1 May 2014 Kiwa Regulations for Certification in accordance with the CPR EC Regulation No. 305/2011 (CPR)
1 May 2014 Kiwa Regulations for Certification in accordance with the CPR EC Regulation No. 305/2011 (CPR) 2014 Kiwa Nederland B.V. All rights reserved. No part of this book may be reproduced, stored in a database or retrieval system, or published, in any form or in any way, electronically, mechanically, by print, photoprint, microfilm or any other means without prior written permission from the publisher. Kiwa Nederland B.V. Sir W. Churchilllaan 273 Postbus 70 2280 AB RIJSWIJK, the Netherlands Tel. 070 414 44 00 Fax 070 414 44 20 www.kiwa.nl
Preface In its certification activities Kiwa 1 employs the following principles: The policies and procedures used by Kiwa are non-discriminatory: all the manufacturers 2 have access to the certification schemes employed by Kiwa and are treated equally by Kiwa for purposes of the provision of certification services; Kiwa is entirely impartial and independent. It has achieved this by creating a strict division between the functions of a) the issuing of rules and regulations, b) implementation and c) dispute settlement in accordance with the trias politica principle with regard to its certification work. Regulations As a notified body (NOBO), Kiwa is obliged to comply with the requirements of EC Regulation No. 305/2011 of the European Parliament and the Council of 9 March 2011. Implementation In the implementation of its certification work Kiwa shall employ impartial and independent certification personnel who have no interest in the products to be certified or in the organisations of the manufacturer and who are obliged to observe the rules of conduct employed by Kiwa in their work. Furthermore, Kiwa has ensured that there is a strict separation between the personnel carrying out the evaluation and personnel taking decisions on certification. Dispute Settlement Appeal may be lodged against decisions or measures taken by Kiwa with the Board of Appeal (College van Beroep), which operates fully independently of Kiwa. This Board of Appeal gives its verdict in the form of an arbitral award. Introduction Certification method Kiwa carries out its certification work in accordance with the methodology set out in abbreviated form below. If there is a social need for a certified product or a certified Factory Production Control, the European Commission will draw up a mandate based on which CEN or EOTA can take care of the content and functioning of the rules and regulations required for the certification in question. This results in a package of requirements that the product and/or the Factory Production Control must meet. In addition to the harmonised standard (hen) or European technical assessment (ETA), for certification Kiwa applies its General Terms and Conditions applying to Assignments granted to Kiwa (AVOK) and the present Regulations. As soon as the manufacturer has made its application for certification known to Kiwa, the latter will make an offer in the form of a draft certification agreement. This draft agreement shall comprise the initial audit and the rights and obligations that apply to both the manufacturer and Kiwa. The agreement shall also comprise the parties rights and obligations after the certificate has been granted, which mainly concerns the agreements on the maintenance of the certificate and the certification scheme. After both parties have signed the certification agreement, Kiwa will proceed to deal with the certification assignment by starting the initial audit. After this initial audit has been completed, an employee who was not involved in the initial audit will decide whether or not the certificate will be granted. If the result is positive, the manufacturer will receive the certificate and will from then on be a certificate holder 3 ; the maintenance phase aimed at the continuation of the certificate will then start. The manufacturer may disclose and give publicity to its certificate and shall act in accordance with its rights and obligations under the agreement to maintain the certificate. Kiwa must also abide by certain rules in the maintenance phase. Kiwa provides certificates and the underlying agreements for an indefinite period of time. Kiwa performs audits on a regular basis in order to verify whether this agreement is fulfilled permanently. The frequency of these audits is in accordance with the package of requirements. If the package of requirements imposes special demands, such as an assessment against all the requirements within a prescribed period, such demands will be respected. If EC Regulation No. 305/2011 (CPR) is amended by the European Commission or the contents of a harmonised standard (hen) or European technical assessment (ETA) that is covered by it, Kiwa will inform the manufacturers about this and about any consequences thereof. The manufacturer will be enabled to adjust its certified products and/or Factory Production Control to the changed requirements. This will be verified by Kiwa on the basis of an audit, after which the certificate will be adjusted within the applicable transitional period. If the result of the initial audit is negative, no certificate will be granted and the earlier-mentioned certification agreement shall also lapse. This certification agreement shall also lapse if there are reasons for terminating or withdrawing the certificate. A manufacturer may lodge an appeal against decisions by Kiwa and may make use of the independent Board of Appeal set up by Kiwa for this purpose 4. The present Regulations set out the work carried out by Kiwa for product certification and/or certification of the Factory Production Control. 1 Kiwa is understood to mean Kiwa in its capacity as a notified body (NOBO). 2 In the CPR, a manufacturer is understood to mean the party that markets the construction product and that is listed with its name and address on the corresponding declaration of performance and the CE marking. 3 The term of certificate holder is not used anywhere else in the present Regulations. 4 The Board of Appeal is governed by the current Kiwa Regulations for the Board of Appeal. Kiwa Nederland B.V. - 1-1 May 2014
