Government Decree No. 266 / 2009 Coll.
Government regulation on technical requirements for marine equipment
Valid
Regulation
Effective from 10.09.2009
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266
GOVERNMENT REGULATION
of 27 July 2009
on technical requirements for marine equipment
The Government orders pursuant to Article 22 of Act No. 22 / 1997 Coll., on technical requirements for products and on the amendment and addition of certain laws, as amended by Act No. 205 / 2002 Coll., ("the Act ') to implement Sections 11 (2), 11 (a) (2), 12 and 13 of the Act:
(1) This Regulation implements the relevant provisions of the European Union1) and lays down technical requirements for equipment intended for use on board seagoing sail2), as set out in Annex 1 to this Regulation (hereinafter referred to as "maritime equipment"). Maritime equipment is specified products within the meaning of § 12 (1) (a) of the Act.
(2) This Regulation shall not apply to marine equipment intended for use on board warships.
In this Regulation, radio communications equipment means equipment referred to in Chapter IV. The International Convention for the Safety of Life at Sea, 19743 ("SOLAS Convention ') and the two-way VHF survival craft radio-telephony.
(1) Maritime equipment must comply with the requirements set out in Annex 1 to this Regulation.
(2) Compliance with the requirements referred to in paragraph 1 shall be demonstrated by the test standards and conformity assessment procedures set out in Annex 1 to this Regulation.
(3) The content of each conformity assessment procedure is set out in Annex 2 to this Regulation.
(4) The requirements of other legislation on marine equipment shall not apply for conformity assessment purposes.
(1) For the assessment of conformity of marine equipment, authorisation may be granted under Article 11 of the Act to a legal person meeting the requirements set out in Annex 3 to this Regulation.
(2) The Office for Technical Standardisation, Metrology and National Testing shall carry out, at least once every two years, checks on the activities of the notified person in accordance with Article 11 (4), whether it meets the criteria set out in Annex 3 to this Regulation.
(3) Where Part A of Annex No 2 to this Regulation allows a certain part of the conformity assessment procedure to be carried out through another person, that person must comply with the same requirements as the notified person.
(1) Marine equipment which is intended to be placed on or on board a seagoing vessel shall bear a mark of conformity, unless otherwise provided for in this Regulation.
(2) The manufacturer or his authorised representative shall affix a mark of conformity to a marine device which complies with the requirements set out in Annex 1 to this Regulation and whose conformity has been verified by the relevant conformity assessment procedure. The mark of conformity shall be affixed to the marine installation at the end of the production phase.
(3) The notified person, the manufacturer or his authorised representative shall indicate the identification number of the notified person who carried out the conformity assessment procedure when involved in the production control phase, and the last two digits of the year in which the marine gear was bearing the conformity mark.
(4) The seagoing establishment or its descriptive label shall bear the mark of conformity always visible, legible and indelible throughout the life of the installation. If technically impossible, the mark of conformity shall be affixed to the packaging of the product or leaflet.
(5) Maritime equipment, its descriptive label, packaging or leaflet must not bear a mark or inscription which may be confused with the mark of conformity.
(6) The graphical representation of the mark of conformity is given in Annex 4 to this Regulation.
(1) Where it is found that marine equipment bearing a conformity mark may endanger the safety and health of persons, property or the marine environment, even if it is correctly installed, maintained and used in accordance with the intended purpose, a safeguard measure may be imposed on such equipment under another legislation4).
(2) Where a safeguard measure has been imposed on a maritime installation pursuant to paragraph 1, the notification of the decision imposing a safeguard measure pursuant to Article 7 (8) of the Act shall indicate whether the non-compliance was caused by:
(a) failure to comply with the requirements set out in Annex 1 to this Regulation;
(b) incorrect application of the test standards referred to in Article 3 (2); or
(c) shortcomings in the test standards referred to in Article 3 (2).
