Guidance on the participation of the notified bodies

Guidance on the participation of the Notified Bodies.
"Guidance on the participation of the Notified Bodies in the attestation of conformity under the Construction Products Directive 89/106/CE" is available for the Notified Bodies on the CPD-GNB CIRCA as document NB-CPD/01/002-rev04. Introduction
It has to be clear from the beginning that the systems of attestation of conformity are described in annex III-2 of the Construction Products Directive 89/106/EEC and that the bodies involved in the attestation have to comply with all requirements laid down in annex III-3 of the Directive. The hierarchy of the documents used in the procedures of attestation is as follows : the Treaty, the CPD and eventually other relevant Directives from the Council, the Decisions of the Commission reproduced in the mandates to CEN, the harmonised part of the technical specifications (Annex ZA of the harmonised standards, resp. the relevant clauses of the ETAs), the Guidance Papers approved by the SCC and, finally additional guidance approved by the Group of Notified Bodies. The procedures for the attestation of conformity are fixed by Decisions of the Commission and reproduced in the mandates issued by the Commission to CEN and EOTA. Priority has to be given to the procedures described in the harmonised part of the technical specifications (Annex ZA of the harmonised standards, resp. the relevant clauses of the ETAs). In principle, attestation rules are fixed in the harmonised part of the technical specifications, while the definition of the operational procedures for the attestation is the duty of the Groups of Notified Bodies. Organisations in charge of the attestation of conformity shall further find useful guidance in Guidance Paper K "Role and tasks of the Notified Bodies under the CPD", approved by the Member States. The attestation bodies operating the system at European level shall, as a minimum, have an organisational structure and utilise personnel, equipment and operating procedures complying with Annex IV of the Directive, further explained in Guidance Paper A "The designation of approved bodies in the field of the Construction Products Directive". The verification of the compliance with these requirements is the duty of the notifying Member States. Under all systems of attestation, the affixing of the CE-marking on a product is based on a declaration of conformity signed by the manufacturer or his authorised representative established within the European Economic Area (EEA). Depending on the system of attestation fixed for the product, this declaration of conformity is based on a certificate (systems 1/1+ and 2/2+) or on a report of initial type-testing (system 3) issued by a notified laboratory. Any attestation scheme under the CPD requires as a prerequisite an harmonised technical specification (European standard or European Technical Approval) necessary for the attestation purposes, as well as the associated supporting documents (usually test standards) concerning the associated test and calculation methods, and/or reference data. Additional documents (guidelines, position papers, …) having been approved by the Advisory Group NB-CPD are recommendations for the work of the Notified Bodies and do not have any legal status. They shall be accepted by the Advisory Group and the Standing Committee for Construction shall be informed accordingly. The text hereunder is intended to provide further guidance to the notified bodies when they are confronted with some imprecision’s concerning the exact execution of tasks insufficiently described in harmonised technical specifications. For the attestation systems based on a certification, it is mostly inspired from the ISO/IEC Guide 28 "General rules for a model third-party certification system for products", which is still used as reference in the last versions of the standards of the series 45.000, in so far as it will be necessary to fulfil the requirements of the CPD. For system 3, the paper recalls the duties of the testing laboratory(ies) as agreed amongst the Member States in Guidance Paper K. Guidance on the participation of the Notified Bodies.
The product certification under systems 1+ and 1
Under systems 1+ and 1, the task assigned to the notified bodies is the certification of conformity of the product based on : • Initial type testing of the product; • Initial inspection of the factory and of the factory production control; • Continuous surveillance, assessment and approval of the factory production control; • Under system 1+, additional audit-testing of samples taken at the factory, on the market or on the The attestation of conformity shall be in the form of a certificate of conformity of the product as figured in annexes 1 (system 1+) and 2 (system 1) of the present document. Basic conditions
The basic conditions for issuing an EC-certificate of conformity are that the applicant follows the general rules as laid down in the harmonised technical specification and, when relevant, the additional guidelines commonly agreed by the relevant sector group of notified bodies. These additional guidelines may be included in specific documents of the Group of Notified Bodies (GNB), which should also be taken into account. These documents should serve as guidelines to ensure that the attestation of conformity is consistent and equivalent for all manufacturers. They have to be approved by the Advisory Group NB-CPD after having consulted the relevant CEN committee according to the procedure laid down in the CEN Reykjavik Resolutions (October 2000). As far as EOTA-Guidelines are concerned the respective Working Group of EOTA should have been involved. Application for EC-certificate of conformity
The application shall be made on a special form obtainable from a notified certification body. The manufacturer or his authorised representative established within the European Economic Area (further referred as "the applicant") shall, in his application, refer to the specific product or group of products determined in the relevant Decision of the European Commission and, when relevant, in the additional guidelines. A notified certification body on acceptance of a completed application form will confirm this to the applicant and provide him with any further information necessary for the processing of his application. Initial inspection of the factory and production control, and initial type-testing
After confirmation of the acceptance of the application, the notified certification body shall make the necessary arrangements with the applicant for the initial inspection, in accordance with the rules of the scheme. The notified certification body is responsible for ensuring that all actions of certification, from initial type-testing of the product and inspection of the factory and of the factory production control through surveillance, assessment and approval of the factory production control are carried out correctly. Under system 1+, the notified certification body is also responsible for the audit-testing of samples, in respect of the relevant characteristics. When the testing of the samples intended for the initial type-testing of the product as well of the samples taken for audit-testing purpose (system 1+ only) is conducted in a laboratory different from the laboratory of the notified certification body, the test results are communicated to the notified certification body. When the inspection of the factory and of the factory production control, as well as the surveillance and assessment of the factory production control are conducted by an inspection body different from the Guidance on the participation of the Notified Bodies.
