united kingdom - production - quality assurance (module D) or product - quality assurance (module E)

application for module D or E

Applicant

The application may be lodged only:

• by the manufacturer directly whether or not he is located in the United Kingdom, or

• by the authorised representative of the manufacturer.

The application is to be lodged with a single Approved Body.Reference is made to “the Regulations” Schedule 2 PART 2 for module D or “the Regulations” Schedule 2 PART 3 for module E.Reference is made to “the Regulations” article 2 for definitions (recalled in the related procedure).

Application form

The application forms to be filled in by the applicant for an initial certification or renewal/modification are given in attached documents.

Documents to be included with the application

The application for initial certificate shall include:

• the application form,

• the existing certification to ISO 9001 and the last audit report, where available,

• when the manufacturer is changing of Approved Body, the quality system approval Module D or E certificate and the audit reports issued by the previous Approved Body (at least the latest one plus the initial audit),

• the list of UNITED KINGDOM type-examination certificates for the product(s) concerned (module B) when they are issued by Recognised Organisation (RO),

• the copy of the UNITED KINGDOM type-examination certificate(s) for the product(s) concerned (module B) and all the supporting technical documentation, when they are not issued by Recognised Organisation (RO),

• the quality system documentation as detailed hereafter,

The quality system documentation shall contain the following elements:

• documents describing the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

• documents describing the manufacturing, quality control and quality assurance techniques, processes and systematic actions that are used,

• in case of a Module D the documents describing the examination and tests that are carried out before, during and after manufacture, and the frequency with which they are carried out,

• in case of a Module E the documents describing the examination and tests that are carried out after manufacture, and the frequency with which they are carried out,

• documents describing the quality records, such as inspection reports and test data, calibration data, qualification of the personnel concerned etc.,

• documents describing the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

In the case of a modification or a renewal, the application shall include the appropriate documents.

Entries in VPM-REC

The application is to be entered in VPM-REC with corresponding data filled up and associated documents uploaded as applicable.

review of application for module D or E

Contract review

The application is reviewed at the RO local office level:

• to check that the application form is correctly filled up and signed,

• to check that the request is within the scope of “the Regulations” and for items for which Recognised Organisation (RO) is notified,

• to check the presence of the required documents as per 1.3,

• to check that RO qualified auditors for UK Modules D & E are available to perform the activity.

Any known difference in understanding with the client is to be resolved, including agreement regarding the requirements and the sites to be audited.DO-EMC may be consulted as found necessary.In case Recognised Organisation (RO) declines the application as a result of the review, the reasons shall be documented and communicated to the manufacturer.Appropriate records of the review are to be kept locally.

agreement between Recognised Organisation (RO) and the manufacturer

General

The contractual terms are to be agreed if the application is considered acceptable.The format of agreement available in attached documents is to be used and is to be attached in VPM.Amendment to the agreement version may be used as judged appropriate (typically for any changes affecting content of Appendix 1 or Appendix 2, could be relevant at the occasion of renewal of the Module D or E certificate).DO-EMC is to be consulted if modifications are brought to the generic articles of the typical agreement forms provided in attached documents.

Audit programme

The audit programme (initial audit, surveillance audits, renewal audit) is to be defined in the agreement taking into consideration the size of the manufacturer’s organisation, the scope of the application and the complexity of the products and their manufacturing processes. The audit programme is to be recorded in VPM-REC.The first surveillance audit date following an initial certification is not to be more than 12 months from the last day of the initial audit.The other surveillance audits shall be programmed with a minimum frequency of one per year. A maximum time window of plus or minus 3 months period may be agreed.Unplanned audits may be performed during the 3 years certification period.Renewal audit is to be programmed before the expiry of the certification period.DO-EMC may be consulted as deemed necessary.

requirements for manufacturer’s quality system

Quality system requirements for Module D

Reference is made to “the Regulations” Schedule 2 about module D article 14.“The quality system must ensure that the products are in conformity with the type described in the UNITED KINGDOM type-examination certificate and that they comply with the requirements of the international standards that apply to them.All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records.It must, in particular, contain an adequate description of :

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,

• the corresponding manufacturing, quality-control and quality assurance techniques, processes and systematic actions that will be used,

• the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

• the quality records, including inspection reports and test data, calibration data, qualification reports on the personnel concerned,

• the means of monitoring the achievement of the required product quality and the effective operation of the quality system.”

