Guidance from the Group of Notified Bodies for the Construction Products Regulation 305/2011/EU

Transcription

1 GNB-CPR AG Guidance from the Group of Notified Bodies for the Construction Products Regulation 305/2011/EU NB-CPR/AG/03/002r3 Issued: 24 May 2013 APPROVED GUIDANCE GNB-CPR AG position paper Guidance to notified bodies on the assessment and verification of constancy of performance under the Construction Products Regulation 305/2011/EU General scope, limitations and aim of this guidance for notified bodies The Construction Products Regulation (CPR) is based on the use of harmonised technical specifications, and these often require the involvement of a conformity assessment body to demonstrate compliance. Such bodies must be designated by the Member States as notified bodies (NBs). CPR Articles 43(11) and 55 require the formation of a group of notified bodies, and that NBs should participate in its work. Article 43(11) states that the notified body shall apply as general guidance the administrative decisions and documents produced as a work result of that group. The GNB-CPR is the group referred to by Article 43(11). This position paper contains guidance for notified bodies (NBs) involved in the assessment and verification of constancy of performance of construction products or their FPC to harmonised technical specifications. The purpose is to help NBs work equivalently and come to common judgments. This guidance contains informative material (which NBs should or may follow), and normative guidance (which NBs shall follow, or at least work equivalently to as circumstances demand). The primary document for NBs is the edition of the relevant harmonised technical specification that is currently cited in the Official Journal of the EU, or the European Technical Assessment, to which the manufacturer works. This guidance is thought necessary to provide clarity and completeness for NBs so that they can work equivalently. It supplements and makes practical for NBs the relevant harmonised technical specifications. This position paper should not contradict nor extend the scope of the work and role of a NB, nor impose additional burdens on the manufacturer, beyond those laid down in the CPR and the relevant harmonised technical specifications. This guidance should be considered valid until guidance from the Commission has changed on relevant matters. Whereupon, the paper should be considered for withdrawal/revision and be replaced by new guidance as necessary. This position paper was considered approved its original form by Advisory Group on 7 April 2001, and in its revision 3 form, for use under the CPR, on 1 May Revision 3 of this position paper was produced to address the CPR; previous versions had addressed the CPD. Revisions 1 and 2 of this position paper were issued to update and extend the horizontal guidance provided by AG, and to remove superseded versions of GNB-CPD example certificates which became available in versions of NB-CPD/AG/03/003. NB-CPR/AG/03/002r3 Page 1 of 18

2 1 Introduction For a manufacturer to affix the CE marking to a construction product, he must draw up a declaration of performance in accordance with Articles 4 and 6 of the Construction Products Regulation 305/2011/EU (CPR). The declaration of performance must conform with the appropriate system for the assessment and verification of constancy of performance (AVCP). These are defined in Annex V(1) of the CPR. Under AVCP systems 1+, 1, 2+ and 3, but not under AVCP system 4, a specific level of intervention by a notified body is specified to support the declaration of performance. Bodies involved in assessment and verification shall comply with all the requirements laid down in Article 43 of the CPR. The procedures for the assessment and verification of constancy of performance are fixed by Decisions of the Commission and reproduced in the mandates issued by the Commission to CEN and EOTA. The procedures described in the harmonised part (usually Annex ZA) of a European standard or the relevant clauses of a European Technical Assessment shall be followed. Assessment and verification rules are given in these technical specifications. The duty of the Group of Notified Bodies is to provide further guidance to facilitate equivalent assessments by notified bodies applying the technical specifications 1 where it is considered such guidance is needed. The basic conditions for issuing a certificate of constancy of performance are that the client follows the general rules as laid down in a currently cited version 2 of the harmonised European standard or a current European Technical Assessment based on a European Assessment Document. Relevant, approved GNB-CPR position papers may give the notified product certification body further guidance on what it should expect from the manufacturer. The assessment and verification bodies operating the system at European level shall, as a minimum, have an organisational structure and utilise personnel, equipment and operating procedures complying with Article 43 of the Regulation. The verification of compliance with these requirements is the duty of the Member State Notifying Authority. Any assessment and verification scheme under the CPR requires as a prerequisite a harmonised European Standard or a European Technical Assessment based on a European Assessment Document to establish the assessment and verification procedure, together with any associated supporting documents (for example test standards) concerning the associated test and calculation methods, and/or reference data. Additional documents (referred to as position papers) approved by the GNB-CPR Advisory Group are recommendations for the work of the notified bodies. Their legal status arises from CPR Article 43(11) A notified body shall participate in, or ensure that its assessment personnel is informed of, the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation and shall apply as general guidance the administrative decisions and documents produced as a work result of that group. GNB-CPR position papers must be approved by the Advisory Group before they form valid guidance. 1 2 In exceptional circumstances, such as an error in a harmonised European standard, a GNB-CPR position paper may, with the agreement of the relevant CEN/TC, specify procedures that are contrary to that harmonised European standard. A version of the harmonised European standard that is currently cited in the OJEU and listed as current on NANDO. European Technical Assessments are not cited in the OJEU or on NANDO. NB-CPR/AG/03/002r3 Page 2 of 18

