Audit Plan to Maintain CE Compliance in Mass Production

Audit Plan to Maintain CE Compliance in Serial Production (Step-by-Step Guide)

Maintaining CE compliance in serial production requires more than initial testing. The audit plan below defines a structured and sustainable production control model designed to ensure continuous conformity with CE requirements throughout the product lifecycle.

1. Incoming Material Inspection (Incoming Quality Control – IQC)

For every production batch, the following checks must be performed:

Has the supplier changed?
Has the part or material specification changed?
Are the parts identical to those used during CE testing?

Important: The use of incorrect or unapproved materials invalidates CE test results.

2. Production Line Conformity Control

The production process must strictly comply with the specifications defined in the CE technical file, including:

Assembly steps
Process parameters
Welding, soldering, and assembly methods
Specified tolerances

Any change in the production process requires an immediate update to the CE technical file.

3. In-Process Controls (Process Internal Audits)

At predefined intervals during production, the following inspections should be conducted:

Electrical checks
Mechanical checks
Visual inspections
Safety interlock and emergency stop tests (for machinery)

These controls are essential for preventing operator errors and process deviations.

4. Final Product Quality Control (Final Quality Control – FQC)

The final product must fully comply with all requirements stated in the CE technical file. Final inspections include:

Electrical safety tests
Visual inspection
Serial number and labeling verification
Correct and legible application of the CE marking
Functional performance tests
Verification of user manual inclusion

Note: A product with an incorrectly applied CE mark is considered non-compliant.

5. Periodic Re-Testing

During serial production, certain tests must be repeated at defined intervals based on risk analysis:

EMC tests (even if the product design remains unchanged)
LVD electrical safety tests
Mechanical strength and durability tests
Chemical tests (such as EN 71-3)

Periodic re-testing ensures ongoing compliance under real production conditions.

6. Keeping the Technical File Up to Date

To maintain CE compliance, the CE technical file must be continuously updated with:

Technical drawings
Bills of materials (BOM)
Test and inspection reports
Risk assessments
User manuals and instructions

7. Archiving Production Records

EU legislation requires manufacturers to retain product-related documentation for at least 10 years. These records include:

Test reports
Batch and production records
Final quality control results
Supplier certificates
Recall and corrective action records

8. Annual Internal Audit and Compliance Review

An annual review of the CE compliance process is strongly recommended:

Have there been regulatory or directive changes?
Have harmonized standards been updated?
Are component or supplier changes still compliant?
Have any test validity periods expired?

This annual audit is critical for sustaining long-term CE compliance.

What Happens If CE Compliance Is Lost?

If CE compliance is compromised during serial production, the following risks may arise:

Products may be withdrawn from the market
Customs detention or border rejection
Administrative fines and legal sanctions
Suspension of Amazon, ETSY, or similar marketplace accounts
Severe damage to brand reputation

For this reason, obtaining a CE certificate is not the end of the process-it is only the beginning.

CE Certification Is a Starting Point, Continuity Is Essential

The CE marking represents a declaration of conformity not only for the first tested product, but for all production batches. Establishing a structured production and audit model is therefore mandatory.