Manufacturing audit for EAC Certification

Within the framework of the EAC conformity assessment, the production audit (analysis of the production status) represents one of the key instruments for assessing a manufacturer’s ability to produce products on a permanent, reproducible, and compliant basis. While testing of product samples provides only a snapshot, the production audit evaluates the entirety of an organization’s organizational, technical, and procedural conditions.

In practice, it is regularly observed that, particularly in the serial production of safety-relevant products—such as machinery, pressure equipment, or explosion-protected equipment—formally correct documentation alone is not sufficient. What is decisive instead is whether the manufacturer can demonstrably maintain the tested product quality consistently over many years. This is precisely where the production audit comes into play.

A production audit is required for EAC certification for serial production. The necessity of an audit is stipulated in the Technical Regulations of the Eurasian Economic Union.

• TR CU 004/2011 On safety of low-voltage equipment
• TR CU 010/2011 On safety of machinery and equipment
• TR CU 020/2011 On electromagnetic compatibility
• TR CU 016/2011 On safety of appliances burning gaseous fuels
• TR CU 012/2011 On safety of the equipment for operation in explosive atmospheres
• TR CU 011/2011 Elevator safety
• TR CU 008/2011 On the safety of toys
• TR CU 032/2013 On the safety of pressure equipment

Analysis of the production status, or the manufacturing audit – is a component of the certification system that comprises a set of measures carried out by the certification body in order to assess whether the manufacturer has the necessary organizational, technical, and procedural conditions to ensure the long-term, consistent conformity of the manufactured products with the requirements defined within the framework of certification.

The audit is carried out on site by an accredited certification body. The conduct of the manufacturing audit is regulated by the standard GOST-R 54293-2020 “Production audit for conformity assessment procedures”. For audits of manufacturers of explosion-protected equipment, GOST-R ISO/IEC 80079-34-2013 “Explosive atmospheres – Part 34: Application of quality management systems for the manufacture of Ex products” is additionally applied.

Procedure and scope of the manufacturing audit

The manufacturing audit is designed as an on-site inspection and goes far beyond a formal review of documentation. Among other aspects, it examines whether the production infrastructure, the machinery used, and the manufacturing processes comply with the requirements of the relevant Technical Regulations of the Eurasian Economic Union.

A particular focus is placed on process traceability. In practice, auditors often require a complete and transparent presentation of the product flow – from incoming goods through individual manufacturing steps to final inspection and delivery.

The following areas are checked:

• infrastructure (territory, production hall, means of transport, etc.)
• documentation (technical documents, business documents, commercial register extract)
• staff
• technological equipment and processes
• measuring equipment
• product labeling
• traceability
• acceptance test and incoming inspection
• quality control and product testing
• process monitoring and product inspections
• handling of non-conforming goods
• complaint management
• preventive and corrective actions
• conditions for storage, labeling, and identification of products
• functioning of the quality management system (if available)

Typical program for analyzing product conditions

Audit results

Based on the audit carried out, a protocol is prepared in the format established by the certification body’s quality management system for products, documenting the audit findings, references to supporting documents and records, and, if necessary, deadlines for correcting any identified non-conformities.

Based on the audit results, the certification body may suspend or terminate the certification process. Certification may, in particular, be discontinued if critical non-conformities cannot be remedied within the specified deadlines through appropriate corrective and preventive actions, or if the fundamental requirements of the Technical Regulations are not met.

Case study: audit within the framework of certification of explosion-protected equipment

In EAC certification of explosion-protected equipment according to TR ZU 012/2011, the production audit is one of the most critical elements of the entire process. It is not sufficient to successfully test a single product. Rather, the manufacturer must demonstrate that all safety-relevant processes are continuously monitored and controlled.

In practice, we often observe that certification bodies require additional evidence regarding the traceability of components, the inspection of explosion-protected parts, and personnel training. The basis for this is GOST R ISO/IEC 80079-34-2013, which explicitly requires a functioning quality management system for the manufacture of Ex products.

The audit usually lasts about 2 days. The standards stipulate that an audit must be accompanied by two experts – one expert is responsible for the quality management system, and the second expert checks the product’s conformity.

The audit consists of two parts:

1. Walkthrough of the production
2. Review of the QM documentation

The production walkthrough is logically structured and starts with the incoming goods inspection.

Incoming goods inspection

The walkthrough begins with the incoming goods inspection. The experts check how the incoming goods inspection is organized. It is important to demonstrate which parameters need to be checked, inspection of incoming goods for compliance with specifications, inspection lot, control methods, documentation of inspection results, labeling of the status of inspected products, and measures to prevent non-conforming incoming materials from being passed on to production.

Handling of non-conforming goods is of utmost importance. It is essential to have a clearly marked area where non-conforming goods are placed. They must be visibly labeled with a tag.

Another important point is to ensure traceability of the parts from receipt of goods to the finished product.

Production and internal inspections

An important and the largest part is the inspection of production. Through this, the entire production process can be clearly demonstrated and evaluated.