(1) Where there is a need to replace seagoing gear on board a seagoing vessel located in a port of a State which is not a Member State of the European Union and where, in view of exceptional circumstances, it is not possible to place on board a seagoing gear bearing a conformity mark, other seagoing equipment may be placed on board provided that:
(a) the seagoing establishment is accompanied by a dossier issued by an entity which is equivalent to the notified person under an international agreement concluded between the European Union and that State; or
(b) the maritime installation shall be accompanied by documentation certifying compliance with the requirements of the International Maritime Organisation (IMO) issued by a State which is a Contracting Party to international agreements setting out the requirements for such equipment, unless the contract referred to in (a) is concluded or an equivalent body exists in that State.
(2) Exceptional circumstances shall consist in particular of excessive long periods or excessive costs associated with the acquisition of marine equipment bearing a conformity mark.
(3) The master of the seagoing vessel on whose board the seagoing gear has been deployed, as referred to in paragraph 1, shall provide without undue delay the data specified in the documentation of the gear to the Maritime Authority. Without undue delay after the seagoing vessel has reached a port within the territory of the European Union, the seagoing establishment referred to in paragraph 1 shall be replaced by a seagoing establishment bearing a conformity mark.
(4) If a marine device is a radio communication device, it shall not be associated with the radio frequency spectrum in an undesirable way.
A seagoing establishment which was on board a seagoing vessel before the date of entry into force of this Regulation shall not be subject to the provisions of this Regulation.
This Regulation shall take effect on the 15th day following its publication.
Prime Minister:
v. PhDr. Kohout v. r.
Deputy Prime Minister and Minister for Foreign Affairs
Minister for Transport:
Ing. Slamecka, MBA v. r.
Příloha č. 1
Annex No. 1 to Government Decree No. 266 / 2009 Coll.
Maritime equipment, technical requirements for maritime equipment, test and conformity assessment procedures to demonstrate compliance with these requirements
1. Maritime equipment is listed in column 2 of Annex A.1 to Council Directive 96 / 98 / EC of 20 December 1996 on maritime equipment, as amended by the European Union ("Directive 96 / 98 / EC ').
2. Maritime equipment shall comply with the technical requirements set out in columns 3 and 4 of Annex A.1 to Directive 96 / 98 / EC.
3. Compliance with the requirements set out in point 2 shall be demonstrated by the test standards and conformity assessment procedures specified in columns 5 and 6 of Annex A.1 to Directive 96 / 98 / EC.
4. The provisions amending Annex A.1 to Directive 96 / 98 / EC shall apply from the date on which the time limit for the Member States of the European Union to adopt and publish the provisions necessary to comply with the European Union Regulation amending and supplementing this Directive has expired.
Příloha č. 2
Annex No 2 to Government Decree No. 266 / 2009 Coll.
Modules for conformity assessment and technical documentation
A. Conformity assessment modules
1.
EC TYPE REVIEW (MODULE B)
1. The person must identify and confirm that the sample characteristic of the production envisaged complies with the provisions of this Regulation relating to that production.
2. The manufacturer or his authorised representative shall submit an application for EC type-examination to the notified person of his choice. The application shall contain:
- the name and address of the manufacturer and, if the application is submitted by an authorised representative, his name and address,
- a written declaration that the same application was not lodged at the same time with another notified person,
- the technical documentation referred to in point 3.
The applicant shall make available to the notified body a representative sample of the production envisaged ("type '). The type may include several product variants provided that the differences between the different variants do not affect the level of safety and other requirements concerning the performance of the product. The notified body may request additional samples if the test programme so requires.
3. The technical documentation shall allow the conformity of the product to be assessed with the requirements of the relevant provisions of this Regulation. The technical documentation shall include, to the extent necessary for such assessment, the design, construction standard, manufacture, installation and operation of the product in accordance with the description of the technical documentation set out in Part B of this Annex.
4. Noticed Person
(a) examine the technical documentation and verify that the type has been manufactured in accordance with the technical documentation;
(b) carry out or have carried out the appropriate checks and tests necessary to determine whether the requirements of this Regulation have been complied with;
(c) agree with the applicant the place where the checks and the necessary tests will be carried out.
