Structural Bearings and Anti-seismic Devices-CE audit content.

The audit begins with validating the clarity and completeness of product definition. Inspectors verify whether the products under certification (structural bearings and anti-seismic devices) are clearly identified and defined. A key requirement is that manufacturers must conduct proper performance assessments of their products through initial type tests, calculations, tabular data, or descriptive documentation. Compliance with relevant technical specifications-such as EN 1337-7 for structural bearings and EN 15129:2009 for anti-seismic devices-is non-negotiable, as these standards form the foundation of CE conformity.

A robust management system is essential for maintaining consistent product quality. Inspectors assess whether the manufacturer has implemented a recognized management system (e.g., compliant with EN ISO 9001, with valid certification) and whether the FPC is documented in a dedicated manual or integrated into existing Quality Management System (QMS) documentation. Clear definition of responsibilities and authority is another critical check: employees must have assigned roles in customer requirement review, procurement of quality-impacting materials, production control, inspections, identification, traceability, and product release. Additionally, the appointment of a management representative for FPC-with the authority to establish and maintain the system-and an authorized person to issue performance declarations is verified.

Effective documentation control ensures transparency and consistency in production processes. Inspectors verify that valid documents-including technical specifications, manufacturing instructions, quality manuals, and external standards (such as EN 1337-7 and EN 15129:2009)-are readily available at relevant workplaces. Record-keeping practices are also scrutinized: manufacturers must maintain comprehensive records of production, inspections, tests, calibrations, and management reviews for a specified period (e.g., 5 years for production records). These records serve as tangible evidence of compliance and traceability.

The quality of end products depends heavily on the quality of raw materials and components. Auditors check if the manufacturer has an approved list of qualified suppliers and clear requirements for input materials. Key inspections include:

Verification of material certificates, conformity declarations, and inspection reports for raw materials (e.g., steel, natural rubber);

Implementation of incoming material inspection procedures in line with control and test plans;

Established processes for handling non-conforming input materials to prevent their use in production;

Proper storage conditions to avoid material degradation.

Inspectors evaluate whether production processes are well-documented in technological or production regulations, which are accessible at workplaces and consistently followed. Critical checks include:

Presence of procedures for material identification and inspection at incoming, in-process, and finished product stages;

Regular maintenance of production and measuring equipment, supported by documented maintenance plans and calibration records (e.g., 2025 calibration plan for test press machine YJW-3000);

Sufficient qualification and training of production personnel to operate and maintain equipment;

Continuous or periodic recording of production processes and timely identification and resolution of non-conformities (e.g., equipment failures, process deviations) with documented corrective actions.

Traceability is also emphasized-products must be identifiable from production to the point of sale, typically through CE marking and unique product labeling.

Reliable testing processes are vital to confirming product compliance. Auditors assess whether the manufacturer has developed a comprehensive control plan covering incoming, in-process, and outgoing inspections. Key requirements include:

Availability of appropriate testing equipment, which is regularly calibrated, uniquely identified, and operated in accordance with written procedures;

Compliance with specified sampling and testing frequencies as per technical specifications;

Proper evaluation of test results and documentation of all inspection activities;

Demonstration of competence for both in-house testing and subcontracted testing services.

Manufacturers must have documented procedures for handling non-conforming products to prevent their unauthorized release. Inspectors verify that non-conformities-including those related to customer complaints-are recorded, investigated, and addressed with appropriate corrective measures. The process must ensure non-conforming products are identified, isolated, and assessed by authorized personnel, with clear responsibilities defined for decision-making.

Proper logistics and packaging are critical to preserving product integrity. Auditors check if the manufacturer has documented procedures for storing and handling critical raw materials and finished products. Storage facilities must be suitable for the product type, protecting against damage or degradation. Packaging and marking must comply with technical specifications and include the mandatory CE mark, ensuring products remain intact during transport and are correctly identified at the point of use.

Competent personnel are a cornerstone of effective FPC. Inspectors review the manufacturer's training plans and records to ensure employees involved in FPC-related activities-including production, inspection, and testing-receive adequate and ongoing training. This ensures staff have the necessary skills to maintain product quality and comply with certification requirements.