What should be shown during assembly:

• The complete production process from material receipt to the finished product.
• Critical control points where quality checks are performed.
• Labeling and traceability of products.
• Handling of non-conforming products (e.g., blocking, rework).
• Interfaces between workstations and departments.
• Inspection and maintenance of machines and other technical equipment.
• Verification that inspection results are correctly recorded and documented.
• Ensuring that the status of inspected products is clearly identifiable.

Packaging and storage

The auditor checks whether the product is packaged according to the packaging and preservation instructions provided by the manufacturer. The packaging must protect the contents throughout the entire transport and storage process from physical damage (impacts, vibrations, deformation) as well as from harmful environmental influences (moisture, dust, temperature fluctuations).

Safety and occupational health measures

Occupational safety is also an important topic during the audit. The auditor checks compliance with safety regulations in the workplace, such as wearing helmets, ear protection, and other protective equipment in hazardous areas.

The presence and use of protective measures in the areas of noise protection, fire safety, and lighting are also checked.

Costs of manufacturing audits and EAC certification

The costs of a manufacturing audit and the subsequent EAC certification cannot be set as a flat rate, as they always depend on the specific product, the applicable Technical Regulation, and the scope of the conformity assessment. In practice, the overall costs are particularly influenced by the product complexity, the number of relevant TR regulations, the necessity of a production audit, the scope of testing, and the type of certification (EAC certificate or EAC declaration).

For mass-produced products, costs regularly increase due to on-site audits, inspection checks, and recurring monitoring measures during the validity period of the certificate. Additionally, expenses arise for the preparation of technical documentation, support during the audit, and – if necessary – for correcting any identified non-conformities. Our experience shows that early, structured preparation for the production audit not only reduces the risk of certification denial but also enables significant cost savings by avoiding rework, repeat audits, and delays.

Schmidt & Schmidt supports manufacturers in transparent cost estimation and in economically sensible planning of the entire EAC certification process – from selecting the appropriate conformity assessment procedure to long-term planning of certification costs.

Liability for violations of requirements

The sale of products without valid EAC conformity certificates or with forged or unreliable documents entails significant penalties under Chapter 14 of the Administrative Offenses Law. These can include fines of up to tens of thousands of euros, as well as suspension of business activities, confiscation of products, and – in cases involving risks to life, health, or the environment – even criminal consequences. An overview of possible sanctions for violations of EAC certification rules can be found in our expert article. Therefore, it is of utmost importance to take the EAC conformity assessment seriously.

Authorized representative for EAC Certification

Manufacturers that are not based in a member state of the Eurasian Economic Union (EAEU) are not allowed to independently apply for EAC certification of their products. Without a partner located in the EAEU, it is therefore impossible to obtain a valid EAC certificate.

In this case, the foreign manufacturer must appoint an authorized representative in an EAEU member state. This representative acts as the applicant towards the certification bodies and represents the manufacturer’s interests throughout the conformity assessment process. The authorized representative coordinates the collaboration with the certification bodies and ensures that the products comply with the technical regulations and safety requirements of the EAEU.

Under applicable law, only a company located within the territory of the Eurasian Economic Union may be appointed as an authorized representative. For European, American, or Asian manufacturers, this is a mandatory requirement for certification and market access in the EAEU.

Schmidt & Schmidt supports manufacturers from Europe, America, and Asia in appointing an authorized representative in the EAEU. Thanks to our legally secure solution via Kazakhstan – an EAEU member state – we can ensure the issuance of EAC certificates. Through our local offices, we ensure that the entire certification process complies not only with the technical regulations of the Eurasian Economic Union but also with European and US sanctions regulations. In this way, our clients gain reliable and legal access to the EAEU market.

Compliance with EU and US sanctions in the context of EAC certification

In addition to the technical regulations of the Eurasian Economic Union (EAEU), European and international companies must also comply with the applicable sanctions regulations of the European Union and the United States when pursuing EAC certification. These regulations particularly concern the export of certain goods, trade with listed individuals and companies, and the provision of technical services. Violations can endanger business relationships and lead to civil and criminal liability.

The situation is especially critical for exports to Russia and Belarus. Due to the geopolitical situation, numerous embargoes and restrictive measures have been introduced since 2014, which can directly affect certification procedures. For example, certification bodies or business partners in the affected countries may be on sanctions lists, making collaboration legally prohibited. Companies must therefore carefully review not only the technical regulations but also the current EU and US sanctions lists.

Another risk arises if shipments are blocked due to sanctions violations. Even a formally correct conformity assessment provides no legal security in such cases. Therefore, close coordination between compliance departments, export control officers, and certification partners is essential to avoid legal conflicts and secure supply chains.

Companies wishing to successfully export their products to Kazakhstan, Russia, or other EAEU member states should not only focus on compliance with technical regulations but also ensure comprehensive sanctions compliance. This includes reviewing end-use as well as selecting suitable authorized representatives and local partners.

Schmidt & Schmidt provides a legally secure solution via Kazakhstan. As an EAEU member state, Kazakhstan is authorized to issue EAC certificates and EAC declarations. Through our local offices, we ensure that all certification processes are conducted in compliance with European and US sanctions regulations, while still providing our clients access to the EAEU market.

For detailed information on the latest developments, see our article EAC certification amidst EU and US sanctions against Russia and Belarus.