Description of the Certification Procedure
 

1.  The main goal of the Certifying Body of BIMEO Ltd. as a notified body is to operate a conformity-certification system for Personal Protective Equipments (PPE) that is acknowledged both nationally and at a European level. To achieve this, our PPE conformity-certification system has been developed and is operated according to the 89/686/EEC Council Directive – or more precisely its Hungarian equivalent the: 18/2008. (XII. 3.) SZMM Decree – and the (MSZ) EN 45011:1999 standard.

Note: For PPE (any category) originating from Third (not EU) Countries, the EC type-certification procedure has to be used.
 

2.  Administration of conformity certification is done by the Certifying Body of BIMEO Ltd., the services of which are available for any customer. The legally regulated field of activity for the Certifying Body of BIMEO Ltd. is:

         EC type-testing of Personal Protective Equipment (footwear, gloves, clothes) prior to its marketing, issuing of EC type-certificate.

The list of PPE certified by the Certifying Body of BIMEO Ltd. is available on the web-site of BIMEO Ltd.

The certification activities of the Certifying Body of BIMEO Ltd. are carried out based on the 17/2008. (XII. 3.) SZMM Decree, as a notified (by the OMMF) body and according to 9-11. and 13-14. § of the 18/2008. (XII. 3.) SZMM Decree (Articles 8-10 of the 89/686/EEC Directive).

Registration No.: 1524
 

3.      Applicant may register its request for an EC type-certificate either by post or hand it in personally (Annexes Tanker-L and Tanker-K/R). The procedure starts with making the contract concerning the certification (Annex Tanszerz).

The contract should contain – among others – the list of documents and PPE samples Applicant has to submit for the certification procedure; the deadline and the price of the certification procedure; the requested languages of the EC type-certificate (e.g. hungarian/english); the course of the conformity examination, the settlement of the costs, the issuing of the EC type-certificate and the announcing of the issuing by the Certifying Body of BIMEO Ltd. The contract has to make provisions for the conditions of the general conformity control that may become necessary in various cases; for the actions that can be expected based on controlling experience and for the regulations on extending, narrowing, suspending or withdrawing the EC type-certificate.
 

4.      Applicant has to attach the following to their application and the necessary amount of PPE samples according to the contract:

• EC Declaration of Conformity relating to the PPE (Annex Megfnyil),

• Test report relating to the PPE, issued by a notified testing laboratory,

• technical documentation of the PPE (Annexes Muszleir-L, Muszleir-K/R),

• consumer Information of the PPE,

• for category 3. PPE, evaluation report according to the contents of 15. § of the 18/2008. (XII. 3.) SZMM Decree prepared by a notified inspection body on the conformity of the manufacturing and end-product controlling system of the PPE,

• any other documentation that may become necessary for the given PPE.

(If the Applicant wishes to later call upon the Inspection Body of BIMEO Ltd. for the controlling of category 3 PPE according to 15. § of the 18/2008. (XII. 3.) SZMM Decree, the conformity of the manufacturing and end-product controlling system of the PPE might be evaluated during the EC type-certification procedure. But it is advisable even in the case of simultaneously calling upon the Inspection Body of BIMEO Ltd. to hand in to the Certifying Body together with the request for EC type-certification, the documentation proving the conformity of the manufacturing and end-product controlling system of the category 3 PPE.)
 

5.      The following is an introduction on the certification procedure used for PPE’s. (For cases that differ from this, the certification procedure is agreed upon when receiving the application and entering the contract.)

5.1.      The Leader of the Certifying Body assigns the personnel for the work according to the application. The evaluators make a declaration of impartiality.

5.2.      Drawing up the contract signed by the Leader of the Certifying Body, posting together with the necessary forms and the invoice.

5.3.      Arrival of the contract signed by the Applicant and the requested annexes, receipt of payment.

5.4.      Examination of the documentation and testing of the PPE submitted by the Applicant.

5.5.      If necessary

• undertaking or requesting additional visual inspection or instrumental tests,

• request for additional test report,

• request for additional information or declarations.

5.6.      If the Leader of the Certifying Body rejects issuing the EC type-certificate, he will instruct the evaluator to review the procedure and to amend the non-conformity he revealed. After repeating the process, the Leader of the Certifying Body will decide upon issuing the EC type-certificate, the need for more amendments or rejecting the application.

