Government Regulation No 345 / 2016 Coll.
Government regulation on marine gear
Valid
Regulation
Effective from 10.11.2016
Text versions:
10.11.2016
26.10.2016
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345
GOVERNMENT REGULATION
of 5 October 2016
on marine gear
The Government orders pursuant to Sections 4, 5 (1) and (2), 6 (2) and (3), 7, 8 (2) and (4), 11, 12 (1), 15 (2), 23 (3), 41 (1) and 50 (5) of Act No. 90 / 2016 Coll., on conformity assessment of specified products when making them available on the market:
Subject matter
This Regulation implements the relevant European Union1 Regulation and provides for
(a) technical requirements for marine equipment;
(b) the method of conformity assessment of marine equipment;
(c) the conditions and rules for drawing up the EU declaration of conformity and for placing the mark of conformity;
(d) details of the activities of economic operators and notified bodies; and
(e) formal deficiencies, the non-removal of which enables the supervisory authority to decide on the adoption of the relevant safeguard measures.
Product intended for conformity assessment
The product under assessment of conformity under this Regulation shall be the marine gear which is or is to be placed on board the ship and which is specified in the directly applicable European Union Regulation governing the requirements for the design, design and location of the marine gear and the test standards for marine equipment.
Technical requirements and conformity assessment
(1) The technical requirements for marine equipment are laid down in international agreements, decisions and other acts of the International Maritime Organisation and Test Standards (hereinafter referred to as the International Code). The international rules to be applied to the product shall lay down a directly applicable European Union regulation governing the design, design and location of marine equipment and testing standards for marine equipment.
(2) Compliance with the technical requirements referred to in paragraph 1 shall be demonstrated in accordance with the test standards and conformity assessment procedures set out in Annex 1 to this Regulation.
Maintenance period of technical documentation
The storage period of the technical documentation shall correspond to the expected service life of the product, but shall not be less than 10 years from the location of the conformity mark on the product.
Information, contact and identification data and product-related security information
(1) The product information and identification data are the type, batch or serial number number or other indication enabling the product to be clearly identified.
(2) The identification and contact details are the name or registered trade mark and address of the manufacturer or importer.
(3) The documents provided for in the international regulation are part of the instructions and safety information attached to the product.
Time of identification of operators
The period for which operators, at the request of the competent supervisory authorities, shall identify the economic operator who supplied the product to them or to whom the product has been delivered shall correspond to the expected lifetime of the product as determined by the manufacturer, but shall not be less than 10 years from the location of the product conformity mark.
EU declaration of conformity
(1) The EU declaration of conformity is drawn up and a copy thereof is attached to all products.
(2) The storage period of the EU declaration of conformity corresponds to the life expectancy of the product as determined by the manufacturer but shall not be less than 10 years from the location of the conformity mark on the product.
Rules on the placement of the conformity mark
(1) A conformity mark, the graphic form of which is set out in Annex 2 to this Regulation, shall be affixed to a product or a production label of a product which meets the technical requirements and for which compliance with those requirements has been verified in accordance with the test standards and conformity assessment procedure.
(2) The conformity mark shall also be integrated into software when such equipment is part of the product.
(3) Where, in view of the nature of the product, it is not possible to place a conformity mark directly on the product or its production label, the conformity mark shall be placed on the packaging of the product and on the documents accompanying it.
(4) The year in which the conformity mark has been affixed to the product shall be indicated after the conformity mark.
Formal deficiencies
A formal deficiency, the non-removal of which allows the supervisory authority to decide on the adoption of the relevant safeguard measures, is a lack of:
(a) the mark of conformity has not been affixed or has been affixed contrary to this Regulation;
(b) the EU declaration of conformity has not been drawn up or has not been drawn up correctly;
(c) a copy of the EU declaration of conformity has not been provided to the operator of the ship on which the product is or is to be placed; or
(d) the technical documentation has not been prepared, unavailable or incomplete.
