A Guide to the BABT Implementation of the Marine
Contents
1. 2 3 2 Original Applications The main information in this guide applies to applications for original certificates 2 3 3 Modifications Please refer to the section Keeping your Type Examination Certificate up to date for specific information related to Modifications For Modification to Brandname products please also refer to the following section Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 4 of 15 2 3 4 Brandname applications Brand name products are normally the same as the original product with the exception of cosmetic difference e g Labels enclosure colours and often follow the same production line processes as the original products Brandname applications may only be made where a substantial amount of the testing applied to the original product still applies to the Brand name e g A Brand name product may have a different housing which would require additional EMC testing but should not vary in functionality or key characteristics Where there are any technical differences TUV SUD BABT reserve the right to require a brand name application be re classified as an original application with original supporting data Note TUV SUD BABT will not accept an application for a Brandname of a product unless we are the NB responsible for the Module B for the original product Where a product is being transferred at the same time as a you are making an application for a2. Where the change has been tested using standards listed on the Certificate the Certificate Annex may be up issued without changing the Certificate front page or altering the expiry information 12 2 9 Changes to the certified product which extend the scope of the certification Such changes must be advised to BABT prior to commissioning any testing TUV SUD BABT will determine whether this change may be progressed as above for changes which potentially affect the conformity or whether a new Certification is required Where TUV SUD BABT determines a new Certification is required the product will be subject to the set of requirements including Standards Issue current at that time Test Data obtained related to the original Certification may be used if still valid In such instances a new Module B Certificate would be issued with a new expiry date Where you extend the functionality of the product invoking differing standards then you must obtain a new certificate 12 2 10 Changes to Standards and IMO regulations Where a standard which is listed on your Type Examination Certificate is up issued you are required to establish compliance with the new version While it is understood standards may have implementation dates and dates of withdrawal of previous versions the expectation is that you will request an up issue of your TEC to list the new version within a reasonable time from the new issue Note Th
3. 12 2 8 Changes to the certified product which potentially affect conformity to the certification requirements covered by the certificate and thus need testing Where a change to the certified part of a product requires testing TUV SUD BABT must authorise the change to enable the certification to be maintained You should either e send full details of the changes and any supplementary information in duplicate to your test laboratory with an instruction to forward one set with the completed test report and a copy of the covering letter or e send two duplicate packages one to your test laboratory and one to T V SUD BABT The letter to should indicate your intended test facility In both cases it is your responsibility to ensure the resulting test report is sent to TUV SUD BABT When testing is required you are not obliged to use the original test laboratory but may use any Test facility which meets the requirement for the original testing Version of standards to be used for Testing Testing must be performed using the latest version of the Standard Where a standard has been replaced in its entirety this must be discussed with TUV SUD BABT Where only partial testing to a given standard is performed the application for the modification must include a justification for the partial testing and a review of any results obtained from a previous version of the standard demonstrating their compliance to the current version
4. is designed and manufactured and its conformity assessed to the essential requirements The Manufacturer must always retain the overall control and have the necessary competence to take responsibility for the product Authorised Representative The Manufacturer may appoint any natural or legal person to act on his behalf as an Authorised Representative The Authorised Representative must be established inside the community An Authorised Representative may be addressed by the authorities of the Member states instead of the manufacturer with regard to the latter s obligations under this directive The Manufacturer remains generally responsible for actions carried out by an Authorised Representative on his behalf Importer An importer a person responsible for placing the product on the market is any natural or legal person established in the community who places a product from a third country on the community market The importer must ensure that he is able to provide the market surveillance authorities with the necessary information regarding the product where the manufacturer is not established in the community and has no Authorised Representative in the community Agent An Agent is a natural or legal person established either within the community or elsewhere in the world appointed by the manufacturer to act on his behalf with respect to the application Where the Agent is not the nominated Authorised Representative the application mu
