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Document 02014L0090-20210811
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (Text with EEA relevance)Text with EEA relevance
Consolidated text: Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (Text with EEA relevance)Text with EEA relevance
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (Text with EEA relevance)Text with EEA relevance
02014L0090 — EN — 11.08.2021 — 001.001
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DIRECTIVE 2014/90/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257 28.8.2014, p. 146) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION DELEGATED DIRECTIVE (EU) 2021/1206 of 30 April 2021 |
L 261 |
45 |
22.7.2021 |
Corrected by:
DIRECTIVE 2014/90/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 July 2014
on marine equipment and repealing Council Directive 96/98/EC
(Text with EEA relevance)
CHAPTER 1
GENERAL PROVISIONS
Article 1
Objective
The objective of this Directive is to enhance safety at sea and to prevent marine pollution through the uniform application of the relevant international instruments relating to marine equipment to be placed on board EU ships, and to ensure the free movement of such equipment within the Union.
Article 2
Definitions
For the purposes of this Directive, the following definitions apply:
‘marine equipment’ means equipment falling within the scope of this Directive in accordance with Article 3;
‘EU ship’ means a ship flying the flag of a Member State and falling within the scope of the international conventions;
‘international conventions’ means the following conventions, together with their protocols and codes of mandatory application, adopted under the auspices of the International Maritime Organization (IMO), which have entered into force and which lay down specific requirements for the approval by the flag State of equipment to be placed on board ships:
‘testing standards’ means the testing standards for marine equipment set by:
‘international instruments’ means the international conventions, together with the resolutions and circulars of the IMO giving effect to those conventions in their up-to-date version, and the testing standards;
‘wheel mark’ means the symbol referred to in Article 9 and set out in Annex I or, as appropriate, the electronic tag referred to in Article 11;
‘notified body’ means an organisation designated by the competent national administration of a Member State in accordance with Article 17;
‘making available on the market’ means any supply of marine equipment on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available of marine equipment on the Union market;
‘manufacturer’ means any natural or legal person who manufactures marine equipment or has marine equipment designed or manufactured, and markets that equipment under its name or trademark;
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks;
‘importer’ means any natural or legal person established within the Union who places marine equipment from a third country on the Union market;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes marine equipment available on the market;
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
‘conformity assessment’ means the process carried out by the notified bodies, in accordance with Article 15, demonstrating whether marine equipment complies with the requirements laid down in this Directive;
‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
‘recall’ means any measure aimed at achieving the return of marine equipment that has already been placed on board EU ships or purchased with the intention of being placed on board EU ships;
‘withdrawal’ means any measure aimed at preventing marine equipment in the supply chain from being made available on the market;
‘EU declaration of conformity’ means a statement issued by the manufacturer in accordance with Article 16;
‘product’ means an item of marine equipment.
Article 3
Scope
Article 4
Requirements for marine equipment
Article 5
Application
Article 6
Functioning of the internal market
Member States shall not prohibit the placing on the market or the placing on board an EU ship of marine equipment which complies with this Directive, nor refuse to issue the certificates relating thereto to the ships flying their flag, or to renew the said certificates.
Article 7
Transfer of a ship to the flag of a Member State
Article 8
Standards for marine equipment
It is of particular importance that the Commission carry out consultations with experts, including Member States’ experts, during the preparation of such delegated acts.
Those technical specifications and testing standards shall apply on an interim basis until such time as the IMO has adopted a standard for that specific item of marine equipment.
It is of particular importance that the Commission carry out consultations with experts, including Member States’ experts, during the preparation of such delegated acts.
Those technical specifications and testing standards shall apply on an interim basis until such time as the IMO has reviewed the standard applicable to that specific item of marine equipment.
