted IECEx format thus reducing the time needed for reporting without loosing quality/information
--> Example of KEMA format
Full audit report is sent to manufacturer

15. Registration of QARs
QARs are only registered on IECEx website when the quality system is found to meet OD 005 (no major NCs, nor many minor NCs)
Before CoC is issued, the on-line QAR is checked:
If type of protection or equipment group are not in the scope of the QAR, manufacturer must contact the ExCB that conducts the audits. CoC placed on hold.
Copy of full audit report is not required, valid on-line QAR with correct scope is sufficient.

16. Thank you for your attention
Theo Pijpker
KEMA Quality B.V.