Quality system requirements for Module E

Reference is made to “the Regulations” Schedule 2 about module E article 20.“The quality system must ensure compliance of the products with the type described in the UNITED KINGDOM type-examination certificate and with the applicable requirements of the international standards.All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records.It must, in particular, contain an adequate description of :

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,

• the examinations and tests that will be carried out after manufacture,

• the quality records, including inspection reports and test data, calibration data, qualification reports on the personnel concerned,

• the means of monitoring the achievement of the required product quality and the effective operation of the quality system.”

initial audit

Audit plan

An audit plan is to be prepared by the auditor and communicated to the manufacturer in general prior to the on-site audit. The audit plan shall include at least the following items:

1. The audit objectives which shall include:

   • Determination of the conformity of the manufacturer’s quality management system with the audit criteria,

   • Evaluation of the ability of the manufacturer’s quality management system to ensure the manufacturer’s organisation meets “the Regulations” requirements for the concerned module,

   • Evaluation of the effectiveness of the manufacturer’s quality management system to ensure the manufacturer’s organisation is continually meeting the “the Regulations” requirements for the concerned module,

2. The audit criteria:

   • “the Regulations” and the UNITED KINGDOM type-examination certificates for the concerned products,

   • the manufacturer’s processes and quality documents,

3. The audit scope:

   • Describes the physical locations, units, activities and processes to be audited,

4. The dates and sites where the audit is to be conducted,

5. The expected time and duration of the on-site audit,

6. The name of the lead assessor and the name and role of the other audit team members if any, Necessary work documents for the audit are to be prepared (forms to record findings, check-lists, report etc.). Typical forms are available in attached documents.

The audit plan is to be recorded in VPM-REC.

Selection of audit team for QMS certified to ISO 9001

The audit team is to be composed by the RO local office based on the following criteria:

• RO lead auditor and other RO auditor as deemed necessary, both qualified as RO auditor for UK Modules D and E as per the network activities qualification procedure considering that at least one member of the team is to have experience in the product technology concerned (typically evidenced in case of a RO auditor having a qualification as RO surveyor for the concerned product),

• The scope and estimated time of the audit, see 5.4.

DO-EMC may be consulted as deemed necessary.Trainee auditors may be included in the audit team as participants provided that a qualified auditor is appointed as tutor and has final responsibility for the activities and findings of the trainee auditor.Technical experts may be included in the audit team and shall operate under the direction of the lead auditor.

Translators or interpreters may be included in the audit team and shall operate under the direction of the lead auditor.The lead auditor shall assign to each team member responsibility for auditing specific processes, functions, sites, areas or activities taking into account their skills and roles (qualified auditor, trainee auditor, and technical expert). Changes may be made as the audit progresses.

Selection of audit team for QMS not certified to ISO 9001

The audit team is to be composed by the RO local office based on the following criteria:

• RO lead auditor qualified as RO senior auditor for UK Modules D and E as per the network activities qualification procedure considering that at least one member of the team is to have experience in the product technology concerned (typically evidenced in case of a RO auditor having a qualification as RO surveyor for the concerned product), Other auditors if any shall be qualified as RO auditors for UK Modules D and E.

• The scope and estimated time of the audit, see 5.4.

DO-EMC may be consulted as deemed necessary.Trainee auditors may be included in the audit team as participants provided that a qualified auditor is appointed as tutor and has final responsibility for the activities and findings of the trainee auditor.Technical experts may be included in the audit team and shall operate under the direction of the lead auditor.Translators or interpreters may be included in the audit team and shall operate under the direction of the lead auditor.The lead auditor shall assign to each team member responsibility for auditing specific processes, functions, sites, areas or activities taking into account their skills and roles (qualified auditor, trainee auditor, and technical expert). Changes may be made as the audit progresses.