5. new Brandname you should make separate applications and advise TUV SUD BABT Where a brandname product is being transferred at the same time as the original product you must ensure that the application is made by a party Manufacturer or Authorised Representative who is responsible for each brandname certificate An Application for a Technical modification to a Brandname which is not also applied to the Original product may result in the link to the Original product being broken such that future test results cannot be read across from the original product A Brandname application must be accompanied by the following e A statement of the differences between the original product and the Brandname product e Where some differences are not cosmetic o A justification for using test data from the original product o Additional relevant testing for the technical differences e Where the Original product was not tested to the versions of the relevant standards current at the time of application for the Brandname certificate then either or a selection of both o A justification showing the previous test results meet the requirements of the current issue of the standard or o Testing to the updated standard entirely or in part Where there are multiple Brand names test results from other Brand names to the latest standard may be used provided there is evidence that permission from that holder has been given It will not in this instance
6. of the Certificate and referenced Amendment to the Directive will remain the same as the previous issue Note It is the responsibility of the Holder to identify every instance of Certificate which is affected by a change e g Module B Module D and C of C Certificates Where a Holder or Manufacturers Company name changes within the same legal company registration this may be advised simply by a known contact from within the company Note For changes to the Certificate Holders Name the supporting DofCs must be up issued in the new name Where the responsible company for the product is changed within a corporate structure e g Divisions being split into separate companies or responsibility for the product is moved then a new application must be made for a certificate in the new company name We advise you to discuss the implications of such a change on current Module B and Module D Certificates as soon as possible If a product is sold outside the corporate structure then a new application must be made If a company becomes a part of a larger corporate structure this does not require to be advised to TUV SUD BABT unless there are consequential changes to the Company name or underlying controls 12 2 6 Changes to aspects of the product covered by other compliance schemes or requirements Where the product has aspects of design necessary to comply with mandatory or optional requirements from other schemes then chan
7. ABT Certification Regulations The current list of products within the scope of TUV SUD BABT are listed on our web site at fhttp www tuv sud co uk uk en about tuev sued tuev sued in the uk tuev sued babt product certification marine product certification If you have a product listed in Annex A 1 of the current amendment within in any of the above categories which is not currently listed within our scope please discuss this with us prior to submitting any application If you require UK National Approval of a product which is listed in Annex A 2 of the current Amendment of the Directive please refer to BABT 816 which details the requirements for such approval Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 2 of 15 1 5 Approval Options and Modules 21 Flow chart for the egy assessment procedures provided for in Directive C on marine equipment EC type examination Annex B Full quality assurance and design examination Annex 8 MODULE Hbis Unit Annex B Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 1 of 15 1 6 Definitions and Terms Manufacturer A manufacturer is the person who is responsible for designing and manufacturing a product with a view to placing it on the Community Market on his own behalf The Manufacturer has an obligation to ensure that a product intended to be placed on the community market
