Foreword. BABT 340 The Production Quality Certification Scheme for Manufacturers

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1 BABT 791 A Guide to the TUV SUD BABT Implementation of Module D (Production Quality Assurance) and Module E (Product Quality Assurance) of the Marine Equipment Directive A Certification Body of TÜV SÜD TUV SUD BABT 2016 Issue 4

2 Foreword This guide explains the TUV SUD BABT Implementation of Modules D and E of the Marine Equipment Directive, 2014/90/EU. This guide should be read in conjunction with the following document: BABT 340 The Production Quality Certification Scheme for Manufacturers The implementation of Modules B and G of the Marine Equipment Directive are described in BABT 740 and the implementation of Modules F of the Marine Equipment Directive are described in BABT 741. The scheme enables a manufacturer of product within the scope of the Marine Equipment Directive to affix the Wheelmark including the TUV SUD BABT Notified Body number after satisfying the requirements of either Module D or E of the Directive. The formal requirements of the scheme are set out in the TUV SUD BABT Certification Regulations. The current versions of these can be found at All publications are available from: (See the download area in Information Services) or TUV SUD BABT Octagon House Concorde Way Segensworth North Fareham Hampshire, PO15 5RL United Kingdom Tel: +44 (0) Fax: +44 (0) BABT@TUV-SUD.co.uk

3 Page i of ii Contents 1: Introduction Scope Conditions for Certification Definitions and Terms : Making an application for Module D or E Certificate Preparation for an application Who to apply to Who can apply Information to be supplied on the application : Progressing your application General Assessment of your Application Documentary Assessment and Generation of an Audit Plan Agreement of the Test Plan(s) Confirmation of Audit Arrangements Audit Clearance of Actions : Certificates and Records Certificate US Coast Guard Number Records Advice to Third Parties : Regulatory Wheel Marking : Continuation of the Certification On-going Audits Annual Continuation of the Certificate Records Avoidance of Certificate Expiry Withdrawal (or limiting the scope) of a Module D or E Certificate : Keeping your Certificate up to Date General Administrative Changes Changes affecting the Quality System Changes affecting the scope Reductions to the overall scope Ceasing manufacture of a product Adding a new Product Changes to Products : Brand Names General Application... 9

4 Page ii of ii 8.3 Documentation required for Brand Name Applications Process for Brand names : Transfer of Module D or E Certification from another Notified Body Annex A Information required for an Application... A.1 A.1 General... A.1 A.2 Applicant Details (Both BABT 339 and BABT 789)... A.1 A.3 For New Applications using Form BABT 339 Only... A.1 A.4 For Applications to Transfer from another Notified Body using Form BABT 789 Only... A.3 A.5 Facility Site Details (Both BABT 339 and BABT 789)... A.3 A.6 Details about your current Module D/E Certification ( For Applications to Transfer from another Notified Body using Form BABT 789 Only)... A.4 A.7 Agreement... A.5 A.8 Documentation to Accompany an Application... A.5 Annex B DECLARATION OF CONFORMITY... B.1

5 Page 1 of 10 1: Introduction 1.1 Scope This guide explains the implementation of the Module D (Production Quality Assurance [PQA]) and Module E (Product Quality Assurance [PQA]) procedures of the Maine Equipment Directive 2014/90/EU. This document should be read in conjunction with BABT 340 The Production Quality Certification Scheme for Manufacturers. The implementation of Modules D and E operates under the TUV SUD BABT Certification Regulations. This implementation requires an assessment of a manufacturer s quality management system against the requirements of BABT 340 The formal output of an application under Modules D or E of the Directive is a certificate listing the scope of operation of the Quality Assurance System, which may be used to enable the manufacturer to supply product compliant to the Marine Equipment Directive referencing TUV SUD BABT as a notified body. 1.2 Conditions for Certification As a prerequisite to the issue of a Module D or E Certificate, you are required to agree to conform to the TUV SUD BABT Certification regulations. 1.3 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 is designed, manufactured, and has 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 Importer Fabricator 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. 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. The production phase of a product realisation may be performed by the person responsible for the product design and for placing it on the market. Under the new approach Directives (e.g. the R&TTE or EMC Directives) this person is referred to as the Manufacturer. The production phase of a product realisation may also be performed by a sub-contract manufacturer. For applications for Marine Equipment Directive Modules D or E the Term Fabricator is used to denote the person or organisation which performs the production phase of a product realisation whether they are a sub-contract manufacturer or the product designer. 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 must include a letter from either the

6 Applicant Guide to the TUV SUD BABT Implementation of Modules D and E of the Marine Equipment Directive Page 2 of 10 Manufacturer or the Authorised Representative authorising TUV SUD BABT to communicate with the Agent for matters related to the application. The Applicant must be either the Manufacturer or the Authorised representative. An application may not be made by an Agent who is not also the Authorised Representative. Brand Name Application A Brand Name Application is an application for a certificate in the name of the holder of a Brandname Module B certificate. Brand Name products are normally the same as the original product with the exception of cosmetic differences (e.g. labels, enclosure colours, etc) and normally follow the same production line processes as the original products. An application for a Module D/E Brandname certificate may only be made where the same fabricator operates the same processes for the Brandname as the Original product 2: Making an application for Module D or E Certificate For information related to making an application for a brand name Module D or E Certificate please also refer to Section 9. For information related to making an application to transfer an existing Module D or E Certificate from another Notified Body please also refer to Section Preparation for an application Prior to formal submission (either as a part of your decision making process, or to ensure efficient progress of your application) you are recommended to discuss your application with TUV SUD BABT. This will give you the opportunity for an early estimate of the costs, timeframes, and documentary aspects associated with the process. This stage may however be omitted for those companies familiar with this process. 2.2 Who to apply to Applications for an original (or Brand Name) Module D or E Certificate should be made on form BABT 339. Applications to transfer a Module D or E Certificate from another Notified Body should be made on form BABT 789. Please complete and sign an application for each location for which certification is required. MED Module D/E Quality Certification is issued on an individual site basis only. Applicants seeking a TUV SUD BABT PQC Certificate (or MID or CPR Certification) using other Annexes BABT 340 should contact TUV SUD BABT for advice of the appropriate forms to use. While BABT will try to combine audits, each application must be made separately Direct applications should be sent to TUV SUD BABT in Fareham either: By CD sent by mail; or By to: Alternatively, you may apply via a local TUV office (e.g. one performing testing in support of a Module B Certificate) who will forward it to TUV SUD BABT for processing. 2.3 Who can apply Applications are normally made by the holders of the Module B certificates which are listed in the application. Where the manufacturer is the holder Authorised Representatives listed on the Module B certificate can apply on behalf of the manufacturer. Agents (who are not Authorised Representatives) may only apply in the name of the Manufacturer provided that the application is accompanied by proof of their status as an Agent. Fabricators who are not also either Manufacturers, Authorised Representatives or agents may not apply.

7 Page 3 of Information to be supplied on the application Information related to the following is required on the application form. Omissions could cause unnecessary audits to be scheduled or full certification to be delayed: Main contact information Requested Scope of Certification Details related to the manufacturing site Details of key personnel Details of sub-contractors Full details about the required information are listed in Annex A. Note: Where information is clearly missing from an application, you will be advised. The certification request may not be progressed until the required information is supplied. 3: Progressing your application 3.1 General The following processing stages are performed in the process to enable a Module D/E Certificate to be generated: Receipt of your application and invoicing Documentary assessment and generation of an Audit Plan Review and agreement of the test Plan(s) Confirmation of audit arrangements Audits Clearance of corrective actions 3.2 Assessment of your Application Once we have received sufficient details (or your actual application) you will receive a confirmation of your order and an allocated reference number which should be used in any future correspondence. We will then schedule the documentary assessment. 3.3 Documentary Assessment and Generation of an Audit Plan The application and enclosed documentation will be reviewed for completeness and consistency to establish the extent of audit required and to produce an Audit Plan. Due consideration is given to the PQC Compliance Plan, any external Quality System certificates (held by the Fabricator and the Manufacturer), and specific documentation supplied by the Applicant (e.g. Test Plans, TECs, etc.). During this stage it is normal that clarifications and further documentation are required to avoid misunderstandings which could result in significant delays to certification or a Module D/E Certificate with reduced scope. Once all issues are resolved and the Audit Plan is produced it will be sent to the Applicant for acceptance. Where information is clearly missing from an application you will be advised and the certification request may not be progressed until the required information is supplied. 3.4 Agreement of the Test Plan(s) The Test Plans to be used for the production testing of the product(s) must be agreed with TUV SUD BABT prior to the Audit taking place. Each Plan will be formally agreed and a unique identification number. The required contents for a test plan are detailed in the annex to this document. 3.5 Confirmation of Audit Arrangements TUV SUD BABT makes use of qualified auditors from the TÜV SÜD group. You will be advised of the proposed audit dates and plans for each location requiring audit and you will be requested to confirm your acceptance.

8 Page 4 of 10 Audit Dates If a proposed date is inconvenient or inappropriate you should immediately advise the audit organisation of the cause and propose a number of alternate dates. Considerations which should be made are Dates during or adjacent to National or Company Holidays Short time working days Clashes with other Audit bodies Availability of relevant staff While every effort should be made to ensure key personnel are available for the audit the presence of authorised deputies is acceptable for most roles. 3.6 Audit The audit will be conducted to the requirements of document BABT 340 as appropriate to the site. Prior to the start of an audit, the scope of the audit and the roles of each of the audit team will be specified. Normally Module D/E Audits are conducted by a single person. A detailed agenda will then be agreed and the audit will progress as scheduled. Where a particular audit extends over more than one day (e.g. Initial Audit or where you have selected additional options of document BABT 340 (i.e. R&TTE Manufacture) you will normally be advised of the provisional findings at the end of each day. At the closure meeting you will receive a verbal report of the audit and any formal findings which have been agreed. Subsequently you will receive an audit report and confirmation of the formal findings requiring corrective actions. You may be required to supply a corrective action plan within a specified timeframe which will be agreed. Alternate Audit Methodology: Alternate audit methodologies will normally be considered provided the overall coverage is the same and the audit effort remains the same. This can be of benefit where key personnel are only available at certain times or where the audit occurs at split locations. Details of the alternate methodology should normally be agreed with the audit organisation in advance of the visit. Where additional auditor resource is required to support the methodology, this must be agreed prior to the audit date. 3.7 Clearance of Actions You should communicate the corrective actions to the audit authority who conducted the audit. You should also enclose any required evidence to demonstrate their completion. Once you have cleared all significant corrective actions you will be advised. Where the audit reported major non-conformities or a significant number of minor non-conformities, TUV SUD BABT may request that a follow-up audit be performed on that site, or that the date of the next scheduled audit be brought forward to verify the corrective actions. Follow-up audit: This audit will focus upon the corrective actions and system performance in the areas of concern. Since this is an additional audit a separate charge may be raised. A follow-up audit of a location will not necessarily change the date of the next planned audit. 4: Certificates and Records 4.1 Certificate The Module D or E certificate will normally be issued when the initial audit is completed, all significant corrective actions have been addressed, and when the applicant complies with the Certification Regulations. Certificates are issued in the name of the Applicant Company who are thereafter referred to as the Holder. Certificates also include: the address of the holder, the name and address of the fabricator reference to the Standard used for audit, the Marine Equipment Directive Product Types (for PQA), or Products (for PrQA)s included within the scope any special conditions to be complied with to maintain the validity of the certification. Furthermore the Annex includes

9 Page 5 of 10 A list of all Products included within the Module D/E. This are listed against their Item type and includes references to the associated Module B Certificate. 4.2 US Coast Guard Number Where a supporting Module B Certificate is for applicable Navigation equipment and has the appropriate wording for a US Coast Guard Number, then the Module D/E Certificate will list the full number. If the equipment is in the list in the MRA such that TUV SUD BABT can issue a US Coast Guard number but the Module B Certificate omits the number, you must request this from TUV SUD BABT if you wish this number to be added to your Module D/E Certificate 4.3 Records TUV SUD BABT maintains records of all the details on a certificate; of each submission and the resulting evaluation for 10 years after the last significant file activity. The Manufacturer or his Authorised representative is required to maintain records the records defined in Module D or E of the Directive for 10 years. 4.4 Advice to Third Parties TUV SUD BABT are required to provide details of all MED Certificates to the MCA and to the European MarED database. This normally occurs within 1 month of the issue of the Certificate. Furthermore, TUV SUD BABT are required to co-operate with Market Surveillance Authorities in resolving concerns and enquiries, and advise the MCA of these activities. 5: Regulatory Wheel Marking The Wheelmark in respect of the Directive shall be only be applied on equipment for which a valid Certificate of Conformity and Declaration of Conformity exists (i.e. completed the production phase requirements). 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 TUV SUD BABT Notified Body number is given in the example below. yy should be replaced by the last 2 digits of the year in which the Wheelmark was placed on the product. The formal definition and size constraint of the mark are given in MSN yy 6: Continuation of the Certification 6.1 On-going Audits During the year following the issue of the certificate (and during subsequent years following renewal of the Module D/E Certificate) you will receive advice of proposed surveillance audit visits in line with the plan. TUV SUD BABT will co-operate with Third Party Certifier audits where this can be arranged to mutual convenience. The cost of these scheduled audits is included within the original (or annual) invoice.

10 Page 6 of 10 These audits will be conducted according to the same process as for the initial audits. Normally a corrective action plan with timescales for any findings will be agreed between your quality representative and the audit organisation appointed by BABT for each audit. Where the findings are significant a special audit may be required for which a separate invoice will be raised. Failure to clear corrective actions in a timely manner could lead to suspension of the particular certificate or an appropriate restriction in the certificate scope and activities relevant to the function of the particular site. TUV SUD BABT reserves the right to make additional audits particularly when there is doubt that the Quality System or essential requirements of product conformance are being maintained. Wherever possible additional audits will be notified to the Module D/E holder, but occasionally unexpected visits may be made to the Fabrication address. 6.2 Annual Continuation of the Certificate In the last 3 months before the anniversary of the issue of the certificate you will be sent the Audit Plan and invoice for the following year. If agreement to the plan and quotation is not achieved by the expiry date of the Module D/E Certificate, then the Certificate may be suspended or subsequently cancelled. Any changes to the scope of the Module D/E should be progressed as detailed in Section 8 Keeping your Certificate up to Date. 6.3 Records For Marine Equipment Directive Certificates, TUV SUD BABT maintain records of all the details on a certificate, all Applications, Recommendations and Certificates after the last significant file activity for 10 years. Audit Schedules, and Audit Reports are retained for 6 years. To meet the record retention requirement requirements of Module D/E, the Holder should keep the following records for 10 years after the last product was manufactured: o All relevant information from all the products manufactured o Documentation concerning the Certified System (and any changes to the quality system). o Copies of the Module B Type Examination Certificates (with any annexes) for products which are fabricated in the listed facility o o o Copies of all the Technical Documentation and any updates) related to each of the products covered by the Module D Certificate Reports from TUV SUD BABT resulting from the initial audit of the quality system and any subsequent audits, either surveillance, re-assessment or unannounced. A record of all complaints, requests for information from surveillance authorities, corrective and remedial actions relating to the quality system. Audit Reports on the Fabricator by the Module D/E Certificate Holder should be kept for 1 year or the next TUV SUD BABT audit, whichever is the longer. 6.4 Avoidance of Certificate Expiry TUV SUD BABT normally issue the Certificate with a 36 month validity. Certificates resulting from a transfer from another Notified Body will normally be issued with the expiry date from the previous (other Notified Body s) Certificate. To avoid the risk of certification lapsing, the re-certification audit should be conducted in sufficient time to ensure that any audit findings have been satisfactorily addressed and cleared by TUV SUD BABT a minimum of 3 weeks prior to the Certificate expiry date. 6.5 Withdrawal (or limiting the scope) of a Module D or E Certificate TUV SUD BABT may at any time withdraw or limit the scope of a Module D/E Certificate where there is evidence that equipment built at that facility fails to meet the appropriate requirements of the Marine Equipment Directive. After withdrawal no further supply of Marine Equipment to the market from the manufacturer will be permitted under that particular certificate.

11 Page 7 of 10 7: Keeping your Certificate up to Date 7.1 General During the lifetime of the operation of your certified system, TUV SUD BABT understands that you may want to make a number of changes to both your quality systems and processes, and to products included within the Module D/E certification. The particular processes involved with progressing each change will depend upon the significance of that change on the quality system and on the compliance of individual products within the scope of the FQA. The following sections detail the normal types of changes. Review each change: Whilst not all changes to the quality system will be significant to compliance with requirements, each change, however small, must be considered for its potential effects and their relevance to the conformance to the relevant standards. 7.2 Administrative Changes These are changes that do not materially change (or require change to) the quality system, or products. These changes should be sent by the Certificate Holder to TUV SUD BABT by traceable means ( , fax, or letter) within eight weeks of them taking effect. Examples of changes which may be considered as administrative are: Simple changes to either the Holders or Fabricator s company name (which do not involve any change in ownership) Changes to the Holder s address Changes of contact information Where the change will impact on the details on the certificate, TUV SUD BABT will then up-issue the certificate accordingly. Changes to Company Name/Product Certificates are not transferable outside of a corporate structure. Changes to the Holder s name or address must be notified to Customer Services in writing by an individual known by TUV SUD BABT to be within the corporate structure of the original Holder. Where a change of company name is a result of a restructuring in a corporate structure, or a change of ownership to a part of the system, this will be progressed as a quality system change. If the change of name of a product is due to a change in ownership of the product design, then this will require closer scrutiny. Changes to Fabricator s Facility Address While in many cases changes to addresses are not significant, they are reviewed as quality system changes to ensure that the integrity of the Module D/E Certification is retained. For example, the move of a facility to a location local to the original site is likely to have less significance on the certification than a move to a location hundreds of miles from the original facility. 7.3 Changes affecting the Quality System These are changes that actually or potentially affect the quality system. Details of the planned changes should be sent to the TUV SUD BABT by traceable means ( , fax, or letter) prior to them taking effect. They should be accompanied by evidence of the implementation (or planned implementation) of the change. The changes should not be implemented prior to agreement by TUV SUD BABT. Urgent Changes to the Quality System Where a change is urgent and normal means of authorisation are not available (e.g. immediate replacement of a key person) then all activities between the change and any formal agreement should be fully documented such that they are available for audit and retroactive action taken if necessary. Details of changes to the quality system as a result of corrective actions for findings identified during a TUV SUD BABT Quality Audit should be sent to the appointed audit organisation. Where a change affects the system operated at a site for which an audit date is confirmed and the audit organisation is known, then a copy of the advice of change and supporting information should be sent to the audit organisation.

12 Page 8 of 10 TUV SUD BABT will progress the changes and will assess their impact on the certification and advise you as appropriate. The following are examples of possible outcomes: Agree the change with no further action Require evidence of an internal audit of the affected area within a predetermined time Require a change in date of the next planned surveillance audit Require a special audit of the affected area 7.4 Changes affecting the scope Reductions to the overall scope These should be accompanied with details of Items (Refer to Directive Annex for the number) which are no longer covered. TUV SUD BABT shall be advised of those products (referencing TEC number) which will no longer be manufactured under the Module D/E certificate. TUV SUD BABT will then amend the Module D/E certificate as appropriate and withdraw the associated Certificates of Conformity which no longer have validity Ceasing manufacture of a product Where a Module D holder no longer intends to manufacture a product (e.g. product ceased production, production moved to another location, Module F being used in future) the list of products manufactured under Module D shall be amended, and TUV SUD BABT shall be informed which products (referencing the TECs) are no longer on this list. No change to the Module D certificate is required. Where a Module D holder no longer intends to manufacture a product, TUV SUD BABT shall be informed which products (referencing the TECs) are no longer to be listed. The Module E certificate will require updating. TUV SUD BABT will withdraw all associated Certificates of Conformity Adding a new Product Where you plan to add a product (or products) to your Module D list or Module E Certificate then you must apply to TUV SUD BABT using form BABT 792. This form required the following information: a. The Holder details and identity of the Module D or E Certificate b. Details of the Item number(s) for the Product c. Details of the Module B TECs for the products to be added d. Where you request to add a product covered by a Module B TEC from another NB please enclose a copy of the certificate and any annex with the application e. Either a new/amended Test Plan or a reference to an existing Test Plan which you intend using for this product (with a justification for its suitability) f. Details of any new/additional test equipment required for this product with details of its calibration status Where the product is of an item type not listed on the Module D/E Certificate, TUV SUD BABT may require additional information or a special audit prior to adding the item. When the requirements are met TUV SUD BABT, will amend the Module D/E Certificate (as required) and issue the appropriate Certificate(s) of Conformity. Within 8 weeks of its issue, a copy of the Declaration of Conformity must be sent to TUV SUD BABT, the fabricator (where they differ from the Manufacturer) and the Module B Notified Body if it differs from TUV SUD BABT

13 Page 9 of Changes to Products All changes to products (including manufacturing deviations) must be agreed by either the appointed TUV SUD BABT Certification Liaison Engineer within the Holders company, or by TUV SUD BABT. Where a change to a product results in the up-issue (or new release) of a Declaration of Conformity, a copy of the Declaration of Conformity must be sent to the Fabricator s company prior to the change taking effect and to TUV SUD BABT and the Module B Notified Body if it differs from TUV SUD BABT within 8 weeks of its issue. 8: Brand Names 8.1 General The Holder of a Module D/E Certificate must be the same company as the Holder of the Module B TEC Certificate. Where a product is marketed under another Company name, then a separate Module B TEC Certificate must be issued (normally using the majority of the original test data). Such products then require separate Module D/E Certificates even where manufactured on the same production line as the original product. Application for such Brand Names must be made by either the Brand Name product manufacturer, his Appointed Representative, or by an Agent (who must accompany information with a letter of appointment from the Brand Name holder. There must be no conflict of interest in personnel from the original product certificate Holder s company acting as an agent for one or more Brand Name product manufacturers. 8.2 Application Applications must be made on form BABT339 for each separate Brand Name in the name of the Brand Name company (or their Authorised Representative). Applications may be made either in parallel to or after the original application. Holders (or applicants for) the original Module D/E Certificate may also act as Agents (or Authorised Representatives if so qualified) for the Brand Name applicants provided that the Brand Name application includes evidence of their appointment to act in that capacity. 8.3 Documentation required for Brand Name Applications The Brandname application shall include the following information: (a) The following: o A statement by the Brand Name applicant that the design and production phases for the Brandname product are controlled by the original product owner using the already certified system; (b) And one or both of these as applicable: o Where any Brand Name products will be tested using the already agreed Test Plan for the original products, a list of products in this category with reference to the agreed test plans; o Test Plans for any Brand Name product for which the Brand Name holder is defining their own Test Plan (c) References to the Module B TECs for the Brand Name products (or equivalent reference if the TUV SUD BABT Module B process is not complete) (d) A Copy of any listed Module B Certificate and any annex which was issued by another NB (e) A copy of the Technical Documentation related to that product (Note: This may be a reference to the Technical Documentation of the original product PLUS the Brandname specific documents (e.g. Labels, and User Manual) (f) And one of the following: o o A statement that the Internal Audit process of the Original Product Holder will be modified to include audit items related to this Certification request, and that a copy of the report and outcome of the audit will be copied to the brand name Certificate Holder; or A copy of the Brand Name Applicant s Internal Audit Procedure; Audit Schedule, and planned Audit Agenda

14 Page 10 of 10 (g) Where the original Module D/E Certificate Holder is not appointed as either an Agent or Authorised Representative of the Brand Name Applicant, authorisation from the original Module D/E Certificate Holder to use their Certificate and supporting information in support of the Brand Name application. 8.4 Process for Brand names The Brand Name process will generally follow the same review process as for the original application. However, TUV SUD BABT do not normally expect to have to conduct an additional audit on the Fabricator s site. However, if there are significant differences between the processes for the original products to those followed for the Brand Name products, then TUV SUD BABT reserves the right to require an audit be conducted. Within 8 weeks of the issue of the Brandname Module D/E., a copy of the Declarations of Conformity from the Brandname Manufacturer must be sent to TUV SUD BABT, the fabricator (where they differ from the Manufacturer) and the Module B Notified Body if it differs from TUV SUD BABT. 9: Transfer of Module D or E Certification from another Notified Body TUV SUD BABT will accept applications for a TUV SUD BABT MED module D/E Certificate making use of an existing valid MED Module D/E Certificate from another Notified Body. The broad guidelines follow current IAF Guidance for such transfers. Applications should be made on form BABT 789. TUV SUD BABT progress the application the same way as for original applications with the following differences: TUV SUD BABT assumes the other Notified Body was competent. TUV SUD BABT views the status of the QMS and then concentrates upon findings from the previous audit and the various requirements which are part of the implementation of the requirements. Wherever possible BABT will transfer the Certification on a documentary basis and require that the next audit takes place within 12 months or on the current due date (whichever is earlier). Scope of Transfer A Transfer may be the transfer of the production of a whole product range currently manufactured under a Module D/E certificate from another Notified Body to a TUV SUD BABT Module D/E Certificate. Alternately you may request only a subset of the products be transferred which the other NB will retain responsibility for the others. Finally, you may effectively have a new certificate which is a Mirror of the current one and choose which NB to use at the time the DOC is raised. TUV SUD BABT will normally only transfer Module D/E certificates for original product Module D /E holders If you wish to transfer a Brand Name Module D/E certificate, please contact TUV SUD BABT prior to any submission. The following additional documents are required: Copy of the current Module D/E Certificate Copy of most recent Notified Body audit report of the facility Copy of the findings, corrective action plan, and status of all the findings (or any other open action with the other Notified Body) Copy of all Module B TECs for product intended for manufacture under the Module D/E Certificate Copy of all the Technical Documentation for any product supported by a Module B from a different NB to TUV SUD BABT. Once an Original Module D/E Certificate has been transferred, TUV SUD BABT will accept Brand Name requests following the normal process. Within 8 weeks after the transfer the Manufacturer shall send TUV SUD BABT copies of all the revised Declarations of Conformity which then reference TUV SUD BABT as the responsible conformity body.

15 BABT 791 Annex A Issue 4 Page A.1 of 5 Annex A Information required for an Application A.1 General The following information is required to progress the application. Where you complete application form BABT339 or BABT789, the required information is mainly self-evident. However, this section provides some notes on the expected contents in the order they appear within the application forms. Where you apply using another form, or through a document of your own, the following information must be clearly represented to avoid delays in the progress of the application. A.2 Applicant Details (Both BABT 339 and BABT 789) A.2.1 Applicant Company Details Company details: This must be the name of the company on whose behalf the application is being made. This is also the company name and address which will appear on the certificate. This must be the same company name and address as the Holder of the related Module B Certificates Contact Details: This is the person within the applicant company who will be the main contact point for communication with TUV SUD BABT. The telephone number listed later may either be a switchboard number or the direct number of this contact Applicant status: Only Manufacturers or Authorised Representatives may apply for Module D/E Certificates. Third party Fabricators may not apply. A.2.2 Other Contacts and Company Information Where the above Company name is a Trading Name which is different from the registered company name please supply, as a part of your application, full details of the registered company name (and number) and the relationship with the trading name. Where the application is from Authorised Representative applying under their own company name it is MANDATORY that you provide full contact details of the Manufacturer. Please supply the full details as a part of your application. Where this application has been made in the name of a Manufacturer established outside the European Community it is MANDATORY that an Authorised Representative within the community is appointed. Please supply full contact details and a copy of the mandate of their responsibilities of the Authorised Representative. Where this application has been made in the name of a Manufacturer established within the European Community you may opt to appoint an Authorised Representative (e.g. Brandname Applicant appoints the Original Manufacturer as Authorised Representative). Where you use this option please supply full contact details and a copy of the mandate of their responsibilities of the Authorised Representative if you have appointed one. Where you wish an agent to be involved with this application please supply an agent s letter on letterhead singed by an employee/official of the applicant company. Local TUV Offices who receive applications and identify missing items do not need to be appointed as Agents as this is viewed as acting on behalf of TUV SUD BABT. Any personnel within TUV offices (or other organisations) who are involved with creating or managing the quality system must be identified if you wish TUV SUD BABT to communicate with them directly. A.3 For New Applications using Form BABT 339 Only A.3.1 Certification Details You must apply for either Module D or Module E. (Note: If in doubt we recommend that you apply for Module D). Please indicate the Type of Application (Original or Brand Name). For Brand Name applications we either need a TUV SUD BABT Certificate Number or Reference Number (for applications in progress). Where you wish to apply for an original certificate and Brand Name certificate at the same time, please contact TUV SUD BABT in advance to reserve a reference number for the original product.

16 Guide to the TUV SUD BABT Implementation of Modules D and E of the Marine Equipment Directive BABT 791 Annex A Issue 4 Page A.2 of 5 You must identify the Product Type(s) (by Item Number) and reference the Marine Equipment Amendment Number relevant at the time of application which will be covered by this certificate. You must identify the Product Names, TEC number of the Module B Certificate, and the number of the Notified Body who Issue the certificate(s). Where the Module B application is in progress, please supply a reference number for this. (Note: This information will be listed on a Module E Certificate. For Module D, the Holder must maintain a List of Products manufactured at the facility which should initially match this list). A.3.2 Holders Quality System and Related Information A Audit Schedule The Holder is required, at least annually, to audit the compliance of the Fabricator s quality system against the relevant requirements of the Directive and TUV SUD BABT standard. You must provide a copy of the Audit Schedule, and a copy of your Internal Audit Report (including resolution of findings). This may either be provided with the application, or any time up-to the audit date. Where you have already conducted an audit to these requirements, you should include this with the application. For Brand Name applications, where appropriate you may reference the Audit Schedule of the original Manufacturer, but must demonstrate that they include your products and interactions within the audit. (This may be demonstrated by a detailed Audit Agenda). A PQC/ (Module D/E) Compliance Plan Please indicate either that a copy is enclosed or the date by which it will be enclosed. Where it is not supplied in sufficient time for a full review, the audit may be delayed. PQC Compliance Plan: A document compliant with the requirements of BABT AP008 Parts 1, 2 and either Annex G or H should be included with the application. A Test Plans for each product You must supply a relevant Test Plan for each product to be manufactured at the facility. Where you do not include all the Test Plans you must supply a date by which they will be provided. Where they are not supplied in sufficient time for a full review, the audit may be delayed. Test Plans: Each product must be covered by a Test Plan. Where appropriate (e.g. Brand Names or derived products) a given Test Plan may cover more than one product. The plan must as a minimum address A list of products which may be tested under the plan The tests to be performed The method of testing (with any derivation for the methods used [ e.g. standards] The pass/fail criteria Equipment to be used Details of the equipment requiring calibration Details of the competence/training criteria for the personnel performing the tests Details specifying how you will ensure the accuracy of the test set-up throughout the testing (e.g. ATM Self testing, testing Golden samples, Just Fail tests etc) ; The tests performed should, as a minimum, cover critical characteristics of the product which could be varied in production. The following would normally be expected to be considered: Output Power; Frequency Stability; Out of Band Emissions; Receiver Sensitivity. Other criteria to be measured would depend on the product item type and resulting applicable standards. Each Test plan must be agreed by TUV SUD BABT in advance of its use. Note: The test plan does not have to directly include all the above details, it is acceptable to reference other controlled documentation provided it is available for review at the time of the agreement, and available at the time of Audit.

17 BABT 791 Annex A Issue 4 Page A.3 of 5 For Module D Certificates, this plan must be agreed prior to the addition of any product to the List of Products maintained by the Holder, and advised to TUV SUD BABT after each change to this list. For Module E Certificates, this plan must be agreed prior to the addition of any product to the Certificate. Addition of Derived or Brand Name Products to an existing Test Plan: Where you wish to add an additional product to an agreed Test Plan you must provide a statement of similarity (or list of differences) to the original product. A.4 For Applications to Transfer from another Notified Body using Form BABT 789 Only A.4.1 Certification Requirements Please indicate the Module for which you are applying to transfer. Please identify the Implementing Regulation (or MED 96/98/EC Amendment) and referenced Item Types for the Equipment to be added to the Module D/E Please identify each product by Product Name, TEC number and the number of the current Notified Body Please indicate the number of Facilities to be included within the Module D/E Certificate. A.4.2 Section The Holder is required, at least annually, to audit the compliance of the Fabricator s quality system against the relevant requirements of the Directive and TUV SUD BABT standard. You must provide a copy of the Audit Schedule, and a copy of your Internal Audit Report (including resolution of findings). This may either be provided with the application, or any time up-to the audit date. Where you have already conducted an audit to these requirements, you should include this with the application. For Brand Name applications, where appropriate you may reference the Audit Schedule of the original Manufacturer, but must demonstrate that they include your products and interactions within the audit. (This may be demonstrated by a detailed Audit Agenda). A.5 Facility Site Details (Both BABT 339 and BABT 789) The following information is required related to the Fabricator s sites. A copy of this section must be completed for each separate facility address to be included within the application: A.5.1 Site Information Comprising: Facility Company name and address Main Company contact numbers (telephone, fax, ) These should be the general switchboard, fax and contacts for the company. These are used where (for whatever reason) the contact is unavailable for communication. A.5.2 A.5.3 Principal Contact for this Site Comprising: Contact Name, Job Title and Department Reference. This should be a person who can be contacted at that address with respect to audit visits/details. Where this person is the main contact (applicant) then a simple cross-reference may be made. Where there are language differences it may be beneficial to provide an English speaking contact Contact specific information (telephone, fax, ) It is frequently useful to be able to contact the main contact directly (especially where the switchboard operates in a language other than English). The telephone number may be a DDI number, extension number or a mobile phone number. The address also enables communication with minimum delay Alternate Contact for this Site Comprising: Contact Name, Job Title and Department Reference. This should be a person who can be contacted at that address if the Principal Contact is unavailable. Where there are language differences it may be beneficial to provide an English speaking contact. Contact specific information (telephone, fax, ) It is frequently useful to be able to contact the alternate contact directly (especially where the

18 BABT 791 Annex A Issue 4 Page A.4 of 5 switchboard operates in a language other than English). The telephone number may be a DDI number, extension number or a mobile phone number. The address also enables communication with minimum delay A.5.4 Main Site Indication Where this site is the only facility address, or is the Main (Controlling Address) please Indicate this as appropriate. Leave blank for other addresses. A.5.5 Employees and Shifts The following information is required to assist with audit planning: Total number of personnel on this site. (Quote Full Time Employees; If the facility operates a shift system, please state how many of those are not available during normal daytime working hours). Total number of personnel on this site involved with Fabrication Module D/E Certificate activities Total number of personnel on this site involved with Quality Assurance activities. A.5.6 Manufacturing Process Please indicate the location where key Manufacturing activities take place Note: Where this is dependent upon individual products the full details shall be provided in the PQC Compliance Plan. A.5.7 Readiness for Audit Please indicate the earliest date when each Site will be available for Audit. For Transfers: While TUV SUD BABT normally follow the audit plan of the previous Notified Body we reserve the right to require earlier or additional Audits. Furthermore, the transfer may be delayed if this date extends beyond our normal Audit periods. A.5.8 Persons or Organisations Providing Consultancy You are required to identify the details of any a person or organisation who has provided consultancy related to your QMS in the last 2 years. In addition, if you wish TUV SUD BABT and/or its associate companies to discuss your application with that named person/company (or any other person) you must formally authorise TUV SUD BABT to discuss your application with them. Please indicate on the application form whether either is applicable and enclose the required information where applicable. A.6 Details about your current Module D/E Certification ( For Applications to Transfer from another Notified Body using Form BABT 789 Only) The following information is required only for applications to transfer from another Notified Body when using application form BABT 789: This section is not applicable for new applications using form BABT 339 A copy of your current Module D or E Marine Equipment Certificate and Annex, along with your registration number and the number of the Notified Body who issued the Certificate. Confirmation of your permission to contact your current Notified Body for verification of the current Certificate status. Details of the required scope of your Certification. Details of the status of your current Module D or E Certification. Details of your current Notified Body s audit planning. A copy of your last audit report from your current Notified Body. Current status of any non-conformities and corrective actions. Status of any complaints received and actions taken. Please note that details of any outstanding complaints at the time of application will also need to be provided.

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