Conformity to Type procedure (module C)

Transcription

1 Conformity to Type procedure (module C) RD_003, Issue 06 This document describes the requirements based on the module C No rights may be derived from the text of this document. Copyright 2014, Telefication Telefication B.V. The Netherlands info@telefication.com

2 RD_003 issue 6 page 2 of 10 Revision record sheet NOTE: The person who initiated the document or modified the document is responsible for maintaining this record sheet. Revision Section Page Date remark(s) Issued by number number 6 Cover KIWA-Telefication B.V. changed in Telefication B.V. RV 2 Revision record sheet added RV EN replaced by ISO/IEC RV Issued/modified by : R. Victoria Function : System Assessor Revision : 06 Date : Verified by : M. Wouters van den Oudenweijer Function : Director Telefication Certification Date : Released by : AJ Gase Function : Quality Assurance Manager Date of release :

3 RD_003 issue 6 page 3 of 10 Contents 1 INTRODUCTION ABOUT TELEFICATION ABOUT THIS DOCUMENT THE PROCEDURE CERTIFICATE OF APPROVAL FOR PRODUCTS IN EUROPE CERTIFICATE OF APPROVAL FOR "TCB" PRODUCTS IN THE USA (FCC) & CANADA (IC) CONDITIONS FOR PRODUCT CHECKS CONTRACT FOR PRODUCT CHECKS EXPIRATION OF THE CONTRACT FOR PRODUCT CHECKS THE DECLARATION OF CONFORMITY THE CERTIFICATE OF APPROVAL INFORMATION ON MODIFICATIONS IN PRODUCTION ANNEX A, DECLARATION OF CONFORMITY TO TYPE ANNEX B, ABBREVIATIONS ADDITIONAL INFORMATION... 10

4 RD_003 issue 6 page 4 of 10 1 Introduction 1.1 About Telefication Telefication Certification is a third party test laboratory and a third party certification and inspection body. The Dutch Council for Accreditation (Raad voor Accreditatie: RvA) has accredited Telefication to ISO/IEC (laboratory) and ISO/IEC (product certification). This procedure is not under the scope of these accreditations. Specialising in the area of information technology and telecommunications equipment and systems (IT&T), the activities of Telefication cover product and quality system certification as well as product inspection. Furthermore, Telefication offers a Liaison for approval service for national approval application in various countries and a package of test services. More information about Telefication is available in RD_560, About Telefication. 1.2 About this document This document describes the requirements and procedures of conformity to type (product surveillance). This procedure is also known, as Module C. This procedure is part of several certification schemes of Telefication. 2 The Procedure The conformity to type procedure relates to the production phase of a product. It means that the manufacturer or importer has to ensure that the products conform to the essential requirements. The manufacturer or importer must draw up a Declaration of conformity himself. In addition, a contract for product checks must be concluded with Telefication, allowing the radio or terminal equipment to be subjected to spot checks. 2.1 Certificate of approval for products in Europe The Conformity to type procedure can be performed only if an (EC) type examination certificate for the radio or MED equipment has been issued or applied for. Telefication issues the applicant with a Certificate of approval and thereby gives the applicant (approval - holder) the right to place the equipment on the market. The approval-holder affixes the CE to all the radio or terminal equipment. An essential part of the procedure is that all products must conform to the specimen tested under the (EC) type examination procedure. How this is to be ensured by the manufacturer is not laid down in the procedure. This means, for example, that a certified production quality system is not compulsory. Consequently Telefication has no insight into the production methods and/or production quality assurance. To obtain an insight into the conformity of the applicable equipment, Telefication will carry out, or have carried out, spot checks on the products.