5. Where the type complies with the relevant provisions of this Regulation, the notified person shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer, details of the equipment, the conclusions of the examination, the conditions of validity of the certificate and the data necessary to identify the approved type. The certificate shall be accompanied by a list of relevant parts of the technical file, the copy of which shall be kept by the notified person. If the notified person refuses to issue an EC type-examination certificate to the manufacturer, he shall state in detail the reasons for this. If the manufacturer reapplies for type-approval for a device which has not been issued a type-certificate, its submission to the notified person shall contain all relevant documentation, including the original test report, a detailed justification for the previous refusal and details of any modifications made to the device.
6. The applicant shall inform the notified person in respect of which the technical documentation relating to the EC type-examination certificate is available of any modification of the approved product subject to additional approval if such modification may affect compliance with the essential requirements or the conditions prescribed for its use. This additional approval shall be issued in the form of an addendum to the original EC-type examination certificate.
7. On request, each notified person shall provide the national authorities of the flag States of the European Union and other notified persons with relevant information concerning the EC type-examination certificates and additions issued or withdrawn.
8. Other notified persons may receive copies of the EC type-examination certificates and their additions. The annexes to the certificates shall be kept available to other notified persons.
9. The manufacturer or his authorised representative, together with the technical documentation, shall keep copies of the EC type-examination certificates and their additions for at least 10 years after the manufacture of the last product.
2.
CONFORMITY WITH TYPE (MODULE C)
1. The manufacturer or his authorised representative shall ensure and declare that the products concerned comply with the type described in the EC type-examination certificate and comply with the requirements of this Regulation which apply to them. The manufacturer or his authorised representative shall affix a conformity mark to each product and draw up a written declaration of conformity.
2. The manufacturer shall take all necessary measures to ensure that the production process ensures conformity of the manufactured products with the type described in the EC-type examination certificate and with the requirements of the provisions of this Regulation which apply to them.
3. The manufacturer or his authorised representative shall keep a copy of the certificate of conformity for at least 10 years after the manufacture of the last product.
3.
PRODUCTION QUALITY SAFETY (MODULE D)
1. The manufacturer who fulfils the obligations referred to in point 2 shall ensure and declare that the products concerned are in conformity with the type described in the EC type-examination certificate. The manufacturer or his authorised representative shall affix a conformity mark to each product and draw up a written declaration of conformity. The conformity mark shall be accompanied by the identification number of the notified person responsible for supervision referred to in point 4.
2. The manufacturer shall use the approved quality system for the production, exit inspection and testing of the products referred to in point 3 and shall be subject to surveillance in accordance with point 4.
3. Quality system
3.1. The manufacturer shall submit to the notified person to whom he has chosen an application for assessment of the quality system for the products in question. The application shall contain:
(a) all relevant information on the product category envisaged;
(b) documentation of the quality system;
(c) the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2. The quality system shall ensure conformity of products with the type described in the EC type-examination certificate. All supporting documents, requirements and regulations used by the manufacturer shall be systematically and in an orderly manner documented in the form of written concepts, procedures and instructions. This quality system documentation shall allow a clear interpretation of the quality programmes, quality plans, manuals and quality records. The quality system documentation shall contain in particular an adequate description
(a) the quality objectives, organisational structure, responsibilities and responsibilities of management, relating to product quality;
(b) the manufacturing process, management and quality assurance procedures and systematic measures to be applied;
(c) checks and tests to be carried out before, during and after manufacture, indicating their frequency;
(d) quality records, such as inspection reports, test results, calibration data, qualification reports of relevant personnel;
(e) means of monitoring the achievement of the required quality of products and the effective functioning of the quality system.
3.3. The notified person shall assess the quality system in order to determine whether it meets the requirements of point 3.2. For systems which comply with the relevant harmonised standard, compliance with these requirements is assumed. The audit team shall have at least one member experienced in assessing the technology of the product. The assessment shall include a check-up at the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the checks and a reasoned assessment decision.
3.4. The manufacturer shall undertake to comply with and maintain the obligations arising from the approved quality system in order to be consistent and effective. The manufacturer or his authorised representative shall inform the notified person who approved the quality system of any intended update of the quality system. The notified person shall assess the proposed changes and decide whether the changed quality system still complies with the requirements of point 3.2 or whether a new assessment is required. The notified person shall notify the manufacturer of his decision. The notification shall contain the conclusions of the checks and a reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. The purpose of supervision shall be to ensure that the manufacturer complies properly with the obligations arising from the approved quality system.