Determination of audit time

The RO local office has to determine the audit time using the guide given in attached documents.In case of multi-sites, each site is to be audited and the corresponding time determined.The audit time determined and the justification for the determination shall be recorded.

Observers

The presence of observers during an audit is to be indicated to the manufacturer (like external auditors or internal auditors). The audit team shall ensure that the observers do not interfere in the audit process.

Documents

Necessary work documents for the audit are to be prepared (forms to record findings, audit check-list, audit report etc.). Forms are available in attached documents.

Review of manufacturer’s Quality Management System documentation and UNITED KINGDOM type-examination certificates

The documentation supplied by the manufacturer is to be reviewed in general prior to the on-site audit to determine if the system, as documented, is satisfying the requirements of the reference documents.A record of the review is to be maintained with appropriate mean (like stamping according to the related qualification procedure or other mean).It is to be verified that UNITED KINGDOM type-examination certificates (module B) concerned by the module D or E application are referring to “the Regulations” requirements in force and instructions given by DO-EMC circulars related to applicable up-to-date version of requirements. In case of doubt MPA Unit specialists are to be consulted.Guidance for the review is given by the check-list available in attached documents.

On-site audit

Opening meeting

An opening meeting with the manufacturer's management or responsible designated persons is to be conducted and shall include the following items (see audit checklist):

• record attendance to opening meeting,

• confirm or amend the audit plan,

• confirm matters related to confidentiality,

• confirm safety and security procedures for the audit team,

• confirm guides designated to accompany the auditors,

• remind that the audit is based on sampling method,

• exchange necessary information including questions from the manufacturer.

Collection and verification of evidences

The audit process is to include the following items:

• Visits of the production facilities and other parts of the organisation with the guides designated by the manufacturer,

• Product focused items of checklist which may include witnessing of examinations or tests,

• The marking foreseen (or applied in case of a surveillance or renewal audit) by the manufacturer is to be checked for its compliance with “the Regulations” article 15, 20 and schedule 2 article 16, 22 requirements for marking (type of marking, format of marking).

• Interviews, observation of processes and activities, review of documentation and records and collection of evidences,

• Verification of evidences with regard to requirements for possible findings and preparation of conclusions,

• Findings shall be discussed with the manufacturer to ensure that the evidence is accurate and that they are understood. The auditor shall refrain from suggesting the cause of findings or their solutions,

• Prepare the audit conclusions: review and agree the findings among the audit team, identify any necessary follow-up action, confirm the appropriateness of the audit programme or identify modification required (like surveillance frequency).

Closing meeting

A closing meeting with the manufacturer's management or responsible designated persons is to be conducted and shall include the following items (see audit checklist):

• record attendance to closing meeting,

• present the audit conclusions and the findings to the manufacturer,

• advise the manufacturer that the audit evidence collected was based on a sample of information, thereby introducing an element of uncertainty,

• give the method and time frame for the audit report,

• give the process and time frame to handle the nonconformities and their consequence on the certification.

• inform about the complaint and appeal process.

audit findings and report

Audit findings

Findings are to be graded as nonconformities or observations.A nonconformity is defined as a non-fulfilment of a requirement specified by “the Regulations” for module D or E, by the manufacturer’s quality documents, by the UNITED KINGDOM type-examination certificate or other applicable documents.Nonconformities shall be recorded against a specific requirement, be clear and based on an evidence.An observation is an audit finding not categorised by the auditor as a nonconformity.The findings are to be recorded in VPM-REC.

Audit report

An audit report is to be issued by RO local office in the agreed time period. The format of report to be used is given in attached documents.The audit report is to be recorded in VPM-REC.

treatment of findings

Nonconformities

Action plan by manufacturer

For each nonconformity issued, the manufacturer has to submit to RO local office within the defined time:

• the description of the correction of the detected nonconformity,

• the analyse of the cause of the nonconformity,

• the corrective action defined in order to eliminate the cause of the nonconformity.

The defined time to submit the action plan is in general one month from the date of the audit unless otherwise defined by the auditor.Note: In the case of nonconformities which directly affect the conformity of the products to the type certified to module B, the manufacturer has to identify all the products concerned and take the appropriate action for their correction.

