BABT 795. A Guide to the TÜV SÜD BABT Implementation of the Factory Production Control requirements of the Construction Products Directive(89/106/EEC)

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1 BABT 795 A Guide to the TÜV SÜD BABT Implementation of the Factory Production Control requirements of the Construction Products Directive(89/106/EEC) TÜV SÜD BABT is a Certification body of TÜV SÜD TÜV SÜD BABT 2012 Issue 1

2 Foreword TÜV SÜD BABT is an accredited Certification Body, and appointed as a Notified Body under the Construction Products Directive (89/106/EEC) This guide details overviews the TÜV SÜD BABT implementation of the Production Control aspects of the Construction Products Directive. The overview of the TÜV SÜD BABT implementation of the Constructions Products Directive is explained in BABT 793. 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. This guide should be read in conjunction with the following document: BABT AP008 - BABT PS 340 The Production Quality Certification Scheme for Manufacturers of Marine, Radio, Telecommunication Terminal Equipment and Electro-Technology Products The formal requirements of the scheme are set out in the TÜV SÜD BABT Certification Regulations. The current versions of these can be found at All TÜV SÜD BABT publications are available from: (See the download area in Information Services) or TÜV SÜD BABT Octagon House Concorde Way Segenesworth North Fareham Hampshire, PO15 5RL United Kingdom Tel: +44 (0) Fax: +44 (0) customer.services@babt.com

3 Page i of ii Contents 1. Introduction Scope Overview Background Conditions for Registration Definitions and Terms Making an application for registration of a Production Control facility 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 Registration of the Production Control facility Certificate of Conformity General Regulatory Marking Continuation of the Registration On-going Audits Annual Continuation of the Registration Records Avoidance of Expiry of the registration Withdrawal (or limiting the scope) of a Registration Keeping your Registration 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 Documentation required for Brand Name Applications Process for Brand names Annex A Information required for an Application... A.1 A.1 General... A.1 A.2 Section B: Facility Site Details... A.1

4 Page ii of ii A.3 Section C Additional Documentation... A.3 A.4 Section D: Manufacturing Functions Performed at this Site... A.3 A.5 Section E: Persons or Organisations Providing Consultancy... A.3 A.6 Section F: Payment Details... A.3 A.7 Section H: Agreement... A.3 A.8 Documentation to Accompany an Application... A.3

5 Page 1 of 9 1. Introduction 1.1 Scope This guide explains the TÜV SÜD BABT Implementation of the Production Control Requirements of the Construction Products Directive [CPD] 89/106/EEC. This document should be read in conjunction with BABT AP008 - BABT PS 340 The Production Quality Certification Scheme for Manufacturers of Marine, Radio, Telecommunication Terminal Equipment and Electro- Technology Products,. plus any Amendment valid at the time of use. 1.2 Overview The TÜV SÜD BABT Implementation of the Production Control Requirements of the CPD operates under the TÜV SÜD BABT Certification Regulations. This implementation requires an assessment of a manufacturer s quality management system against the requirements of BABT document AP008. Fees are applied on an annual basis dependent upon the scope of the Quality Assurance Certification. The formal output of an application for Registration of a Production Control Facility related to the CPD is a formal registration document listing the scope of operation of the Quality Assurance System, which may be used to enable the manufacturer to supply product compliant to the CPD referencing TÜV SÜD BABT as a Notified Body. 1.3 Background Many New Approach Directives require formal certification of the Production Facilities. This is detailed under Module D of this approach. While the CPD predates the New Approach, the requirements for Production Control under the CPD closely match those in Module D in the New Approach. TÜV SÜD BABT have based the requirements for the CPD on the existing Production Quality Certification Scheme which addresses similar requirements under the R&TTE and Marine Equipment Directives. The Requirements of Parts 1 and 2, and Annex J of BABT AP008 - BABT PS 340 apply. Formal registration of the Production Control Facility is a prerequisite for a TÜV SÜD BABT Product Certificate of Conformity under the CPD. Registration can include production of different products and types of products. 1.4 Conditions for Registration As a prerequisite to registration you are required to agree to conform to the TÜV SÜD BABT Certification regulations. 1.5 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 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