8. Equipment and identification Of EQUIPMENL ececeeeeeeeeeeeeeeeeeeeeneneeeeeeeeeeeeenees 5 4 Eege Le EE 5 5 Circuit Diagrams and PCB layout Diagrams ccssecceseeesseeseseeeeneeeeeeeeeesnaeseseeeeeeeeeseaeseseeeeneeaeeeenes 5 6 Parts List Bill f Matertalekt Gaga ce2sevecesectee cctecens seacacee coecaees staneeutes ceded stauceencreseetastaueeeces EENEG Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 5 7 5 8 5 9 5 10 5 11 5 12 6 1 6 2 7 1 7 2 7 3 7 4 7 5 7 6 7 6 1 8 1 8 2 10 10 1 10 1 1 10 1 2 10 2 13 14 14 1 1 Page ii of ii Software and firmware VersiOns ccccssesceeesseeceeeeeeeceensneeeeensaaeseenseaeeeensaeseenseaeseensneeeenseeeeeenss 8 Photographs Or Illustrations ceceeeeceeeee ee eeeee ee eeeeee ee neeeeeseseeeeeseseeneeseseeneesaseeneeeaseeeensesesnenenseenenes 8 Compliance Strategie eege ee eld ech a eg ede ede heey 8 Ueeripnstrtetleone ege 8 RR HR 8 Manufacturing Test Plann e cccsccetect cect fecedecs deed ieee cect cececete EEN EES 8 Testing and fest TOPOMMS ncciscsecescoseeats cen eter costenettenceten ienei anarai cosbentntesbette aieka aiana iaaa Riina Naai 9 AEE OCU EE 9 Requirements for Test Facilities cccceecceeeeeeeseeeeeeeseeeeeeeseeeeeseseeneesesesnensesesnensaseeneeseseenenseseenenes 9 Verification Of the test program uu ssecccceeecccccernnseceennesecsenseseneensese
9. N e DEI D A Guide to the T V S D BABT Implementation of the Marine Equipment Directive 96 98 EC BABT 740 A Certification Body of TUV SUD BABT 2013 Foreword This guide overviews the BABT Implementation of Modules B D E F and G of the Marine Equipment Directive MED 96 98 EC The implementations of Modules D and E are explained in more detail in BABT 791 The implementation of Module F is explained more fully in BABT 741 If you require UK National Approval of a product which is listed in Annex A 2 of the current Amendment of the Directive please refer to BABT 816 which details the requirements for such approval This guide is designed so that the essential information can be read quickly by reading the main text only Where you require more information refer to the appropriate shaded text The scheme enables a manufacturer of a product within the scope of the MED to affix a Wheel mark including the BABT Notified Body number after satisfying the appropriate module s of the MED The formal requirements of the scheme are set out in the Certification Regulations All publications are available from http www tuv sud co uk babt or TUV SUD BABT Octagon House Concorde Way Segensworth North Fareham Hampshire PO15 5RL United Kingdom Tel 44 0 1489 558306 Fax 44 0 1489 558101 Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page i of ii Conten
10. TUV SUD BABT has received your application and evaluated the initial information we will e ask you to pay an application fee The fee relates to the assessment of the application Where you have identified a specific contact to whom to send the invoice it will be sent to them otherwise it will be sent to the main contact e inform you of the reference number assigned to your application This number should be quoted in all further correspondence e review your application for completeness and consistency e Where information is missing from an application or the reviewing Engineer raises a query further work on that application will be suspended at an appropriate time and will only be resumed after the response Where TUV SUD BABT is satisfied we will formally issue the Type Examination Certificate or Unit Verification Certificate as appropriate We will advise you when this occurs e If there is a significant shortfall which either cannot be remedied or where the remedy is not submitted in a timely fashion TUV SUD BABT may dismiss the application Note If additional testing is required TUV SUD BABT will expect to be advised when this is due for completion Each certificate will detail the applicant product identity ies and standards complied with the certificate annex will detail information relevant technical information and the identities of the test reports Each Original Certificate has a validity of 5 years from the time of issue Tran
11. UE 2 3 MDDI HOT 2 3 1 VPC eee ee Deen eebe Enger eebe AEA rette eebe ER 2 3 2 eieiei te E 2 3 3 lee tte rnle TT 234 Brandname applications sek kNNEEEEKRREEEEENEEEEENE NEEN En 3 Information required ON the application form secccccceeececcenenceccensnsecsensnseaeenseseasenseseaeeneseseenenseneenes 3 1 GMO al EE 3 2 Section A Applicant Details sccssseeeeseeeeseeeeeneeeneeeeeeaeeeseaeeeneeeeneeeeseaesaseeeenseeeseeeeeseaesaneeeeeseeeeeas 3 3 Section B Your Certification requirements ccccccceseesseeeeeneeeeeeeeseeseseeeneeeeseeeseseaeseseeeenseeeneas 3 3 1 Marine Equipment Directive Certftcaton nsen nnnn 3 3 2 Recognition of Marine Equipment Directive Certificates in North America 3 4 Section C Product Detail S 20 05 ccccccscsecasccerccteescee cesecescaceescsecescsetacctecteudesade si atesstuecescsetesteestencecedeadenee 3 4 1 Products SUBMITED EE 3 4 2 PROGUCT TYPO EE 3 4 3 N mber ot Production Cu EE 3 4 4 Related lte Te 3 5 Commercial Informatio M serie ceencecesece stcccedesccedececustateecudeentecsscesFecceedececestedsesuceetaecesacers 3 6 PACT COINS I ae cee as ace re ee 3 7 719 T 67 EE Progressing the Applieetiofn deed 5 Information to ACCOMPANY AN application reecccceeeccccennnceceenenseecensnseecennseaeeneseaeenseseeeenseseaeennseneenes 5 1 GO TEE 5 2 Technical Documentation File IndeX ccccseeccceeeeeeeeeseeeeeeeseeseeeneeeseeeseeeeeensueeeeenseeeeeenseeeseenseeeeeenas 5 3 Purpose of
