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RECOMMENDATION FOR USE

CO-ORDINATION BETWEEN NOTIFIED BODIES

DIRECTIVES 96/48/EC, 2001/16/EC AND 2008/57/EC ON

THE INTEROPERABILITY OF THE RAIL SYSTEM WITHIN THE COMMUNITY

RFU-STR-001

Issue 03 Date: 10/02/2010 Page 1 of 8

TITLE CONTENT OF ISSUED CERTIFICATES ORIGINATOR NB Rail Sub-Group Strategy SUBJECT RELATED TO Directives 96/48/EC, 2001/16/EC, 2004/50/EC, 2007/32/EC, 2008/57/EC and 2009/131/EC Decision 768/2008/EC

DESCRIPTION AND BACKGROUND EXPLANATION Harmonisation of certificate presentation. Decision 93/465/EEC was setting out modules used to assess conformity. These are further detailed in Railway Interoperability TSIs until end 2009. The decision 768/2008/EC on a common framework for the marketing of products is repealing Decision 93/465/EC. In the future, the modules will be detailed in a separate Decision and no more inside the TSIs. The identification of the new modules is not yet incorporated in this RFU. Existing modules will remain applicable according to the application of that TSI in which they are described. Certificates vary in form and validity depending on the assessment module used. NB Rail recommends a uniform format of certificate for each assessment module and has defined two certificate models. Due to the broad range of possible certification NB Rail does not propose to fully standardise the content of the certificates. However, it judged that the following indications are at least to be found in any case on the front page and an additional annex. The notified body is free to complete the certificate and its technical file with the indications deemed to be appropriate for comprehensive information and to improve a mutual recognition. Certificates including their annex can be issued in monolingual or bilingual versions. For the technical file a monolingual version is sufficient to avoid translation errors. Translations of documents shall be marked as such with reference to the original version. RFU PROPOSAL A) Contents of Certificate RFU Proposal: Necessary indications of a Certificate to be included in its front page and an additional annex (in case of bilingual certificate: language of applicant in the community and English) 1) Type and identification number of the certificate (see below B and C) 2) European legal base and reference of Directives 96/48/EC, 2001/16/EC, 2004/50/EC, 2007/32/EC, 2008/57/EC, 2009/131/EC where applicable. 3) Designation of the interoperability constituent/subsystem certified (type, product family, identification, version number, etc) 4) Name and address of applicant: the manufacturer (or of his authorized representative established within the

RECOMMENDATION FOR USE

RECOMMENDATION FOR USE

CO-ORDINATION BETWEEN NOTIFIED BODIES

DIRECTIVES 96/48/EC, 2001/16/EC AND 2008/57/EC ON

THE INTEROPERABILITY OF THE RAIL SYSTEM WITHIN THE COMMUNITY

RFU-STR-001

Issue 03 Date: 10/02/2010 Page 2 of 8

Community) or the applicant for a certified interoperability constituent the contracting entity or manufacturer (or his authorized representative established within the Community) for a certified subsystem (or its phase / part in case of intermediate statement of verification) and, if applicable, company(ies) responsible for the design of the subsystem and the assembly of sub-assemblies and manufacture of the subsystem Location of Manufacture (if different from address as mentioned above) Company name and location whose quality management system has been assessed (if different from name and location as mentioned above) 5) Name and address of the Notified Body and its registration number at the European Commission 6) Statement about the certification results (NB's statement declaring the conformity of the Interoperability constituent, subsystem or its phase / part, or quality management system with the appropriate requirements or formally confirming the results of his investigations. This is the central statement in the certificate) 7) Framework of assessment / verification o TSI's o Standards or other documents referred to in the TSI's (and hence mandatory), where applicable o Standards or other documents not referred to in the TSI's (and hence voluntary), where applicable 8) Reference to annex 9) Restrictions and conditions (conditions for use, functioning, time period of validity); not for QMS Approval 10) Modules used 11) Where applicable, reference to superseded certificate in case of replacement, extension or renewal 12) Place, date of issue, signature of the authorized signatory of the Notified Body B) Certificate Types Rail Notified Bodies may issue EC certificates of the following types: 1. Type Examination Certificate (B, SB) 2. Design Examination Certificate (H2, SH2) 4. Quality Management System Approval (D, SD, H1, H2, SH2)* 5. Certificate of Conformity (A1, F, SD, SF, SG, SH2) 7. Suitability for Use Certificate (V)** 8. Intermediate Statement of Verification (SB, SD, SF, SG, SH2) In brackets the Module that leads to the indicated type is given.

