MINISTRY OF THE SEA, TOURISM, TRANSPORT AND DEVELOPMENT

70

Pursuant to Article 98 (1) of the Telecommunications Act (Official Gazette 122/03, 158/03 and 60/04) the Minister for the sea, tourism, transport and development passes the following

ORDINANCE

ON CONDITIONS CONCERNING PLACING ON THE MARKET, PUTTING INTO SERVICE AND USE OF RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

I GENERAL PROVISIONS

Contents of the Ordinance

Article 1

This Ordinance shall prescribe the conditions relating to placing on the market, putting into service and use of radio equipment and telecommunications terminal equipment (hereinafter: R&TT equipment), the manner and procedures of conformity assessment of the R&TT with the essential requirements set out in Article 98, paragraph 3 of the Telecommunications Act (hereinafter: the essential requirements), the manner and procedures of notifying a body within the system of R&TT conformity assessment, the procedure of issuing approvals for import and/or placing on the market of R&TT equipment, the marks and manner of marking of R&TT equipment and the publication of lists of harmonised Croatian standards as well as other European and international standards necessary for R&TT equipment conformity assessment.

Terms and definitions

Article 2

For the purpose of this Ordinance the following definitions shall apply:

1. harmonised standard means a technical specification serving as support for compliance to essential requirements;

2. declaration of conformity means a declaration made under full responsibility by the person responsible for placing R&TT equipment on the market, that the R&TT equipment the said declaration refers to complies with the essential requirements;

3. conformity assessment means any action relating to directly or indirectly establishing whether certain technical requirements for products have been satisfied;

4. radio equipment means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication;

5. interface means: a) all network termination points, which are physical connection points at which a user is provided with access to the public telecommunications network, and/or, b) an air interface specifying the radio path between radio equipment and their technical specifications;

6. technical construction file means a file describing the device and providing information and explanations as to how the applicable essential requirements have been implemented;
7. telecommunications terminal equipment means a product enabling communication or a relevant component thereof, which is intended to be connected directly or indirectly by any means whatsoever to interfaces of the public telecommunications network, for the purpose of transmission, processing and reception of statements and data;

8. conformity assessment body: a legal person that meets the essential requirements laid down in Article 12 of this Ordinance and that has the authority designated to it by the Council of the Croatian Telecommunications Agency;

9. device means any equipment that is either radio equipment or telecommunications terminal equipment, or both.

II CONDITIONS RELATING TO PLACING R&TT EQUIPMENT ON THE MARKET

Article 3

The R&TT equipment, compliant with the essential requirements, can be placed on the market by a legal or physical person, registered for such activity, which has acquired prior approval of the Croatian Agency for Telecommunications (hereinafter: the Agency)

Article 4

(1) The person responsible for placing the R&TT equipment on the market must provide the user with the information concerning the instructions for use and technical characteristics of that equipment along with the declaration of conformity to the essential requirements as well as the copy of the original declaration of conformity.

(2) When placed on the market, the R&TT equipment shall bear the conformity marking referred to in Article 14 of this Ordinance.

III PUBLICATION OF INTERFACE TECHNICAL SPECIFICATIONS

Article 5

(1) Operators of public telecommunications networks in the Republic of Croatia shall publish types of interfaces of their telecommunications network.

(2) The Agency will ensure that operators referred to in paragraph 1 of this Article, publish accurate and adequate technical specifications of their telecommunications network interfaces before telecommunications services provided through those interfaces are made publicly available, and regularly publish any updated technical specifications.

(3) The specifications must be in sufficient detail to permit the design of telecommunications terminal equipment capable of utilising all telecommunications services provided through the corresponding interface. The specifications shall include, inter alia, all the information necessary to allow manufacturers to carry out, at their choice, the relevant tests for the purpose of satisfying the essential requirements applicable to the telecommunications terminal equipment.