12. be presumed even if the original holder is an agent for both e Where you have appointed an Agent a letter from the Manufacturer appointing them The original Manufacturer may be appointed to act as the agent of the Brand name manufacturer This may be beneficial where original and Brand name applications are made in parallel as the same person is authorised to make a response to common concerns in several applications e Where the Original Manufacturer is not the Agent of the Brandname holder then a letter from the original Certificate holder authorising the use of their test and technical date in support of the Brandname application Agents who are the Original Manufacturer are assumed to authorise themselves e Either o A copy of the Brandname User manual or o A statement that the only changes if any to the Original Holder User manual will be changes related to the Product name and manufacturer e Any of the other items required for original application where they differ significantly with that of the original product 3 Information required on the application form 3 1 General In general TUV SUD BABT require the same information for all types of application Please refer to BABT 775 or BABT 806 for transfers when reviewing this section Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 5 of 15 3 2 Section A Applicant Details Section A 1 identifies the perso
13. ceenseseseenseseasenseseaeenseseaeenseseaeenseseaeenes 9 On site testing Testing outside a Test Organisation Site ccccsseeceeeseeeeeeeseeeeeeseeeeeeneees 9 Requirements for UN aCcredited testing cceecccceeeeeceeeeneeeeeeneeeeeeeneeseeesneeseeesneeseeeeeeseeesnenseeeenes 10 Supply Of IMPOrMAtION e e ae een e r aar a ae a AE a e aa reaa E eaha eaaa EE aA e aoaaa eiaa 10 Compliance Test langue EES EENEE dadaa adate 10 TestHebotte ees 10 Aspecis ol Testing ees 10 heeten A A gta Ss 10 Certificates and RecordS EE 10 E e E 10 RI EE 11 Activities after the Issue of a Module B Certificate 21 s1scccceccssercssseesssennssersssnencaseensesennsnsnenssanes 11 Regulatory Marking svsscocccissccatevstesactutsscncevaveonisisieiainystecsctuesscucevevesaceisveiadnesveoncpeessousrteveoaisiesstainesbess 11 oea E E E scucececceesnce 11 Module EE 11 Module EE 11 Wheel Mark stee n TE SE EES EE 12 Annual Continuation Of the CertifiCate ssccssscccceccsercsssecsseensncenssnencssnnsssennsnenseanansaseensesenssnsnasananes 12 Keeping your Type Examination Certificate up to Date 1 1 csecccseccssseccssernssersssnenssseensssenssnsnensees 12 General EE 12 Authorisation of Changes to Certified Equipment and Certificate Information seen 12 COMO A ten deeg Eege AE ee elei atads O Unededervedeaacies 12 Broad Categories of Changes ntun tnntnnsttnstnnnnnnnenannn nnn 12 Certified Liaison Engineer CLE sessesesesisesrnssrnssrrsstnsstr
14. certification and conformance to the relevant IMO regulations and the standards listed for that item type in the Amendment of the Directive current at the time of the change 12 2 Authorisation of Changes to Certified Equipment and Certificate Information 12 2 1 General Changes may be authorised by one of the following dependant on the category of change e T V SUD BABT or e a T V SUD BABT appointed Certification Liaison Engineer CLE or e the Holder acting on their own responsibility 12 2 2 Broad Categories of Changes e Changes to product supporting items unrelated to the product certification This include such items as packaging warranty cards cabling for non certified ports e Changes to the Certificate unrelated to the product realisation e g Address of Holder e Changes to aspects of the product solely covered by other certification schemes or requirements e Changes to the certified product which are believed not to have potential to affect compliance to the requirements covered by the certificate e Changes to the certified product which potentially affect the compliance to requirements covered by the certificate and thus need testing Changes to extend the scope of the certification which may or may not entail changes to the product Changes to Standards Changes to the Referenced Marine Equipment Directive Amendment Expiry of the Type Examination Certificate Guide to the TUN SUD BABT Implementation of the Marine Equi