Requirements for notified bodies
(1) The technical means and staffing of the notified body are in accordance with:
(a) Czech Technical Standard EN ISO / IEC 17025 (01 5253) Conformity assessment - General requirements for the competence of test and calibration laboratories; and
(b) Czech technical standard ČSN EN ISO / IEC 17065 (01 5256) Conformity assessment - Requirements for bodies certifying products, processes and services.
(2) The Czech technical standards referred to in paragraph 1 are publicly available at the headquarters of the Ministry of Transport.
Transitional provision
Until the entry into force of the directly applicable European Union regulation governing the design, design and location of marine equipment and test standards for marine equipment,
(a) consider as products under this Regulation maritime equipment pursuant to Government Regulation 266 / 2009 Coll., on technical requirements for maritime equipment, as effective before the date of entry into force of this Regulation; and
(b) for the purpose of determining the technical requirements and procedures for proving compliance with them pursuant to Article 3 and Annex 1 to this Regulation, they shall use the technical requirements and procedures for demonstrating compliance with them referred to in Government Regulation 266 / 2009 Coll., on technical requirements for maritime equipment, as effective before the date of application of this Regulation.
Repeal
The following shall be deleted:
1. Government Decree No. 266 / 2009 Coll., on Technical Requirements for Maritime Equipment.
2. Government Regulation No. 113 / 2010 Coll., amending Government Regulation No. 266 / 2009 Coll., on Technical Requirements for Marine Equipment.
3. Government Regulation No. 228 / 2011 Coll., amending Government Regulation No. 266 / 2009 Coll., on Technical Requirements for Marine Equipment, as amended by Government Regulation No. 113 / 2010 Coll.
4. Government Regulation No. 335 / 2012 Coll., amending Government Regulation No. 266 / 2009 Coll., on Technical Requirements for Marine Equipment, as amended.
Efficacy
This Regulation shall enter into force on the 15th day following its publication.
Prime Minister:
Sobotka v. r.
Minister for Transport:
Ing.
Příloha č. 1
Annex No 1 to Government Regulation No 345 / 2016 Coll.
CONFORMITY ASSESSMENT PROCEDURES
A. GENERAL RULES FOR CONFORMITY ASSESSMENT
1. The conformity assessment procedures (modules) shall be used to assess the conformity of a product with the technical requirements in accordance with the directly applicable European Union Regulation on design, design and location requirements for marine equipment and testing standards for marine equipment.
2. Where Module B (EU type-examination) is used for the conformity assessment of a product, module D (conformity to type based on quality assurance of the production process), module E (conformity to type based on product quality assurance) or module F (conformity to type based on product verification) shall also be used for each product before it is placed on the market. If the product is manufactured individually or in small numbers, module G (conformity based on verification of each product) may be used.
3. The conformity assessment by module shall be carried out in accordance with the procedure set out in Part B of this Annex.
B. CONFORMITY ASSESSMENT PROCEDURES BY SINGLE MODULE
1. EU TYPE REVIEW (MODULE B)
1.1. The EU type-examination is the part of the conformity assessment procedure in which the notified body checks the technical design of the marine equipment and verifies and confirms that the technical design of the marine equipment meets the relevant requirements.
1.2. EU type-examination may be carried out in any of these ways
(a) by testing a complete product sample representative of the production envisaged (production type);
(b) an assessment of the adequacy of the technical design of the marine equipment on the basis of the examination of the technical documentation and supporting evidence referred to in points 1.3 and 1.4 with the examination of the samples of one or more essential parts of the product representative of the intended production (combination of production type and design type).
1.3. The manufacturer shall submit an application for EU type-examination to the single notified body which he has chosen.