IV APPROVAL FOR IMPORT AND/OR PLACING R&TT EQUIPMENT ON THE MARKET

Application for the issue of approval

Article 6

(1) Approval for import and/or placing on the market of R&TT equipment (hereinafter: the approval) shall be issued by the Agency at the request of a legal or physical person which is registered for performance of the activities of import and/or placing on the market of R&TT equipment.

(2) In the case of repeated import and/or placing on the market of R&TT equipment of the same manufacture, the same type marking and equal technical characteristic, for which the approval of the Agency was acquired on the occasion of the first import and/or placing on the market, it shall not be necessary to acquire new approval.

(3) The form and contents of the approval application form, which is submitted to the Agency, shall be laid down and adequately published by the Agency, with prior consent of the Ministry competent for the field of telecommunications.

Documentation enclosed with the application

Article 7

(1) The documentation given in Appendix 1 to this Ordinance, printed with and comprising an integral part hereof, shall be enclosed in the application for the issue of approval for telecommunications terminal equipment, which for its operation does not make use of radio waves, as well as for radio equipment which operates only as a receiver, and in relation to which the harmonised standards in the procedure of assessing the conformity with the essential requirements are applied.

(2) The documentation referred to in Appendix 2 to this Ordinance, printed with and comprising an integral part hereof, shall be enclosed in the application for the issue of approval for R&TT equipment which does not contain the equipment referred to in paragraph 1 of this Article.

Issue of approval

Article 8

(1) The Agency shall, on the basis of the received application for the issue of approval and enclosed documentation referred to in Article 7 of this Ordinance, carry out the procedure of establishing whether the conditions for import and/or placing on the market of R&TT equipment have been met.

(2) Where the Agency ascertains that the conditions laid down in the Telecommunications Act and this Ordinance have been satisfied, it shall issue the approval for import and/or placing on the market of R&TT equipment within the period of 30 days following the receipt of the application for the issue of approval.

(3) In case of non-compliance with the conditions referred to in paragraph 2 of this Article, the Agency shall, by means of a decision, reject the application for the issue of approval.

(4) The Agency must, in an adequate manner, publish the list of R&TT equipment for which the approval has been issued.

Import of R&TT equipment for personal needs

Article 9

(1) A legal or physical person can import R&TT equipment, which is given in the list referred to in Article 8, paragraph 4 of this Ordinance, into the Republic of Croatia for personal needs without acquiring the Agency’s approval.

(2) For the import for personal needs of R&TT equipment, which is not given in the list referred to in paragraph 1 of this Article, a legal or physical person has to acquire the Agency’s approval in accordance with the provisions of Articles 6, 7, and 8 of this Ordinance.

Import of R&TT equipment samples

Article 10

(1) The samples of R&TT equipment intended for tests, public display and demonstrations in the Republic of Croatia, may be imported upon acquiring the Agency’s approval referred to in Article 6 of this Ordinance.

(2) Basic technical characteristics of R&TT equipment samples referred to in paragraph 1 of this Article, shall be enclosed in the application for the issue of approval referred to in paragraph 1 of this Article.

(3) R&TT equipment which does not comply with any of the essential requirements, may be publicly displayed and demonstrated in the Republic of Croatia provided that a visible sign clearly indicates that the use of such equipment is not permitted in the Republic of Croatia.

V PROCEDURES FOR CONFORMITY ASSESSMENT OF R&TT EQUIPMENT

Article 11

(1) The Agency, or a conformity assessment body, shall carry out the procedures of R&TT equipment conformity assessment for the purpose of establishing compliance of that equipment with the relevant essential requirements.

(2) The conformity assessment of telecommunications terminal equipment, which for its operation does not make use of radio waves, as well as of radio equipment which operates only as a receiver, and in relation to which the harmonised standards in the procedure of assessing the conformity with the essential requirements are applied, shall be carried out, at the choice of the equipment manufacturer, using one of the procedures specified in Appendices 3, 4 and 5 to this Ordinance, printed with and comprising an integral part hereof.