Contents 1 Definitions 3 2 Requirements 4 3 Implementation 4 4 The Manufacturer 5 5 Certification Agreement 5 6 Meaning, Contents and Period of Validity of the Certificate 5 7 Terms and Conditions of Delivery 6 8 Publication, affixing the CE marking and stating Kiwa's NOBO number 6 9 Costs of Certification 7 10 Secrecy 7 11 Application Procedure 8 12 Performance of the Assignment 8 13 Changes 12 14 Contracting out Production 13 15 Termination 13 16 Further Provisions 14 17 Complaints and Appeals 15 18 Final Provisions 15 Kiwa Nederland B.V. - 2-1 May 2014
1 Definitions 1.1 Certification In the present Regulations the term certification is understood to mean the activities carried out by Kiwa, such as the inspection of prototypes and products and supervision on production and Factory Production Control, on the basis of which Kiwa certifies that there is a legitimate expectation that a clearly described product and/or Factory Production Control meets the applicable harmonised standard (hen) or issued European technical assessment (ETA). 1.2 Specific Definitions Specific definitions within the framework of the present Regulations are the following: 1.2.1 Certificate systems 5 1.2.1.1 Certificate system 1+ A certificate of the product's constancy of performance based on: the establishment of the product type based on the type examination (including sampling), type calculation, tabulated value or descriptive documentation of the product; the initial inspection of the production installation and the Factory Production Control; permanent monitoring, assessment and evaluation of the Factory Production Control; random check of samples before the product is marketed. 1.2.1.2 System 1 Certificate A certificate of the product's constancy of performance based on: the establishment of the product type based on the type examination (including sampling), type calculation, tabulated value or descriptive documentation of the product; the initial inspection of the production installation and the Factory Production Control; permanent monitoring, assessment and evaluation of the Factory Production Control. 1.2.1.3 System 2+ Certificate A certificate of conformity of the Factory Production Control based on: the initial inspection of the production installation and the Factory Production Control; permanent monitoring, assessment and evaluation of the Factory Production Control. 1.3 Audit The systematic assessment by Kiwa of a clearly described product and/or Factory Production Control based on the harmonised standard (hen) or issued European technical assessment (ETA). An audit is aimed at ascertaining whether the manufacturer complies with the harmonised standard (hen) or issued European technical assessment (ETA) and is making proper use of the certificate, the CE marking and the statement of Kiwa's NOBO number. 1.4 Manufacturer In the CPR, a manufacturer is understood to mean the party that markets the construction product and that is listed with name and address on the corresponding declaration of performance and the CE marking. The manufacturer to which reference is made in the Certificate is also the legal entity that enters into the Certification Agreement with Kiwa. 1.5 Product A single or composite product, or a component thereof. 1.6 Quality System The recorded organizational structure, responsibilities, procedures, processes and provisions required to implement quality management. 1.7 Factory Production Control (FPC) The English name for the quality system described under 1.7. 1.8 Non-Conformity The conclusion that a certification requirement has not been met. 5 The texts concerning the content of the certificates are derived from Schedule V to the CPR. Kiwa Nederland B.V. - 3-1 May 2014
1.9 Certification requirements The requirements laid down in a harmonised standard (hen) or issued European technical assessment (ETA) and the CPR, which Kiwa applies in order to: a. assess the product and/or Factory Production Control during an initial audit; b. supervise the certified product and/or Factory Production Control by means of audits after a certificate has been granted. 1.10 CE marking The marking on a construction product that the manufacturer uses to indicate that it assumes responsibility for that product's conformity to its stated performance. 1.11 Declaration of Performance (DoP) A document that must accompany a construction product covered by a harmonised standard or in respect of which a European technical assessment has been issued and in which the manufacturer makes a statement about the performance with respect to the essential features of the building product in accordance with the relevant harmonised technical specifications. 1.12 Certification Agreement An agreement containing all the rights and obligations which the manufacturer and Kiwa have towards each other. The Certification Agreement shall comprise the initial audit as well as all the procedures after the Certificate has been granted. 1.13 Board of Appeal The Board of Appeal set up by Kiwa in accordance with the current Kiwa Regulations for the Board of Appeal. The Board gives its verdict in the form of an arbitral award. 2 Requirements 2.1 The requirements to be met by a product and/or Factory Production Control in order to qualify for a Certificate under the present Regulations have been recorded in the harmonised standard (hen) or the issued European technical assessment (ETA) that applies to the certification and the CPR. 2.2 If Kiwa uses the harmonised standard or issued European technical assessment that applies to the certification, their provisions will apply, even in the case of a conflict with the present Regulations. 2.3 Because Kiwa has been appointed by the government to implement certification prescribed by law, EC Regulation No. 305/2011 (CPR) applies in addition to these Regulations. The CPR applies if any provisions conflict with the present Regulations. 2.4 In the implementation of this certification, Kiwa is bound by EC Regulation No. 305/2011 (CPR). Insofar this EC Regulation contains criteria that relate to the relationship between Kiwa and the Manufacturer, the provisions contained in these criteria shall be applicable, even if they conflict with the present Regulations. 2.5 If an employee of the Dutch Accreditation Council (RvA) or an employee of Kiwa so desires, the Manufacturer must allow them access to its business in order to be able to observe the audit team during its Audits. 3 Implementation 3.1 The certification work is carried out by staff that has been qualified by Kiwa 6. 3.2 Subcontracting of certification work by Kiwa 7 If Kiwa subcontracts duties to subsidiaries and subcontractors, the provisions of Article 45 of the CPR will apply to this. 6 Qualification requirements have been laid down in the Kiwa Operations Manual. 7 Texts are derived from Article 45 of the CPR. Kiwa Nederland B.V. - 4-1 May 2014