Review of manufacturer’s action plan by RO local office

The replies and documents submitted by the manufacturer are to be reviewed by RO local office.RO local office shall inform the manufacturer of the acceptance or non-acceptance of the described correction, of the cause analysis and of the proposed corrective action.In case of acceptance the RO local office shall inform the manufacturer of the defined time to submit the evidences of actions taken. The defined time to submit the evidences is in general three months from the date of the audit unless otherwise defined by the auditor. Defined time shall not exceed six months.Acceptance shall be recorded in VPM-REC.In case of non-acceptance, the manufacturer has to submit a new proposal.

Verification of evidences of actions taken and resolution of nonconformity

Upon completion by the manufacturer of the accepted actions, RO local office shall verify the submitted evidences of implementation of any correction and corrective actions.The verification of evidences of implementation of correction and corrective actions may be carried out based on a review of documentation provided by the manufacturer, or where necessary, through verification on-site (additional visit or audit).The client shall be informed of the result of the verification. In case of acceptance, the manufacturer shall be informed that the nonconformity is resolved. In case of non-acceptance, the manufacturer has to submit additional evidencesThe evidence obtained from the manufacturer to support the resolution of nonconformities shall be recorded, with appropriate record in VPM-REC.

Verification of effectiveness of actions taken

The effectiveness of correction and corrective action is to be verified at the next audit as foreseen in the audit checklists.

Observations

Actions by manufacturer

For each observation issued, the manufacturer has to submit to RO local office within the defined time:

• proper action defined for the resolution of the observation.

Review by RO local office

The replies and documents submitted by the manufacturer are to be reviewed by RO local office.RO local office shall inform the manufacturer of the acceptance or non-acceptance of the defined action.In case of non-acceptance, the manufacturer has to submit a new proposal.In case of acceptance, the evidence obtained from the manufacturer to support the resolution of the observation shall be recorded, with appropriate record in VPM-REC.

Additional audit

It may be necessary to conduct an additional audit on-site or an additional limited audit on-site to verify the correction of the detected nonconformity, the implementation of the corrective action and their effectiveness.

decision on initial or renewed certification

General

The decision on certification is to be taken based on the results of the audit and the recommendations made by the audit team.The process for certificate management in VPM-REC ensures that the review of evaluation results and the decision are taken independently from the audit team by the RO local manager and the HO Manager or by the HO manager.The notification of the decision on certification is made in general using the audit report and the certificate, if any, delivered to the manufacturer.

Decision and treatment of observations

The decision on certification may be taken before the manufacturer’s proposal for action.

Decision and treatment of nonconformities not directly affecting conformity to type

Where a nonconformity does not directly affect the conformity to type, the decision on certification is to be taken once the manufacturer’s proposals for correction and corrective action have been reviewed and found acceptable by RO local office.

Decision and treatment of nonconformities directly affecting the conformity to type

Where a nonconformity is directly affecting the conformity to type, the decision on certification is to be taken once the manufacturer’s correction and corrective action have been implemented and have been reviewed, found effective and acceptable by Recognised Organisation (RO).

surveillance of quality system approval

Programmed surveillance audit

General

The surveillance audits programmed as per the signed agreement are to be performed at the request of the manufacturer during the agreed time frame in accordance with these instructions within +/- 3 months of the anniversary date.If the surveillance audit is not applied in due time by the manufacturer, RO local office has to inform the manufacturer of the situation including possible suspension or withdrawal of the certification.

Audit plan

Reference is made to 5.1.The surveillance audits are not necessarily covering all the requirements for “the Regulations” Module D or E.The following items related to the Quality System are to be audited:

• management review and internal audits,

• review of actions taken on nonconformities identified during the previous audit,

• treatment of complaints,

• continuing operational control of production and traceability,

• review of any changes,

• use of United Kingdom conformity marking and references to certification.