(3) The conformity assessment of R&TT equipment which does not contain the equipment referred to in paragraph 2 of this Article, shall be carried out, at the choice of the equipment manufacturer, using one of the procedures specified in Appendices 4 and 5 to this Ordinance, printed with and comprising an integral part hereof.

(4) All applications and documentation relating to the conformity assessment procedures referred to in paragraphs 2 and 3 of this Article, shall be in the Croatian language, or in a language determined by the Agency or the conformity assessment body.

VI PROCEDURE FOR DESIGNATING CONFORMITY ASSESSMENT BODIES

Basic criteria to be met by the conformity assessment body

Article 12

The conformity assessment body must satisfy the following basic conditions:

1. The conformity assessment body, its director and the staff responsible for carrying out the tasks for which the conformity assessment body has been designated, must not be a designer, manufacturer, supplier or installer of R&TT equipment, or a telecommunications network operator or telecommunications service provider, nor the authorised representative of any of such parties. They must be independent and not become directly involved in the design, construction, marketing or maintenance of R&TT equipment, nor represent the parties engaged in these activities. This does not exclude the possibility of exchanges of technical information between the manufacturer and the conformity assessment body.
2. The conformity assessment body and its staff must carry out the tasks for which the conformity assessment body has been designated, with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of any testing procedures, especially from persons or groups of persons with an interest in such results.
3. The conformity assessment body must have at its disposal the necessary staff and facilities to enable it to properly perform the administrative and technical work associated with the tasks for which it has been designated.
4. The staff responsible for supervision must have sound technical and professional training, satisfactory knowledge of the requirements of the tests that are carried out and adequate experience in such testing procedure, and the ability to draw up the certificates, records and test reports required to authenticate the performance of the tests.
5. The impartiality of the supervision staff must be guaranteed. Their remuneration must not depend on the number of tests carried out nor on the results of such tests.
6. The conformity assessment body must be insured for the tasks it carries out, in accordance with special regulations;
7. The staff of the conformity assessment body is bound to observe professional secrecy with regard to all information gained in carrying out its tasks.

Granting and revocation of R&TT equipment conformity assessment

Article 13

(1) The Agency shall grant the authorisation for performance of activities relating to R&TT equipment conformity assessment in accordance with the special Ordinance referred to in Article 35, paragraph 3 of the Telecommunications Act, on the basis of the application submitted by a legal person, and the procedure that has been carried out for the purpose of establishing whether the conditions set out in Article 12 of this Ordinance have been satisfied.

(2) The authorisation referred to in paragraph 1 of this Article shall be granted for the period laid down in the special Ordinance referred to in Article 35, paragraph 3 of the Telecommunications Act.

(3) The conformity assessment body must satisfy the conditions referred to in Article 12 of this Ordinance and conditions laid down in the special Ordinance referred to in Article 35, paragraph 3 of the Telecommunications Act, during the whole period of validity of the authorisation referred to in paragraph 1 of this Article.

(4) The Agency shall, in accordance with the provisions of the Telecommunications Act, this Ordinance and other regulations adopted on the basis of the Telecommunications Act, adopt the decision concerning the revocation of the authorisation if it is ascertained that the conformity assessment body does not perform the activities for which it was granted the authorisation referred to in paragraph 1 of this Article.

VII INSCRIPTIONS AND MARKING OF R&TT EQUIPMENT

Article 14

(1) Device complying with all relevant essential requirements shall, before being placed on the market, shall bear the conformity marking referred to in paragraph 4 of this Article.

(1) The conformity marking referred to in paragraph 4 of this Article shall be affixed by the device manufacturer, its authorized representative in the Republic of Croatia, or the person responsible for import and/or placing the device on the market.

(2) The conformity marking referred to in paragraph 4 of this Article must be affixed to the device and packaging, if any. It must be affixed visibly, legibly and indelibly beside any other conformity marking, provided that the visibility and legibility of those markings is not thereby reduced.