3 This position paper is intended to provide further guidance to notified bodies towards fulfilling the requirements of the CPR when they are confronted with tasks that are not described in sufficient detail in the relevant harmonised technical specifications. Much of the guidance for the assessment and verification systems requiring certification is taken from ISO/IEC Guide 28 Conformity assessment - Guidance on a third-party certification system for products, which is referred to by standards EN 45011, EN ISO/IEC and EN ISO/IEC This paper only addresses conventional series production to a harmonised technical specification. It does not address transition arrangements from the CPD to the CPR, which are covered briefly in NB-CPR/AG/13/010 Transition arrangements from the CPD to the CPR for NBs. 2 Definitions 2.1 Suspension and withdrawal EN ISO/IEC 17000:2004 definitions EN ISO/IEC 17000:2004 gives the following definitions: 6.2 suspension temporary invalidation of the statement of conformity for all or part of the specified scope of attestation 6.3 withdrawal revocation cancellation of the statement of conformity Broad meanings of suspension and withdrawal for GNB-CPR use Suspension of certification means that the certificate ceases to be valid for a period of time. (Typically the notified certification body will agree a date with the manufacturer when it is expected that the problem(s) causing certification to be suspended will be corrected. When appropriate the notified certification body will confirm that the corrections have been made, and certification will be declared valid again.) Withdrawal of certification means that the certificate ceases permanently to be valid. Any renewal of certification would require a new certificate with a different number. In both cases, it is implicit that during the suspension or following the withdrawal of certification, no further construction products covered by the certification shall be CE-marked or made available on the market. NB-CPR/AG/03/002r3 Page 3 of 18

4 3 Certification of constancy of performance of the construction product under systems 1+ or General For construction products under assessment and verification of constancy of performance systems 1+ or 1, a manufacturer s declaration of performance must be supported by a certificate of constancy of performance for the product issued by a notified product certification body. The task of certification of constancy of performance of the construction product, assigned to a notified product certification body, is based on: (i) determination of the product-type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product, and; (ii) initial inspection of the manufacturing plant and of factory production control, and; (iii) continuous surveillance, assessment and evaluation of factory production control, and; (iv) under system 1+, audit-testing of samples taken before placing the product on the market 3. Notified product certification bodies may subcontract the tasks of sampling, testing, inspection and surveillance to other organisations, in accordance with CPR Article 45 (which requires the agreement of the client, that the notified body ensures the subcontractor meets the requirements of CPR Article 43, and that the notified body retains responsibility). However, a notified body cannot subcontract the decision whether or not to issue certificate. 3.2 Basic conditions The basic conditions for issuing a certificate of constancy of performance are that the client follows the general rules as laid down in a currently cited version 2 of the harmonised European standard or a current European Technical Assessment. Relevant, approved GNB-CPR position papers may give the notified product certification body further guidance on what it should expect from the manufacturer. 3.3 Application for certificate of constancy of performance It is recommended that the notified product certification body provides an application form to a manufacturer seeking certification of a construction product. The information requested by this application form should include: the relevant harmonised European standard(s) or European Technical Assessment; the product(s) and/or product families to be certified as identified in the harmonised annex(s) of the relevant European standard(s), or in the relevant European Technical Assessment; 3 Commission Services has explained that the CPR Article 2(17) definition placing on the market means the first making available of a construction product on the Union market; refers to making each single copy of that product available, after it has been manufactured. (In contrast, in Article 9(2) The CE marking shall be followed by the two last digits of the year in which it was first affixed, first affixed refers to the year when the CE marking was first affixed to the product-type, which will always remain as the year in which the product-type was launched.) NB-CPR/AG/03/002r3 Page 4 of 18