notified certification body, a report on the performed inspections and assessments is communicated to the notified certification body. The bodies involved in attestation of conformity (testing/inspection) are responsible for carrying out their tasks. The notified certification body is responsible for assembling all the relevant information, verifying that the tasks have been carried out according to the technical specifications and assessing and certifying the conformity of the product. The notified certification body shall inform the applicant of the results of the initial inspection and testing. If all the requirements for the attestation of conformity are not being met, the notified certification body will inform the applicant of those aspects in which his application has failed. If the applicant can show that remedial action has been taken to meet all requirements within a specified
time limit, the notified body concerned will repeat only the necessary parts of the initial inspection
procedure and/or testing. Otherwise the application shall be cancelled.
Re-inspection may not be needed for subsequent applications for the same product.
Assessment of factory production control
Assessment of the applicant’s system of factory production control forms part of the initial inspection. This has to comply with the requirements laid down in the harmonised technical specification and may be done according to the specific guidance agreed by the group of notified bodies for the product. Ideally, guidance for these elements should be included in the harmonised standard or in the ETAG/CUAP/ETA. All records produced for implementation of the factory production control system related to certification shall be made readily available for attestation body inspection. The applicant shall ensure that the question of responsibility towards the notified certification body for the factory production control is clearly defined, e.g. by appointing a designated person who is independent from production management [in the case of SME with reduced staff, this condition is not of application] as far as the technical performance of his function is concerned and who is qualified to maintain the contact with the notified certification body, to ensure that the above provisions have been observed. In case of ETAs it should in particular be recalled that the notified certification body shall seek to obtain from the Approval Body the relevant technical documentation which is essential for the fulfilment of its tasks of attestation of conformity (i.e. the relevant elements contained in the possible confidential part of the ETA). The notified certification body should also inform the Approval Body of its investigation results, in particular in cases of significant non-conformity to allow it to keep the ETA-file updated. Initial type-testing of the product
The selection of samples for tests and examination shall be based on the rules fixed in the harmonised specification. When no rules are defined in the harmonised specification, the rules for the selection of samples shall be defined in the specific guidance agreed by the group of notified bodies. When the CE-certificate is issued for a product for which some characteristics are under system 1/1+ and other under system 3 or 4, the notified certification body is responsible for the sampling of all samples necessary for the performance of the tests of all characteristics. Samples shall be representative of the product to be certified in respect of all its characteristics taken together, and be made from production tools and assembling methods used for the production run. Where testing is performed on prototype samples, confirmation tests or examination, as appropriate, should be confirmed on production samples, as soon as available. In order to minimise the costs for the manufacturer, the notified certification body shall, in the case of products under a European Technical Approval, take over and validate, as far as possible and relevant, Guidance on the participation of the Notified Bodies.