In addition to the above quality management system aspects, the following quality records relative to the scope of product(s) covered by the Module D are to be audited :

• manufacturer's inspection reports and traceability records,

• manufacturer's or laboratory's test reports performed on manufactured products,

• testing equipment calibration data,

• qualification reports of the personnel concerned.

If possible, during the audit, inspections and tests carried out by the manufacturer during the various stages of manufacturing (module D) and for the final acceptance of the product(s) (module D or E) may be witnessed.It is to be verified that UNITED KINGDOM type-examination certificates (module B) concerned by the module D or E application are referring to “the Regulations” in force and instructions given by DO-EMC circulars related to applicable up-to-date version of requirements. In case of doubt MPA Unit specialists are to be consulted.The manufacturer must keep RO local office informed of any intended updating of the quality system.Appropriate actions are to be taken by RO local office like a specific audit as necessary.

Selection of audit team for QMS certified or not certified to ISO 9001

The audit team is to be composed by the RO local office based on the following criteria:

• RO lead auditor and other RO auditor as deemed necessary, both qualified as RO auditor for UK Modules D and E as per the network activities qualification procedure considering that at least one member of the team is to have experience in the product technology concerned (typically evidenced in case of a RO auditor having a qualification as RO surveyor for the concerned product),

• The scope and estimated time of the audit.

DO-EMC may be consulted as deemed necessary.Trainee auditors may be included in the audit team as participants provided that a qualified auditor is appointed as tutor and have final responsibility for the activities and findings of the trainee auditor.Technical experts may be included in the audit team and shall operate under the direction of the lead auditor.Translators or interpreters may be included in the audit team and shall operate under the direction of the lead auditor.The lead auditor shall assign to each team member responsibility for auditing specific processes, functions, sites, areas or activities taking into account their skills and roles (qualified auditor, trainee auditor, and technical expert). Changes may be made as the audit progresses.

Observers

The presence of observers during an audit is to be indicated to the manufacturer (like external auditors or internal auditors). The audit team shall ensure that the observers do not interfere in the audit process.

Documents

Necessary work documents for the audit are to be prepared (forms to record findings, check-lists, report etc.). Typical forms are available in attached documents.

On-site audit

Reference is made to 5.8.

Audit report and treatment of findings

Reference is made to SECTION 6 and SECTION 7.Surveillance audits reports and findings are to be recorded in VPM-REC.The findings are to be treated as instructed in SECTION 7.For any nonconformity that may lead to a suspension or withdrawal, the lead auditor has to contact Head Office DO-EMC to determine whether the certification may be maintained.

Non-programmed surveillance audit

Reference is made to 9.1.Non-programmed surveillance audits means audits not included in the audit programme set in the agreement.Non-programmed audits may be included in the surveillance activities as deemed necessary.

renewal of quality system approval

Renewal audit

The purpose of the renewal audit is to evaluate the continued fulfilment of all of the requirements of “the Regulations” for the concerned Module and for the scope of products covered.Reference is made to SECTION 5.The renewal audit shall include the review of previous surveillance audit reports and is to be performed within 3 months of the anniversary date.

Audit report and treatment of findings

Reference is made to SECTION 6 and SECTION 7.

Decision for renewal

Reference is made to SECTION 8.

reduction, suspension or withdrawal of quality system approval

Reduction of the scope of Module D or E certificate

A Module D or E certificate is listing one or several UNITED KINGDOM type-examination certificates.The reduction of the scope of Module D or E certificate means that given UNITED KINGDOM type-examination certificate(s) have to be removed from the Module D or E certificate.The scope of the module D or E certificate is to be reduced in the following cases :

• an audit has evidenced that the manufacturer’s quality system has persistently or seriously failed to meet the applicable requirements for given products,

• the UNITED KINGDOM type-examination certificate(s) are no longer referring to the applicable requirements,

• upon a voluntary request of the manufacturer to reduce the scope of the Module D or E certificate.

The manufacturer is to be notified of the situation in writing by the RO Local Office.The reduction of the scope is to be processed using the modification or renewal process of the quality system approval certificate in VPM-REC as applicable.