(3) The form and inscriptions of the conformity marking are given in Appendix 6 to this Ordinance.

(4) Device, for which the approval referred to in Article 6 of this Ordinance has been issued and which has been marked with a conformity marking issued abroad and demonstrating compliance with essential requirements identical to essential requirements set out in this Ordinance, need not be additionally marked with the conformity marking referred to in paragraph 4 of this Article.

VIII HARMONISED STANDARDS

Article 15

(1) The Agency shall regularly harmonise and update the list of harmonised standards necessary for the assessment of the conformity of R&TT equipment with essential requirements, and publish it when appropriate, and at least once a year, in the Official Gazette. The list may be also published on the Internet or in any other appropriate manner.

(2) Where device meets harmonised standards referred to in paragraph 1 of this Article, compliance with essential requirements shall be presumed.

(3) The Croatian Standards Institute shall be obliged to provide, in accordance with the provision of Article 5, paragraph 2 of the Standardisation Act, data concerning the harmonised standards referred to in paragraph 1 of this Article, that are adopted in the Republic of Croatia.

(4) If, in the Republic of Croatia, the Croatian standards relating to R&TT equipment are not adopted and published, adequate European and international standards may be applied for the assessment of conformity of R&TT equipment with essential requirements.

IX FEES

Article 16

(1) For the authorisation referred to in Article 13 of this Ordinance, the fee shall be paid in the manner and in the amount laid down in the Ordinance on fees for performance of telecommunications services and activities.

(2) A person that submits the application for the conformity assessment shall pay the fee for the procedure of R&TT conformity assessment to the Agency or the conformity assessment body.

(3) The amount of the fee referred to in paragraph 2 of this Article shall be approved by the Agency.

(4) For submission of the application for issue of the approval referred to in Articles 6, 9, and 10 of this Ordinance as well as the application for issue of the authorisation referred to in Article 13 of this Article, the administrative fee shall be paid in accordance with a special regulation.

X SUPERVISION

Article 17

(1) Supervision of inspection over the implementation of the provisions of this Ordinance, relating to supervision of R&TT equipment on the market, shall be carried out by the telecommunications inspector and inspector of the State Inspectorate (hereinafter: the inspector), in accordance with the provisions set out in Article 112 of the Telecommunications Act.

(2) When performing supervision of the R&TT equipment on the market, the inspector shall in particular check the documentation referred to in Article 4 of this Ordinance, and the conformity marking referred to in Article 14 of this Ordinance. He/she may request insight into the technical documentation referred to in point 4 of Appendix 3 to this Ordinance.

(3) Within the framework of measures he/she is authorised to take, on the basis of the Telecommunications Act, the inspector shall have the right to order R&TT equipment tests.

(4) In the case that during the tests referred to in paragraph 3 of this Ordinance, it is established that R&TT equipment is not compliant with any of the essential requirements, the costs of the tests shall be borne by the legal or physical person responsible for import and/or placing on the market of the said R&TT equipment.

(5) The inspector shall keep minutes of performing supervision he/she performs, of R&TT equipment on the market.

(6) In the case referred to in paragraph 4 of this Article, the inspector shall, by means of a decision, temporarily prohibit the import and/or sale of the R&TT equipment, and order removal of deficiencies established on the mentioned R&TT equipment and he shall provide the Agency with a copy of the minutes thereof, referred to in paragraph 5 of this Ordinance.

(7) In the case of failure to act according to the inspector’s decision referred to in paragraph 6 of this Article within the time period specified, the Agency shall adopt the Decision on expiry of the validity of the approval for import and/or placing on the market of R&TT equipment, and the person referred to in paragraph 4 of this Article is obliged to withdraw the mentioned R&TT equipment from the market, without delay.