the Approval Testing performed on the product (or the test results obtained by the Approval Body during the ETA issuing procedure) as Initial type-testing. To perform this Approval Testing, the Approval Bodies are recommended to use, as far as possible, testing laboratories notified by the Member States for this type of tests. In special cases however (e.g. for tests under the 9.2 procedure of the CPD) it is recognised that Approval Bodies might refer to specialised test bodies, which are not necessarily notified. The initial type-testing is carried out in accordance with the applicable harmonised technical specification and the specific guidance agreed by the group of notified bodies for the product. Where the notified certification body uses test data produced by others, it shall ensure that the party conducting the testing was duly qualified for the performance of those tests. EC-certificate of conformity
The notified certification body, when complete fulfilment of the requirements laid down in Annex ZA of the harmonised standard or in the relevant ETA has been established, informs the applicant accordingly and issues an EC-certificate. The EC-certificate covers one product [In some cases, the concept "product" may be extended to "product family" i.e. when the products in the family only differ in dimensions or other parameters that do not have an influence on the declared harmonised characteristics] and should normally be issued for one factory. In any case, the covered factory(ies) have to be clearly identified on the EC-certificate. EC-certificate for other products from the same factory or from another factory
A manufacturer wishing to obtain EC-certificate(s) of conformity for additional type(s) or model(s) of product(s) made in the same factory to the same harmonised standard or to another ETA as the product for which an EC-certificate is already held, shall apply to the notified certification body, using the usual application form. The notified certification body can decide in such case not to carry out or only to carry out partial factory inspection but shall conduct type-testing of the additional product(s) to determine if they comply with the harmonised specification. If the tests are successful, additional EC-certificate(s) will be granted. If the manufacturer wishes to apply the certification to additional types of products made at the same factory, but to different harmonised technical specifications, or if the manufacturer wishes to apply for certification to be applied in an additional factory that is not covered by the earlier EC-certificate, the elements that have already be assessed during the previous assessment(s) could be used again when relevant, in accordance with sector group practices. In case of doubt, the notified body shall consult the sector group concerned. Surveillance and/or audit-testing
The notified certification body exercises the surveillance of the factory production control and (under system 1+) the audit-testing of the relevant characteristics of the products on the basis of the requirements of the relevant harmonised technical specification and on the basis of the specific guidance agreed by the Group of Notified Bodies for the product. The notified certification body may appoint an inspection body and/or a laboratory to carry out the surveillance under its authority and responsibility, exercised under agreed conditions. The manufacturer shall be informed of the results of the surveillance and/or of the audit testing of the samples. The manufacturer shall inform the notified certification body about any intended modification of the FPC or of the product, where these go beyond the scope of any direct application rules or beyond the definition of a family, and where these are likely to affect the stated performance of the product. It is up to the notified certification body to determine whether the announced changes require another initial type-testing and inspection or other further investigations. In such cases the manufacturer is not allowed to release Guidance on the participation of the Notified Bodies.
CE-marked products resulting from such changes until the notified certification body has notified the manufacturer accordingly. In the case of an ETA, the notified body shall inform the Approval Body that issued the ETA in the case of non-conformity and by any modification of the product and/or of the FPC to allow him either to update the ETA file of the product or to renew the ETA when relevant. The manufacturer shall keep a record of all non-conformities and complaints relative to the product covered by the EC-certificate and make this available to the notified certification body on request. The certification of the factory production control under systems 2+ and 2
Under systems 2+ and 2, the task assigned to the notified bodies is the certification of the factory production control based on : 1. Initial inspection of the factory and of the factory production control; 2. Under system 2+, continuous surveillance, assessment and approval of the factory production The identification of conformity shall be in the form of a certificate of factory production control as figured in annexes 3 (system 2+) and 4 (system 2) of the present document. Basic conditions
The basic conditions for issuing a certificate of factory production control are that the applicant follows the general rules as laid down in the harmonised technical specification and, when relevant, the additional guidelines commonly agreed by the relevant sector group of notified bodies. These additional guidelines may be included in specific documents of the Group of Notified Bodies (GNB), which should also be taken into account. These documents should serve as guidelines to ensure that the attestation of conformity is consistent and equivalent for all manufacturers. They have to be approved by the Advisory Group NB-CPD after having consulted the relevant CEN committee according to the procedure laid down in the CEN Reykjavik Resolutions (October 2000). As far as EOTA-Guidelines are concerned the respective Working Group of EOTA should have been involved. Application for a certificate of factory production control
The application shall be made on a special form obtainable from a notified FPC-certification body. The manufacturer or his authorised representative established within the European Economic Area (further called "the applicant") shall, in his application, refer to the specific product or group of products determined in the relevant Decision of the European Commission and, when relevant, in the additional guidelines. It should normally cover one factory only. A notified FPC-certification body on acceptance of a completed application form will confirm this to the applicant and provide him with any further information necessary for the processing of his application. Initial inspection of the factory and production control
After confirmation of the acceptance of the application, the certification body shall make the necessary arrangements with the applicant for the initial inspection, in accordance with the rules of the scheme. The notified FPC-certification body is responsible for all actions of certification of the factory production control including inspection of the factory and of the factory production control, but should pay particular attention to those characteristics identified as being relevant for FPC in Annex 3 of the mandate. Under system 2+, the notified FPC-certification body is also responsible for surveillance, assessment and approval of the factory production control. Guidance on the participation of the Notified Bodies.