3.2.1 If Kiwa subcontracts specific duties in connection with the duties of third parties for the assessment and verification of constancy of performance or if it has such duties carried out by a subsidiary, it warrants that the subcontractor or subsidiary meets the requirements of Article 43 of the CPR and it shall inform the notifying authority thereof. 3.2.2 Kiwa assumes the full responsibility for the duties that are carried out by subcontractors or subsidiaries, regardless of their registered office. 3.2.3 Activities may only be subcontracted or carried out by a subsidiary if the customer has given its consent. 3.2.4 Kiwa shall keep all relevant documents on the assessment of the qualifications of each subcontractor or subsidiary and on the duties carried out by such parties pursuant to Schedule V of the CPR available for the notifying authority. 4 The Manufacturer 4.1 If the Manufacturer (within the meaning of Article 15 of the CPR) does not produce the products itself, the responsibility must be laid down in a written agreement between itself and the actual producer, in which at least the following subjects are arranged: the manner in which the Manufacturer verifies that the products and/or the Factory Production Control (FPC) of the actual producer meet the harmonised standard (hen) or issued European technical assessment (ETA); that the Manufacturer may demand that the actual producer manufacture products that comply with the applicable harmonised standard (hen) or issued European technical assessment (ETA); that the CE marking may only be affixed to products that comply with the Declaration of Performance (DoP); that Kiwa may carry out all the required work for purposes of the certification at both the Manufacturer and the actual producer s works, including taking measures if Non-Conformities are found; If an employee of the Dutch Accreditation Council (RvA) or an employee of Kiwa so desires, the Manufacturer must request the actual producer to allow them access to the factory in order to be able to observe the audit team during its Audits. In accordance with Article 15 of the CPR, Kiwa regards an importer or distributor as a Manufacturer if it markets a product under its name or trademark or if it changes a construction product that is already on the market in such a manner that the conformity with the Declaration of Performance (DoP) may be compromised. In that case, the importer or distributor shall be bound by the obligations imposed on the Manufacturer in accordance with Article 11 of the CPR. 5 Certification Agreement 5.1 The Manufacturer and Kiwa shall conclude an agreement for the performance of certification work. This will include the following at a minimum: the nature of the services rendered by Kiwa; the Manufacturer s obligation to always comply with the provisions on certification recorded in or pursuant to the agreement; the General Terms and Conditions applying to Assignments granted to Kiwa (AVOK) and the applicable regulations; the applicable harmonised standard (hen) or issued European technical assessment (ETA) and the CPR; if the product is produced at a fixed location: the production place/places; the fee payable to Kiwa. 6 Meaning, Contents and Period of Validity of the Certificate 6.1 In System 1+ and 1 Certificates, Kiwa certifies that all rules regarding the assessment and verification of constancy of performance (AVCP) described in the applicable harmonised standard or European technical assessment at level 1+ or 1 respectively are applied and that the product complies/products comply with all stated requirements. Kiwa Nederland B.V. - 5-1 May 2014
6.2 In System 2+ Certificates, Kiwa certifies that all rules regarding the assessment and verification of constancy of performance (AVCP) described in the applicable harmonised standard or European technical assessment at level 2+ are applied and that the Factory Production Control complies with all stated requirements. 6.3 The following shall in any case be recorded in the Certificate: the name and the address of the Manufacturer; the harmonised standard (hen) or the issued European technical assessment (ETA) against which the products have been tested; the effective date of the Certificate; any product parameters (performance level, classification of product features). Description of the product (identification and intended application according to the Manufacturer's Declaration of Performance (DoP). 6.4 If desired, the following may also be stated in the Certificate: the production location; the name of the distributor or importer. 6.5 A Certificate is granted for an indefinite period. 6.6 A Certificate shall lapse upon the termination of the Certification Agreement between Kiwa and the Manufacturer. 6.7 An adaptation of the Certificate is required if there is any change in one or more of the points stated under 6.3. 7 Terms and Conditions of Delivery 7.1 The provisions of the present Regulations apply to all deliveries of products with a Declaration of Performance (DoP) and CE marking in which Kiwa is named as the NOBO. 7.2 The Manufacturer may deliver these CE-marked products under different trade names, provided that Kiwa has given its permission for this and that the traceability of the origin of the products is guaranteed. 7.3 The terms and conditions of delivery of the Manufacturer may not be in conflict with the Certification Agreement. If this is the case, the provisions of the Certification Agreement shall apply. 8 Publication, affixing the CE marking and stating Kiwa's NOBO number 8.1 Publication by the Manufacturer 8.1.1 The Manufacturer may publish the fact that it has a Kiwa Certificate for its product and/or Factory Production Control in question, but such publication may only and unequivocally concern the product and/or Factory Production Control specified in the Certificate. A breach of this provision will be considered as improper use within the meaning of article 16.2.2 of these Regulations. 8.1.2 The Manufacturer shall be obliged, when so requested, to provide each customer with a complete copy of the Certificate. 8.1.3 The Manufacturer is obliged to provide products for which Kiwa has issued a certificate of the product's constancy of performance or a certificate of conformity of the Factory Production Control with a CE marking on which the Kiwa NOBO number is stated. The Declaration of Performance (DoP) that accompanies the CE marked products must also state the Kiwa NOBO number as well as the unique certification number of the Certificate issued by Kiwa. 8.1.4 The method of marking in general shall be recorded in the harmonised standard (hen) or in the issued European technical assessment (ETA) and the CPR. Kiwa Nederland B.V. - 6-1 May 2014
