Manufacturing audit

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:

Technical documentation for manufacturing audits

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 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 of manufacturing audits

The cost for manufacturing audits depend 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.

The EAC certificate of the Eurasian Economic Union (EAEU) is an official document, that proofs the conformity of the products with the harmonized technical regulations of the member states of the EAEU. The products, whose conformity with the technical regulations could be confirmed by the certificate of the EAEU, may be moved and sold in the whole customs area of the member states of the EAEU.

The EAC Declaration of the Eurasian Economic Union (EAEU) is an official document that proofs, that the products meet the minimum requirements of the technical regulations of the EAEU. An EAC declaration is issued by the manufacturer, importer or an authorized representative and listed in the official register. Those products, whose conformity with the technical regulations are confirmed by the declaration, have the permission to be freely moved and sold in the whole customs territory of the member states of the EAEU.

The EAC certificate can only be issued after a quality assessment, which has to be carried out by a certification body accredited in one of the member states of the Eurasian Economic Union. The certification is conducted on the basis of technical documentations, company-internal created test reports, or rather test reports provided by accredited test laboratories, as well as on basis of a manufacturing audit on site. The certificate is printed on an official pre-printed form, which has several forgery-proof elements and is authenticated by the signature and seal of an accredited body. The EAC certificate is usually issued for “complex” products that require an extensive control by the authorities.

With the EAC Declaration the manufacturer, importer or authorized representative declares the conformity of his products with the minimum requirements of the technical regulation of the Eurasian Economic Union (EAEU). As distinguished from the EAC certificate, the EAC declaration is issued by the manufacturer or importer himself. All necessary tests and analysis are or made by the manufacturer or in some cases by the laboratory. The applicant issues the EAC declaration himself on a usual piece of paper. The EAC declaration has to be listed in the uniform register of the EAEU by an accredited certification body of one of the member states of the EAEU.

Qualified team of experts and consultants

Our experts have many years of experience in export and certification

Certification of all product types

We work with clients from all branches of industry

Quick processing of orders

We handle client's needs individually and process the requests quickly

Profound knowledge of technical regulations

Due to our technical and legal know-how, we guarantee high quality of services

Free delivery of documents

Your documents will be provided free of charge in the shortest possible time

News

A new standard for the oil and gas industry

A new standard for the oil and gas industry

13.04.2021

GOST R 59411-2021 “Glass fiber reinforced plastic pipes for industrial use. Construction and Operating Rules” has been approved on behalf of Rosstandart. This standard has thus become the first document to promote the use of non-metallic pipes in the oil and gas industry.

What to look out for when applying for EAC certification

What to look out for when applying for EAC certification

08.04.2021

Despite sanctions and political disputes, the Eurasian and especially the Russian market remain attractive for many european manufacturers. The corresponding conformity assessment - EAC certification or EAC declaration - is a major obstacle for many foreign entrepreneurs due to its complexity, language differences and the very dynamic development of technical regulations and legislation in the field of industrial safety and consumer protection.

A public discussion about the draft changes in TR CU 010/2011 has started

A public discussion about the draft changes in TR CU 010/2011 has started

08.04.2021

On March 26, 2021, the public discussion on the draft amendments in TR CU 010/2011 "On safety of machinery and equipment" began. The discussion ends on April 22, 2021.

The Technical Regulation TR CU 005/2011 will be changed

The Technical Regulation TR CU 005/2011 will be changed

06.04.2021

On March 31, 2021, the draft amendments in TR CU 005/2011 "On safety of packaging" No. 4 were published on the website of the Eurasian Economic Commission.