4.2. The manufacturer shall allow the notified person to enter the premises intended for production, inspection and testing and to provide him with all the necessary information, in particular:
(a) documentation of the quality system;
(b) quality records, such as inspection reports, test results, calibration data, qualification reports of relevant personnel.
4.3. The person nominated shall carry out regular audits to ensure that the manufacturer maintains and uses the quality system and to transmit an audit report to the manufacturer.
4.4. In addition, the notified person may carry out unexpected inspection visits with the manufacturer. During these inspections, the notified person may, if necessary, carry out tests or have them carried out to verify that the quality system is functioning properly. The notified person shall provide the manufacturer with a control report and a test report when carrying out the test.
5. The manufacturer shall keep for at least 10 years after the manufacture of the last product:
(a) the documentation referred to in point 3.1 (b);
(b) the update referred to in the second sentence of point 3.4;
(c) decisions and reports of the notified person referred to in points 3.4, fourth and fifth sentences, and points 4.3 and 4.4.
6. Each notified person shall, on request, provide the national authorities of the flag States of the European Union and other notified persons with relevant information concerning quality system approvals issued and withdrawn.
4.
Product Quality Security (MODULE E)
1. The manufacturer who fulfils the obligations referred to in point 2 shall ensure and declare that the products concerned are in conformity with the type described in the EC type-examination certificate. The manufacturer or his authorised representative shall affix a conformity mark to each product and draw up a written declaration of conformity. The conformity mark shall be accompanied by the identification number of the notified person responsible for supervision referred to in point 4.
2. The manufacturer shall use the approved quality system for the output inspection and testing of the products referred to in point 3 and shall be subject to surveillance in accordance with point 4.
3. Quality system
3.1. The manufacturer shall submit to the notified person to whom he has chosen an application for assessment of the quality system for the products in question. The application shall contain:
(a) all relevant information on the product category envisaged;
(b) documentation of the quality system;
(c) where appropriate, the technical documentation of the approved type and a copy of the EC type-examination certificate.
3.2. Each product shall be checked according to the quality system and appropriate tests shall be carried out to ensure compliance with the relevant requirements of this Regulation. All supporting documents, requirements and regulations used by the manufacturer shall be systematically and in an orderly manner documented in the form of written concepts, procedures and instructions. This quality system documentation shall allow a clear interpretation of the quality programmes, quality plans, manuals and quality records. The quality system documentation shall contain in particular an adequate description
(a) the quality objectives, organisational structure, responsibilities and powers of management as regards product quality;
(b) the checks and tests to be carried out after manufacture;
(c) means enabling the quality system to function effectively;
(d) quality records, such as inspection reports, test results, calibration data, qualification reports of relevant personnel.
3.3. The notified person shall assess the quality system in order to determine whether it meets the requirements of point 3.2. For systems which comply with the relevant harmonised standard, compliance with these requirements is assumed. The audit team shall have at least one member experienced in assessing the technology of the product. The assessment shall include a check-up at the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the checks and a reasoned assessment decision.
3.4. The manufacturer shall undertake to comply with and maintain the obligations arising from the approved quality system in order to be consistent and effective. The manufacturer or his authorised representative shall inform the notified person who approved the quality system of any intended update of the quality system. The amended person shall assess the proposed changes and decide whether the changed quality system still complies with the requirements of point 3.2 or whether a new assessment is required. The notified person shall notify the manufacturer of his decision. The notification shall contain the conclusions of the checks and a reasoned assessment decision.
4. Supervision for which the notified person is responsible
4.1. The purpose of supervision shall be to ensure that the manufacturer complies properly with the obligations arising from the approved quality system.
4.2. The manufacturer shall allow the notified person, for control purposes, to enter the premises intended for inspection, testing and storage and shall provide him with all necessary information, in particular:
(a) documentation of the quality system;
(b) technical documentation;
(c) quality records, such as inspection reports, test results, calibration data, qualification reports of relevant personnel.