CHAPTER 2
THE WHEEL MARK
Article 9
The wheel mark
Article 10
Rules and conditions for affixing the wheel mark
Article 11
Electronic tag
CHAPTER 3
OBLIGATIONS OF ECONOMIC OPERATORS
Article 12
Obligations of manufacturers
Article 13
Authorised representatives
An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the marine equipment concerned;
further to a reasoned request from a competent authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
cooperate with the competent authorities, at their request, on any action taken to eliminate the risks posed by products covered by its mandate.
Article 14
Other economic operators
For a period of at least 10 years after the wheel mark has been affixed and in no case for a period shorter than the expected life of the marine equipment concerned, economic operators shall, on request, identify the following to the market surveillance authorities:
any economic operator who has supplied them with a product;
any economic operator to whom they have supplied a product.
CHAPTER 4
CONFORMITY ASSESSMENT AND NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 15
Conformity assessment procedures
Member States shall ensure that the manufacturer or the manufacturer's authorised representative has the conformity assessment carried out, through a notified body, for a specific item of marine equipment, by using one of the options provided by means of implementing acts adopted by the Commission in accordance with the examination procedure referred to in Article 38(2), from among one of the following procedures:
where the EC type-examination (module B) is to be used, before being placed on the market, all marine equipment shall be subject to:
where sets of marine equipment are produced individually or in small quantities and not in series or in mass, the conformity assessment procedure may be the EC unit verification (module G).
Article 16
EU declaration of conformity
Article 17
Notification of conformity assessment bodies
Article 18
Notifying authorities
Article 19
Information obligation on notifying authorities
Article 20
Subsidiaries of, and subcontracting by, notified bodies
Article 21
Changes to notifications
Article 22
Challenges to the competence of notified bodies
Article 23
Operational obligations of notified bodies
Article 24
Obligation of notified bodies to provide information
Notified bodies shall inform the notifying authority of the following:
any refusal, restriction, suspension or withdrawal of a conformity certificate;
any circumstances affecting the scope of, and the conditions for, notification;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
CHAPTER 5
UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS, SAFEGUARD PROVISIONS
Article 25
EU market surveillance framework
Article 26
Procedure for dealing with marine equipment presenting a risk at national level
Where, in the course of that evaluation, the market surveillance authorities find that the marine equipment does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the marine equipment into compliance with those requirements, to withdraw the marine equipment from the market, or to recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
The information on the measures taken by the market surveillance authorities referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant marine equipment, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator concerned. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either:
failure of the marine equipment to comply with the applicable design, construction and performance requirements as laid down pursuant to Article 4;
non-compliance with the testing standards referred to in Article 4 during the conformity assessment procedure;
shortcomings in those testing standards.
Article 27
EU safeguard procedure
The Commission shall furthermore be empowered to adopt, by means of delegated acts in accordance with the procedure referred to in Article 37, interim harmonised requirements and testing standards for that specific item of marine equipment. The criteria laid down in Article 8(3) shall apply accordingly. These requirements and testing standards shall be made accessible free of charge by the Commission.
Article 28
Compliant products which present a risk to maritime safety, to health or to the environment
Article 29
Formal non-compliance
Without prejudice to Article 26, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
the wheel mark has been affixed in violation of Article 9 or Article 10;
the wheel mark has not been affixed;
the EU declaration of conformity has not been drawn up;
the EU declaration of conformity has not been drawn up correctly;
technical documentation is either not available or not complete;
the EU declaration of conformity has not been sent to the ship.
Article 30
Exemptions based on technical innovation
Article 31
Exemptions for testing or evaluation
A flag State administration may permit marine equipment which does not comply with the conformity assessment procedures or which is not covered by Article 30 to be placed on board an EU ship for reasons of testing or evaluation, if the following cumulative conditions are complied with:
the marine equipment shall be given a certificate by the flag Member State which shall at all times be carried with the equipment, state that Member State’s permission for the equipment to be placed on board the EU ship, impose all necessary restrictions and lay down any other appropriate provisions as regards the use of the equipment concerned;
the permission shall be limited to the period considered by the flag State as being necessary to complete the testing, which should be as short as possible;
the marine equipment shall not be relied on in place of equipment which meets the requirements of this Directive and shall not replace such equipment, which shall remain on board the EU ship in working order and ready for immediate use.