RECOMMENDATION FOR USE

RECOMMENDATION FOR USE

CO-ORDINATION BETWEEN NOTIFIED BODIES

DIRECTIVES 96/48/EC, 2001/16/EC AND 2008/57/EC ON

THE INTEROPERABILITY OF THE RAIL SYSTEM WITHIN THE COMMUNITY

RFU-STR-001

Issue 03 Date: 10/02/2010 Page 3 of 8

Notes: · Certificate type 3, Design examination report, is now incorporated within Certificate type 2, Design Examination Certificate and is no longer supported. Certificates of type 3 that have been issued continue to remain valid until their normal expiry. Certificate type 6, Certificate of EC Verification (in 2008/57/EC: EC Certificate of Verification), is now incorporated within Certificate type 5, Certificate of Conformity and is no longer supported. Certificates of type 6 that have been issued continue to remain valid until their normal expiry. *This is not an approval for the Quality Management System documentation but of its suitability for the intended purpose to deliver compliance with the interoperability Directives and its effective implementation ** Suitability for use is defined in module V to be equivalent with conformity by in service experience

·

·

·

C) Certificate numbering A certificate is to be numbered as follows: NNNN / T / M / YR / SSS / C1C2 / # NNNN: Notified Body Registration number at the European Commission T: Type number of certificate ­ See above B) M: Module (SB, SH2 etc.) as appropriate 1, 2 or 3 characters YR: Year of first issue (2 digits are sufficient) SSS: Subsystem concerned · INS / INF Infrastructure (according to different TSI versions) · RST Rolling Stock · ENE Energy · CCS Command/Control/Signalling C1: Master Language of certificate and Technical File (use EU codes) · e. g. DE = German, EN = English, FR = French etc. C2: Second language of certificate (where used) #: Unique number(s) as desired by each NoBo. Note: The original issuing Notified Body may continue to use a previously issued number on reissue of a certificate, provided that there is no change to scope, there are no changes to the product, the product continues to comply with the TSI in force and there has been no break in certification from the previously issued certificate. Where a previous number is retained, the Certificate number must include an issue reference. Example Certificate Front Page and annex templates for the different types of certificates are listed in the annex 1 to this RFU. DATE OF AGREEMENT AT NB RAIL PLENARY MEETING 10/02/2010 (PM 28)

RECOMMENDATION FOR USE

REF: RFU-STR-001 Annex 1 Certificate templates Issue Date: 10/02/2010

This Annex defines templates and additional annexes for the certificates described above Notes: The certificates are shown only to demonstrate a common layout in order that certificates used across different Member States might appear similar and contain the same information in the same places. The precise text, including any legal attestations, is the responsibility of the issuing Notified Body and no vicarious liability is accepted by NB Rail or any contributors to these documents.

LOGO

[Type Examination Certificate][Design Examination Certificate][Certificate of Conformity][Suitability for Use Certificate] [Intermediate Statement of Verification]

Certificate Number: NNNN / T / M / YR / SSS / C1C2 / # In accordance with Directive [96/48/EC of 23rd July 1996 on the interoperability of the transEuropean high-speed rail system] [2001/16/EC of 19th March 2001 on the interoperability of the trans-European conventional rail system] [as amended by Directive 2004/50/EC of 29th April 2004 and 2007/32/EC of 1st June 2007] [2008/57/EC of 17 June 2008 on the interoperability of the rail system within the Community] [as amended by Directive 2009/131/EC of 16th October 2009] the following [Interoperability Constituent][Subsystem] (as detailed in the attached annex): (DESIGNATION) (and UNIQUE SERIAL NUMBERS ­ A1, F, SF, SG Only) of Applicant: (NAME, ADDRESS) (and MANUFACTURING LOCATION, if different from this address) has been assessed by: (NB NAME & APPOINTED ADDRESS) [in respect of compliance with the applicable requirements of ([Type][Design] Examination Certificate Number NNNN / T / M / YR / SSS /C1C2/# - if applicable, not module V - and)] [to ascertain suitability for use demonstrated by type validation by in-service experience as detailed in ­ V only] the above Directive. The [Interoperability Constituent][Subsystem] was shown to comply*, subject to any restrictions and conditions listed on the attached annex, which forms part of this certificate. This [Type Examination][Design Examination][Conformity Assessment][Type Validation by inservice Experience][Intermediate Statement of Verification] has been performed (for the [design][production] phase ­ ISV only) by application of Module [A1, B, D, F, H2, V, SB, SD, SF, SG, SH2] of the relevant decision adopted pursuant to the Directive. This certificate is valid [until (if applicable, duration according to relevant TSI)] for the (DESIGNATION) (and UNIQUE SERIAL NUMBERS ­ A1F, SF, SG Only), the design, ratings and operational parameters of which are described in the annex (and associated EC Declaration of Conformity and Certificates of Type or Design Examination ­ V only). (Where applicable:) This certificate supersedes / replaces / extends certificate number ... Place and Date of Issue: (DATE) Identification Number of Notified Body: xxxx Signature:____________________________ On behalf of (Notified Body) Name:_____________________________ Title:______________________________

The Essential Requirements have been assessed as being met through compliance with the technical requirements of the relevant TSI only.