15. drivers in PCs then installation conditions must be provided either as a part of the software installation package or in the user guide Where special software is provided to enable testing then the version of such software must be recorded with a clear statement about the relationship of this software to the production sample 5 8 Photographs or Illustrations Photographs or illustrations showing the external features of the complete equipment are required where the user instructions supplied Installation instructions do not include this information 5 9 Compliance Strategy You should include details of the compliance strategy This should include e details of the Standards and IMO regulations related to this product and e any limitations in applicability of standards or tests that have been used 5 10 User Instructions You should supply in English a draft or published set of User Instructions and where relevant Installation Instructions For complex equipment you may only include the sections of the user instructions relating to the compliance of the equipment with the standards and IMO regulations rations User Instructions should contain all the information for installation use and maintenance required for conformance to the relevant standards and should not give details of adjustments which can take the equipment outside compliance unless it is made clear how to adjust the equipment to maintain compliance and that any non comp
16. e an additional charge where this is necessary Where you are applying for Unit Verification and it is impractical to send the unit s for test at a test facility you should advise TUV SUD BABT of the site where the equipment may be tested inspected Observation Testing Certain standards require specific display information Manufacturers may with the agreement of TUV SUD BABT perform such tests at their own facility The Results of the observation inspection tests should be recorded in an appropriate report listing the requirements with compliance information The report shall also include full evidence e g Photographs of a sample of the tests We will reserve the right to request evidence of other selected tests Declarations Where a standard permits compliance to a requirement be declared or where TUV SUD BABT have agreed to accept such in lieu of test the Declaration must be made on company headed paper and signed by a person suitably qualified to make the declaration Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 10 of 15 7 2 Requirements for un accredited testing Where you perform testing at a location or on your own site which is unaccredited for the particular test in addition to agreeing the location with TUV SUD BABT prior to the start of testing you shall e Where you have tested using the test methods invoked in the standards make a statement confirming this in th
17. e report e Where you have used any test method not specified in a standard provide details of the test method followed either in the report or separately e Provide details of the competence of the person performing the test e g experience training qualification e Provide details of test equipment used and the calibration status of the equipment e Provide Measurement Uncertainty values for critical tests 7 3 Supply of Information We recommend that you supply as much of the supporting information for your product to your test facility as early as possible preferably with a copy of your application to TUV SUD BABT This will assist in the preparation of test plans and early identification of any differences within the documentation e g Product Names revision status 7 4 Compliance Test Plans Where you have not previously tested and submitted a type of product to TUV SUD BABT we recommend that you discuss your compliance test plan with us in advance of commissioning the testing This will reduce the risk of under or over testing and may assist in the evaluation of the submitted technical documentation 7 5 Test Reports The test report s must follow the requirements for test reports included within ISO IEC 17025 clause 5 10 Where the build level of the sample tested differs from that for which certification is sought the Technical Documentation File must include a justification that the test results are representative of the build le
18. e version of the standard is often checked at the time of the commissioning of new equipment on board vessels so it is advisable to list the current version as soon as possible On occasion up dates to IMO resolutions come into effect before the Standards body has up issued the supporting standard Where this occurs we recommend that you discuss this with TUV SUD BABT to establish a route wherein the latest version of the IMO resolution may be listed on the TEC In all the above cases where full testing to the latest requirement has not taken place the application for the modification must include a justification of why the results obtained using the previous version of the standard are sufficient to demonstrate compliance to the relevant clauses of the current issue Guide to the T V SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 15 of 15 12 2 11 Expiry of the Type Examination Certificate If you wish your certificate to be renewed you must present T V SUD BABT with a full set of test data to a set of standards current at the time of the expiry Where you use test reports obtained for the original certification it must be accompanied with a justification for its use with for the renewal You may either provide a completely new pack of supporting information or a statement of the relevance of the previous documents to the current product T V SUD BABT will perform a full re assessment of compliance bef