Article 32
Exemptions in exceptional circumstances
The marine equipment placed on board shall be accompanied by an interim certificate of approval issued by the flag Member State or by another Member State, stating the following:
the equipment bearing the wheel mark which the certified equipment is due to replace;
the exact circumstances under which the certificate of approval has been issued, and in particular the unavailability in the market of equipment bearing the wheel mark;
the exact design, construction and performance requirements against which the equipment has been approved by the certifying Member State;
the testing standards applied, if any, in the relevant approval procedures.
CHAPTER 6
FINAL PROVISIONS
Article 33
Exchange of experience
The Commission shall provide for the organisation of exchanges of experience between the Member States’ national authorities responsible for notification policy, especially as regards market surveillance.
Article 34
Coordination of notified bodies
Article 35
Implementing measures
The Commission shall set up and maintain a database containing at least the following information:
the list and essential details of the conformity certificates issued pursuant to this Directive, as provided by the notified bodies;
the list and essential details of the declarations of conformity issued pursuant to this Directive, as provided by the manufacturers;
an up-to-date list of the applicable international instruments, and of the requirements and testing standards applicable by virtue of Article 4(4);
the list and full text of the criteria and procedures referred to in paragraph 2;
the requirements and conditions for electronic tagging referred to in Article 11, when applicable;
any other useful information with a view to facilitating correct implementation of this Directive by the Member States, the notified bodies and the economic operators.
That database shall be made accessible to the Member States. It shall also be made available to the public for information purposes only.
Article 36
Amendments
The Commission shall be empowered to adopt delegated acts in accordance with Article 37 in order to update the references to standards, as referred to in Annex III, when new standards become available.
Article 37
Exercise of the delegation
Article 38
Committee
Article 39
Transposition
They shall apply those provisions from 18 September 2016.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 40
Repeal
Article 41
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 42
Addressees
This Directive is addressed to the Member States.
ANNEX I
WHEEL MARK
The mark of conformity must take the following form:
If the wheel mark is reduced or enlarged the proportions given in the graduated drawing must be respected.
The various components of the wheel mark must have substantially the same vertical dimension, which may not be less than 5 mm.
That minimum dimension may be waived for small devices.
ANNEX II
CONFORMITY ASSESSMENT PROCEDURES
I. MODULE B: EC TYPE-EXAMINATION
1. EC type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of marine equipment and verifies and attests that the technical design of the marine equipment meets the relevant requirements.
2. EC type-examination may be carried out in either of the following manners:
3. The manufacturer shall lodge an application for EC type-examination with a single notified body of its choice.
The application shall include:
a general description of the marine equipment;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation of the marine equipment;
a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with this Directive, together with a description of the solutions adopted to meet those requirements;
results of design calculations made, examinations carried out, etc.; and
test reports;
4. The notified body shall:
For the marine equipment:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the marine equipment;
For the specimen(s):
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant requirements and testing standards, as well as the elements which have been designed without applying the relevant provisions of those standards;
carry out appropriate examinations and tests, or have them carried out, in accordance with this Directive;
agree with the manufacturer on a location where the examinations and tests will be carried out.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of the specific international instruments that apply to the marine equipment concerned, the notified body shall issue an EC type-examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of the international instruments, the notified body shall refuse to issue an EC type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
7. If the approved type no longer complies with the applicable requirements, the notified body shall determine whether further testing or a new conformity assessment procedure is necessary.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EC type-examination certificate of all modifications to the approved type that may affect the conformity of the marine equipment with the requirements of the relevant international instruments or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EC type-examination certificate.