5.7.      After settling the possible additional costs the EC type-certificate will be issued in the languages requested by the Applicant (e.g. hungarian or english). The sample of the PPE with the necessary identification markings (see Article 13.) will be given to the Applicant to keep as an authentic sample.

5.8.      The Leader of the Certifying Body takes care of informing the notifying body OMMF on the particulars of the certified PPE and also of publishing these on the web-page of the company.
 

6.      When issuing an EC type-certificate the Certifying Body BIMEO Ltd. may grant at the request of the Applicant the usage of its trade-marked “Certified by BIMEO” brand on the certified PPE. Usage of the “Certified by BIMEO” brand is regulated in a separate contract by the Certifying Body of BIMEO Ltd. The Certifying Body of BIMEO Ltd. will propose a contract on the usage of the “Certified by BIMEO” brand in work-phase 5.2. Accepting and signing the contract by the Applicant has to be done prior to finishing work-phase 5.7.

If a contract is established on the usage of the “Certified by BIMEO” brand the Certifying Body of BIMEO Ltd. will inform also the market controlling authority NFH on the issuing of the EC type-certificate and the grant of usage of the “Certified by BIMEO” brand in work-phase 5.8.

The Certifying Body of BIMEO Ltd. controls the usage of the “Certified by BIMEO” brand in its own competence as well as utilizing the market controlling inspections of the OMMF and the NFH. (In the case of marketing non-conforming PPE the grant to use the “Certified by BIMEO” brand will be withdrawn; in the case of unwarranted use the appropriate legal steps will be.)
 

7.      If an accident happens while using PPE certified by the Certifying Body of BIMEO Ltd., or someone makes a notice concerning the conformity of such PPE or concerning the non-conformity of its protection level, or if the Certifying Body of BIMEO Ltd. obtains information that casts doubt on the consistence of the conformity or protection level of the PPE, the Leader of the Certifying Body has to ordain a conformity control according to 14. § of the 18/2008. (XII. 3.) SZMM Decree.

In the course of a general conformity control – depending on the cause for the controlling – the following steps have to be taken:

• In the case of an accident that occurred during the use of the PPE, it has to be tested in a testing laboratory designated/notified in the field relating to its property and/or protection capability that is presumably wrong.

• A random sample taken from the manufacturing line or from the market has to be tested in a testing laboratory designated/notified in the field relating to the property that is presumably wrong.

• If the tests undertaken by a notified testing laboratory for the purposes of the general conformity control of a category 3 PPE show its non-conformity, it is necessary to inform the notified inspection body indicated in the EC Declaration of Conformity that a review of the manufacturing and end-product controlling system that is endangering the consistence of the PPE’s conformity is due.

Financing the general conformity controls is based on the relevant contracts and on the principle that if the PPE is found to be faulty all inspection costs beyond the necessary steps of market control and the ones taken in own competence are charged on the manufacturer or vendor at fault.

Depending on the result of the emergency conformity control the Leader of the Certifying Body of BIMEO Ltd. decides upon maintaining (work-phase 8.1.), narrowing (work-phase 8.3.), suspending (work-phase 9.) or withdrawing (work-phase 10.) the validity of the EC type-certificate. He also informs the notifying body OMMF and the market controlling authority NFH if necessary.

8.      Obtaining the EC type-certificate

Terms:

·        The PPE has to meet the requirements of the 89/686/EEC Directive [18/2008. (XII. 3.) SZMM Decree].

·        Applicant has to fulfil the terms of the contract.
 

8.1. Maintaining the validity of an EC type-certificate of PPE certified by the Certifying Body of BIMEO Ltd.

Terms:

• The characteristics of the PPE determining its conformity are unchanged.
• The requirements for the PPE remain unchanged.
• Applicant fulfils its contractual obligations.
• Warranted use of the EC type-certificate (and in the case of a relevant contract: the “Certified by BIMEO” brand) by the Applicant.
• In the absence of justified complaints or notices regarding the PPE [Section 1-2. of 14. § of the 18/2008. (XII. 3.) SZMM Decree], or if the inspection had a favourable result for category 3 PPE.