5 if relevant, the CE marking method(s) 4 used to determine performances and properties relating to the Basic Requirements for Construction Works for structural products, and; if certifying a construction product to a European Technical Assessment, the notified product certification body shall require the manufacturer to provide a copy of the European Technical Assessment including its confidential control plan, and any other relevant documentation, before starting its work towards assessment and verification of constancy of performance. The notified product certification body shall also request the manufacturer to submit all of the documentation it has regarding the Assessment testing performed on the product during the European Technical Assessment issuing procedure, which can be considered as the determination of the product-type, or taken into consideration as part of this, in order to minimise the costs for the manufacturer. See below for conditions under which the notified product certification body should accept the Assessment testing towards the determination of the product-type. On acceptance of a completed application form the notified product certification body shall confirm receipt to the client and inform if any further information is required for processing their application. 3.4 Initial inspection of factory and of factory production control, and determination of the product-type General After confirmation of the acceptance of the application, the notified product certification body shall make the necessary arrangements with the client for the initial inspection, in accordance with the rules in the harmonised European standard or European Technical Assessment and any specific guidance for the construction product agreed by the GNB-CPR. The notified product certification body is responsible for ensuring that all actions of certification, from determination of the product-type and inspection of the manufacturing plant and of factory production control through surveillance, assessment and evaluation of factory production control are carried out correctly. Under system 1+, the notified product certification body is also responsible for the audit-testing of samples, in respect of the relevant characteristics. The notified product certification body should send a report informing the client of the results of the initial inspection and determination of the product-type, within an agreed period of time. If the notified product certification body is not satisfied that all the requirements for the assessment and verification of constancy of performance were met, it shall inform the client of those aspects in which their application has failed. The notified product certification body and client should agree a time limit for remedial action. If the client can show that remedial action has been taken to meet all requirements within the agreed time limit, the notified product certification body concerned shall repeat only the necessary parts of the initial inspection procedure and/or determination of the product-type. 4 Many technical specifications for structural products specify methods of determining performances and properties relating to the Basic Requirements for Construction Works for mechanical resistance and stability that include determination according to the Eurocodes, as explained in Commission Guidance paper L. These are commonly described as Method 1, Method 2 and Method 3 (sometimes subdivided into Method 3a and Method 3b). At the time of writing, CEN is developing guidance on CE marking methods. NB-CPR/AG/03/002r3 Page 5 of 18

6 3.4.2 Assessment of factory production control Assessment of the client s system of factory production control forms part of the initial inspection. Ideally, guidance for these elements should be included in the harmonised European standard or in the European Technical Assessment. The assessment shall comply with the requirements laid down in the harmonised European standard or European Technical Assessment and should comply with any specific guidance for the construction product agreed by the GNB-CPR. All records produced for implementation of the factory production control system related to certification shall be readily available for inspection by the notified product certification body. PD ISO/IEC Guide 28: states The applicant should ensure that the question of responsibility to the certification body for the quality system is clearly defined. This could be by appointing a designated person who is independent of the production management as far as the technical performance of this function is concerned, and who is qualified to maintain contact with the certification body. Tasks, responsibilities, authorities and skills within the factory production control system shall be documented and shall be kept up to date. A checklist, prepared by the notified product certification body, should support the inspector in their assessment of the factory production control. See NB-CPR/AG/03/004 for further information about checklists. Items found not to be in compliance shall be reported. In the case of a European Technical Assessment, the notified product certification body shall if required by the European Technical Assessment inform directly the Technical Assessment Body (TAB) of the results of its investigation or check that the manufacturer is supplying this information. If nonconformities were detected during the initial inspection, all of these must be dealt with to the satisfaction of the notified product certification body Determination of the product-type Under AVCP systems 1+ and 1, the notified product certification body is responsible for determination of the product type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the construction product. In the case of a product subject to cumulative AVCP, the manufacturer is responsible for sampling for testing related to characteristics under AVCP systems 2+, 3 and 4. The selection of samples for determination of the product type shall be based on the rules given in the harmonised European standard or European Technical Assessment. If any rules for sampling defined in the harmonised European standard or European Technical Assessment, combined with the guidance given below, are not sufficiently clear, and the relevant GNB-CPR Sector Group has not yet provided further guidance, notified bodies are requested to alert that Sector Group to the lack of guidance. Samples shall be representative of the construction product to be certified in respect of all its characteristics taken together, and be made using the production tools and assembly methods used for the production run. An exception is where testing is performed on prototype samples. In this case, confirmation testing or examination, as appropriate, should be undertaken on production samples, as soon as these are available. The determination of the product-type is carried out in accordance with the applicable harmonised European standard or European Technical Assessment and the specific guidance agreed by the GNB-CPR for the construction product. NB-CPR/AG/03/002r3 Page 6 of 18