8.1.5 Products which do not meet the specification stated in the Declaration of Performance (DoP) may not be provided with a CE marking with the Kiwa NOBO number. The Manufacturer shall be under the obligation to ensure this and to remove any marks already affixed. 8.2 Publication by Kiwa On request Kiwa shall provide anyone with information on the validity of Certificates. 9 Costs of Certification 9.1 Kiwa shall submit an offer for the performance of certification work. If the Manufacturer declares in writing that it accepts this offer, the Certification Agreement referred to in Section 5 is thereby concluded. Kiwa may charge the estimated costs in connection with the initial audit by way of advance. Such costs shall in any case include the costs of third parties called in by Kiwa as well as the hotel and travelling expenses if the work is to be performed outside the Netherlands. Costs of re-approval, if the product and/or Factory Production Control initially do not meet the requirements defined, will be charged additionally. 9.2 Kiwa shall charge the costs relating to the certification, as recorded in the Certification Agreement, to the Manufacturer. These costs concern: a) the actual or estimated costs of the initial audit; b) the costs of granting a Certificate after the initial audit has been completed with a positive decision in accordance with article 12.5. These costs concern the audits and the maintenance of the Certificate; c) the extra costs for assessing actions taken by the Manufacturer on account of any Non-Conformities found during the initial audit or during Audits; d) the extra costs involved in any of the measures within the meaning of article 12.7; e) the additional costs of re-inspection of a product. 9.3 If the Manufacturer fails to pay the charged costs in time, Kiwa may: suspend or terminate the application procedure and/or the granting of the Certificate; suspend or terminate the validity of the Certificate. In the event of termination the Certification Agreement shall also lapse, unless otherwise agreed. 9.4 Unless agreed otherwise, the Manufacturer shall pay Kiwa compensation for the administration costs. This compensation shall be annually determined by Kiwa. 9.5 Costs of Cancellation If the Manufacturer has made an appointment for an initial audit or Audit and fails to cancel it in time, Kiwa may charge costs up to a maximum of: 50% of the time reserved for the initial audit or Audit, if the appointment is cancelled between 6 and 10 working days before the scheduled appointment; 100% of the time reserved for the initial audit or Audit, if the appointment is cancelled 5 or fewer working days before the scheduled appointment. 10 Secrecy 10.1 The employees of Kiwa shall be obliged to observe secrecy towards third parties in respect of all information that comes to their knowledge as a result of carrying out certification work, except in the case of: statutory obligations; obligations to allow the Dutch Accreditation Council (RvA) 8 inspection with regard to certification activities; an appeal lodged with the Board of Appeal 9 against a decision or measure taken by Kiwa. 10.2 If Kiwa provides confidential information because this is required by law, Kiwa shall inform the Manufacturer concerned. 8 The Dutch Accreditation Council is obliged to observe secrecy. 9 Members of the Board of Appeal for their part are obliged to observe secrecy. Kiwa Nederland B.V. - 7-1 May 2014
10.3 If external experts are called in for the purpose of carrying out certification work, they shall sign a declaration in which they undertake to observe secrecy as laid down in article 10.1. 10.4 Members of an audit team shall be bound to the following rules of conduct: 10.4.1 They shall report only on what they have found. They shall not report on anything other than that which is directly related to their evaluation of the product and/or Factory Production Control to be certified. If there are reasons to report on observations not made by themselves, mention shall be made of this in the report. 10.4.2 They may request information from all those whom they wish to involve in an initial audit, but shall refrain from issuing comments or instructions to such persons. 10.4.3 They shall keep confidential all that has been entrusted to them as confidential information during an Audit of a product and/or Factory Production Control to be certified as well as all information which they should reasonably understand to be confidential. This confidentiality shall not affect Kiwa s authority to make public announcements on the existence, withdrawal or suspension of the Certification Agreement or its duty to provide information on the basis of statutory requirements and/or appeal procedures. 10.4.4 They shall make use of the information obtained during the Audit in the above-mentioned report only. Moreover, they shall not make such information known any further than is required for the implementation of the certification procedure. The provisions of article 10.4.3. shall also continue in effect after an Audit conducted at a Manufacturer has ended. If so desired by either of the parties, this may be deviated from by mutual agreement. 11 Application Procedure 11.1 Information 11.1.1 At a Manufacturer s request Kiwa shall provide it with all the required information on the application procedure, the requirements used therein, the working method to be employed and the costs involved in certification. 11.2 Offer 11.2.1 At a Manufacturer s request Kiwa will make an offer, in the form of a draft Certification Agreement, for the certification of the Manufacturer s products and/or Factory Production Control. This offer will be based on the information to be provided by the Manufacturer, which shall in any case include the following: general information on the Manufacturer and its legal status; the nature of the products and/or Factory Production Control to be certified and the harmonised standard (hen) or issued European technical assessment (ETA) to be used for that purpose; the location where the products are produced. This offer shall inter alia include an estimate of the time and the costs, the services rendered by Kiwa, the applicable requirements, the General Terms and Conditions applying to Assignments granted to Kiwa (AVOK) and the present Regulations. 