1.4. The application contains:
(a) the name and address of the manufacturer and, where the application is made by an authorised representative, his name and address;
(b) a written declaration that the same application has not been lodged with another notified body;
(c) technical documentation. The technical documentation shall allow the conformity assessment of marine equipment with the relevant requirements of the international regulation and shall include appropriate risk analysis and assessment. The technical documentation shall specify the relevant requirements and shall cover, to the extent necessary for the assessment, the design, manufacture and operation of the marine equipment. The technical documentation shall include, where appropriate, at least the following particulars:
- general description of the equipment;
- conceptual design and production drawings and diagrams of components, sub-assemblies and circuits;
- descriptions and explanations necessary for understanding the drawings and diagrams and the operation of the marine equipment;
- a list of the requirements and test standards applicable to the equipment in question in accordance with this Regulation, together with a description of the solutions chosen to meet those requirements;
- the results of the design calculations and the examinations carried out, and
- test reports;
(d) samples representative of the production planned. The notified body may require additional samples if the test programme so requires;
(e) supporting evidence of the adequacy of the technical solution to the proposal. This supporting evidence refers to all documents used. The supporting evidence shall include, where appropriate, the results of the tests carried out by the appropriate laboratory of the manufacturer or other test laboratory on his behalf and under his responsibility.
1.5 The notified body shall examine the technical documentation and supporting evidence for the equipment to assess the adequacy of the technical design of the equipment.
1.6 Notified body for sample
(a) verify that the samples have been produced in conformity with the technical documentation and identify the elements which have been designed in accordance with the relevant requirements and test standards, as well as those which have been designed without applying the relevant provisions of those standards;
(b) carry out appropriate examinations and tests in accordance with this Regulation or ensure that they are carried out; and
(c) agree with the manufacturer where the examinations and tests are to be carried out.
1.7 The notified body shall draw up an evaluation report recording the activities carried out under points 1.5 and 1.6 and their results. Without prejudice to the obligations of the notified body towards the Authority, the notified body shall publish the content of the report, in its entirety or in part, only with the agreement of the manufacturer.
1.8 If the type complies with the requirements of the specific international regulation applicable to the marine equipment concerned, the notified body shall issue an EU type-examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity of the certificate and the data necessary to identify the approved type. The certificate may be accompanied by one or more annexes. The certificate and its annexes shall contain all relevant information to enable the product to be evaluated as being in conformity with the type tested and to carry out an in-service check.
1.9 If the type does not comply with the relevant requirements of the international regulation, the notified body shall refuse to issue an EU-type examination certificate and inform the applicant thereof, stating in detail the reasons for the refusal. If the approved type no longer complies with the relevant requirements, the notified body shall decide whether further tests or reassessment of conformity are needed.
1.10. The manufacturer shall inform the notified body which keeps the technical documentation relating to the EU-type examination certificate of any modifications to the approved type which may affect the conformity of the marine equipment with the requirements of the international regulation or the conditions of validity of the certificate. These adaptations require additional approval in the form of an addendum to the original EU-type examination certificate.
1.11. The notified body shall inform the Office of the EU type-examination certificates or additions thereto which it has issued or withdrawn, and shall make available to the Office, on a regular or on request, a list of certificates or additions which it has rejected, suspended or otherwise restricted.
The notified body shall inform the other notified bodies of the EU type-examination certificates or additions which it has rejected, withdrawn, suspended or otherwise restricted, and of the certificates or additions it has issued, upon request.
The notified body shall, upon request, forward to the European Commission, the Member States and the other notified bodies a copy of the EU-type examination certificates or additions thereto. It shall also forward to the European Commission and the Member States, upon request, a copy of the technical documentation and the results of the examinations carried out. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as a file of the technical file, including the documentation submitted by the manufacturer, until the expiry of the period of validity of the EU-type examination certificate.
1.12. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions, together with the technical documentation, for the expected lifetime of the marine equipment concerned, but for at least 10 years after the conformity mark has been placed on the last manufactured product.
1.13. The manufacturer's authorised representative may submit the application referred to in points 1.3 and 1.4 and fulfil the obligations set out in points 1.9 of the second sentence, 1.10 and 1.12, where the manufacturer has so provided in the authorised representative.
2. CONFORMITY WITH TYPE INCLUDED IN THE SAFETY OF THE PRODUCTION PROCEDURE (MODULE D)
2.1 Conformity to the type based on quality assurance of the production process is the part of the conformity assessment procedure which the manufacturer fulfils the obligations set out in points 2.2 and 2.5 and guarantees and declares on his own responsibility that the equipment in question is in conformity with the type described in the EU-type examination certificate and meets the requirements of the international regulation applicable to it.