*

TypeExamination /Design Examiantion / Conformity /Suitability for Use/ ISV Certificate Template 10/02/2010

Page 1 of 2

Annex to [Type Examination Certificate][Design Examination Certificate][Certificate of Conformity][Suitability for Use Certificate][Intermediate Statement of Verification] Number NNNN / T / M / YR / SSS / C1C2 / # for the [Interoperability Constituent][Subsystem] (DESIGNATION) (and UNIQUE SERIAL NUMBERS ­ A1, F, SF, SG Only) of Applicant: (NAME & ADDRESS) (and MANUFACTURING LOCATION, if different from this address) Technical file: Description Reference Status

Characteristics of the [Interoperability Constituent][Subsystem]: List the key characteristics, example line speed, voltage etc Scope of assessment: E.g. complete subsystem or part (e.g. CCS - trackside or onboard equipment), upgrade/renewal (list changes), geographical area. Applicable TSI and further regulatory framework: List and references of TSI, notified national technical rules, RID etc. Applicable Restrictions and conditions: List any restrictions or detail the section in the technical file where the list of restrictions can be found.

(Where applicable:) Details of associated Interoperability Constituents references to Declarations ­ date, reference, Notified Body etc ­ or reference to section of technical file where list can be found: List of Standards (or the section of the

technical file where the list can be found) Standard Number Title Revision

List of Approved Documents (or the section of the technical file where the list can be found) (to include concluding report of findings from testing organisation) Title Description Origin / Reference Reference Revision Issuing Body

Relevant issued certificates e.g.

(Where applicable:) The data detailing servicing, routine maintenance and adjustment can be found in section xxxx of the technical file (Where applicable:) The applicant has included information within their application affirming compliance of the [interoperability constituent][subsystem] with the following Directives in addition to Directive [96/48/EC][2001/16/EC][2008/57/EC]: (Where applicable:) Information supplied by the applicant has been included in section XX of the Technical File. (Module V only:) Details of Infrastructure manager and Train operating Company(s) relating to the in-service experience:

Place and Date of Issue: (DATE) Signature:____________________________ On behalf of (Notified Body)

Type Examination /Design Examination / Conformity /Suitability for Use/ ISV Certificate Template 10/02/2010

Page 2 of 2

LOGO

Quality Management System Approval *

Certificate Number: NNNN / 4 / M / YR / SSS / C1C2 / # In accordance with Directive [96/48/EC of 23rd July 1996 on the interoperability of the transEuropean high-speed rail system], [2001/16/EC of 19th March 2001 on the interoperability of the trans-European conventional rail system] [as amended by Directive 2004/50/EC of 29th April 2004 and 2007/32/EC of 1st June 2007] [2008/57/EC of 17 June 2008 on the interoperability of the rail system within the Community] [as amended by Directive 2009/131/EC of 16th October 2009] the Quality Management System of: (NAME) at (LOCATION) has been assessed by: (NB NAME & APPOINTED ADDRESS) in respect of compliance with the applicable requirements of the above Directive. The assessment found the quality management system to comply for the technical and functional scopes associated with the following [Interoperability Constituents][Subsystems]; (DESIGNATION) This certificate is valid until ... The validity of this certificate is subject to (continued compliance with the [Design][Type] Examination Certificate(s) as listed on the attached annex, which forms part of this certificate and - D, H2, SD, SH2 Only) the continued maintenance of the Quality Management System in accordance with the requirements of the above Directive as monitored through regular and unannounced surveillance. The Quality Management System Approval has been performed by application of Module [D, H1, H2, SD, SH2] of the relevant decision adopted pursuant to the Directive. (Where applicable:) This certificate supersedes / replaces / extends certificate number ...

Place and Date of Issue: (DATE) Identification Number of Notified Body: xxxx Signature:____________________________ On behalf of (Notified Body) Name:_____________________________ Title:______________________________

This certificate indicates that the Notified Body has verified the existence, suitability and active management of a quality system relating to the particular Interoperability Constituent and/or Subsystem. It is not a formal granting of ISO9001 etc status. The Essential Requirements have been assessed as being met through compliance with the technical requirements of the relevant TSI only.

*

QMS Approval Template 10/02/2010

Page 1 of 2

Annex to Quality Management System Approval Number NNNN / 4 / M / YR / SSS / C1C2 / # for the Quality Management System of Applicant: (NAME & ADDRESS) (and MANUFACTURING LOCATION, if different from this address) List of Approvals and other certification (This list must include the Design/Type Examination Certificates included as part of the assessment. References to any existing Quality System Certificates must be restricted to those directly pertaining to this certificate) Title Issuing Organisation Certificate No. Date Validity/Expiry

The initial assessments and continued surveillance of the Quality Management System are conducted in accordance with the TSI. Copies of all audit reports are retained by the Notified Body, file reference xxxx. Relevant issued certificates (D, H2, SD, SH2 only) e.g. Description Reference Issuing Body

(Where applicable): The data detailing servicing, routine maintenance and adjustment can be found in section xxxx of the technical file. (D, H2, SD, SH2 Only) The applicant has included information within their application affirming compliance of the [interoperability constituent][sub-system] with the following Directives of the European Parliament, in addition to Directive [96/48/EC][2001/16/EC][2008/57/EC]: (Where applicable) Information supplied by the applicant has been included in section XX of the Technical File.

Place and Date of Issue: (DATE) Signature:____________________________ On behalf of (Notified Body)

QMS Approval Template 10/02/2010

Page 2 of 2

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