11.2.2 When submitting an offer, Kiwa shall also provide the Manufacturer with the AVOK and a copy of these Regulations. The applicable harmonised standard (hen) or issued European technical assessment (ETA) and the CPR will not be provided by Kiwa. 11.2.3 Kiwa reserves the right to wait with its offer as long as the Manufacturer is in default in paying the costs resulting from other obligations towards Kiwa. 11.2.4 Kiwa reserves the right not to make an offer if the certification activities intended by the Manufacturer are beyond Kiwa s sphere of activities. 12 Performance of the Assignment 12.1 After the receipt of the Certification Agreement signed by the Manufacturer, Kiwa shall contact the Manufacturer in order to make arrangements in respect of the initial audit to be conducted. Kiwa Nederland B.V. - 8-1 May 2014
12.1.1 Kiwa shall not make any statements to third parties about the assignment and its performance by Kiwa, except with the Manufacturer s written permission. 12.1.2 The Manufacturer shall not create the impression that the products and/or Factory Production Control for which it has given Kiwa an assignment have been certified as long as the Certificate has not been granted. A breach of this provision will be considered as improper use within the meaning of article 16.2.2 of these Regulations. 12.1.3 Kiwa reserves the right not to deal with the assignment. Kiwa shall give the Manufacturer notice hereof in which it shall give the reasons for its decision. 12.2 Initial audit 12.2.1 General The initial audit to be carried out by Kiwa takes place based on the harmonised standard (hen) or issued European technical assessment (ETA) that applies to the product concerned and/or the Factory Production Control and shall, depending on the system of the assessment and verification of constancy of performance, include the following: the establishment of the product type based on the type examination (including sampling), type calculation, tabulated value or descriptive documentation of the product; the initial inspection of the production installation and the Factory Production Control; permanent monitoring, assessment and evaluation of the Factory Production Control; random check of samples before the product is marketed. The initial audit may be conducted on a limited scale if use can be made of relevant facts known to and accepted by Kiwa. Such facts may have been obtained from evaluations for the purpose of initial audits for another product certified by Kiwa or from an evaluation report on a quality system certified by Kiwa. 12.2.2 The Manufacturer shall make all samples and information relevant to the assessment available to Kiwa free of charge. 12.2.3 Acceptance of Test Reports Submitted by the Manufacturer If the Manufacturer submits reports on tests carried out at its instructions in order to demonstrate that the harmonised standard (hen) or issued European technical assessment (ETA) is met, Kiwa shall accept such reports as if these were the findings of initial audits carried out by Kiwa itself, provided the tests were carried out: with regard to the same products as those for which the Manufacturer submitted an application; in accordance with the same testing method as the one described in the harmonised standard (hen) or issued European technical assessment (ETA); by a body which meets the accreditation standard applicable to the work concerned. A body shall be deemed to meet these criteria if: an accreditation certificate issued by the Dutch Accreditation Council (RvA) or an accreditation body with which RvA has concluded an agreement of mutual acceptance can be submitted; the accreditation certificate relates to the required tests. If no accreditation certificate can be submitted, Kiwa shall either verify for itself, in consultation with the Manufacturer, whether the body meets the accreditation standard or carry out the tests itself or have them carried out by a third party. As a NOBO, Kiwa is always responsible for sampling in the factory with respect to products for which the applicable harmonised standard (hen) or issued European technical assessment (ETA) prescribes an AVCP system 1 or 1+. 12.2.4 The establishment of the product type based on the type examination (including sampling), type calculation, tabulated value or descriptive documentation of the product. Only if an AVCP system 1 or 1+ has been prescribed for a product shall Kiwa test the products to be certified, or have them tested by third parties, against the product and/or performance requirements included in the harmonised standard (hen) or issued European technical assessment (ETA). Kiwa or a third party to be determined by Kiwa will take the necessary samples for this purpose. 12.2.5 The initial inspection of the production installation and the Factory Production Control The purpose of the initial inspection of the production installation and the Factory Production Control is to verify whether the Manufacturer is able to preferably manufacture products that comply with the harmonised standard (hen) or issued European technical assessment (ETA). The assessment of the Factory Production Control shall take place during the work in progress. This assessment shall at least cover the following: 12.2.6 Assessment of the FPC. The assessment of the FPC will at least cover: Kiwa Nederland B.V. - 9-1 May 2014