Suspension of Module D or E certificate

The module D or E certificate is to be suspended in the following cases:

• an audit has evidenced that the manufacturer’s quality system has persistently or seriously failed to meet the applicable requirements,

• the manufacturer does not allow the surveillance audits or the renewal audits to be conducted at the required intervals,

• upon a voluntary request of the manufacturer to suspend the Module D or E certificate.

The manufacturer is to be notified of the situation in writing by the RO Local Office with a statement that the certificate module D or E is temporarily not valid and that appropriate actions are to be submitted in the agreed time frame.The suspension is to be limited in time and should normally not exceed 6 months.The RO Local Office has to consider the proposals made by the manufacturer to clear the findings and to determine if an audit is necessary in order to unsuspend the certification.Failure to resolve the issues that have resulted in the suspension in the agreed time shall result in withdrawal or reduction of the scope of module D or E certificate, as applicable.The suspension of the module D or E certificate is to be processed using the request for suspension inVPM-REC which is to be transmitted to DO-EMC for confirmation.Upon satisfactory outcome, the certification may be unsuspended with a modification or renewal of the suspended certificate, as applicable. To this end, a request for modification or renewal of the suspended certificate is to be processed in VPM-REC.

Withdrawal of Module D or E certificate

The module D or E certificate is to be withdrawn in case the manufacturer fails to resolve the issues that have resulted in the suspension in a time established by the RO Local Office.The manufacturer is to be notified of the situation in writing by the RO Local Office.

quality system approval certificate

Initial quality system approval certificate

The initial quality system approval certificate is processed using VPM-REC. The certificate is generally issued with an expiry date corresponding to a 3 years period.The initial certificate is numbered automatically with the format :SMS.UK.D/9999/A0 for module D where 9999 is the Recognised Organisation (RO) company code registered in the tool "Company".SMS.UK.E/9999/A0 for module E where 9999 is the Recognised Organisation (RO) company code registered in the tool "Company".

Modification of a quality system approval certificate

The manufacturer may apply for a change to the quality system approval certificate.Appropriate actions are to be taken by RO local office like a specific audit, an editorial change etc.The modification of the certificate is processed using VPM-REC. The expiry date of the certificate is not changed in general.The modified certificate will be automatically numbered with the format:SMS.UK.D/9999/A1, A2 etc. for module D where 9999 is the Recognised Organisation (RO) company code registered in the tool “Company”.SMS.UK.E/9999/A1, A2 etc. for module E where 9999 is the Recognised Organisation (RO) company code registered in the tool “Company”.

Renewal of a quality system approval certificate

The quality system approval certificate subject to renewal is processed using VPM-REC. The expiry date of the certificate is extended to the next 3 years period.The renewed certificate will be automatically numbered with the format:SMS.UK.D/9999/B0, C0 etc. for module D where 9999 is the Recognised Organisation (RO) company code registered in the tool “Company”.SMS.UK.E/9999/B0, C0 etc. for module E where 9999 is the Recognised Organisation (RO) company code registered in the tool “Company”.

Refusal to grant the quality system approval certificate

When Recognised Organisation (RO) decides to refuse to grant the quality system approval certificate, the refusal and the reason of the refusal are to be notified by the RO local office to the manufacturer in writing.

Particular cases

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In case of request for a UK Module D/E when MED Module D/E exists (issued by Recognised Organisation (RO)) and corresponding audit is not due, UK Module D/E certificate can be issued by UK qualified auditor with same validity as MED Module D/E if :

• valid UK Module B exists,

• procedure related to UK marking & UK declaration of conformity exists,

• MED Module D/E audits are up to date.

In this case, please follow below instruction to issue the UK Module D/E:

• Please request a dedicated application form and agreement,

• Create an initial audit for UK Module D/E with the following information:

  • Carried out: put the dates of the last MED audit,

  • Audit plan / Audit report / Audit checklist: put the files corresponding to last MED audit,

  • Other documents: put the procedure related to UK marking & UK declaration of conformity,

  • Date of next audit: put the same date as next MED audit,

• Validity date of UK Module D/E is to be manually set to the same as MED Module D/E.