19. ed for all circuits which may have an effect on conformity Circuit Diagrams and PCB layout Diagrams must show all network or radio interface circuits active speech processing devices hybrids and transducers line signalling components power supplies ports and all network affecting circuit elements including any components providing user isolation Circuit elements need only be shown in sufficient detail to explain the above Circuit diagrams should match up with the actual samples submitted for certification 5 6 Parts List Bill of Materials Parts lists for those areas of circuit detail identified in the circuit diagrams and data sheets for any Radio Critical component Parts List Critical tolerances should be identified where applicable and the manufacturers of safety critical Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 8 of 15 components all transducers and components affecting the signal path including all second sources should be stated If more than one source of a critical component e g line interface IC is to be used samples from all sources should be submitted for assessment 5 7 Software and firmware Versions The version of any software and firmware supplied with the apparatus which may affect compliance with the certification requirements must be declared Software Where the relevant software is installed separately from the hardware e g device
20. ential requirements of ISO IEC 17025 or equivalent to TUV SUD BABT Details of acceptable sources of Test Data and RTF listing may be found in document BABT 766 This document may be found on the BABT Web site http Avww tuv sud co uk babt 7 Verification of the test program Where you opt to test at TUV SUD and advise them of the intent of applying to TUV SUD BABT for a certificate we will allocate a TUV SUD BABT Certifier to confirm the commissioned testing is sufficient to demonstrate the compliance Where you choose another test facility you may request that TUV SUD BABT check the test program but will have to authorise the Test Laboratory to communicate with us and to supply all supporting information 7 1 On site testing Testing outside a Test Organisation site Where you require on site testing then you should advise T V S D BABT of the site where the equipment may be tested inspected You should confirm whether the Testing organisation is suitably accredited recognised to perform such tests outside their normal location If your selected Testing organisation does not hold suitable accreditation for testing outside their laboratory site you must request they identify the process by which they will ensure the validity of their intended testing and provide such to TUV SUD BABT in advance of the commencement of testing TUV SUD BABT will advise you whether we require to witness some or all of the testing Note There will b
21. ered by the Module G certificate Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 12 of 15 10 2 Wheel Mark The Wheel mark in respect of the Directive shall be applied only to equipment for which a valid Certificate of Conformity and Declaration of Conformity exists This shall be followed by number of the Notified Body who have issued the Certificate covering the selected production conformity module and a year indication The BABT notified body number is given in the example below The yy should be replaced by the last 2 digits of the year in which the wheel mark was placed on the product i e It must change each year The formal definition and size constraint of the mark are given in MSN 1734 Annex C 11 Annual Continuation of the Certificate There is no annual fee for the continuation of either a Module B Type examination or Module G Unit Verification certificate However modifications to certificates are charged for in line with the resource required to progress the change 12 Keeping your Type Examination Certificate up to Date 12 1 General Over the lifetime of a product and the supporting certificate TUV SUD BABT understands that it is likely that you will want to make a number of changes Review each change Whilst not all changes will be significant to the certification each change however small must be considered for its potential effects and their relevance to the
22. from one for which you currently hold a T V SUD BABT Certificate and you wish to make use of any of the previous data please indicate this and provide the Certificate number related to that product While this could reduce the assessment time we will need a clear justification within the Technical file for the use of the earlier results Likewise for Brandname products or applications covering more than one model we require details of the differences between the models Note Where an application covers more than one model TUV SUD BABT may charge an additional portion of our fee for assessing the additional model s 3 5 Commercial Information Please complete this information Clients who do not currently have approved credit facilities must include a completed Credit Details Form with the application Alternatively payment in advance is accepted The appropriate forms may be downloaded from www tuv sud co uk babt 3 6 Agreement This forms the contract with the Certification body It must be completed and signed on or on behalf of the applicant Normally it is signed by the listed main contact 3 7 Annex A This section is intended as a brief checklist of possible contents of a Technical File sent with the application It is not mandatory that this annex be completed or included with the application form does not have to be included Refer later for more details on the contents of a technical file 4 Progressing the Application When