4.3. The person nominated shall regularly carry out audits to ensure that the manufacturer maintains and uses the quality system and shall transmit an audit report to the manufacturer.
4.4. In addition, the notified person may carry out unexpected inspection visits with the manufacturer. During these inspections, the notified person may, if necessary, carry out tests or have them carried out to verify that the quality system is functioning properly. The notified person shall provide the manufacturer with a control report and a test report when carrying out the test.
5. The manufacturer shall keep for at least 10 years after the manufacture of the last product:
(a) the documentation referred to in point 3.1 (b);
(b) the update referred to in the second sentence of point 3.4;
(c) decisions and reports of the notified person referred to in the fourth and fifth sentences of points 3.4, 4.3 and 4.4.
6. Each notified person shall, upon request, provide the national authorities of the flag State of the European Union and other notified persons with relevant information concerning the quality system approvals issued and withdrawn.
5.
PRODUCTION VERIFICATION (MODULE F)
1. The manufacturer or his authorised representative shall ensure and declare that the products referred to in point 3 comply with the type described in the EC type-examination certificate.
2. The manufacturer shall take all necessary measures to ensure that the production process ensures compliance of the products with the type described in the EC-type examination certificate. The manufacturer shall affix a conformity mark to each product and issue a written declaration of conformity.
3. The person nominated shall carry out appropriate checks and tests to verify the conformity of the product with the requirements of this Regulation, either by checking and testing each product as referred to in point 4 or by checking and testing the products on the basis of the statistical methods referred to in point 5.
3.1. The manufacturer or his authorised representative shall keep a copy of the certificate of conformity for at least 10 years after the manufacture of the last product.
4. Verification by inspection and testing of each product
4.1. Each product shall be individually checked and appropriate tests carried out to verify the conformity of the products with the type described in the EC-type examination certificate.
4.2. The notified person shall affix or have each approved product bear its identification symbol and draw up a written certificate of conformity concerning the tests carried out.
4.3. The manufacturer or his authorised representative shall be able to submit on request certificates of conformity issued by the notified person.
5. Statistical verification
5.1. The manufacturer shall submit his products in the form of equal doses and shall take all necessary measures to ensure that the production process ensures the homogeneity of each batch produced.
5.2. All products in the form of homogeneous doses must be made available for verification. A sample shall be taken from each dose by random sampling. The products in the sample shall be individually checked and appropriate tests shall be carried out to verify the conformity of these products with the requirements of the provisions of this Regulation which apply to them and decide whether the dose will be accepted or rejected.
5.3. Where benefits are accepted, the notified person shall affix or have each product assigned his identification number and issue a written certificate of conformity relating to the tests carried out. All sample products may be placed on the market except for those sample products for which no conformity has been established. If the dose is rejected, the notified person shall take appropriate measures to prevent the placing on the market of the dose. In case of frequent refusal of doses, the notified person may suspend the statistical verification. The manufacturer may, during the production process, affix the products under the responsibility of the notified person with its identification number.
5.4. The manufacturer or his authorised representative shall be able to submit on request certificates of conformity issued by the notified person.
6.
VERIFICATION OF EACH SINGLE PRODUCT (MODULE G)
1. The manufacturer shall ensure and declare that the product for which the certificate referred to in point 2 has been issued complies with the requirements of this Regulation which apply to it. The manufacturer or his authorised representative shall affix a mark of conformity to the product and draw up a declaration of conformity.
2. The person nominated shall check each individual product and carry out appropriate tests to verify its conformity with the provisions of this Regulation. The authorised person shall affix or affix the approved product his identification number and issue a certificate of conformity relating to the tests carried out.
3. The purpose of the technical documentation shall be to enable conformity to be assessed with the requirements of this Regulation and to understand the design, manufacture and operation of the product.
7.
COMPLETE QUALITY SECURITY (MODULE H)
1. A manufacturer who fulfils the obligations referred to in point 2 shall ensure and declare that the products concerned comply with the requirements of this Regulation which apply to them. The manufacturer or his authorised representative shall affix a conformity mark to the product and draw up a written declaration of conformity. The conformity mark shall be accompanied by the identification number of the notified person responsible for supervision referred to in point 4.