2.2 The manufacturer shall use the approved quality system for the production, output control and testing of the products concerned in accordance with point 2.3 and shall be subject to supervision in accordance with point 2.4.
2.3. Quality system
2.3.1. The manufacturer shall submit a request to the notified body which has chosen to assess his quality system for the marine equipment concerned.
2.3.2. The application shall contain:
(a) the name and address of the manufacturer and, where the application is made by an authorised representative, his name and address;
(b) a written declaration that the same application has not been lodged with another notified body;
(c) all relevant information on the category of marine gear envisaged;
(d) the quality system documentation; and
(e) the technical documentation of the approved type and a copy of the EU-type examination certificate.
2.3.3. The quality system ensures conformity of products with the type described in the EU-type examination certificate and with the requirements of the international regulation applicable to them.
2.3.4 All the supporting documents, requirements and regulations adopted by the manufacturer are systematically and properly documented in the form of written concepts, procedures and instructions. The quality system documentation shall allow a uniform interpretation of the quality programmes, plans, manuals and records.
2.3.5 The quality system documentation shall contain in particular an appropriate description
(a) the quality objectives and the organisational structure, responsibilities and powers of management as regards product quality;
(b) the corresponding methods, procedures and systematic activities to be used in the manufacture, control and quality assurance;
(c) the examinations and tests to be carried out before, during and after manufacture, indicating their frequency;
(d) inspection reports, test data, calibration data, qualification reports for relevant personnel and other quality records; and
(e) the means of monitoring the achievement of the required product quality and the efficient operation of the quality system.
2.3.6. The notified body shall assess the quality system to determine whether it meets the requirements of paragraphs 2.3.3 to 2.3.5. Persons carrying out a quality system assessment on behalf of a notified body, hereinafter referred to as the "audit team ', shall have the necessary experience with quality management systems and at least one of its members shall have the necessary experience with the assessment in the relevant area of marine equipment and the assessment of the technology of the marine equipment and knowledge of the relevant requirements of the international regulation. The audit shall include an evaluation visit at the manufacturer's premises. The audit team shall review the technical documentation referred to in point 2.3.2 (e) to verify:
that the manufacturer is able to identify the relevant requirements of the international regulation and carry out the necessary checks to ensure that the product complies with those requirements. The audit findings, including their justification, shall be communicated by the manufacturer.
2.3.7. The manufacturer shall follow the approved quality system and maintain it in order to remain adequate and effective.
2.3.8. The manufacturer shall inform the notified body which approved the quality system of any intended change to the quality system. The notified body shall assess the proposed changes and decide whether the modified quality system will continue to comply with the requirements of points 2.3.3 to 2.3.5 or whether a new assessment is needed. The notified body shall notify the manufacturer of the conclusions of its examination, including their justification.
2.4. Surveillance by a notified body
2.4.1. The purpose of supervision is to ensure that the manufacturer properly fulfils the obligations arising from the approved quality system. For the purpose of the assessment, the manufacturer shall allow the notified body access to the premises intended for production, inspection, testing and storage and shall provide it with all necessary information, in particular:
(a) documentation of the quality system;
(b) inspection reports, test data, calibration data, qualification reports of relevant personnel and other quality records.
2.4.2. The notified body shall regularly carry out audits to ensure that the manufacturer maintains and uses the quality system and shall submit an audit report to the manufacturer.
2.4.3. In addition, the notified body may make unannounced visits to the manufacturer, except where such visits are subject to restrictions under another legislation. During such visits, the notified body may, if necessary, carry out or have products tested to verify that the quality system is functioning properly. The notified body shall provide the manufacturer with a visit report and a test report if the tests have been carried out.
