FAQ - Alienor-Certification

f.a.q.

You have questions. We have answers.

Do not hesitate to contact us at contact@alienor-certification.fr if you can't find the answer to your question in the list below or if you need more information.

What is a CE mark?

The CE marking was created within the framework of the European technical harmonization legislation. It is the visible commitment of the manufacturer that his product respects the regulatory requirements for its free circulation on the whole territory of the European Union.

Why is it necessary?

The CE mark must be affixed to many products before they can be sold in the EU. It indicates that a product has been assessed by the manufacturer and found to comply with EU safety, health and environmental protection requirements.

CE marking is mandatory for all products covered by one or more European regulatory texts (directives or regulations) that explicitly provide for it.

To date, some 20 technical harmonization regulatory texts (directives or regulations) provide for the affixing of the CE marking, covering broad product categories. Only products covered by these texts must bear the CE marking.

The regulations relating to Personal Protective Equipment (PPE) are the Regulation (EU) 2016/425 .

How to get it?

If you are a manufacturer, or a legal representative of a manufacturer, you must follow these 6 steps to affix a CE marking on your product:

1- Identify the applicable directive(s) and harmonized standards
2- Verify the specific requirements of the product
3- Determine if an independent conformity assessment (by a notified body) is necessary
4- Test the product and verify its conformity
5- Establish and keep available the required technical documentation
6- Affix the CE marking and establish the EU declaration of conformity

As a manufacturer, do you need a notified body?

For products with higher safety risks, the safety cannot be checked by the manufacturer alone. In these cases, an independent body, in particular a notified body appointed by the national authorities, must carry out the safety check. The manufacturer can only affix the CE marking to the product once this check has been carried out.

If your product does not have to be checked by an independent body, you must ensure that it complies with the technical requirements. In particular, you must estimate the potential risks associated with the use of the product and report them.

Manufacturers of category II and III PPE must go through a notified body in order to be able to affix the CE mark to their products.

Aliénor Certification is a notified body N°2754 which can provide you with CE certification services for your PPE.

What are the evaluation procedures?

The conformity assessment of products is generally done in two stages, which relate to the design phase of the product and its manufacturing phase.

4 types of assessment procedures (or "modules") are applicable to PPE according to their category:
- Module A: For PPE category I
- Module B: For PPE category II and III
- Module C and C2: For PPE category III
- Module D: For PPE category III

Aliénor Certification is notified to carry out the module B and the Module C2.

How can I check the validity of a certificate?

Characteristics that the document must have: Aliénor Certification logo, COFRAC accreditation logo, notified body number, as well as the signatures of Aliénor Certification personnel

How to certify a product when no harmonized standard is applicable to it?

In the absence of a harmonized standard, PPE models may undergo an EU type examination against a technical specification or protocol proposed by the manufacturer.

Eleanor Certification cannot offer advice or consultation on the development of this technical specification/protocol, but can put you in contact with a competent testing laboratory that can provide this service.

Once developed, this protocol must be reviewed by an expert from Eleanor Certification to ensure that the Essential Health and Safety Requirements (EHSR) applicable to the PPE are met. If all this is satisfactory and the PPE models can be tested against the proposed technical specification, the certification process continues as normal.

Is the product certification still valid when the state of the art has changed?

5For the certification of PPE, when the state of the art changes (i.e. the harmonized standard or technical specification that was applied during the EU type examination is no longer in force) the EU type examination certificate remains valid until it expires.

Although changes to the standard do not invalidate the certification, it is strongly recommended that the manufacturer take note of of any changes, consider the implications for their product and make the make the necessary modifications to their model to comply with the new standard.

You can ask for a complementary certificate or wait for the moment certificate renewal to comply with to comply with the new changes.

Can a PPE be both UKCA and CE marked?

Yes, products can carry both the UKCA and CE mark, provided they fully comply with UK and EU legislation.

If the product is sold in both the UK and the EU, you will need to put both markings on the product. Both markings must remain visible and legible and must be in the required proportions.

How much does certification cost?

The cost of a certification varies considerably depending on the condition of the product, the existence or not of test reports and the variants of the product. A price list is available upon request, so do not hesitate to feel free to contact us.

What are the certification deadlines?

It is our policy to provide as quick a turnaround as possible, while maintaining the requirements of care and accuracy. In all cases, an estimate of time would be indicated in the quote

The time from sample receipt to test report issuance varies considerably - depending on many factors, including current workload, preconditioning times, problems with the product or communications during the test program, etc. problems with the product or communications during the test program, etc.

Please contact us for more information.

To whom should I address an appeal, recommendation or complaint regarding the certification service?

Please contact our quality manager at m.gaschard@alienor-certification.fr.

Complaints and appeals should also be addressed to our quality manager or directly on our website by filling in the contact form .

All complaints are acknowledged, recorded and investigated independently and impartially. You can consult our complaints procedure by clicking here.

What should the technical file contain?

A technical file describes the means used by the manufacturer to ensure that the PPE complies with the applicable Essential Health and Safety Requirements (EHSRs).
The manufacturer must include the following elements in its technical file

A complete description of the PPE, its intended use, drawings of its design and manufacture, diagrams of its components / sub-assemblies and circuits.
The explanations necessary to understand the drawings and diagrams referred to in the above point as well as the operation of the PPE
A list of (SESA) applicable to the IPS
An assessment of the risks against which the EI is intended to protect
The references of the harmonized standards or other technical specifications that have been applied in whole or in part for the design and manufacture of the PPE.
The results of design calculations, inspections and examinations performed to verify the PPE's compliance with applicable SESAs.
Test reports to verify the PPE's compliance with applicable SESAs and to establish the corresponding protection class
A description of the means used during manufacture to ensure that the manufactured PPE complies with the design specifications (for category III PPE).
A copy of the instructions and information provided by the manufacturer
For PPE produced individually for a given user, all the instructions necessary for the manufacture of this PPE based on the approved basic model
For mass-produced PPE where each unit is tailored to a specific user, a description of the measures to be taken by the manufacturer during the tailoring and production process to ensure that each unit of PPE conforms to the approved type and applicable SESAs

Each compliance standard will have different requirements. For more information, please contact us.

Where should the name and number of the notified body appear?

The name, address and identification number of the notified body responsible for the EU type examination must be included in the user information supplied with the product.

For Category III products (such as lifejackets, harnesses and earplugs), the number of the Notified Body performing Module D or Module C2 surveillance must be displayed with the UKCA marking on the product itself. The declaration of conformity must also state the name and number of the notified body.

Does the test report I received from my provider mean that the PPE is compliant?

A test report is a supporting document used by a notified body to issue a type examination certificate. You should not rely solely on a test report as it does not constitute proof of certification. proof of certification.

What test reports can Eleanor Certification accept to support the EU type examination?

Reports should reflect the state of the art and be as current as possible. Normally, to be accepted, test reports must be less than 10 years old.

All test reports must be performed by an ISO/IEC 17025 accredited laboratory. In the absence of such accreditation, a report will only be accepted if competence has been demonstrated to the satisfaction of Eleanor Certification, normally through an internal audit visit.