In the case of accidents, complaints or notices [Section 1-2. of 14. § of the 18/2008. (XII. 3.) SZMM Decree], the fulfilment of the terms is controlled by the Certifying Body of BIMEO Ltd. or by the notified inspection body indicated on the EC Declaration of Conformity for category 3 PPE.

Warranted use of the “Certified by BIMEO” brand is controlled by the Certifying Body of BIMEO Ltd. according to Chapter 17. of the TMKK (internal certification regulations of BIMEO).
 

8.2. Extending the validity of an EC type-certificate of PPE certified by the Certifying Body of BIMEO Ltd.

Terms:

·        The characteristics of the PPE, which is the subject of the extension should correspond to the certified PPE’s (e.g. they are members of the same model-family).

The extension of the EC type-certificate can be initiated by the Applicant similarly to the certification procedure (Annexes Tankiterker-L and Tankiterker-K/R). The procedure for the extension agrees with Article 5., fulfilment of the terms is determined by the same person who performed the evaluation before by completing a new evaluation and EC type-testing.

The fact of the extension of the EC type-certificate will be transcribed on the list of PPE certified by BIMEO (Annex Tanjegyz) by the Leader of the Certifying Body of BIMEO Ltd. He will also inform the notifying body OMMF and also – in the case of an agreement on the use of the “Certified by BIMEO” brand – the NFH.
 

8.3.Narrowing the validity of an EC type-certificate of PPE certified by the Certifying Body of BIMEO Ltd.

The validity of the EC type-certificate may be narrowed at the request of the Applicant if the manufacture of a PPE from a certified group ceases or if its protection characteristics change and it becomes certain that the PPE no longer satisfies the relevant requirements.

The basis for narrowing the validity of the EC type-certificate might be:

• request by the Applicant;

• an accident occurred while using the PPE or there has been a notice about the inadequate protection level or quality of the PPE;

• the Certifying Body of BIMEO Ltd. Obtains information, which casts doubt on the consistence of the adequacy of the PPE’s conformity and protection level;

• request by the notifying body OMMF or by the NFH.

After narrowing the validity, the reference number of the EC type-certificate will be identical to the one before.  The fact of the narrowing of the EC type-certificate will be transcribed on the list of PPE certified by BIMEO by the Leader of the Certifying Body of BIMEO Ltd. He will also inform the notifying body OMMF and the NFH.
 

9.      Suspending the validity of an EC type-certificate of PPE certified by the Certifying Body of BIMEO Ltd.

The validity of the EC type-certificate may be suspended by the Certifying Body of BIMEO Ltd. for the following reasons:

·        A serious non-conformity that alters the protection level of the PPE is found during a control following an accident, notice or complaint or in the case of category 3 PPE during a control undertaken by the inspection body indicated on the EC Declaration of Conformity of the PPE.

·        Such changes have been made to the PPE that significantly alter its protection level or the relevant requirements.

·        The regulations forming the basis of the EC type-testing of the PPE have changed and the deadline set out by the Certifying Body of BIMEO Ltd. for applying these has been passed.

·        The legal entity of the Applicant has changed.

In the cases described above, the Leader of the Certifying Body of BIMEO Ltd. ordains an emergency control. If the results of this are unfavourable, he takes action to suspend the validity of the EC type-certificate. Before suspending the validity the Certifying Body of BIMEO Ltd. asks with a deadline of 5 working days if the Applicant wants to maintain the EC type-certificate. The Certifying Body of BIMEO Ltd. will take steps according to the answer.

The Leader of the Certifying Body will inform the Applicant and the notifying body OMMF in writing on the fact of the suspension and will at the same time publish it on the web-page of BIMEO Ltd. The Annex Tanfelfugg contains the list of suspended EC type-certificates – also indicating the cause for the.
 

The time of the suspension is determined by the nature of the revealed fault or in the case of category 3 PPE: the time needed for the inspection of the manufacturing conditions. The requirement for lifting the suspension is eliminating the non-conformity.
 

The suspension will be lifted if the non-conformities that caused it have been eliminated and the Certifying Body has made sure of this. The Leader of the Certifying Body will inform the Applicant, the notifying body OMMF and the NFH of this in writing, as well as publishing the fact on the web-site of BIMEO Ltd.
 

