Inspection Audit

Inspection Audit refers to the assessment of production conditions and quality-related processes during the validity period of certain EAC Certificates for serial production as part of EAC Certification. It may form part of the mandatory Inspection Control and is intended to verify whether the conditions for maintaining the certificate continue to be met.

Inspection Audit and Inspection Control are not identical. Inspection Control refers to the surveillance of an existing certificate as prescribed by the applicable Certification Procedure. Depending on the Certification Scheme, it may include a production Audit, the sampling and testing of products, or other surveillance measures.

An Inspection Audit is intended in particular to:

  • assess the stability of certified production,
  • verify compliance with relevant production and quality requirements,
  • identify changes to products and manufacturing processes,
  • evaluate the effectiveness of testing and control measures,
  • verify that the conditions for maintaining the validity of the EAC Certificate continue to be met.

Whether Inspection Control is required, and to what extent, depends on the applicable Technical Regulations (TR EAEU / TR CU), the Certification Scheme, the product type and the conditions of the issued certificate.

Inspection Audits are particularly relevant to EAC Certificates issued under Serial Production Certification. Different requirements may apply to individual products or one-off deliveries.

During an Inspection Audit, the following areas may be examined:

  • production conditions and manufacturing processes,
  • quality assurance and production controls,
  • incoming goods inspections and in-process testing,
  • testing and measuring equipment,
  • handling of non-conforming products,
  • technical and quality-related records,
  • changes to products, components or manufacturing processes,
  • consistency of ongoing production with the certified product.

A certified Quality Management System is not required in every case. The decisive factor is whether the production conditions and existing control measures enable consistent Product Compliance.

Depending on the Certification Scheme, Inspection Control may include Product Testing in addition to an Audit. While Product Testing examines the technical characteristics of a product, an Inspection Audit primarily assesses production conditions and the ability of the Manufacturer to continue producing compliant products.

An Inspection Audit performed during the certificate’s validity period must also be distinguished from the initial Factory Audit. An initial audit may be required before an EAC Certificate is issued, whereas subsequent Inspection Control serves to monitor compliance throughout the certificate’s validity period.

Inspection Control may be relevant, for example, to serial production certification under the following Technical Regulations:

Before an Inspection Audit, it should be verified whether any relevant changes have occurred since the original certification. These may include:

  • changes to design or technical characteristics,
  • new or modified components and materials,
  • changes to manufacturing processes or production sites,
  • modifications to testing and control procedures,
  • deviations from the originally certified production conditions.

The Technical Documentation and ongoing production records are also important. They must remain consistent with the current product version and actual manufacturing conditions.

The results of the Inspection Audit are documented and considered by the responsible Certification Body when deciding whether the certificate may be maintained.

If non-conformities are identified, the following measures may be required, depending on their significance:

  • implementation of corrective actions,
  • submission of additional technical evidence,
  • supplementary product testing,
  • follow-up inspections or further assessments,
  • measures concerning the existing EAC Certificate.

Serious or unresolved non-conformities may lead to the suspension or termination of the certificate’s validity. The current Conformity Status therefore also depends on the proper completion of mandatory surveillance measures.

Inspection Control must be distinguished from official Market Surveillance. While Inspection Control is carried out as part of a certification procedure, Market Surveillance involves government supervision of products already placed on the market.

For Manufacturers, it is important to schedule mandatory Inspection Controls in good time and maintain the necessary production and certification records. Careful preparation helps identify non-conformities early and maintain the conditions required for the continued validity of existing EAC Certificates.

We support manufacturers and exporters in preparing for Inspection Audits and Inspection Controls under existing EAC Certifications. Our services include reviewing certification documents and Technical Documentation, assessing product and production changes, and preparing and coordinating the required surveillance measures with the responsible accredited Certification Body.

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