2.5. The manufacturer shall place the mark of conformity and the identification number of the notified body referred to in point 2.3.1 on each individual product which is in conformity with the type described in the EU-type examination certificate and meets the relevant requirements of the international regulation. The manufacturer shall draw up a written declaration of conformity for each product model and, for the expected lifetime of the marine equipment concerned, for at least 10 years after the mark of conformity has been placed on the last manufactured product, shall keep it for the purpose of the administration. The certificate of conformity shall indicate the model of the marine gear for which it has been drawn up. A copy of the certificate of conformity shall be made available to the competent authorities upon request.
2.6. The manufacturer shall keep available to the public authorities for the expected lifetime of the marine equipment concerned, but not less than 10 years after the mark of conformity has been placed on the last manufactured product.
(a) the documentation described in paragraph 2.3.2;
(b) the approved amendments referred to in point 2.3.8; and
(c) the conclusions, reports and protocols of the notified body referred to in points 2.3.8, 2.4.2 and 2.4.3.
The notified body shall inform the Authority of the quality system approvals it has issued or withdrawn and shall make available to the Authority, on a regular or on request, a list of quality system approvals it has refused, suspended or otherwise restricted. The notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted and, upon request, of the quality system approvals it has issued.
2.8 The obligations of the manufacturer set out in paragraphs 2.3.1, 2.3.2, 2.3.8, 2.5 and 2.6 may be fulfilled on his behalf and under his responsibility by his authorised representative, provided that the manufacturer has so provided in the authorised representative.
3. CONFORMITY WITH TYPE RELATED TO THE SAFETY OF THE PRODUCTION QUALITY (MODULE E)
3.1 Conformity to the product quality assurance type is the part of the conformity assessment procedure which the manufacturer fulfils the obligations set out in points 3.2 and 3.5 and guarantees and declares on his own responsibility that the equipment in question is in conformity with the type described in the EU-type examination certificate and meets the requirements of the international regulation applicable to it.
3.2 The manufacturer shall use the approved quality system for the output inspection and testing of the products concerned in accordance with point 3.3 and shall be subject to supervision in accordance with point 3.4.
3.3. Quality system
3.3.1. The manufacturer shall submit a request to the notified body which has chosen to assess his quality system for the marine equipment concerned.
3.3.2. The application shall contain:
(a) the name and address of the manufacturer and, where the application is made by an authorised representative, his name and address;
(b) a written declaration that the same application has not been lodged with another notified body;
(c) all relevant information on the category of marine gear envisaged;
(d) the quality system documentation; and
(e) the technical documentation of the approved type and a copy of the EU-type examination certificate.
3.3.3 The quality system ensures conformity of products with the type described in the EU-type examination certificate and with the relevant requirements of the international regulation. All supporting documents, requirements and regulations adopted by the manufacturer shall be systematically and properly documented in the form of written concepts, procedures and instructions. The quality system documentation shall allow a uniform interpretation of the quality programmes, plans, manuals and records.
3.3.4. The quality system documentation shall contain in particular an adequate description of:
(a) the quality objectives and the organisational structure, responsibilities and powers of management as regards product quality;
(b) the examinations and tests to be carried out after manufacture;
(c) inspection reports, test data, calibration data, qualification reports for relevant personnel and other quality records; and
(d) means enabling the efficient operation of the quality system to be supervised.
3.3.5. The notified body shall assess the quality system in order to determine whether it meets the requirements of paragraphs 3.3.3 and 3.3.4. The audit team shall have experience with quality management systems and at least one of its members shall have experience in evaluating the relevant area of marine equipment and evaluating the technology of the marine equipment concerned and knowledge of the relevant requirements of the international regulation. The audit shall include an evaluation visit at the manufacturer's premises. The audit team shall review the technical documentation referred to in point 3.3.2 (e) to verify that the manufacturer is able to identify the relevant requirements of the international regulation and to carry out the necessary checks to ensure compliance of the product with those requirements. The audit findings, including their justification, shall be communicated by the manufacturer.
3.3.6. The manufacturer shall follow the approved quality system and maintain it in order to remain adequate and effective.
