Documentary Services

Your industry, our focus

Index:

Technical File Review (TCF)
Technical Sheets
Markings & Label Check
Instruction Manual and Artwork Check
Product Information File Audit
Safety Data Sheet (SDS)

Please note that certain services listed below may not be available in relation to Medical Devices. Eurofins provide EU Notified Body Services through Eurofins Product Testing Italy Srl (NB No. 0477), Eurofins Electric & Electronics Finland Oy (NB No. 0537) and Eurofins Product Service GmbH (NB No. 0681). To prevent any conflict of interest, or perception of conflict of interest, we are unable to provide certain services to Notified Body customers. For more information, please contact our Medical Device Certification team at EENBServices@eurofins.com.

Technical File Review (TCF)

Importers, manufacturers, and retailers must ensure their products comply with all the relevant standards and regulations in the country in which their product will be sold.
The TCF is a file including all the documents that should accompany the product in its journey to the end user. It’s the product’s passport, that we can help you set up:

Collecting / claiming the samples and all available documents.
Determining the scope of compliance.
Chasing the supplier or the concerned party (e.g. lab) for the missing certifications and lab test reports and providing assistance to arrange and / or perform the missing steps.
Reviewing and checking the whole for:
- Completion - Subsequently, it will be checked whether the provided test reports and certificates cover the scope of compliance as defined in the earlier stage.
- Authenticity - Once received in digital format, our team will determine the presumption of authenticity of the provided certificates based on visual check and experience.
  Should there be any doubt with regards to the veracity of any of the said documents, the issuing lab may be contacted.
  Under no circumstances, should this verification be considered as a foolproof protection against elaborate forgery, the person in charge merely establishes that there is a reasonable likelihood of genuineness.
  The reputability of the issuing body will be assessed by us, the minimum criterion being the accreditation through an internationally recognized scheme.
- Accuracy
  - The certificates should refer clearly and without ambiguity to the provided sample with description, appearance and reference.
  - Finally, it will be checked that the latest version of the standards have been used to test the product.
- Validity - By default and unless the client says otherwise, a certificate of less than 2 years will be considered as acceptable if no newer version or amendments have a potential bearing on the tested results.

Should there be any unsatisfactory findings, we would send an alert to the client’s QA team to provide or arrange the missing or additional testing or certification to complete the TCF.

With the completion of the TCF a report shall be issued and delivered along with all gathered documentation.

In the frame of a customized program, the TCF report together with any previous partial conformity and performance tests, construction checks and/or product validation reports, would be the closing step for the pre-purchase procedures after which, the “go ahead” signal for mass-production would be given.

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Technical Sheets

Generic Technical Sheets (GTS)

The GTS, conceived per product family (e.g. “Indoor seatings”, including chairs, sofas, stools, etc) is a file to be considered by all persons involved in QA and QC all along the supply chain, from product selection, development validation, all throughout the production and down to forwarding, warehousing and after-sales.

These files are regarded as flexible tools for future adaptations or additions, based on the feedback provided by the client.

The network of Eurofins Consumer Product Testing can assist your team in reviewing the existing protocols or designing new GTS for those ranges where such tool is still missing.

Content of a basic GTS

Applicable Standards, Regulations and Norms
According compulsory markings (labelling and warnings)

Content of an extended GTS

The two points mentioned above
Indication of the measurable criteria to be considered on a potential (future) Specific Technical product Sheet (e.g. dimensions, weight, capacity…)
List of product’s key attributes that would be reckonable or measurable in a “fit for use” or performance program, considered as important parameters to benchmark the product’s quality (e.g. friendly-userness, clearly understandable instruction or assembly manual, resistance to corrosion for outdoor products…)
List of the lab tests to be applied
- Full testing (recommended)
- Partial (minimally advisable)
Definition of the inspection protocols to be used including inspection criteria such as:
- AQL and defect classification
- Grade (intensity) of control
- Sort (DPI, FRI, self-inspection by manufacturer, loading check, etc.) and frequency
Flowchart of the process monitoring

Specific Technical Sheets (STS)

If so determined in the General Technical Sheet (if previously existing) -or due to the special characteristics, risk assessment or your stringent Quality policy- some of the products within one product family might be subject to an additional corroboration process whereby, on top of the generic features observed in the GTS, also the following –non exhaustive bulleted list, to be customized case by case- may be checked for validation:

Dimensions, capacity, weight
Attributes, shape, colour
Determination of critical points to be additionally tested to ensure the manufactured product is the one that was validated for mass production (e.g. pre-shipment testing / spot tests / flash tests to perform)
Instruction manuals
Functions as per the instruction manual or claims made on product/packaging
Compulsory markings specifically for the product
Specific QA/QC protocols to implement to the product, other than the standard for the range (as per the corresponding GTS)

Notes:

According to the singular nature of these files, the “Basic GTS” can be quoted with a fixed tariff whereas the extended GTS version or the STS, that are to be customized according to the client’s needs, are to be quoted on hourly basis.
Even our best technical specialists, perfectly knowledgeable and aware of the technical and production features of the products, do have limited access to the regulations of specific countries.

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Markings & Label Check

Product labels are the primary method of communicating product information to consumers.

Labels provide basic product information while also promoting the brand and company.

As consumers are becoming increasingly conscious, they rely on product labels as a way of differentiating between products and brands to make conscious and sensible choices.

Regulatory authorities have established and enforced the policies and standards used to protect consumers against false or misleading representation on products, whether on the mandatory labels or on the product’s artwork and packaging markings (warnings, etc.).

Eurofins experts can provide technical labels and marking review to verify accuracy, quality, and compliance.

Instruction Manual and Artwork Check

As the definition advocates, this service is aimed to attest that the instructions displayed on the packaging (also called Artwork) or those on the Instruction Manual are compliant and according to the regulatory framework of the product’s destination market and written in the said market official language(s).

Such verification covers two key aspects:

1. Corroboration of the contents to be in compliance to the applicable legislations and standards (content information)
2. Verification of the correct and standardized wording, required symbols and pictograms displayed

Product Information File Audit

Commonly known as PIF, the Product Information File encloses all necessary data to prove the product’s compliance to Article 11 (+ Annex 1) of the Cosmetic Regulation.

Eurofins companies provide the audit service consisting of a thorough check of the data contained in PIFs.

For detailed information contact our experts.