6 Fabricator Guide to the Factory Production Control under the CPD Page 2 of 9 information regarding the product where the Manufacturer is not established in the Community and has no Authorised Representative in the Community. Where an Imported performs the compliance assessment and authorises the use of the CE mark they become the Manufacturer within the terms of this document and the CPD. 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. Under the Construction Products Directive the location of the production is sometimes referred to as the Factory. However for commonality in the requirements document 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 Applicant 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 Manufacturer or the Authorised Representative authorising TÜV SÜD 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 Registration of the Production Control Facility in the name of the Applicant for a Brand name Product Conformity 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 Brandname Production Control Registration may only be made where the same fabricator operates the same processes for the Brandname as the Original product 2. Making an application for registration of a Production Control facility For information related to making an application for brand name registration 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 TÜV SÜD 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) Registration should be made on form BABT 796. Please complete and sign an application for each location for which Registration is required; Registration is issued on an individual site basis only. Applicants seeking a TÜV SÜD BABT PQC Certificate for Annexes A through E of BABT AP008 / BABT PS 340 should apply on form BABT AF018. Applicants seeking Marine Equipment Directive Module D or E Certification should refer to document BABT 791 and make the application using form BABT 339. While TÜV SÜD BABT will try to combine audits, each application must be made separately TÜV SÜD BABT are also a Certification body for ISO9001. You may apply to TÜV SÜD BABT for transfer of an existing ISO9001 or a new certificate. On request we will align the Audit plans with the CPD Audit to enable combined audits to be made limiting disruption of the Production Facility. Direct applications should be sent to TÜV SÜD BABT in Fareham either: By CD sent by mail; or By to: Customer.services@BABT.com

7 Page 3 of 9 Alternatively you may apply via a local TUV office (e.g. one performing testing in support of an application for a Product Conformity Certificate) who will forward it to TÜV SÜD BABT for processing. 2.3 Who can apply Applications can only be made by applicants/holders for/of a CPD Certificate of Conformity. The related certificates references must be are listed in the application. Where the manufacturer is the holder an identified Authorised Representatives can apply on behalf of the a 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. 2.4 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 registration to be delayed: Main contact information Requested Scope of Registration 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 Registration 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 registration of a Production Control facility 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 Plan list, Product Types, etc.). During this stage it is normal that clarifications and further documentation are required to avoid misunderstandings which could result in significant delays to the registration, or a reduction to the requested scope of registrtation.. 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 registration 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 either be agreed with TÜV SÜD BABT prior to the audit taking place, or derived from plans agreed with TÜV SÜD BABT.. The applicant/holder must maintain a list of agreed Test Plans and supply both the list and plans to the Fabricator.

8 Page 4 of 9 Where derived plans are used at the production facility they must be traceable back to the agreed test plan with TÜV SÜD BABT. For VMS signs it is expected that each derived Family member based on the Test module component parts will have its own Production Test plan which will be reviewed by the Auditor for traceability to the agreed plan. Note it is permitted to vary the method of compliance to the test requirements ( e.g. Smaller signs may be subject to test, whereas Large signs may be covered by compliance via calculation). 3.5 Confirmation of Audit Arrangements TÜV SÜD BABT makes use of qualified auditors from TÜV SÜD BABT, TUV, and other audit organisations local to the site locations. You will be advised of the proposed audit dates and plans for each location requiring audit from either TÜV SÜD BABT or one of the audit organisations and you will be requested to confirm your acceptance. 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. Additionally where manufacturing locations only produce product under the CPD at certain times the planned times or dates should be advised to the audit organisation. 3.6 Audit The audit will be conducted to the requirements of BABT document AP008 (plus any Amendment current at that time) 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 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. where the Fabricator does not hold an accredited ISO9000 Certificate, or where you have selected additional options of document BABT AP008 (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, TÜV SÜD 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.

9 4. Registration of the Production Control facility Guide to the Factory Production Control under the CPD Page 5 of 9 The registration 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. A Registration is issued in the name of the Applicant Company who is hereafter referred to as the Holder. The registration also includes: the address of the Holder, the name and address of the Fabricator the name and address of the Manufacturer (where the EC Representative manufacturer is the holder) reference to the Standard used for audit the Product Types included within the scope any special conditions to be complied with to maintain the validity of the Registration. 5. Certificate of Conformity 5.1 General For every product to be manufacturer under a Production Control Certificate the Holder shall hold a Certificate of Conformity and a valid Declaration of Conformity for that product. This Certificate of Conformity links the Product assessment with the Fabricators Facility. 6. Regulatory Marking The CE mark in respect of the Directive shall be only be applied on equipment for which a valid Certificate of Conformity and Declaration of Conformity exists. Details of the Marking requirements are given in Documents BABT 793 and BABT AP Continuation of the Registration 7.1 On-going Audits During the year following the registration (and during subsequent years ) you will receive advice of proposed surveillance audit visits in line with the plan. TÜV SÜD 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. 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 TÜV SÜD 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 regristration or an appropriate restriction in the scope and activities relevant to the function of the particular site. TÜV SÜD 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 holder, but occasionally unexpected visits may be made to the Fabrication address. 7.2 Annual Continuation of the Registration In the last 3 months before the anniversary of the registrtastion 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 then it may be suspended or subsequently cancelled. Note: Where a Registration is Suspended this also suspends the Product Conformity Certificate unless an alternative Fabricator is named on that Certificate Any changes to the scope of registration should be progressed as detailed in Section 8 Keeping your Registration up to Date.