7 If the notified product certification body is asked to consider using test data that was not produced under its responsibility, it shall consider: any relevant provisions in the harmonised technical specification or any GNB-CPR Sector Group position paper addressing the specification; whether it can be satisfied that the sampling procedure was appropriate, and the product tested was the same as current production, and; whether the organisation conducting the testing was duly qualified for the performance of those tests. It may also be appropriate to refer to NB-CPR/AG/03/006 The use of historic data by NBs for CE marking purposes against hens. For construction products under a European Technical Assessment, it is often appropriate for the notified product certification body to take over the Assessment testing performed on the product by the Technical Assessment Body and supplied to the notified product certification body by the manufacturer as the determination of the product-type, or as testing to be taken into consideration as part of this. This might be required or suggested by the European Technical Assessment, and will minimise costs for the manufacturer. The notified product certification body shall verify that the samples for the assessment testing are suitable to represent the current production. If this is in doubt, the notified product certification body might consider limited testing to validate the results of the Assessment testing on current production. At the request of the manufacturer, and where justified by technical, economic or logistic reasons, CPR Article 46 permits notified bodies to carry out or supervise tests for the assessment and verification of constancy of performance using the equipment of others. However, CPR Article 46 requires bodies to be specifically designated as competent to work away from their own accredited test facilities. At the time of writing, the Commission is preparing guidance on the designation process. When this is available, NB-CPD/AG/03/005r2 The use of manufacturer s testing facilities by NBs will be revised to conform with practice under the CPR. 3.5 Certificate of constancy of performance General When the notified product certification body is satisfied that the manufacturer has fulfilled all of the requirements laid down in the harmonised annex of the European standard, or in the relevant European Technical Assessment, applicable to the product and intended end use, and which the body is responsible for certifying, the notified product certification body shall inform the client accordingly and issue a certificate of constancy of performance. The certificate for the product shall be in accordance with the generic form for the appropriate system, and for the appropriate specification (harmonised European standard or European Technical Assessment), shown in the latest version of NB-CPR/AG/03/003 Revised generic forms for NB certificates. Once issued, a certificate remains valid only whilst supported by the notified product certification body and can be suspended or withdrawn by the notified product certification body in accordance with CPR Article 52.4 and In addition, a failure to meet contractual obligations can allow the notified product certification body to suspend or withdraw the certificate. An individual certificate may cover more than one product and/or production unit provided that all production is under an identical factory production control. Alternatively, separate certificates may NB-CPR/AG/03/002r3 Page 7 of 18

8 be provided for individual production units, product families or products 5, 6. In all cases, the product(s) and factory(ies) covered shall be clearly identified on the certificate. NOTE On coded formats, Commission Guidance Paper D 5.4 states For reasons of traceability, the place of production of the product in question shall also be identified, possibly in a coded format. Although these Guidance Papers were written for the CPD, their guidance is considered to remain valid when not in conflict with the CPR. The place of production may identify particular manufacturing plants, lines or facilities. If the place(s) of production is/are coded, the notified product certification body shall maintain a key to the code(s) and shall provide the manufacturer with a copy of this key where the manufacturer did not provide the code(s) Certificate of constancy of performance for other construction products from the same factory or from another factory If a client wishes to obtain certificate(s) of constancy of performance for additional type(s) or model(s) of construction product(s) made in the same factory to the same harmonised European standard or to a similar European Technical Assessment as the product for which a certificate is already held, the notified product certification body should invite a further application, which may be made using the usual form. The notified product certification body can decide in such a case to carry out no or only a partial factory inspection, but shall conduct the determination of the product-type of the additional construction product(s) to determine whether it complies with the harmonised European standard or European Technical Assessment. If the determination and any inspection are successful, the scope of the certification will be extended. If extended certification is granted, the certificate(s) shall continue to identify clearly the products and factory(ies) covered, and the certificate(s) or supporting documentation shall continue to identify clearly the dates from which each product has been covered. Possible ways to extend the certification are: if the extension falls within the wording of the original certificate, update the supporting documentation, which must be clearly dated, or; issue a revised version of the certificate, with the same number but a greater scope and a revised date, or; issue a replacement certificate, with a new number and a greater scope, or; leave the original certificate valid and issue additional certificate(s) covering the additional construction product(s). If the client wishes to apply the certification to additional types of construction products made at the same factory, but to different harmonised technical specifications, or if the client wishes to apply for certification to be applied in an additional factory that is not covered by the earlier certificate, the elements that have already been assessed during the previous assessment(s) could be used again when relevant, in accordance with the harmonised European standards or European Technical Assessments. In the case of extending certification to cover an additional factory, the assessment shall include a visit to the additional factory unless the technical specification specifically addresses this scenario, or there is an approved Sector Group position paper covering the scenario (See also 5 6 An advantage of issuing separate certificates for different plants and construction products is that it may be easier to withdraw one certificate, if problems arise with one type of product (or the product is not produced anymore), than to revise a complex certificate covering multiple products and sites. Some cases have arisen where it is appropriate for a single product to be CE marked in accordance with more than one technical specification under the CPR. In this event, it is recommended that a NB enters all the technical specifications under which it is certifying the product on a single certificate. NB-CPR/AG/03/002r3 Page 8 of 18