(8) The Agency shall publish, in an adequate manner, the list of R&TT equipment for which the Decision on expiry of the approval validity referred to in paragraph 7 of this Article, has been issued.

XI TRANSITIONAL AND FINAL PROVISIONS

Transitional provisions

Article 18

(1) Approvals for import and/or placing on the market of R&TT equipment, which were issued pursuant to regulations which were valid prior to entry into force of this Ordinance, shall be valid until the expiry of the time period for which they were issued, along with the conditions set out in the approval, in accordance with the provisions of the Telecommunications Act.

(2) Until the issue of the authorisation referred to in Article 13 of this Ordinance, the Agency shall carry out all the tasks of the conformity assessment body as laid down in this Ordinance.

Entry into force of this Ordinance

Article 19

This Ordinance shall enter into force on the eighth day from its publication in the Official Gazette.

Class: 011-01/04-02/98

Number: 530-10-04-1

Zagreb, 27 December 2004

MINISTER

Božidar Kalmeta, m.p.

APPENDIX 1

DOCUMENTATION ENCLOSED FOR R&TT EQUIPMENT REFERRED TO IN ARTICLE 7, PARAGRAPH 1 OF THIS ORDINANCE

Along with the application for issue of approval, the following documentation must be submitted to the Agency:

1. Decision on registry in the register of companies or the trade licence (only in case when a certain legal or physical person submits the application for the issue of approval for the first time), from which it is visible that the legal or physical person is registered for import and/or placing on the market of R&TT equipment;
2. Evidence of assuring maintenance of device in the period of validity of its warranty and during its service life;
3. Instructions for use in the Croatian language, and exceptionally in the English language in the case of special R&TT equipment which requires professional persons to install and use it. In that case the instructions for use must contain technical characteristics of the mentioned equipment;
4. Warranty;
5. Declaration of conformity with the essential requirements, in the original form, which was issued by the manufacturer, its authorised representative in the Republic of Croatia or the person responsible for import and/or placing on the market of R&TT equipment;
6. A copy of the original declaration of conformity if the R&TT equipment was not manufactured in the Republic of Croatia;
7. The list of applied standards;
8. Detailed technical description of device;
9. Detailed documentation list (with exact specification of test reports) serving for the conformity assessment of R&TT equipment with the essential requirements.

APPENDIX 2

DOCUMENTATION ENCLOSED FOR R&TT EQUIPMENT REFERRED TO IN ARTICLE 7, PARAGRAPH 2 OF THIS ORDINANCE

Along with the application for the issue of approval, the following documentation must be submitted to the Agency:

1. Decision on registry in the register of companies or the trade licence (only in case when a certain legal or physical person submits the application for the issue of approval for the first time), from which it is visible that the legal or physical person is registered for import and/or placing on the market of R&TT equipment;
2. Evidence of assuring maintenance of device in the period of validity of its warranty and during its service life;
3. Instructions for use in the Croatian language, and exceptionally in the English language in the case of special R&TT equipment which requires professional persons to install and use it. In that case the instructions for use must contain technical characteristics of the mentioned equipment;
4. Warranty;
5. Declaration of conformity with the essential requirements, in the original form, which was issued by the manufacturer, his authorised representative in the Republic of Croatia or the person responsible for import and/or placing on the market of R&TT equipment;
6. A copy of the original declaration of conformity if the R&TT equipment was not manufactured in the Republic of Croatia;
7. Conformity certificate or technical construction file referred to in point 3 of Appendix 4 to this Ordinance and application for the conformity assessment where the procedure of the conformity assessment has not been carried out.