10 7.3 Records Guide to the Factory Production Control under the CPD Page 6 of 9 TÜV SÜD BABT maintain records of all the details on a registration document, all Applications, and Recommendations after the last significant file activity for 10 years. Audit Schedules, and Audit Reports are retained for 6 years. The Quality Management System of the Holder shall specify the records to support the Declaration of Conformity and retention periods for such documents. The CPD does not specify any record retention period. It is a requirement for TÜV SÜD BABT Certification that the following are retained for at least 3 years. However TÜV SÜD BABT recommend that in keeping with other New Approach directives the Holder should keep the listed records for 10 years after the last product was manufactured to support enquiries from Surveillance authorities.: o All relevant information from all the products manufactured o Documentation concerning the Certified System (and any changes to the quality system). o Reports from TÜV SÜD BABT resulting from the initial audit of the quality system and any subsequent audits, either surveillance, re-assessment or unannounced. o The Certificates and Reports from any third party QMS Certification which TÜV SÜD BABT has taken into consideration in granting the Registration and any subsequent audits, either surveillance, re-assessment or unannounced Audit Reports on the Fabricator by the Registration Holder should be kept for 1 year or the next TÜV SÜD BABT audit, whichever is the longer. 7.4 Avoidance of Expiry of the registration TÜV SÜD BABT normally issue the registration with a 36 month validity. To avoid the risk of registration lapsing, the re-registration audit should be conducted in sufficient time to ensure that any audit findings have been satisfactorily addressed and cleared by TÜV SÜD BABT a minimum of 3 weeks prior to the registration expiry date. 7.5 Withdrawal (or limiting the scope) of a Registration TÜV SÜD BABT may at any time withdraw or limit the scope of a Registration where there is evidence that equipment built at that facility fails to meet the appropriate requirements of the CPD. After withdrawal no further supply of Equipment under the CPD to the market from the manufacturer will be permitted under that particular registration. 8. Keeping your Registration up to Date 8.1 General During the lifetime of the operation of your certified system, TÜV SÜD 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 Production Control Registration. 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 CPD. 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. 8.2 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 Registration Holder to the TÜV SÜD BABT 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)

11 Page 7 of 9 Changes to the Holder s address Changes of contact information Where the change will impact on the details on the registration, TÜV SÜD BABT will then up-issue it accordingly. Changes to Company Name/Product Registrations are not transferable outside of a corporate structure. Changes to the Holder s name or address must be notified to TÜV SÜD BABT Customer Services in writing by an individual known by TÜV SÜD 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 Registration 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 registration than a move to a location hundreds of miles from the original facility. 8.3 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 TÜV SÜD 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 TÜV SÜD 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 TÜV SÜD 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. TÜV SÜD BABT will progress the changes and will assess their impact on the registration and advise you as appropriate. The following are examples of possible outcomes: TÜV SÜD BABT agree the change with no further action TÜV SÜD BABT require evidence of an internal audit of the affected area within a predetermined time TÜV SÜD BABT require evidence that the third party certifier who has certified the system (e.g. ISO9000 certifiers) have assessed and agreed to the changes (with details of any outstanding corrective actions where they performed a special audit) TÜV SÜD BABT require a change in date of the next planned surveillance audit TÜV SÜD BABT require a special audit of the affected area 8.4 Changes affecting the scope Reductions to the overall scope These should be accompanied with details of Items (Reference Product Type and Standard) which are no longer covered. TÜV SÜD BABT shall be advised of those products (referencing TEC number) which will no longer be manufactured under the Registration. TÜV SÜD BABT will then amend the Registration as appropriate and withdraw/suspend the associated Certificates of Conformity which no longer have validity.