9 NB-CPD/AG/07/008r1 7 Guidance to NBs on their duties in certifying (system 1+, 1, 2+ and 2) suppliers own brand labelled products and those involving significant subcontract manufacturing ). (If a notified product certification body needs additional advice, it should consult the Sector Group concerned.) 3.6 Surveillance and (for system 1+) audit-testing The notified product certification body shall require the manufacturer to inform it of any intended modification of the factory production control or of the construction 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 declared performances and properties of the product. It is up to the notified product certification body to determine whether the announced changes require another determination of the product-type and inspection or other further investigations. In such cases the notified product certification body shall inform the manufacturer that the certificate does not entitle the manufacturer to release any CE-marked products resulting from such changes until the notified product certification body has informed the manufacturer accordingly. In the case of a European Technical Assessment, the notified product certification body shall attempt to ensure that the Technical Assessment Body that issued the European Technical Assessment is informed of any nonconformity or of any modification of the construction product and/or of the factory production control to allow the Technical Assessment Body to update the European Technical Assessment file of the product and/or to renew the European Technical Assessment when relevant. However, maintaining confidentiality may require that the notified product certification body does not inform the Technical Assessment Body directly, but instead checks that the manufacturer is supplying this information. The notified product certification body is responsible for the surveillance, assessment and evaluation of factory production control and (under system 1+) the audit-testing of the relevant characteristics of the construction products on the basis of: the requirements of the relevant harmonised European standard or European Technical Assessment, and; any specific guidance agreed by the GNB-CPR for the construction product, and; the original assessment of factory production control. The inspector shall check whether: the manufacturer is still working to the same version of the harmonised European standard or European Technical Assessment that applied when the previous surveillance visit was made (or, in the case of the first surveillance visit, the initial inspection), and; in the case of a harmonised standard, it is a currently cited version 2. If either of the above conditions is not met, in the case of a harmonised European standard, the notified product certification body shall refer to the guidance in NB-CPR/AG/08/009 The consequences for NBs of corrigenda, amendments and revisions to harmonised European standards. The inspector shall ensure that the manufacturer keeps a record of all nonconformities and complaints relating to the construction product covered by the certificate and makes this available to the notified product certification body on request. The notified product certification body shall inform the manufacturer of the results of the surveillance and/or of the audit testing of the samples, and of any nonconformities it has raised. If nonconformities are raised, the notified product certification body has three options for its response, depending on the severity and extent of the nonconformities: NB-CPR/AG/03/002r3 Page 9 of 18