8. Each notified body shall inform its notifying authorities concerning the EC type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EC type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EC type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
9. The manufacturer shall keep a copy of the EC type-examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
II. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. |
Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on its sole responsibility that the marine equipment concerned is in conformity with the type described in the EC type-examination certificate and that it satisfies the requirements of the international instruments that apply to it. |
2. |
Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4. |
3. |
Quality system 3.1. The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the marine equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
—
a written declaration that the same application has not been lodged with any other notified body;
—
all relevant information for the marine equipment category envisaged;
—
the documentation concerning the quality system;
—
the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2. The quality system shall ensure that the products are in conformity with the type described in the EC type-examination certificate and that they comply with the requirements of the international instruments 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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational 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, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; and
—
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant marine equipment field and marine equipment technology concerned, and knowledge of the applicable requirements of the international instruments. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in the fifth indent of point 3.1 in order to verify the manufacturer’s ability to identify the relevant requirements of the international instruments and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. |
Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
—
the quality system documentation;
—
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer, except where, under national law, and for defence or security reasons, certain restrictions apply to such visits. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. |
Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the wheel mark referred to in Article 9, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product that is in conformity with the type described in the EC type-examination certificate and that satisfies the applicable requirements of the international instruments. 5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. The declaration of conformity shall identify the marine equipment model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
The manufacturer shall keep at the disposal of the competent authorities, for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned:
—
the documentation referred to in point 3.1;
—
the change referred to in point 3.5, as approved;
—
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
|
7. |
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued. |
8. |
Authorised representative The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate. |
III. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE
1. |
Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on its sole responsibility that the marine equipment concerned is in conformity with the type described in the EC type-examination certificate and that it satisfies the requirements of the international instruments that apply to it. |
2. |
Manufacturing The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4. |
3. |
Quality system 3.1. The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the marine equipment concerned. The application shall include:
—
the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;
—
a written declaration that the same application has not been lodged with any other notified body;
—
all relevant information for the marine equipment category envisaged;
—
the documentation concerning the quality system; and
—
the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2. The quality system shall ensure compliance of the products with the type described in the EC type-examination certificate and with the applicable requirements of the international instruments. 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 shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
—
the quality objectives and the organisational 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, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
—
the means of monitoring the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant marine equipment field and marine equipment technology concerned, and knowledge of the applicable requirements of the international instruments. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in the fifth indent of point 3.1, in order to verify the manufacturer’s ability to identify the relevant requirements of the international instruments and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. |
Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
—
the quality system documentation;
—
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer, except where, under national law, and for defence or security reasons, certain restrictions apply to such visits. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. |
Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the wheel mark referred to in Article 9, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product that is in conformity with the type described in the EC type-examination certificate and that satisfies the applicable requirements of the international instruments. 5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. The declaration of conformity shall identify the marine equipment model for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
The manufacturer shall keep at the disposal of the competent authorities, for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned:
—
the documentation referred to in point 3.1;
—
the change referred to in point 3.5, as approved;
—
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
|
7. |
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. |
8. |
Authorised representative The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate. |
IV. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
1. |
Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on its sole responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EC type-examination certificate and that they satisfy the requirements of the international instruments that apply to them. |
2. |
Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EC type-examination certificate and with the requirements of the international instruments that apply to them. |
3. |
Verification A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EC type-examination certificate and with the appropriate requirements of the international instruments. The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every product as specified in point 4 or by examination and testing of the products on a statistical basis as specified in point 5. |
4. |
Verification of conformity by examination and testing of every product 4.1. All products shall be individually examined and tested in accordance with this Directive, in order to verify conformity with the approved type described in the EC type-examination certificate and with the appropriate requirements of the international instruments. 4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. |
5. |
Statistical verification of conformity 5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present its products for verification in the form of homogeneous lots. 5.2. A random sample shall be taken from each lot. All products in a sample shall be individually examined and tested in accordance with this Directive, in order to ensure their conformity with the applicable requirements of the international instruments and to determine whether the lot is accepted or rejected. 5.3. If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. 5.4. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots, the notified body may suspend the statistical verification and take appropriate measures. |