12 8.4.2 Ceasing manufacture of a product Guide to the Factory Production Control under the CPD Page 8 of 9 Where a holder no longer intends to manufacture a product ( e.g. product ceased production, production moved to another location) the list of products manufactured under Registration shall be amended, and TÜV SÜD BABT shall be informed which products (referencing the Certificate of Conformity) are no longer on this list. No immediate change to the Registration is required. TÜV SÜD BABT, at the time of renewal of the certificate, will review the products listed and test capability of the Fabricator and may amend the scope at that time. The associated Certificate of Conformity will be suspended/withdrawn if an alternate location with a Production Control Registration has not been identified to TÜV SÜD BABT Adding a new Product Where you plan to add a product (or products) to your list of products covered by the Registration then you must apply to TÜV SÜD BABT using form BABT 797. This form requires the following information : a. Identity of the Registration b. Details of the Product Name(s), Type of Product( List Standard), and the number allocated for the TÜV SÜD BABT Certificate of Conformity c. 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) d. Details of any new/additional test equipment required for this product with details of its calibration status e. An amended List of Products to be manufactured under the Registration Where the product is of a type ( e.g. Standard) not listed in the Registration, TÜV SÜD BABT may require additional information or a special audit prior to adding the item. When the requirements are met TÜV SÜD BABT, will amend the Registration (as required) and issue/amend the appropriate Certificate(s) of Conformity. 8.5 Changes to Products All changes to products (including manufacturing deviations) must be agreed by either the appointed TÜV SÜD BABT Certification Liaison Engineer within the Holders company, or by TÜV SÜD 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 both the Fabricator s company prior to the change taking effect and to TÜV SÜD BABT within 8 weeks of its issue. 9. Brand Names 9.1 General The Holder of a Registration must be the same company as the Holder of the Certificate of Conformity or be the listed Authorised Representative Where a product is marketed under another Company name, then a separate Certificate of Conformity must be issued (normally using the majority of the original test data).

13 Page 9 of Options for listing Brandnamed Products on Production Control Registrations Such products must be covered by a Production Control Registration held by a party listed on the Product Conformity Certificate as either the holder or Authorised Representative. Where the Original product Certificate holder is from within the EU they may be listed as the Authorised Representative on the Brandname Holders Product Conformity Certificate.In these circumstances the Production Control Registration covering the original product may have the Brandname certificate also added Where the Holder of the Production Control Registration for the original product is from outside the EU then they are not qualified to be listed as the Authorised Representative and consequently the Holder of the Brandname Product Conformity Certificate will require a separate Brandname Certificate. Yes Brandname Manufacturer may be listed on the OEM Production Control Registration Product may be listed on the Production Control Registration of the original Manufacturer Brandname Product Does Product Label list the OEM Manufacturer as the Manufacturer No Is the OEM Manufacturer listed as the Authorised Rep on the Product Conformity Certificate No A Brandname Production Control Regustration will be required Yes Product may be listed on the Production Control Registration of the original Manufacturer Amended Product Control Registration New Brandname Production Control Registration Amended Product Control Registration Separate applications 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. 9.3 Application Applications must be made on form BABT796 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 Production Control Registration 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. 9.4 Documentation required for Brand Name Applications The Brandname application shall include the following information: (a) One of 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; o A copy of the ISO9000 (or equivalent) certificate held by the Brand Name company; o A statement that the Brand Name Holder does not have certification to ISO9000 or equivalent certification. (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 Plan;

14 Page 10 of 9 o Test Plans for any Brand Name product for which the Brand Name holder is defining their own Test Plan. (c) References to the Certificates of Conformity (or allocated reference numbers) for the Brand Name products (d) 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 Registration request, and that a copy of the report and outcome of the audit will be copied to the brand name Registration Holder; A copy of the Brand Name Applicant s Internal Audit Procedure; Audit Schedule, and planned Audit Agenda. (e) Where the original Registration Holder is not appointed as either an Agent or Authorised Representative of the Brand Name Applicant, authorisation from the original Registration Holder to use their Registration and supporting information in support of the Brand Name application. 9.5 Process for Brand names The Brand Name process will generally follow the same review process as for the original application. However TÜV SÜD 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 TÜV SÜD BABT reserves the right to require an audit be conducted.

15 A.1 of 1 Annex A Information required for an Application A.1 General The following information is required to progress the application. Where you complete application form BABT796, 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.1.1 A.1.2 A.1.3 A.1.4 Sections A.1-2 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 both the Registration and the Certificate of Conformity. Contact Details: This is the person within the applicant company who will be the main contact point for communication with TÜV SÜD 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 CPD Certificates. Third party Fabricators may not apply. Section A.3 Other Contacts Where an Authorised Representative signs the application on behalf of the manufacturer ( i.e. the manufacturer is the applicant) then you should provide details of the Authorised Representative. Where the Applicant wishes another party to either manage the application (or be otherwise involved) they must include with the application a letter clearly defining the scope of the Agent s activities. 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 TÜV SÜD 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 TÜV SÜD BABT to communicate with them directly. Section A.4-5 Application Details A.4: Please indicate the Type of Application (Original or Brand Name). For Brand Name applications we either need a TÜV SÜD BABT Registration Number or TÜV SÜD BABT Reference Number (for applications in progress).where you wish to apply for an original Registration and Brand Name Registration at the same time, please contact TÜV SÜD BABT in advance to reserve a reference number for the original product. A.5: You must identify the Product Name, Type of Product by referencing the applicable standard, and the Allocated TÜV SÜD BABT Certificate of Conformity number Section A.6-8 Holders Quality System and Related Information A.6-7: Where the Applicant s company holds a Certificate to ISO9000 or equivalent, then please include a copy of the certificate (and any annex) in English with the application. A.8: 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 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.2 Section B: Facility Site Details The following information is required related to the Fabricator s site: A.2.1 Section B.1: Site Information Comprising: Facility Company name and address