10 require the manufacturer to make corrections or changes within an appropriate period, whilst maintaining the validity of certification, or; suspend certification until the manufacturer has made corrections or changes, or; withdraw certification from the manufacturer. Key actions to be taken when following one of these options are given below. Where a nonconformity is identified, it is the responsibility of the manufacturer to investigate the root cause(s) of the problem and report to the notified product certification body effective corrective action measures appropriate to the nature of the nonconformity raised NB action when nonconformities have been identified but the certification is maintained If surveillance has raised nonconformities, and the notified product certification body considers that it is appropriate to maintain the manufacturer s certificate whilst these are resolved, the notified product certification body shall require the manufacturer to make corrections or changes within an appropriate period. The notified product certification body may decide that a further visit is required to confirm that the required changes have been made. In the case of failure to implement suitable corrective action, the notified product certification body shall inform the manufacturer of the action it intends to take. The notified product certification body may decide to suspend or withdraw certification and, in such cases, the manufacturer shall be informed as soon as this is practicable NB action when certification is suspended or withdrawn because of severe nonconformities If certification is suspended or withdrawn because of a failure by the manufacturer to maintain the requirements of their certification, the notified product certification body shall inform the competent authority in its Member State, giving the reasons for suspension/withdrawal, or follow the procedures required by its Member State Authority. It may be necessary for the notified product certification body to attempt to determine from when the construction products became unsuitable to be certified. If the notified product certification body has suspended certification until the manufacturer has made corrections or changes, a date for these changes to be completed will normally be agreed. An inspection, supported if appropriate by additional testing, shall be made to confirm these changes before certification is reinstated 7. If the notified product certification body has withdrawn the certificate, at some time in the future it may agree with the manufacturer to reassess the construction product. In this case, a detailed inspection shall be made to confirm fulfilment of the requirements laid down in the harmonised European standard or European Technical Assessment. If the requirements are met, the notified product certification body shall issue a new certificate with a different number to the previous one. 7 A NB shall always maintain a record of the dates when its certificates became valid or ceased to be valid. Issuing a new certificate, with either the original number or a new number, may be a convenient way to show the commencement of validity. NB-CPR/AG/03/002r3 Page 10 of 18

11 4 Certification of conformity of the factory production control under system General For construction products under assessment and verification of constancy of performance system 2+, a manufacturer s declaration of performance must be supported by a certificate of conformity of the factory production control issued by a notified factory production control certification body. The task of certification of factory production control, assigned to a notified factory production control certification body, is based on: (i) initial inspection of the manufacturing plant and of factory production control, and; (ii) continuous surveillance, assessment and evaluation of factory production control. Notified factory production control certification bodies may subcontract the tasks of inspection and surveillance to other organisations, in accordance with CPR Article 45 (which requires the agreement of the client, that the notified body ensures the subcontractor meets the requirements of CPR Article 43, and that the notified body retains responsibility). However, a notified body cannot subcontract the decision whether or not to issue certificate. 4.2 Basic conditions The basic conditions for issuing a certificate of conformity of the factory production control are that the client follows the general rules as laid down in a currently cited version 2 of the harmonised European standard or European Technical Assessment. Relevant approved GNB-CPR position papers may give the notified factory production control certification body further guidance on what it should expect from the manufacturer. 4.3 Application for a certificate of conformity of the factory production control It is recommended that the notified factory production control certification body provides an application form to a manufacturer seeking certification of the factory production control of a construction product. The information requested by this application form should include: the relevant harmonised European standard(s) or European Technical Assessment; the product(s) and/or product families for which the conformity of the factory production control is to be certified as identified in the harmonised annex of the relevant European standard(s), or in the relevant European Technical Assessment; if relevant, the CE marking method(s) 4 used to determine performances and properties relating to the Basic Requirements for Construction Works for structural products, and; if certifying conformity of the factory production control to a European Technical Assessment, the notified factory production control certification body shall require the manufacturer to provide a copy of the European Technical Assessment including its confidential control plan, and any other relevant documentation, before starting its work towards assessment and verification of constancy of performance. NB-CPR/AG/03/002r3 Page 11 of 18