23. g A product model due to be replaced but remaining in manufacture for several additional months TUV SUD BABT are willing to use the transfer process in cases where the original NB will retain the Module D Certification for certain products and TUV SUD BABT take over the responsibility for others This could enable a staged transfer of products between NBs Note A given product should not be listed more than one Module D Certificate except during the Hand over time allowing for different NB Processes The Declaration of Conformity and Wheelmark for each product must list the NB responsible for the Module D under which the product is produced Each NB would still have to audit the production facility and meet its obligations for products listed on the Module D certificate which it has issued Normal Applications for Module D should be made using document BABT 339 Application for MED Module D Production Quality Assurance or Module E Product Quality Assurance Certificate 1 9 Module E Product Quality Assurance Under this module you must document and operate a quality assurance system relevant for a particular product or product range such that all production items in that range which fall within the scope of the MED are compliant with the requirements of the MED with their performance traceable to the original tested sample The formal requirements for the scheme are listed in MSN 1734 Annex B including any amendments current at t
24. ges within that area of design which do not impinge on an area covered by a TUV SUD BABT certification e g FCC where BABT has acted as the TCB may be made without redress to ourselves Regulatory requirements Certificate holders are required to maintain compliance with regulatory and legal requirements pertaining to their certified products at all times 12 2 7 Changes to the certified product which do not affect conformity to the certification requirements Where a CLE has been appointed changes which are within the scope of his her authority will be assessed using the change control procedure agreed at the time of their appointment as a CLE The CLE may authorise the change without involving BABT Where a CLE has not been appointed you must send full details of changes to BABT for authorisation If exceptionally TUV SUD BABT determines that testing is necessary you will be advised You may then negotiate directly with the test laboratory concerning the test work to be performed Modifications to embedded software TUV SUD BABT may accept modifications to software which is stored in memory within the certified product provided that you can give an assurance that the new version does not affect conformance to the relevant standards and is uniquely identified If we determine that testing is necessary you will be advised Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 14 of 15
25. he time of application The BABT implementation of this Module is described in BABT 791 The assessment standard for this scheme is BABT AP008 BABT PS 340 Production Quality Certification For Module E Parts 1 2 and Annex H of BABT AP008 BABT PS 340 apply Where you hold and existing Module E Certificate from another Notified Body you may apply to Transfer this to BABT for some or all your products Application details for transfers may be made using document BABT 789 Application for transfer of a MED Module D or Module E Quality Management Certificate to BABT Normal Applications for Module E should be made using document BABT 339 Application for MED Module D Production Quality Assurance or Module E Product Quality Assurance Certificate 1 10 Module F Product Verification Under this module you identify the number of product items you intend to manufacture within a specified time A product sampling plan is then agreed under which you will test the sample to an agreed test plan and supply the reports to TUV SUD BABT These are inspected or tested as appropriate to ensure they are representative of the original tested products Obligations remain upon the manufacturer with respect to individual unit inspection and test product marking and record retention The formal requirements for the scheme are listed in MSN 1734 Annex B including any amendments current at the time of application Details of this scheme are provided in doc