The maximum time of the suspension is 6 months; if the non-conformity is not eliminated until this time, the EC type-certificate will be withdrawn.
 

10.  Withdrawing an EC type-certificate of PPE certified by the Certifying Body of BIMEO Ltd.

The Certifying Body of BIMEO Ltd. will withdraw the EC type-certificate in the case of

• not amending the causes, non-conformities responsible for the suspension of the validity, possible incorrigibility or repeated occurrence of these, as well as overstepping the maximum time of the suspension.

• unwarranted use of the EC type-certificate.

• a written declaration of the Applicant on the ceasing of manufacturing the PPE or on their wish not to maintain the validity of the EC type-certificate.

• termination without legal successor.

The Leader of the Certifying Body will take action on the withdrawal and on the deletion from the register. In the case of withdrawal the Leader of the Certifying Body will inform the Applicant, the notifying body OMMF and the NFH. The list of the withdrawn EC type-certificates is published similar to the list of issued certificates, and will be included in BIMEO’s electronic data-base. The withdrawn EC type-certificates, indicating the cause for withdrawal are listed in the Annex: Tanvivon.

11.  Appeal

The Certifying Body of BIMEO Ltd. declares the conformity of the PPE on the EC type-certification, in the case of non-conformity it issues a list of necessary amendments. If the Applicant does not accept the EC type-certificate, it has the right to hand in a complaint or appeal within 15 days of its receipt. Deadline for reviewing an appeal is 20 working days and 12 working days for a complaint.
 

Complaints will be reviewed by the Leader of the Certifying Body, appeals by the Committee overseeing the certification (TFB further on). Only such persons may be members of the TFB, who did have no part in the previous decision-making.
 

The TFB will investigate the contents, comprehensiveness and soundness of all the documents related to the certification procedure under appeal. The TFB will reach a decision based on the investigation and the Leader of the Certifying Body will take the necessary steps according to this and will also inform the Applicant. If the Applicant does not accept the decision it can bring a civil lawsuit against the Certifying Body of BIMEO Ltd.

12.  Validity

EC type-certificates are valid until withdrawal. The validity of the EC type-certificate is limited by 13.§,  article a. and b.of the 18/2008. (XII. 3.) SZMM Decree.

As a result of a necessary general control of conformity the validity of the EC type-certificate may be suspended, or in the case of serious non-conformity promptly withdrawn. The Certifying Body of BIMEO Ltd. will inform the Applicant of the results of the control of conformity, in the case of unfavourable results also the notifying body OMMF and the NFH (the authority on market controlling).
 

13.  Identification markings on the authentic PPE sample

Linked to the EC type-certificate the PPE samples will be furnished with explicit identification markings.

The identification tag is to be attached to the PPE sample (for model-families, a sample of every member is needed). The identification tag is printed on paper bearing the bimeo logo and the following information on one side:

• the manufacturer of the PPE or its authorized representative,

• identification code or number of the PPE,

• protection level of the PPE,

as well as

• the number of the EC type-certificate,

• the date of issue of the EC type-certificate,

• the stamp of the Certifying Body and signature of its Leader,

• the notification number of the Inspection Body (if necessary and/or if there is one),

• the number of the contract (if there is one) on the usage of the “certified by BIMEO” brand

on its other side.

The identification tag is placed between plastic sheets and is attached to the PPE with a lead bearing the „b” logo.
 

14.  Procedure concerning notices on PPE that has been certified by another Certifying Body than BIMEO

The Leader of the Certifying Body of BIMEO Ltd. will forward the notice and the details of the other Certifying Body that issued the EC type-certificate to the notifying body OMMF and the NFH, who will decide within their own jurisdiction upon the method for investigating the case.
 

15.  Price of the Procedure

The price of the certification procedure will be determined according to the valid price-list of the Certifying Body of BIMEO Ltd. The price covers the normal procedure (one request for amendments at most). Where more amendments or supplementary test are necessary, these will be charged additionally.

BIMEO Ltd. Certifying Body

PPEs  certified by the Certifying Body of BIMEO Ltd.

Suspended EC type-certificates                                                   Withdrawn EC type-certificates

Contract form for the certification procedure

Forms which may be downloaded