12 On acceptance of a completed application form the notified factory production control certification body shall confirm receipt to the client and inform if any further information is required for processing their application. 4.4 Initial inspection of factory and of factory production control General After confirmation of the acceptance of the application, the notified factory production control certification body shall make the necessary arrangements with the client for the initial inspection, in accordance with the rules in the harmonised European standard or European Technical Assessment and any specific guidance for the construction product agreed by the GNB-CPR. The notified factory production control certification body is responsible for all actions of certification of conformity of the factory production control including initial inspection of the manufacturing plant and of factory production control and for surveillance, assessment and evaluation of factory production control identified as tasks for the notified factory production control certification body in the harmonised annex of the standard or in the European Technical Assessment. The notified factory production control certification body should send a report informing the client of the results of the initial inspection within an agreed time after the initial inspection, normally not longer than 6 weeks. If the notified factory production control certification body is not satisfied that all the requirements for the certification of conformity of the factory production control were met, it shall inform the client of those aspects in which their application has failed. The notified factory production control certification body and client should agree a time limit for remedial action. If the client can show that remedial action has been taken to meet all requirements within the agreed time limit, the notified factory production control certification body concerned shall repeat only the necessary parts of the initial inspection procedure Assessment of factory production control Assessment of the client s system of factory production control forms part of the initial inspection. Ideally, guidance for these elements should be included in the harmonised European standard or in the European Technical Assessment. The assessment shall comply with the requirements laid down in the harmonised European standard(s) or European Technical Assessment and should comply with any specific guidance for the construction product agreed by the GNB-CPR. All records produced for implementation of the factory production control system related to certification shall be readily available for inspection by the notified factory production control certification body. The manufacturer will have used the test results from their determination of the product-type to ensure that their construction product conforms with the test requirements of the harmonised European standard or European Technical Assessment including declared performances and properties. The factory production control may incorporate tests that demonstrate compliance with these requirements, and/or may ensure that the production process remains the same as that for the samples used for the determination of the product-type. The notified factory production control certification body shall check that the manufacturer has documented results for all tests and/or calculations required for the determination of the producttype, and that the factory production control is in accordance with the harmonised European standard or European Technical Assessment and shows that the production achieves the NB-CPR/AG/03/002r3 Page 12 of 18

13 characteristics required by the harmonised European standard or European Technical Assessment and all declared performances and properties. If the factory production control certification body notices anything about the manufacturer s determination of the product-type that seems questionable or incomplete, in relation to the harmonised European standard or European Technical Assessment, it should draw its concerns to the attention of the manufacturer. However, the manufacturer remains responsible for the determination of the product-type. PD ISO/IEC Guide 28: states The applicant should ensure that the question of responsibility to the certification body for the quality system is clearly defined. This could be by appointing a designated person who is independent of the production management as far as the technical performance of this function is concerned, and who is qualified to maintain contact with the certification body. Tasks, responsibilities, authorities and skills within the factory production control system shall be documented and shall be kept up to date. A checklist, prepared by the notified factory production control certification body, should support the inspector in their assessment of the factory production control. See NB-CPR/AG/03/004 for further information about checklists. Items found not to be in compliance shall be reported. In the case of a European Technical Assessment, the notified factory production control certification body shall if required by the European Technical Assessment inform directly the Technical Assessment Body (TAB) of the results of its investigation or check that the manufacturer is supplying this information. If nonconformities of the factory production control were detected during the initial inspection, all of these must be dealt with to the satisfaction of the notified factory production control certification body. 4.5 Certificate of conformity of the factory production control General When the notified factory production control certification body is satisfied that the manufacturer has fulfilled all of the requirements laid down in the harmonised annex of the European standard, or in the relevant European Technical Assessment, which are applicable for the product and intended end use, and which the body is responsible for certifying, the notified factory production control certification body shall inform the client accordingly and issue a certificate of conformity of the factory production control. The certificate shall be in accordance with the generic form for the appropriate system, and for the appropriate specification (harmonised European standard or European Technical Assessment), shown in the latest version of NB-CPR/AG/03/003. Once issued, a certificate remains valid only whilst supported by the notified factory production control certification body and can be suspended or withdrawn by the notified product certification body in accordance with CPR Article 52.4 and In addition, a failure to meet contractual obligations can allow the notified factory production control certification body to suspend or withdraw the certificate. An individual certificate may cover more than one product and/or production unit provided that all production is under an identical factory production control. Alternatively, separate certificates may be provided for individual production units, product families or products 5, 6. In all cases, the product(s) and factory(ies) covered shall be clearly identified on the certificate of conformity of the factory production control. NB-CPR/AG/03/002r3 Page 13 of 18