the presence, within the structure of the organization, of an officer in charge of the management of the quality system; the manufacturer's supervision of: - the supplied raw materials or composite materials; - the production process; - the end-products; - the status of measuring and testing means; - the internal transport, the storage and identification or manner of marking semi-manufactures and end-products. For each of these elements the Manufacturer must have demonstrably recorded: the inspection aspects; the inspection method used; the inspection frequency; the manner in which the inspection results are recorded and kept. 12.2.7 Assessment of Procedures Kiwa shall ascertain whether the harmonised standard (hen) or the issued European technical assessment (ETA) are in place and are being used. These procedures shall invariably include the following: 1. the procedure for dealing with products showing deviations; 2. the procedure for corrective actions to be taken if Non-Conformities are found; 3. the procedure for dealing with complaints; this procedure should in any case lay down that the Manufacturer: keeps a record of all complaints about its CE-marked products and/or Factory Production Control; should take appropriate actions with respect to such complaints; should document the actions it has taken on account of complaints. 12.2.8 Assessment of Processing Instructions Kiwa shall assess, where appropriate, whether the processing instructions for the product concerned as formulated by the Manufacturer are practicable and offer sufficient security that the performance requirements are met upon application. 12.2.9 Assessment of the Agreement If the Manufacturer is not the producer of the products to be certified, Kiwa shall assess the agreement between the Manufacturer and the actual producer referred to in article 4.1. 12.3 Suspension, Termination and Withdrawal of initial audits 12.3.1 If it transpires in the course of the application procedure that there is a likelihood of the budget or time schedule being seriously overrun, Kiwa shall consult the Manufacturer on this matter. 12.3.2 If applicable, Kiwa shall inform the Manufacturer as to which harmonised standard (hen) or issued European technical assessment (ETA) has not been met as well as which supplementary evaluation or test is required to ascertain that all the requirements are met as yet. If the Non-Conformities can be remedied within 6 months in the opinion of the Manufacturer and Kiwa, the parties may in mutual consultation decide to prolong the application procedure. Prior to the supplementary assessment or test the Manufacturer must be able to show that it has taken the required corrective actions. 12.3.3 If it transpires during the initial or supplementary audits that a positive decision on the granting of a Certificate cannot, in all fairness, be expected, the application procedure may be terminated by mutual agreement. In the event of a termination the Certification Agreement shall terminate, unless otherwise agreed. 12.3.4 Kiwa shall also inform the notifying authority and the Manufacturer of any refusal, limitation, suspension or withdrawal or Certificates based on Article 53 of the CPR. 12.3.5 The Manufacturer may at all times withdraw its application in the interim. In that case, it shall be obliged to pay for any costs already incurred by Kiwa. 12.4 Recording the results of initial audit 12.4.1 Kiwa shall report the results of the initial audit. 12.4.2 Within 1 month of the completion of the initial audit, the Manufacturer will receive a report on the outcome of the initial audit carried out, in which the findings with regard to all the imposed requirements are recorded. 12.5 Decision on the Application and Grant of the Certificate Kiwa Nederland B.V. - 10-1 May 2014
12.5.1 Kiwa shall decide on the application within 1 month after the initial audit has been completed. 12.5.2 Its decision will be notified to the Manufacturer in writing. 12.5.3 In the case of a positive decision, the Manufacturer shall receive the Certificate and the right to use the Certificate number and Kiwa's NOBO number in the CE marking and the corresponding Declarations of Performance. With this decision the Certification Agreement shall also continue in effect. 12.5.4 In the event of a negative decision Kiwa shall reject the application, stating the reasons for its decision in writing. As a result, the Certification Agreement shall be terminated, unless otherwise agreed. 12.5.5 Kiwa shall inform the notifying authority of the refusal to grant the Certificate pursuant to Article 53 1a of the CPR. 12.5.6 If an application has been rejected, Kiwa will only entertain a new application if the Manufacturer can demonstrate that it has taken remedial action to meet all the requirements imposed. If this new application is submitted within 6 months from the rejection, Kiwa s initial audit will be limited to those aspects that resulted in the initial application being rejected. 12.6 Maintenance of the Certificate 12.6.1 During the period of validity of the Certification Agreement the Certificate must be maintained. 12.6.2 The maintenance of the Certification Agreement shall be based on the results of the periodic Audits. 12.6.3 In accordance with the CPR, the Manufacturer is obliged to ensure that the products affixed with a CE marking and accompanied by a Declaration of Performance (DoP) containing the Kiwa NOBO number and Kiwa's unique Certificate number comply with the requirements set for the product and/or the Factory Production Control and the description given in the Certificate under 6.1 and 6.2. 12.6.4 In accordance with the CPR and when delivering products manufactured according to the Declaration of Performance (DoP) to an EU Member State where the products are used, the Manufacturer is obliged to always quote the Kiwa NOBO number upon delivery. 12.6.5 If the Manufacturer delivers products with a CE marking that are accompanied by a Declaration of Performance (DoP) quoting the Kiwa NOBO number and Kiwa's unique Certificate number, all conditions of the Certification Agreement shall apply to this delivery. 12.6.6 The Manufacturer shall grant the co-operation required for the Audit to be carried out. The Manufacturer shall make the required samples and equipment available free of charge. 12.6.7 If it concerns products which are produced in situ at varying locations, the Manufacturer shall keep Kiwa informed of its work, while stating the place, time or period of implementation as well as the scope of the work. 12.6.8 In the event of minimal or irregular production of CE-marked products, the Manufacturer shall inform Kiwa in sufficient time of planned production. 12.6.9 Kiwa shall carry out Audits at regular intervals to check whether the Manufacturer complies with its obligations, which Audits shall be combined as much as possible with audits ensuing from other obligations. The Audit shall be carried out by officers of or on behalf of Kiwa. 12.6.10 The Audits will be carried out at the Manufacturer company and also: a) if the product is not produced at the Manufacturer s company: at the production installation; b) if the Manufacturer is not the producer: at the producer s company. 