16 A.2 of 1 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.2.2 A.2.3 A.2.4 Section B.2: 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 Section B.3: 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 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 Sections B 4-6: Employees 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 of CPD products Total number of personnel on this site involved with Quality Assurance activities. A.2.5 A.6.5 Sections B.7-9 The following information is required about the Fabricator s quality system: B.7 : A statement on whether the site operates under a documented quality system. B.8: If so, to which standard is the quality system compliant. B.9: If ISO 9001 or Other, then please supply a copy of the Certificate and any associated Annex with the application in English. B.10. Indicate the earliest date when the facility will be ready for an audit to be able to demonstrate a compliant quality system. Quality System currently certified by TÜV SÜD BABT : Where the facility holds an ISO9001, PQC, or FQA Certificate from TÜV SÜD BABT then you only need to list the number. Quality System currently certified by another Certifier: If you wish your current certification to be taken into account during our audit visit, your certificate must be issued by a TÜV SÜD BABT recognised ISO/IEC accredited certification body, and our auditor must be given full access to relevant audit records to verify the maintenance elements pertinent to your certification during our visit. Parallel Certification to ISO9001: Where you do not hold a third party ISO9001 quality system certification for a site you may apply to TÜV SÜD BABT in parallel to your Product Control Registration application (noting on each the parallel application). TÜV SÜD BABT will where possible combine audits to the CPD and ISO9001 requirements. Alternatively if you have an ISO9001 certification in progress with another certifier you may advise TÜV SÜD BABT who will, on request, postpone reviewing the ISO9001 specific requirements until either the third party certificate is granted or you request a separate TÜV SÜD BABT audit to the relevant requirements. Additional Options within the PQC Scheme : Where you have requested a PQC certificate to another module of the standard this may be included within an extended audit to cover both certification instances. You must however apply for each separately but advise TÜV SÜD BABT that parallel applications are being made.

17 A.3 of 1 A.3 Section C Additional Documentation A.3.1 Section C.1: 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: The Compliance Plan has 2 purposes Record of how the manufacturer demonstrates compliance with the relevant requirements of BABT AP008 parts 1, 2 and Annex J with reference to the relevant quality processes, location where they are met and who (or which department/organisation) holds the responsibility for the compliance { e.g. which processes are controlled by the Holder and which by departments of the Fabricator} Aid to the Auditor in planning future Audits of the Facility in an efficient and beneficial manner. It is not necessary to include details within the plan where references out to the Quality Manual or Process Documentation provide the necessary information. A.3.2 Section C.2- List of Test Plans for each product You must supply a list of the relevant agreed Test Plans for each product to be manufactured at the facility under the CPD Where some/all the Test Plans have not yet been agreed you must supply a date by which the list will be provided. (Note: TÜV SÜD BABT cannot confirm an Audit date without this information). A.4 Section D: Manufacturing Functions Performed at this Site Please identify the locations performing the functions detailed in the table. A.5 Section E: 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 TÜV SÜD BABT and/or its associate companies to discuss your application with that named person/company (or any other person) you must formally authorise TÜV SÜD 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 Section F: Payment Details This details information required relating to your intended method of payment. Where you already have a contract with a TUV Office (or TÜV SÜD BABT) for a number of services, including this one, you do not have to complete this section. Work is carried out on receipt of either payment in advance or a valid purchase order number. Clients applying directly to TÜV SÜD BABT (i.e. not through any other TUV Group office), who do not currently have approved credit facilities with either TÜV SÜD BABT or TUV Product Service 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 name or address differs from the Main Contact listed previously (to be included with supporting information). Purchase Order or Credit Card details. A.7 Section H: Agreement Normally the person named in Section A is required to formally agree to conform to the TÜV SÜD BABT Certification Regulations. However an Agent may sign provided they hold the appropriate authorisation from the Applicant. A.8 Documentation to Accompany an Application The Checklist provides a ready list of required documents.