When the inspection of the factory and of the factory production control, as well as the surveillance and assessment of the factory production control are conducted by an inspection body different from the notified FPC-certification body, a report on the performed inspections and assessments is communicated to the notified FPC-certification body. The inspection body involved in the attestation of conformity is responsible for carrying out its tasks. The certification body is responsible for assembling all the relevant information, verifying that the tasks have been carried out according to the technical specifications and assessing and certifying the factory production control. The notified FPC-certification body shall inform the applicant of the results of the initial inspection. If the notified FPC-certification body is not satisfied that all the requirements for the certification of FPC are being met, it will inform the applicant of those aspects in which his application has failed. If the applicant can show that remedial action has been taken by him to meet all requirements within a specified time limit, the notified body concerned will repeat only the necessary parts of the initial inspection procedure. Otherwise the application shall be cancelled. Re-inspection may not be needed for subsequent applications for the same product. Assessment of factory production control
Assessment of the applicant’s system of factory production control forms part of the initial inspection. This may be done according to the specific guidance agreed by the group of notified bodies for the product. Ideally, guidance for these elements should be included in the harmonised standard or in the ETAG/CUAP/ETA. All records produced for the implementation of the factory production control related to certification shall be readily available for attestation body inspection. The applicant shall ensure that the question of responsibility to the notified FPC-certification body for the factory production control is clearly defined, e.g. by appointing a designated person who is independent from production management [In the case of SME with reduced staff, this condition is not of application] as far as the technical performance of his function is concerned and who is qualified to maintain the contact with the notified FPC-certification body, to ensure that the above provisions have been observed. In case of ETAs it should in particular be recalled that the notified FPC-certification body shall seek to obtain from the Approval Body the relevant technical documentation which is essential for the fulfilment of its tasks of attestation of conformity (i.e. the relevant elements contained in the possible confidential part of the ETA). The notified certification body should also inform the Approval Body of its investigation results, in particular in cases of significant non-conformity to allow it to keep the ETA-file updated. Certificate of factory production control
The notified FPC-certification body, when complete fulfilment of the requirements laid down in Annex ZA of the harmonised standard or in the relevant ETA has been established, informs the applicant accordingly and issues a certificate of factory production control. The certificate should normally be issued for one factory in respect of one harmonised specification. In any case, the factory(ies) covered have to be clearly identified on the certificate of factory production control. Certificate of factory production control for other products from the same factory
A manufacturer wishing to obtain certificate(s) of factory production control for additional type(s) or model(s) of product(s) made in the same factory to the same harmonised standard or another ETA as the product for which a certificate of factory production control is already held, shall apply to the certification Guidance on the participation of the Notified Bodies.
body, using the usual application form. The certification body can decide in such case not to carry out or to only carry out partial factory inspection and to grant the corresponding certificate. If the manufacturer wishes to apply the certification of the factory production control to additional types of products made at the same factory, but to different harmonised technical specifications, or if the manufacturer wishes to apply for certification of factory production control to be applied in an additional factory that is not covered by an earlier EC-certificate or certificate of factory production control, the elements that have already be assessed during the previous assessment(s) could be used again when relevant, in accordance with sector group practices. In case of doubt, the notified body shall consult the sector group concerned. Surveillance (system 2+ only)
The certification body exercises the surveillance of the factory production control on the basis of the requirements of the relevant harmonised technical specification and of the additional guidance of the scheme and on the basis of the original assessment of the factory production control. The certification body may appoint an inspection body to carry out the surveillance under its authority and responsibility, exercised under agreed conditions. The manufacturer shall be informed about the results of the surveillance. The manufacturer shall inform the notified certification body about any intended modification of the production process or factory production control, where this is likely to have an effect on the stated properties of the product. It is up to the certification body to determine whether the announced changes require another inspection or other further investigations. In such cases the manufacturer is not allowed to release CE-marked products resulting from such changes until the certification body has notified the manufacturer accordingly. In the case of ETA, the notified body shall inform the Approval Body that issued the ETA in the case of non-conformity and by any modification of the FPC to allow him either to update the ETA file of the product or to renew the ETA when relevant. The manufacturer shall keep a record of all non-conformities and complaints relative to the product covered by the certificate of factory production control and make this available to the certification body on request. The initial type-testing of the product under system 3
Under system 3, the only task assigned to the notified bodies is the performance of the initial type-testing of the relevant characteristics, on samples provided by the manufacturer or the validation of the testing performed by the Approval Body for the granting of the ETA. Basic conditions
The basic conditions for issuing a test-report for the initial type-testing are that the applicant follows the general rules as laid down in the harmonised technical specification and follows the procedure of identification of the product as laid down in Guidance Paper K. When initial type-testing is to be performed on the same product in more than one notified laboratory, each laboratory shall make sure it is responsible for at least all the tests foreseen under one essential requirement in the mandate covering the product. Test report
The test report issued by the notified laboratory shall reproduce the full identification of the product as laid down in Guidance Paper K [Identification of the product, the production line, the date and time of production.], as provided by the applicant at the time of delivery, and mention the essential requirement(s) covered by the tests in the report when the testing is performed by different notified laboratories.

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