For next audit, both MED and UK Module D/E audits will have to be carried out at the same time (for UK audit, "ADDITIONAL CHECK-LIST TO MED 2014/90/EU MODULE D AUDIT CHECK-LIST" available in attached files).

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In case of request for a UK Module D/E when MED Module D/E exists (issued by Recognised Organisation (RO)) and corresponding audit is due:

• Specific UK Module D/E check-list, additional to MED D/E one is to be used by UK qualified auditor,

• UK Module D/E Certificate can be issued by UK auditor with same validity as MED-D/E

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In case of request for a UK Module D/E when MED Module D/E ((issued by Recognised Organisation (RO)) does not exists:

• full UK check-list is to be used by UK qualified auditor,

• UK Module D/E Certificate can be issued by UK qualified auditor with 3 years validity.

marking of the product

Marking in compliance with “the Regulations”

Reference is made to “the Regulations” article 16 for the requirements on marking.The format of marking is defined in the MSN 1874 as amendment as defined in “the Regulations” article 16.The United Kingdom conformity mark shall be followed by the Recognised Organisation (RO) Marine & Offshore identification number 8517 and by the year (4 digits or last 2 digits) in which the mark is affixed.The United Kingdom conformity mark shall be affixed at the end of the production phase.Example of United Kingdom conformity marking:

8517/YY

Or

8517/YYYY

where 8517 is Recognised Organisation (RO) Approved Body Number and YY the year of affixing the conformity mark.

Marking of product where the USCG marking is requested based on the US - UK MRA on marine equipment

Case 1:Recognised Organisation (RO) Marine & Offshore has performed the assessment for both modules B+D or B+E. In that case the marking is to be according to the following format:USCG Approval category / UK8517 / number of UK type-examination certificate issued by Recognised Organisation (RO) Marine & Offshore where the USCG approval category is the number assigned by USCG to the type of product concernedExample of USCG marking:165.101 / UK8517 / 9999 A.0 UK in case of a magnetic compass.Case 2:The assessment for module B has been performed by an other Notified Body but Recognised Organisation (RO) Marine & Offshore has performed the assessment for the module D, E or F.In such case the marking is to be according to the following format:USCG Approval category / number of Approved Body 1 / Unique identifier assigned by Approved Body 1 / UK8517 where the USCG approval category is the number assigned by USCG to the type of product concerned and where the unique identifier is the identifier given by the Approved Body 1 for the product concerned (refer to the Module B certificate which shall contain such information, in general it is the certificate number).Example of USCG marking :165.101 / Number of approved Body 1/ xxxx / UK8517 in case of a magnetic compass with UK type-examination certificate issued by the Approved Body 1 who has given the unique identifier number xxxx.

Recognised Organisation (RO)’s trademark usage

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Reference is made to the Recognised Organisation (RO) Marine & Offshore Legal, Risk & Compliance handbook available in:https://bureauveritas.sharepoint.com/teams/RO-LegalCommunity2

manufacturer’s united kingdom declaration of conformity

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Reference is made to the related procedure.It is the exclusive manufacturer's responsibility to draw up a written UNITED KINGDOM declaration of conformity declaring each manufactured product conform to type as stated in the UNITED KINGDOM type-examination certificate or to delegate it to his authorised representative.This declaration remains solely under the responsibility of the manufacturer and must not be endorsed or stamped by Recognised Organisation (RO).A copy of the UNITED KINGDOM declaration of conformity is to be provided to RO local office (ref. The Regulations article 16.3) for archiving.

filing

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The documentation related to module D or E certification of a manufacturer is either recorded in VPM-REC or filed by the RO local office as per the related qualification procedure.The documentation is to be filed in a way traceable to the documents issued by Recognised Organisation (RO).The documentation typically includes:

• Administrative documents (application forms, proposal, agreement and order, correspondence etc.),

• UNITED KINGDOM type-examination certificates and technical documentation (if non Recognised Organisation (RO) or if not in VPM-MPA),

• Documentation about quality system submitted for the audit,

• Documents issued by Recognised Organisation (RO) (findings reports, assessment reports, letters, etc.),

• Other documents as necessary.

process

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