5 RD_003 issue 6 page 5 of 10 Figure 1: Conformity to type procedure for products in Europe Contract for product checks (for Europe) Declaration of conformity Telefication Certificate of approval 2.2 Certificate of approval for "TCB" products in the USA (FCC) & Canada (IC) The required surveillance for products can be performed after obtaining a certificate for the applicable equipment. With this certificate the applicant has proven that the applicable product(s) comply with the requirements stated in the standards. Further Telefication needs to perform a product check. In case of a positive result a certificate of approval will be granted. Remark: A certified production quality system is not compulsory. Consequently Telefication has no insight into the production methods and/or production quality assurance. To obtain an insight into the conformity of the applicable equipment, Telefication will carry out, or have carried out, spot checks on the products. Figure 2: Surveillance procedure for products FCC & IC Contract for product checks TCB Certificate Declaration of conformity Telefication Certificate of approval

6 RD_003 issue 6 page 6 of 10 3 Conditions for product checks Spot checks mean that one or more specimens of a product type are verified. In addition to a visual inspection, the whole product or part of it may be tested. The associated costs are born by the approval holder (the manufacturer or importer). To enable Telefication to carry out these spot checks, the applicant has to complete a Contract for product checks (form RF_251). Such a contract must be concluded with Telefication before the certificate of approval will be issued. The frequency of the spot checks is once per year. If the approval-holder fails to comply with the conditions for product checks or if it is terminated prematurely, Telefication will withdraw the Certificate of approval. The approval holder sends a sample to Telefication for inspection. When the sample is inspected (visual / electrical) and compliance is questionable, the sample will always be taken for further examination. Telefication will determine what test needs to be done and contact the approval holder on steps that need to be taken. Other possibility is that the approval-holder have to indicate at which geographical location(s) the product is available for inspection. These locations need to be in The Netherlands. Costs due to any possible damage to the product are for the applicant's account. In the scope of he contract Telefication reserves the right to subcontract activities to third parties, without previous consultation with the approval holder. Upon completion the product(s) taken, will be returned to the approval-holder. 4 Contract for product checks The product contract is the contract for product checks. It relates to one single product. The fee for a product contract is fixed and needs to be paid once, upon signing the contract. For OEM products, one (product) contract may be sufficient, providing all OEM products are available at one and the same location and all OEM products are 100% identical except for their trademark(s) and or type designation(s) The applicant should agree that the products for which the contract is granted will be produced to the same specifications as the sample that Telefication found by review to be in compliance with the standard. 4.1 Expiration of the contract for product checks A product will no longer be subject to spot checks if at least one of the following conditions is satisfied: The product is not longer marketed. In this case Telefication needs to be informed as such, in advance of an inspection, by means of a written statement of the approval holder; The product has been inspected at least three times; After three years of signing the contract. 5 The declaration of conformity The manufacturer or importer (who is responsible for placing it on the market) must draw up a declaration of conformity to type. A model of the declaration of conformity to type can be found in annex A.

7 RD_003 issue 6 page 7 of 10 6 The certificate of approval Strictly speaking, Telefication should not issue a Certificate of approval until the applicant: Has drawn up a Declaration of conformity; and has conducted a Contract for product checks. If it is established that terminal equipment for which a Certificate of approval has been issued no longer conforms to the applicable essential requirements, Telefication will withdraw the Certificate of approval so that further trading is prohibited. 6.1 Information on modifications in production The applicant shall inform Telefication of any intended modification in the product, the manufacturing process or the quality management system controlled by the specific certification program.

8 RD_003 issue 6 page 8 of 10 7 Annex A, Declaration of conformity to type Declaration of Conformity to Type We (Name and address) Hereby declare entirely on our own responsibility that the product: (Name, type, etc.) to which this declaration relates, is equal to the product tested and certified to the following standard(s) or normative document(s): (Titles and publication dates of the standard(s)) (Place and date) (Name and signature)

9 RD_003 issue 6 page 9 of 10 8 Annex B, Abbreviations EC European Community CE Conformité Européenne FCC Federal communications commission of the United States IC Industry Canada OEM Original Equipment Manufacturer Telefication B.V. Third party accreditation body, accredited by the Dutch Council of Accreditation (Raad voor de Accreditatie) TCB Telecommunication Certification Body

10 RD_003 issue 6 page 10 of 10 9 Additional information For more information contact: Telefication Phone: Fax: Info@Telefication.com Mailing Address: Edisonstraat 12A 6902 PK Zevenaar The Netherlands Web-site: