BABT 807. A Guide to the Attestation of Equipment to the Machinery Directive by TUV SUD BABT. TUV SUD BABT is a Certification Body of

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1 BABT 807 A Guide to the Attestation of Equipment to the Machinery Directive by TUV SUD BABT TUV SUD BABT is a Certification Body of TUV SUD BABT 2018 Issue: 2

2 Foreword TUV SUD BABT is the Certification body of TÜV SÜD Ltd which is part of the TÜV SÜD group of companies. This guide explains the TUV SUD BABT Attestation of Machines which do not require a formal Notified Body Type Examination Certificate under the Machinery Directive, 2006/42/EC. The TUV SUD BABT Implementation of Annexe IX in of the Machinery Directive, 2006/42/EC and issue of a formal Notified Body Type Examination Certificate is described in BABT document BABT 804. This scheme assists a manufacturer of machinery within the scope of the Machinery Directive to verify their compliance to the Essential Health and Safety Requirements and issue the required Declaration of Conformity. As an option this scheme may additionally address the requirements of the EMC and LVD Directives. Machines are normally also subject to other Directives (e.g. EMC, LVD). TUV SUD BABT also is a Notified body for the EMC Directive 2014/30/EU. The TUV SUD BABT Implementation of EMC Directive 2014/30/EU and issue of a formal Notified Body Type Examination Certificate is described in BABT document BABT 746. TUV SUD BABT and other Certification bodies within the TÜV SÜD group are also able to certify against other directives (e.g. ATEX, LVD). The formal requirements of the scheme are set out in the TUV SUD BABT Testing and Certification Regulations, which is available via the following link. All TUV SUD BABT publications are available from: or TUV SUD BABT Octagon House Concorde Way Segensworth North Fareham United Kingdom Tel: +44(0) BABT@tuv-sud.co.uk Page 2 of 12

3 Contents 1. Introduction Scope Overview Definitions and Terms Overview Flowchart Initial Enquiry Preparing for an Application Making an Application Who to Apply To Who Can Apply Types of Application Scope of Application Information Required for an Application TCF Documentation Progressing the Application Scheduling and Conducting the On-site Inspection Completion of Annex IX Process Regulatory Marking Keeping your TCF up to date... 9 Annex A Information to be Included within a TCF A.1 General A.2 General Description of the Machine A.3 Overview and Detailed Drawings of the Machine A.4 Procedures used to Ensure Compliance A.5 Documentation on Risk Assessment A.6 Test Data A.7 Declarations and Design Calculations A.8 Other Documentation Page 3 of 12

4 1. Introduction 1.1 Scope This guide explains the TUV SUD BABT Attestation of Machines which do not require a formal Notified Body Type Examination Certificate under the Machinery Directive, 2006/42/EC. 1.2 Overview The TUV SUD BABT Attestation of Equipment to the Machinery Directive Implementation of Annex IX of the directive operates under the TUV SUD BABT Certification Regulations. The formal output from TUV SUD BABT is an Attestation that the equipment and supporting documentation demonstrates compliance to the relevant requirements of either the Machinery Directive, or the Machinery, and EMC Directives. The current scheme only addresses the requirements for complete machinery. If you require an Attestation for a partially complete Machine, please apply to the Certification Manager of TUV SUD BABT to agree the appropriate requirements. Where after reasonable efforts it is not possible to demonstrate the required compliance after appropriate opportunities then the formal output will be a letter informing the applicant of the results of the assessment. 1.3 Definitions and Terms Applicant/Holder This is the person in whose name the Attestation will be issued. Agent An Agent is a natural or legal person, established either within the community or elsewhere in the world, appointed by the Applicant/Holder r to act on his behalf with respect to the application. The application must include a letter from the Applicant Authorising TUV SUD BABT to communicate with the Agent for matters related to the application. Essential Health and Safety Requirements (EHSRs) Essential requirements as listed in Annex I of the Machinery Directive (2006/42/EC) Technical Construction File (TCF) The Technical File for Machinery as defined in Annex VII of the Machinery Directive (2006/42/EC) Page 4 of 12

5 1.4 Overview Flowchart Initial request for Certificate Initial Review and Quotation Assuming Sufficient Information supplied Purchase Requisition and Formal Application Application must include required information Review of Application by TUV SUD BABT Client returns remedies No Any Concerns or shortfalls Yes Schedule Inspection Date(s) Conduct Inspection Any Findings No Yes Client returns remedies Yes Further Inspection required? No Final review and Attestation Issue Attestation sent to the Client 2. Initial Enquiry We recommend that you make an initial enquiry to our Billingham office with details of the Machinery for which you require Attestation. Where practical one of our Engineers will either visit you, or phone you to establish the nature of the equipment and better understand the work related to any application This will enable us to size the work, answer any queries. Page 5 of 12

6 However, if you wish you can go straight to the Application stage. 3. Preparing for an Application You will need to prepare the TCF Where you require Testing you should either approach a Test Laboratory accredited for the standard which you will be tested against. Your local TUV SUD company can help advise you of capability within our group of companies; and/or where the testing will take place where the Machine is located/ or at an unaccredited address (e.g. Subcontractors premises); or using partial requirements then you should contact TUV SUD BABT as we will need to send an expert to witness the testing. Where compliance will be shown by inspection the TCF should indicate this in a draft document. Assembly of the TCF TUV SUD UK Ltd can assist in the assembly of the TCF by identifying shortfalls and detailing the exact requirements). You should apply separately for this service from your application for the Machinery Directive Annex IX Notified Body as personnel involved with such activities are barred from later involvement in the Notified body work Design Advice TUV SUD UK Service can provide advice on the design of the product, including assistance in writing required documentation. However, where you require this service then TUV SUD BABT will be unable to offer any Notified Body assessment for that product due conflicts of interest and the rules of our appointment. 4. Making an Application 4.1 Who to Apply To The application should normally be made to either directly to TUV SUD BABT Customer Service or via another TUV SUD Office (e.g. TUV SUD at Billingham) The application must be sent electronically and include: A completed application form (BABT 808); and Sufficient information to enable TUV SUD BABT to plan resources and establish the appropriate standards and EHSRs for the Machine. Ideally this is a partial or complete TCF. Testing to EMC and LVD TÜV SÜD Ltd are a UKAS accredited test laboratory for EMC and Safety and can test to many of the standards invoked by those respective directives. You should apply separately for this service from your application for the Machinery Directive Attestation as personnel involved with such activities are barred from later involvement in the Notified body work 4.2 Who Can Apply Applications can be made by or on behalf of manufacturers, or Authorised Representatives Optionally, the applicant may in addition authorise TUV SUD BABT to liaise with another party (e.g. a TUV company/agent/consultant) acting on behalf of the applicant in matters relating to the application. TUV SUD BABT will require evidence that the representative or consulting agency is authorised by the applicant company to act on their behalf and there is a section of the example application form for this purpose. 4.3 Types of Application You should also indicate whether this is an original submission for an Attestation or an Administrative Change to an Attestation Machines which have had technical modifications applied will require a new Attestation. Applications may cover either one product or a set of related products having significant design similarities. Derived Products or Sisters with differing features but where there are significant design similarities may be submitted on the same application. However, information demonstrating their similarity will be required and additional testing/test results may be required for technical aspects which differ between models. Page 6 of 12

7 4.4 Scope of Application The Machinery may be subject to the EMC and LVD Directives in addition to the Machinery Directive. You may either limit the Attestation to the Machinery Directive or request attestation to the Machinery, EMC and LVD Directives. Note A: Provided TUV SUD BABT or TÜV SÜD Ltd have not given design advice, or assistance in writing any part of the TCF you may alternatively apply separately to TUV SUD BABT for a Notified Body Type Examination Certificate covering the EMC Directive. Note B: Where the Machine is subject to other directives (e.g. PPE or ATEX) other Certification Bodies within TUV SUD may be able to assist you, we recommend discussing this with your local TUV SUD contact. 4.5 Information Required for an Application The following information should be supplied as appropriate as a part of the application. Entries for this information are included in form BABT 808. Main contact name and address Details of the authorised signatory within the company applying for the certification and responsible for the certification request and order. This named person may not be an agent. Location of the Equipment Where the equipment has been inspected at the final location for installation and this differs from the Applicants address this may be listed on the Attestation. An Agent/Consultant name and address (to be included with supporting information) Where you have used an agent/consultant to assist or submit the application, e.g. if you are submitting through TUV SUD BABT ICM or a TUV PS company this should be their details). Certification options (as described above). Product name(s)/model(s) must be clearly stated as this will appear on the certificate and serve as a prime identifier of the certified product(s). Brief Description of Product This is necessary to ensure that suitably qualified personnel are involved with the assessment, and to ensure that standards used are within their appropriate scope. TCF overall document file identity must be included as this also will appear on the certificate. Where there is no overall TCF identity then the Document number of the TCF Index (or Contents listing) should be provided An explanation of the relationship between models where you have submitted an application covering more than one model. One can be derived from another by sub-equipping/ depopulation and whether they have substantial areas of circuitry or software in common. Information related to your intended method of payment Work is carried out on receipt of either payment in advance or a valid purchase order number. Clients applying directly to TUV SUD BABT (i.e. not through any other TUV Group office), who do not currently have approved credit facilities with either TUV SUD BABT or TUV SUD UK must include a completed Credit Details Form with the application. Alternatively, payment in advance is accepted. The appropriate forms may be downloaded from Name or address to which invoices and accounts should be sent where the person or address differs from the Main contact listed previously (to be included with supporting information). Purchase Order or Credit Card details A statement that you understand and agree to abide by the TUV SUD BABT Testing and Certification Regulations. The application should also be accompanied with supporting information as detailed. 4.6 TCF Documentation General While the TCF is not normally complete at the time when the application is made using form we request you advise us on Form 808 when you anticipate the TCF being ready for review. We understand that this TCF may not be formally complete as you may be dependent upon our Inspection to establish certain characteristics. Page 7 of 12

8 The TCF must be sent (or available) via electronic media (e.g. On a CD, or via attachments). Documents should be in Word. Excel, Adobe PDF, or images in JPEG formats. Where you wish to use other formats or employ encoding please contact TUV SUD BABT prior to submission to ensure we will have ready access to the files. All documentation should be readily identifiable with either revision indication or an issue date. Multiple paged documents should have indications, page numbers or listed sections) to ensure they are complete TCF Contents Since each TCF is unique there is no fixed structure for file. Annex VII of the Directive however mandates a minimum set of contents or mandated set of contents. EMC Directive Where the Attestation will include the EMC, directive refer also to the mandated contents in Annex IV of the EMC Directive. In addition to that list TUV SUD BABT require that you either provide an issue controlled named index to the TCF, or an overall Issue conscious TCF Identity which can be referenced on the Certificate l Further details of the contents are included for information in Annex A of this document. 4.7 Progressing the Application When TUV SUD BABT has received your application and evaluated the initial information, we will: If we have not already issued a quotation we will ask you to pay an application fee. The fee relates to o the assessment of the application as well as the issuing of the Certificate. o the Inspection Fees related to the on-site visit required Auditor time Note: Any Travel and sustenance costs related the site visit, and any additional On-site time related to a review of findings from the initial Site visit will be invoiced separately. inform you of the TUV SUD BABT project number assigned to your application. This number should be quoted in all further correspondence. advise you of any obvious omissions of items required for assessment (e.g. required drawings) When TUV SUD BABT has received all the required items the application will be allocated to an engineer for formal review. 4.8 Scheduling and Conducting the On-site Inspection Following a review of the supplied technical information TUV SUD BABT will advise you of the selected inspector (or Inspection team) and agree with you the inspection date(s). On-Site Inspection Due to the complexity of much of the Machinery within the Scope of appointment TUV SUD BABT normally expect to inspect the Machinery at an on-site location. Exceptionally where full compliance has been shown through independent testing then this may not be necessary. During the Inspection the inspector will inspect the TCF and correlate this by inspecting the Machine. The Inspector will advise you of any findings before the end of the visit. Findings are rated o Major Non-compliances which must be remedied before the certificate can be issued o Minor Non-compliances for which you must provide a plan of action You will be issued with a copy of the Inspection report with a determination on whether the findings can be addressed met through documentary evidence or whether a further on-site inspection is required. Once all the Major findings have been addressed and the corrective actions for any minor findings agreed then the Inspector will forward the report and supporting information for the Certification review, 4.9 Completion of Annex IX Process Assessment Process After any/all the findings from the TCF Review and Inspection are resolved the Inspector forwards the documentation to a TUV SUD BABT Technical Certifier who will review the supplied TCF, the Inspectors Report and any supporting information, for completeness, consistency and whether it demonstrates the product will be compliant with the requirements of Annex IX of the directive. Page 8 of 12

9 If during the assessment the Certifier concludes that Required documentation is omitted; or The TCF includes unexplained inconsistencies; or Documentation is incorrect or incomplete; then the Certifier will contact the Inspector to progress a suitable response Assessment Outcome Where after assessment of the application, Inspectors Report, and supporting documentation the Technical Certifier determines that compliance has been demonstrated with the requested essential requirements of the Directive (s), TUV SUD BABT will issue an Attestation confirming compliance; Attestations are issued in the name of the Applicant Company which is referred to as the holder. Attestations also include: the address of the holder (or an alternate address where identified within the application), Optionally the name and address of the Location where the equipment was inspected and will be installed. The Machine identity(ies) (including any variants/models), the reference to the TCF (including Date or version information) Other data necessary for identification of the product, and any conditions for its validity. If any concerns remain outstanding after an appropriate timeframe for a response the TCF in the view of TUV SUD BABT still does not demonstrate it complies with the requirements of the Directive(s), TUV SUD BABT will issue a letter informing the applicant of the results of the assessment Records TUV SUD BABT maintain records of all the details on a certificate; of each submission and the resulting evaluation for 15 years after the last significant file activity You are required to maintain records the records defined in the Directive for 15 years. 5. Regulatory Marking The CE marking shall be applied only to Machinery which meets the requirements of all applicable Directives for which a valid Declaration of Conformity exists. 6. Keeping your TCF up to date If you make any technical modifications to the Machine this invalidates the Attestation. If you require an attestation covering the new build level of the Machine you must apply for a new Attestation. If you make non-technical changes (e.g. Company Name or Holder address details) you may apply for an upissued Attestation using the updated information. Page 9 of 12

10 Annex A Information to be Included within a TCF A.1 General Each TCF is unique accordingly there is no fixed structure. Annex VII of Directive 2006/42/EC mandates a minimum set of contents for inclusion in a TCF supporting completed Machinery. The following list identifies this and provides further guidance related to each type of data. Where the Attestation will include the EMC and LVD, these directives also mandate certain contents in Annex IV of the EMC Directive, and Annex IV of the LVD. Where these apply you must include test reports, and documentation as required for those directives. It remains the responsibility of the manufacturer (or the person placing the product on the EU market) to hold the TCF and maintain its accuracy. For applications to TUV SUD BABT we prefer that the TCF is sent via electronic media, e.g. On a CD, or via attachments). For Regular customers we can also set up an FTP account. Documents should be in Word. Excel, Adobe PDF or JPEG formats. Where you wish to use other electronic formats or employ encoding please contact TUV SUD BABT prior to submission to ensure we will have ready access to the files. Where you submit the TCF in paper form TUV SUD BABT may charge a handling fee. All documentation should be readily identifiable with either revision indication or an issue date. Multiple paged documents should have indications, page numbers or listed sections) to ensure they are complete. A.1.1 Index or Contents List The TCF should be structured in a logical format and have either a table of contents or an index. Where the TCF covers multiple variants of a product the index/table of contents should be in sufficient detail to readily determine common items and documentation specific to single variants. Either the TCF itself or the Index/Contents list must be titled issue controlled. The identity of the TCF (or index) is listed on the Certificate. A.2 General Description of the Machine The following documentation should be considered: A.2.1 Overview This should be an overview or brief description of the purpose of the Machine and where more than one Machine design is included in the TCF it should contain brief details of the relationships and differences between models. A.2.2 Identification of Equipment This should be a list of all model names and associated numbers of all product models included within the TCF. Where documentation is included using prototype names, or names from other markets then the relationship with the models named within the TCF should be detailed. A.2.3 Explanations These should be sufficient to provide for an understanding of the operation of the equipment A.3 Overview and Detailed Drawings of the Machine A.3.1 Overview Drawing of the Machinery You should include an overall drawing showing the following details for simple apparatus a complete circuit diagram may be satisfactory): points of connection to other equipment other ports (including ac power, dc power, signal & control) indicators of key functionality connections to earth (protective or functional). Page 10 of 12

11 A.3.2 Photographs or Illustrations To assist in identification and assessment it is advised that where relevant the TCF includes Photographs or illustrations showing the external features of the complete equipment. A.3.3 Full Detailed Drawings These shall be accompanied by any calculation notes, certificates etc to check the conformity of the machinery with the essential requirements A.4 Procedures used to Ensure Compliance A.4.1 Compliance Strategy To assist in the evaluation, we request that you include documentation describing the compliance strategy including the measures for externally supplied sub-assemblies. A.4.2 List of Standards and Technical Specifications Applied You should include a list of all relevant standards and EHSRs applied to ensure conformity. For standards this list should include the issue level of the standard. A.5 Documentation on Risk Assessment This should include a list of the EHSRs which apply to the machinery. It must also include a description of the protective measures implemented to eliminate identified hazards or to reduce risk, and when appropriate the indication of the residual risks associated with the Machinery A.6 Test Data A.6.1 Test Reports These should follow the guidelines in ISO/IEC Clause Test Results from an Accredited Test Laboratory Where testing is covered by an accreditation the test methods used, competence of personnel and calibration of equipment as assumed to be covered. Test Results from an Unaccredited Source (Including Manufacturers Own Testing) The test results must be able to be demonstrated to have been obtained in a controlled and consistent manner. Details of the test methods used, the calibration of relevant equipment, clear identification of the equipment samples tested, and competence information related to the personnel performing the tests must be included (or available for review Where the testing will take place where the Machine is located/ or at an unaccredited address (e.g. Subcontractors premises); or using partial requirements then you should contact TUV SUD BABT as we will need to send an expert to witness the testing Test Methods Where the standards used do not include test methods or where alternate test methods have been used they should be detailed with justifications for their appropriateness to demonstrate the requirement. Details should include the equipment used, the calibration status of test equipment, and the estimated measurement uncertainty. Where relevant you should include the following justifications: Justifications * Justification of tests not performed If there are any aspects for which testing has not been performed then a clear technical justification for this shall be provided. This should include details of what alternative processes have taken place to establish compliance to the essential requirements. * Justification for using test data from a different standard Where you test data from other standards this may be included instead of the harmonised standard with a justification for using this to demonstrate compliance to the relevant essential requirement. For example, you may have test data from testing to a non-harmonised standard derived from the same global standard. * Justification for omitting tests Where the functionality of your equipment does not encompass a normal sub-set of tests from a standard you should provide a justification for omitting those tests; Page 11 of 12

12 Where due to design constraints, or industry wide lack of test capability tests cannot be performed then you should include justifications (with appropriate supporting data) why the apparatus complies with the requirement. * Related Products/Models Where the TCF covers a range of related products or models the test reports shall be sufficient to cover the range taking into consideration the supporting documentation of similarity between products. Where differences in implementation could affect requirements testing to those requirements should take place on sufficient variants to cover each different implementation. The justifications to limit testing should either be included with the data or product descriptions. * Validity of test results obtained prior to modification Where you include test, results obtained using apparatus at a build level different from the current level then there should be a justification of the continuing validity of those results. This may be in the form of a positive assertion of the results, or a negative assertion of any effect on the compliance held against individual engineering changes. A.7 Declarations and Design Calculations A.7.1 Declaration Related to Incorporated Machinery Where appropriate the declaration of incorporation of partly completed machinery and the relevant assembly instructions Where appropriate the declaration of Conformity of incorporated machinery and the relevant assembly instructions Note: These are not relevant for Partly completed machinery A.7.2 Declarations and Design Calculations Where you use calculations or Declarations instead of independent test data to demonstrate compliance, these should be clearly included with details of the person who performed such calculations/declarations A.8 Other Documentation A.8.1 User/Installation/Special Instructions You should supply (in English) a draft or published set of Instructions for the Machine, or for complex equipment, those sections of the instructions which relate to compliance with the Directive. They should: contain all the information required for conformance to the relevant standard; include a draft copy of the Declaration of conformity, 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-compliant setting would invalidate the certification. A.8.2 Declaration of Conformity The submitted TCF should contain a draft Declaration of Conformity. This must be formally issued prior to application of the CE mark on products. Note: This is not relevant for partly completed machinery Page 12 of 12