14 NOTE On coded formats, Commission Guidance Paper D 5.4 states For reasons of traceability, the place of production of the product in question shall also be identified, possibly in a coded format. Although these Guidance Papers were written for the CPD, their guidance is considered to remain valid when not in conflict with the CPR. The place of production may identify particular manufacturing plants, lines or facilities. If the place(s) of production is/are coded, the notified factory production control certification body shall maintain a key to the code(s) and shall provide the manufacturer with a copy of this key where the manufacturer did not provide the code(s) Certificate of conformity of the factory production control for other construction products from the same factory If a client wishes to obtain certificate(s) of factory production control for additional type(s) or model(s) of construction product(s) made in the same factory to the same harmonised European standard or to a similar European Technical Assessment as the product for which a certificate of conformity of the factory production control is already held, the notified factory production control certification body should invite a further application, which may be made using the usual form. The notified factory production control certification body can decide in such a case to carry out no or only a partial inspection of the manufacturing plant and of factory production control. Also, the body shall consider whether any additional test reports are needed from the manufacturer s determination of the product-type. If extended certification is granted, the certificate(s) shall continue to identify clearly the construction products and factory(ies) covered, and the certificate(s) or supporting documentation shall continue to identify clearly the dates from which each product has been covered. Possible ways to extend the certification are: if the extension falls within the wording of the original certificate, update the supporting documentation, which must be clearly dated, or; issue a revised version of the certificate, with the same number but a greater scope and a revised date, or; issue a replacement certificate, with a new number and a greater scope, or; leave the original certificate valid and issue additional certificate(s) covering the additional construction product(s). If the client wishes to apply the certification of the conformity of the factory production control to additional types of construction products made at the same factory, but to different harmonised technical specifications, or if the client wishes to apply for certification of the conformity of the factory production control to be applied in an additional factory that is not covered by an earlier certificate of constancy of performance or certificate of conformity of the factory production control, the elements that have already been assessed during the previous assessment(s) could be used again when relevant, in accordance with the harmonised European standards or European Technical Assessments. In the case of extending certification to cover an additional factory, the assessment shall include a visit to the additional factory unless the technical specification specifically addresses this scenario, or there is an approved Sector Group position paper covering the scenario (See also NB-CPD/AG/07/008r1 7 Guidance to NBs on their duties in certifying (system 1+, 1, 2+ and 2) suppliers own brand labelled products and those involving significant subcontract manufacturing ). (If a notified factory production control certification body needs additional advice, it should consult the Sector Group concerned.) 4.6 Surveillance The notified factory production control certification body shall require the manufacturer to inform it of any intended modification of the production process or factory production control, where this is likely NB-CPR/AG/03/002r3 Page 14 of 18

15 to have an effect on the declared performances and properties of the construction product. It is up to the notified factory production control certification body to determine whether the announced changes require another inspection or other further investigations. In such cases the notified factory production control certification body shall inform the manufacturer that the certificate does not entitle the manufacturer to release any CE-marked products resulting from such changes until the notified factory production control certification body has informed the manufacturer accordingly. In the case of a European Technical Assessment, the notified factory production control certification body shall attempt to ensure that the Technical Assessment Body that issued the European Technical Assessment is informed of any nonconformity or of any modification of the construction product and/or of the factory production control to allow the Technical Assessment Body to update the European Technical Assessment file of the product and/or to renew the European Technical Assessment when relevant. However, maintaining confidentiality may require that the notified factory production control certification body does not inform the Technical Assessment Body directly, but instead checks that the manufacturer is supplying this information. The notified factory production control certification body is responsible for the surveillance, assessment and evaluation of factory production control on the basis of: the requirements of the relevant harmonised European standard or European Technical Assessment, and; any specific guidance agreed by the GNB-CPR for the construction product, and; the original assessment of the factory production control. The inspector shall check whether: the manufacturer is still working to the same version of the harmonised European standard or European Technical Assessment that applied when the previous surveillance visit was made (or, in the case of the first surveillance visit, the initial inspection), and; in the case of a harmonised standard, it is a currently cited version 2. If either of the above conditions is not met, in the case of a harmonised European standard, the notified factory production control certification body shall refer to the guidance in NB-CPR/AG/08/009 The consequences for NBs of corrigenda, amendments and revisions to harmonised European standards. The notified factory production control certification body shall ensure that the manufacturer keeps a record of all nonconformities and complaints relating to the construction product covered by the certificate of conformity of the factory production control and makes this available to the notified factory production control certification body on request. The notified factory production control certification body shall inform the manufacturer of the results of the surveillance, and of any nonconformities of the factory production control it has raised. If nonconformities are raised, the notified factory production control certification body has three options for its response, depending on the severity and extent of the nonconformities: require the manufacturer to make corrections or changes within an appropriate period, whilst maintaining the validity of certification, or; suspend certification until the manufacturer has made corrections or changes, or; withdraw certification from the manufacturer. Key actions to be taken when following one of these options are given below. NB-CPR/AG/03/002r3 Page 15 of 18