12.6.11 The Audits shall invariably include the following: inspections to ascertain whether the product specification stated in the Certificate is complied with; inspections of the production process; inspections of the FPC in use and the results of the inspections carried out by the Manufacturer since the previous Audit; inspection of the correct manner of affixing the Kiwa Certificate number and Kiwa NOBO number on the CE-marked products and the corresponding Declarations of Performance; inspections to ascertain whether the Manufacturer is complying with the required procedures; inspections of the other obligations of the Manufacturer laid down in the harmonised standard (hen) or issued European technical assessment (ETA). 12.6.12 If the Supplier is not the producer of the CE-marked products, Kiwa shall also inspect whether the agreement referred to in article 4.1 is being complied with. 12.6.13 Kiwa shall submit a report to the Manufacturer on the Audit carried out. 12.6.14 Kiwa shall evaluate the findings and the results of the Audits at the Manufacturer to decide whether or not the Certificate and the Certification Agreement will be continued. Kiwa Nederland B.V. - 11-1 May 2014
12.7 Non-Conformities and Measures in the Event of Non-Conformities 12.7.1 If Non-Conformities are found during the Audit, the Manufacturer shall be obliged to indicate within a period stated by Kiwa, calculated from the date of the audit report, which corrective actions it will take as well as what it will do or has done with any goods and/or products showing deviations. 12.7.2 If Non-Conformities are found during the Audit or on the basis of other information, it will depend on the seriousness of such Non-Conformities whether or not Kiwa will see cause for taking one or more of the following measures: a. a written warning; b. extra Audits and/or taking extra samples; c. an adjustment of the FPC; d. a temporary increase of the audit frequency; e. a suspension of the right to make use of the Certificate during a specific period of time; f. immediate withdrawal of the Certificate; g. publication of the measures stated under f. or g. 12.7.3 Kiwa shall inform the Manufacturer in writing of its decision while stating its reasons. Any extra costs involved in any measure taken shall be charged to the Manufacturer. 12.7.4 Within the suspension period referred to in article 12.7.2 under e.: the Certification Agreement shall remain in force; Kiwa shall supervise the actions to be taken by the Manufacturer which must lead to lifting the suspension; the Manufacturer may not use the Certificate and may no longer deliver any products provided with a CE marking and accompanied by a Declaration of Performance (DoP) that includes the Kiwa NOBO number and Kiwa's unique Certificate number. A breach of this provision will be considered as improper use within the meaning of article 16.2.2 of these Regulations. 12.7.5 If the Manufacturer has not taken appropriate corrective actions within the period of suspension, Kiwa shall withdraw the Certificate. In the event of withdrawal the Certification Agreement shall lapse, unless otherwise agreed. 12.7.6 Kiwa reserves the right to inform the customer or customers of the Manufacturer concerned in the event of a safety risk and/or to prevent damage. The Manufacturer shall in those cases be obliged to provide Kiwa with a list of its customers. 12.7.7 Kiwa shall report any suspension or withdrawal of the Certificate to the notifying authority in accordance with Article 53 1a of the CPR. 13 Changes 13.1 Changes on the Part of the Manufacturer 13.1.1 The Manufacturer shall not make any changes that are or may be directly connected with the quality of its products 10 and/or the Factory Production Control before Kiwa has agreed to these changes in writing. 13.1.2 After the Manufacturer has given notice of a change in writing, Kiwa shall determine whether a supplementary test is required and shall inform the Manufacturer accordingly. 13.1.3 If a supplementary test is required, Kiwa may forbid the Manufacturer to supply any products quoting the Certificate, Certificate number or Kiwa NOBO number which have been manufactured under the changed circumstances during the period in which the supplementary test is being carried out. This prohibition shall end as soon as Kiwa has informed the Manufacturer that the result of the supplementary test is positive. 13.2 Changes to harmonised standard (hen) or issued European technical assessment (ETA). 13.2.1 Kiwa shall inform the Supplier in good time of any expected changes to the harmonised standard (hen) or issued European technical assessment (ETA), their validation date and the transitional period, if any. In addition, Kiwa shall indicate the nature, scope and costs of any supplementary test that may be required. This does not discharge the Manufacturer from its obligation to always include a correct CE marking and Declaration of Performance (DoP) with its products. The Manufacturer has ultimate responsibility. 13.2.2 If the Manufacturer does not agree to the changes and/or the proposed supplementary test, it shall inform Kiwa thereof in writing within 30 days at the latest. In that case, the Certificate shall lapse on the date on which 10 Such changes may concern changes to the product specification or changes to the ownership, structure, FPC or management of the Manufacturer s company. Kiwa Nederland B.V. - 12-1 May 2014
the changed harmonised standard (hen) or issued European technical assessment (ETA) is validated or after the transitional period has expired. As a result the Certification Agreement shall also terminate, unless otherwise agreed. 13.2.3 If the Manufacturer accepts the changes and if the decision based on the supplementary test turns out to be positive, the Manufacturer shall receive a new Certificate. 13.2.4 If the decision based on the supplementary test is negative, the Certificate shall lapse on the date on which the changed harmonised standard (hen) or issued European technical assessment (ETA) is validated or after the transitional period has expired. As a result the Certification Agreement shall also terminate, unless otherwise agreed. 13.2.5 Kiwa shall report any suspension or withdrawal of the Certificate to the notifying authority in accordance with Article 53 1a of the CPR. 14 Contracting out Production 14.1 The Manufacturer may contract out parts of the production process to a third party, provided the work concerned takes place within the FPC used by the Manufacturer, as referred to in article 12.2.6. 