For obtaining a conformity assessment of some products which underlie an obligatory EAC Certification, a manufacturing audit must be conducted. It is required first of all by an EAC Certification for a series production. The following technical regulations of the Eurasian Economic Union require a manufacturing audit:

In some cases a production audit may be replaced by certification of the quality management system if the manufacturer is ISO 9001 certified. Such certification makes it possible to obtain an EAC certificate with the maximum possible duration of five years.

The audit is carried out by a notified body on site. Performance of the production audit is governed by the national standard of the Russian Federation GOST-R 54293-2010 "Production audit for conformity assessment procedures".

The aim of the audit is to determine if the production processes meet the requirements set out in the technical regulations. The procedure and objects of the audit are defined in the technical regulations, for example in Annex 13 of TR CU 018/2011 On safety of wheeled vehicles.

The following areas are checked:

  • infrastructure (territory, production hall, means of transport, etc.)
  • documentation (technical documents, business documents, commercial register extract)
  • staff
  • technological equipment
  • measuring equipment
  • product labeling
  • acceptance test and incoming inspection
  • process monitoring

The following documents must be provided:

Inconsistency in the production or absence of the necessary documentation may result in the refuse of certification. The manufacturer must then submit the missing documents and eliminate the discrepancies within the specified deadline.

After the manufacturing audit, the auditors prepare a final report. The report is decisive for the further conformity assessment procedure.

Typical production audit program

Audit objects in accordance with GOST R 54293-2010:

  • technical documents (project and (or) design, and (or) technological, and (or) operational documents) for the product
  • competence of staff performing work affecting compliance of the product with technical regulations requirements
  • manufacturing infrastructure (all the objects on the territory of manufacturer necessary for manufacturing process (manufacturing facilities, transport etc.))
  • tools, jigs and fixtures as well as their technical maintenance and repair
  • control, measurement and test equipment management
  • measuring facilities required for ensuring conformity of the product to technical regulations requirements
  • initial production check of purchased product affecting safety indicators of the product subject to certification (raw materials, materials, components); manufacturing methods including special ones
  • acceptance control and periodic inspections of end product to control features for which the technical regulation has mandatory requirements
  • end product marking, its storage, packaging and preservation conditions
  • interaction with consumers (including processing of complaints and reclamations regarding products of the manufacturer)
  • product identification and traceability
  • correcting and preventive measures

Our services

We offer a competent and professional audit support. We are always on your side in the preparation and execution of the manufacturing audit. Our translators are also ready to help you.

Our experienced experts develop high-quality technical documentation for the conformity assessment: EAC Certificate, EAC Declaration, state registration, fire safety certification, etc. If necessary, we can translate your documents into Russian.

Your benefits

An individual approach to each customer, loyalty, transparency and the highest quality are the foundations of our company. That's why we offer you:

Typical program for analyzing product conditions

Subject of the test Documents
Infrastructure This can be checked: site plan, construction of workshops,
installation of machines and other equipment, plan of ventilation systems, scheme of product movement within the plant, information about the finishing materials of the premises, etc.
Documents
  • The documents prescribed in the technical regulations;
  • Technical passports, operating documents, schedules for inspections, maintenance, repairs and so on
  • Test procedures, information on the measurement procedure, protocols, files, reports
Machinery and equipment Documentation of manufacturing process, testing of technological equipment
Measuring devices Verification certificate, verification of correct use and storage of the measuring device
Staff If specified in the technical regulations: requirements for competence and qualification, evidence of hygiene training etc.
Incoming inspection of the material, product Test frequency, test methods, scope of control, test results
Special processes Process validation protocols, reports on sample tests, documents on the certification of technological processes
Marking EAC or EX Marking
Additionally ISO certificates, quality manual, organization chart

Costs for the preparation of the safety justification

The cost for preparation of the safety justification depends on various factors. We always find an individual concept and offer a variety of payment options to meet the needs of our customers.

If you have any questions regarding the creation of the safety justification, please contact us, we will gladly consult you about the offer. 

In our video, we explain what an EAC Certification is and how and where to certify or declare your products for the introduction on the EAEU market.

The EAC Certification and the EAC Declaration are complex procedures that attest your products the conformity with the technical regulations of the EAEU and require a lot of know-how. Schmidt & Schmidt will support you with the certification of your products for the EAEU market.

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