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IECEx 02 Audits: Benefits & Procedures | ISO Certification, Audit Types, Major NCs

This informative guide explores the importance of IECEx 02 audits, benefits of ISO 9001 certification, audit procedures, common non-conformities, and reporting protocols in the manufacturing industry. Learn about audit differences, multiple production sites challenges, and how to handle major and minor non-conformities effectively. Gain insights into the significance of quality management systems and the registration process for Quality Assessment Reports (QARs) on the IECEx website.

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IECEx 02 Audits: Benefits & Procedures | ISO Certification, Audit Types, Major NCs

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  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 80079-34 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.

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