2. The manufacturer shall use the approved quality system for the design, manufacture, exit inspection and testing of the products referred to in point 3 and shall be subject to surveillance in accordance with point 4.
3. Quality system
3.1. For the products in question, the manufacturer shall submit to the notified person an application for an assessment of the quality system. The application shall contain:
(a) all relevant information on the product category envisaged;
(b) quality documentation.
3.2. The quality system shall ensure that the products comply with the requirements of the provisions of this Regulation which apply to them. All supporting documents, requirements and regulations used by the manufacturer shall be systematically and in an orderly manner documented in the form of written concepts, procedures and instructions. This quality system documentation shall allow a clear interpretation of quality and procedures, such as quality programmes, quality plans, quality manuals and quality records. It shall contain, in particular, an adequate description of:
(a) quality objectives, organisational structure, responsibilities and powers of management with regard to the quality of design and products;
(b) the technical specifications of the proposal, including the standards to be applied and, where the standards referred to in Article 5 are not fully applied, a description of the means to be used to ensure compliance with the essential requirements of this Regulation applicable to the products;
(c) the methods of checking and verifying the design, procedures and systematic measures to be used in the design of products falling within the relevant product category;
(d) the corresponding methods, procedures and systematic measures to be used in the manufacture, management and quality assurance;
(e) checks and tests to be carried out before, during and after manufacture, indicating the frequency;
(f) quality records, such as inspection reports, test results, calibration data, qualification reports of relevant personnel;
(g) means of monitoring the achievement of the required quality of design and products and the effective functioning of the quality system.
3.3. The notified person shall assess the quality system in order to determine whether it meets the requirements of point 3.2. For systems using the relevant harmonised standard, compliance with these requirements is assumed. The audit team shall have at least one member experienced in assessing the technology of the product. The assessment shall include a check-up at the manufacturer's premises. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the checks and a reasoned assessment decision.
3.4. The manufacturer shall undertake to comply with and maintain the obligations arising from the approved quality system in order to be consistent and effective. The manufacturer or his authorised representative shall inform the notified person who approved the quality system of any intended update of the quality system. The notified person shall assess the proposed changes and decide whether the changed quality system still complies with the requirements of point 3.2 or whether a new assessment is required. The notified person shall notify the manufacturer of his decision. The notification shall contain the conclusions of the checks and a reasoned assessment decision.
4.EC supervision for which the notified person is responsible
4.1. The purpose of supervision shall be to ensure that the manufacturer complies properly with the obligations arising from the approved quality system.
4.2. The manufacturer shall allow the notified person to enter the premises for design, manufacture, inspection, testing and storage for inspection and shall provide him with all necessary information, in particular:
(a) documentation of the quality system;
(b) the quality records required in the design section of the quality system, such as the results of analyses, calculations, tests,
(c) the quality records required in the production section of the quality system, such as inspection reports, test results, calibration data, qualification reports of the relevant personnel.
4.3. The person nominated shall regularly carry out audits to ensure that the manufacturer maintains and uses the quality system and shall transmit an audit report to the manufacturer.
4.4. In addition, the notified person may carry out unexpected inspection visits with the manufacturer. During these inspections, the notified person may, if necessary, carry out tests or have them carried out to verify that the quality system is functioning properly. The notified person shall provide the manufacturer with a control report and a test report when carrying out the test.
5. The manufacturer shall keep for at least 10 years after the manufacture of the last product:
(a) the documentation referred to in the second sentence of point 3.1 (b);
(b) the update referred to in the second sentence of point 3.4;
(c) decisions and reports of the notified person referred to in points 3.4, fourth and fifth sentences, and points 4.3 and 4.4.
6. Each notified person shall provide the other notified persons with relevant information concerning quality system approvals issued and withdrawn.
7. Design examination
7.1. The manufacturer shall submit an application for design examination to a single notified person.
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Regulation Information
| Citation | Government Regulation No. 266 / 2009 Coll., on Technical Requirements for Marine Equipment |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.08.2009 |
|---|---|
| Effective from | 10.09.2009 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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