3.3.7. The manufacturer shall inform the notified body which approved the quality system of any intended change to the quality system. The notified body shall assess the proposed changes and decide whether the modified quality system will continue to comply with the requirements of paragraphs 3.3.3 and 3.3.4 or whether a new assessment is needed. The notified body shall notify the manufacturer of the conclusions of its examination, including their justification.
3.4. Surveillance by a notified body
3.4.1 The purpose of supervision is to ensure that the manufacturer complies properly with the obligations arising from the approved quality system.
3.4.2. For the purpose of assessment, the manufacturer shall allow the notified body to access the premises intended for production, inspection, testing and storage and shall provide it with all necessary information, in particular:
(a) the quality system documentation; and
(b) inspection reports, test data, calibration data, qualification reports of relevant personnel and other quality records.
3.4.3. The notified body shall regularly carry out audits to ensure that the manufacturer maintains and uses the quality system and shall submit an audit report to the manufacturer.
3.4.4. In addition, the notified body may make unannounced visits to the manufacturer, except where such visits are subject to restrictions under another legislation. During such visits, the notified body may, if necessary, carry out or have products tested to verify that the quality system is functioning properly. The notified body shall provide the manufacturer with a visit report and a test report if the tests have been carried out.
3.5. Conformity marking and declaration of conformity
The manufacturer shall affix the mark of conformity and the identification number of the notified body referred to in point 3.3.1 to each individual product conforming to the type described in the EU-type examination certificate and meeting the relevant requirements of the international regulation.
3.5.2. The manufacturer shall draw up a written declaration of conformity for each product model and, for the expected lifetime of the marine equipment concerned, for at least 10 years after the mark of conformity has been placed on the last manufactured product, shall keep it for the purpose of the administration. The certificate of conformity shall indicate the model of the marine gear for which it has been drawn up. A copy of the certificate of conformity shall be made available to the competent authorities upon request.
3.6. The manufacturer shall keep available to the public authorities for the expected lifetime of the marine equipment concerned, but for at least 10 years after the conformity mark has been placed on the last manufactured product.
(a) the documentation described in paragraph 3.3.2;
(b) the approved amendments referred to in point 3.3.7; and
(c) the conclusions, reports and protocols of the notified body referred to in points 3.3.7, 3.4.3 and 3.4.4.
3.7 The notified body shall inform the Authority of the quality system approvals it has issued or withdrawn and shall make available to the Authority, on a regular or on request, the list of quality system approvals it has refused, suspended or otherwise restricted.
3.8 The notified body shall inform the other notified bodies of the quality system approvals which it has rejected, suspended or withdrawn and, upon request, of the quality system approvals it has issued.
3.9 The obligations of the manufacturer set out in points 3.3.1, 3.3.2, 3.3.7, 3.5 and 3.6 may be fulfilled on his behalf and under his responsibility by his authorised representative, if the manufacturer has so provided in the authorised representative.
4. CONFORMITY WITH TYPE RELATED TO PRODUCTION VERIFICATION (MODULE F)
4.1 Conformity to type based on product verification is the part of the conformity assessment procedure which the manufacturer fulfils the obligations set out in points 4.2, 4.6.1 and 4.7 and guarantees and declares on his own responsibility that the products concerned which have been subject to the provisions of points 4.3 and 4.4 are identical to the type described in the EU-type examination certificate and comply with the requirements of the international regulation applicable to them.
4.2 The manufacturer shall take all necessary measures to ensure that the manufacturing process and its control ensure compliance of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of the international regulation applicable to them.
4.3. The notified body which has chosen the manufacturer shall carry out appropriate examinations and tests to verify the conformity of the products with the approved type described in the EU-type examination certificate and with the relevant requirements of the international regulation.
4.4 Tests and tests to verify the conformity of products with the relevant requirements shall be carried out, at the choice of the manufacturer, either by testing and testing each product in accordance with point 4.5 or by testing and testing the products on a statistical basis in accordance with point 4.6.
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Regulation Information
| Citation | Government Decree No. 345 / 2016 Coll., on marine equipment |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.10.2016 |
|---|---|
| Effective from | 10.11.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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