26. her details of the application requirements and process for Type Examination follow later in this document Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 2 of 15 1 8 Module D Production Quality Assurance Under this module you must document and operate a quality assurance system such that all production items falling within the scope of the MED are compliant with the requirements of the MED with their performance traceable to the original tested sample The formal requirements for the scheme are listed in either MSN 1734 Annex B or the MED 96 98 EC including any amendments current at the time of application The implementation of this Module is described in BABT 791 The assessment standard for this scheme is BABT AP008 BABT PS 340 Production Quality Certification For Module D Parts 1 2 and Annex G of BABT AP008 BABT PS 340 apply Where you hold an existing Module D Certificate from another Notified Body you may apply to Transfer this to TUV SUD BABT for some or all your product scopes Application details for transfers may be made using document BABT 789 Application for transfer of a MED Module D or Module E Quality Management Certificate to TUV SUD BABT Partial Transfers of Module D It is recognised that under some circumstances a Manufacturer may not wish to transfer all the products listed on a Module D Certificate from the existing NB to TUV SUD BABT e
27. here TUV SUD BABT allocates a number under the MRA there is no fee otherwise an appropriate additional fee will be applied to cover the necessary work Where FCC and Industry Canada Approval is required separate applications for these may be made using the appropriate forms mechanism See web site for details 3 4 Section C Product Details 3 4 1 Products Submitted This information is normally used to identify the product on the certificate TUV SUD BABT will check this information with other identifying information within the application any unexplained differences will cause delays in certification Guide to the TUN SUD BABT Implementation of the Marine Equipment Directive BABT 740 Issue 5 Page 6 of 15 3 4 2 Product Type Please identify the product type of your equipment after making reference to the list of types of product at the start of this document TUV SUD BABT is only appointed for certain types of products If your type of product does not appear on the list please contact the TUV SUD BABT Certification Manager in advance of the application to make sure that we are able to progress the application For some products it is helpful if you provide additional information to assist us in understanding the scope of the certification Please provide this information either on the form or in a separate document 3 4 3 Number of Production Items Please provide this estimate 3 4 4 Related Products If your product is derived
28. liant setting would invalidate the certification The presence of user instructions at the earliest stages of assessment even if in draft form will give you the best possible chance of an accurate test schedule being written rapidly and a smooth assessment If the User guide does not provide photographs or illustrations showing the external features of the complete equipment this shall be provided separately 5 11 DofC You should include a draft or actual Declaration of Conformity to Type within the Technical Documentation File The format of the declaration include all the relevant information as specified in MarED 01 016 Gen 008 5 12 Manufacturing Test Plan Where you plan that the production phase of the product will be under a Module D certificate issued by TUV SUD BABT we require that you provide either e A manufacturing Test Plan highlighting in particular the production tests which ensure the manufactured product complies with the relevant requirements of the Directive or e Areference to an existing agreed Manufacturing test plan with a justification of its relevance to the current product Manufacturing Test Plans These may be generic documents for certain item types or specific for a given product realisation They should indicate the tests and pass fail criteria and any specific test equipment requirements e g calibration use of just fail While TUV SUD BABT do not require that this plan is separate from
29. n within the organisation with whom TUV SUD BABT will communicate The Company name and Address are used as the address for the Certificate Where you are an Authorised Representative applying under your own company name it is MANDATORY that you provide full contact details of the manufacturer including a contact name within the manufacturers company This information must be part of the application Where you are a manufacturer established outside the Community it is recommended that you appoint an Authorised Representative within the community Where an Authorised Representative has been appointed please provide full contact details of the Authorised Representative on headed paper from the manufacturer You may identify a consultant agent to act on your behalf who is not formally appointed as an Authorised Representative TUV SUD BABT require that you include a formal letter appointing the Agent on headed paper an