14.2 Without prejudice to its obligations under the Certification Agreement, the Manufacturer may temporarily contract out the production process to a third party, subject to the following conditions: The third party is the producer of CE-marked products produced based on the same harmonised standard (hen) or issued European technical assessment (ETA); Kiwa shall be informed in advance that the production process will be contracted out; Kiwa must indicate in writing that the subcontracting of the production is approved; the characteristics and recognisability of the marks to be affixed shall be agreed upon beforehand between the Manufacturer and Kiwa; the Manufacturer must be able to show which products have been manufactured by the third party. 14.3 The Manufacturer who contracts out the production process shall have the obligation to ensure that the Audits can be carried out in accordance with article 12.6.11. 14.4 A Manufacturer who contracts out the production process shall continue to be fully responsible for the compliance with the Certification Agreement concluded between it and Kiwa. 14.5 If it concerns an altered product for the third party, Section 13 shall also apply. 15 Termination 15.1 A Certificate may be withdrawn by Kiwa with immediate effect in the following cases: if serious Non-Conformities are found by Kiwa; see article 12.7.2 under f; failure to take adequate improvement measures during a suspension period; see article 12.7.2 under e; if the Manufacturer has acted in serious conflict with one or more of its obligations under the Certification Agreement, including its financial obligations; if the Manufacturer has seriously harmed the interests of Kiwa. 15.2 A Certificate may be terminated with immediate effect by the Manufacturer if Kiwa has acted in serious conflict with one or more of its obligations under the Certification Agreement or if Kiwa has seriously harmed the interests of the Manufacturer. 15.3 In any cases other than those described above, and subject to the provisions of Article 13.2 (termination as a result of changes in the harmonised standard (hen) or issued European technical assessment (ETA)), the Certificate may only be terminated with due observance of a notice period of 3 full calendar months. Kiwa Nederland B.V. - 13-1 May 2014
15.4 Kiwa may, after consultation with the Manufacturer, withdraw a Certificate or suspend the right to use a Certificate if the Manufacturer s production has been so small or irregular during a prolonged period of time that the Audits referred to in articles 12.6.10 and 12.6.11 cannot be carried out in accordance with the requirements of the applicable harmonised standard (hen) or issued European technical assessment (ETA). 15.5 The termination shall be notified to the other party by registered letter, stating the date of termination. In the event of a termination by Kiwa, Kiwa shall also state the reasons for the termination in the letter. 15.6 The termination of the Certificate shall not affect any financial obligations that the Manufacturer already has towards Kiwa. 15.7 Upon termination of the Certificate the Certification Agreement concluded with the Manufacturer shall lapse, unless otherwise agreed. 15.8 As from the date of termination of the Certificate, the Manufacturer may not use the Certificate and may no longer deliver any products provided with a CE marking and accompanied by a Declaration of Performance (DoP) that includes the Kiwa NOBO number and Kiwa's unique Certificate number. Nor may it create the impression that it is still entitled to use the Certificate and a CE marking accompanied by a Declaration of Performance (DoP) that include the Kiwa NOBO number and Kiwa's unique certificate number. A breach of this article will be considered improper use within the meaning of article 16.2. If it is found that this provision has been breached, Kiwa may impose on the Manufacturer an immediately claimable fine with a maximum of 5,000 as well as a maximum fine of 500 for each day such breach continues. This fine shall be in addition to the damage suffered by Kiwa as a result of such breach. 16 Further Provisions 16.1 Complaints from Third Parties 16.1.1 If Kiwa receives a complaint from a third party about CE-marked products and/or Factory Production Control, it shall contact the Manufacturer as to the investigation to be carried out into the nature and the cause of the Non-Conformities and shall ensure that the complaint is dealt with within a reasonable period of time. 16.1.2 Kiwa reserves the right to carry out an independent investigation on account of a complaint received. Kiwa may charge the costs of such an investigation to either the complaining party or to the Manufacturer, depending on which of the parties is found to be in the wrong. 16.1.3 If a complaint proves to be valid, this may cause Kiwa to consult the Manufacturer on corrective actions to be taken or on the review of the FPC, or to take one of the measures referred to in article 12.7. 16.1.4 Kiwa shall not participate in any consultations on the financial consequences of the defectiveness of the products delivered, unless the customer and the Manufacturer jointly and explicitly request Kiwa to do so. 16.2 Improper use of Certificates and the statement of the Kiwa NOBO on declarations of performance and the CE marking 16.2.1 Improper Use by Third Parties 16.2.1.1 Kiwa undertakes to ensure that no improper use is made of Certificates and the statement of the Kiwa NOBO number on the declaration of performance and the CE marking by third parties. 16.2.1.2 Actions to protect the use of Kiwa Certificates, Certificate numbers and/or the Kiwa NOBO number shall be reserved to Kiwa. 16.2.1.3 Kiwa may, whether alone or together with the Manufacturer of certified products and/or Factory Production Control, bring an action against third parties making improper use of Certificates, Certification Marks, pictograms or logos. 16.2.2 Improper Use by the Manufacturer 16.2.2.1 Kiwa shall ensure that no improper use is made of Certificates, Certification Marks, pictograms or logos by Manufacturers. This shall also include their use during a period of suspension and their use within a period of 6 months 11 after the termination of a Certificate. 11 After this period of six months Kiwa shall take action against improper use in conformity with the provisions of article 16.2.1. Kiwa Nederland B.V. - 14-1 May 2014