APPENDIX 3

SUPERVISION OF THE EQUIPMENT MANUFACTURER

1. This Appendix 3 describes the procedure for conformity assessment whereby the manufacturer or its authorised representative in the Republic of Croatia ensures and declares that the products concerned satisfy the essential requirements. The manufacturer or its authorised representative in the Republic of Croatia must affix the conformity marking, referred to in Article 14 of this Ordinance, to each product and draw up a written declaration of conformity.
2. The manufacturer must establish the technical documentation described in point 4 of this Appendix and it or its authorised representative in the Republic of Croatia must keep it for a period of at least 10 years after the last product has been manufactured, during which time it must be at the disposal of the Agency or the inspector referred to in Article 17 of this Ordinance for supervision purposes.
3. Where neither the manufacturer nor its authorised representative are established in the Republic of Croatia, the obligation to keep the technical documentation at the disposal of the Agency or the inspector referred to in Article 17 of this Ordinance is the responsibility of the person who places the product on the market.
4. The technical documentation must enable assessment of the conformity of the device with the essential requirements. It must cover the design, manufacture and operation of the device, in particular:
   - a general description of the device,
   - conceptual design and manufacturing drawings and schematic diagrams, sub-assemblies, circuits, etc.,
   - descriptions and explanations necessary for the understanding of said drawings and schematic diagrams, and of the operation of the device,
   - a list of the harmonised standards, applied in full or in part, and in case when such harmonised standards have not been applied or do not exist, descriptions and explanations of the solutions adopted to meet the essential requirements,
   - results of design calculations made, examinations carried out, etc.,
   - test reports.
5. The manufacturer or its authorised representative in the Republic of Croatia must keep a copy of the declaration of conformity with the technical documentation.
6. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in point 2 of this Appendix and with the requirements of the Telecommunications Act and this Ordinance.

APPENDIX 4

TECHNICAL CONSTRUCTION FILE

This Appendix 4 consists of Appendix 3 of this Ordinance plus the following supplementary requirements:

1. For each type of device, all essential radio tests must be carried out by the manufacturer or on his behalf. The identification of the tests that are considered to be essential is the responsibility of the Agency except where the tests are defined in the harmonised standards.
2. The manufacturer or his authorised representative established in the Republic of Croatia, or the person responsible for import and/or placing the device on the market must declare that these tests have been carried out and that the device complies with the essential requirements.
3. The declaration of conformity referred to in point 2 of this Appendix and the technical documentation described in point 4 of Appendix 3 to this Ordinance, must form a technical construction file.
4. The manufacturer, its authorised representative in the Republic of Croatia or the person responsible for import and/or placing the device on the market, shall submit to the Agency the application for conformity assessment of the device. With the application they shall present the technical construction file referred to in point 3 of this Appendix.
5. For radio stations for which the Agency issues a general licence referred to in Article 87 of the Telecommunications Act, except radio stations that require registration with the Agency, providing data on the user and the location of the radio station, the application for the conformity assessment may be submitted to the conformity assessment body.
6. The Agency or the conformity assessment body must review the technical construction file referred to in point 3 of this Appendix, and issue the conformity certificate to the applicant, if it ascertains that the conformity of the device with the essential requirements is orderly demonstrated. The conformity assessment body must regularly and in an adequate manner, notify the Agency of the data concerning the conformity certificates issued.
7. The manufacturer or its authorised representative in the Republic of Croatia, or the person responsible for import and/or placing the device on the market, must keep the technical construction file referred to in point 3 of this Appendix for a period of at least 10 years after the last device has been manufactured, during which time it must be at the disposal of the Agency and inspector referred to in Article 17 of this Ordinance.

APPENDIX 5

FULL QUALITY ASSURANCE

1. Full quality assurance is the procedure whereby the manufacturer who satisfies the obligations of point 2 of this Appendix ensures and declares that the product concerned satisfies the requirements of this Ordinance. The manufacturer must affix the marks referred to in Article 14 of this Ordinance to each product and draw up a written declaration of conformity, which must be enclosed with each product.
2. The manufacturer must operate an approved quality system for design, manufacture and final product testing as specified in point 3 of this Appendix and must be subject to supervision as specified in point 4 of this Appendix.
3. Quality system:
3.1. The manufacturer must submit an application for assessment of its quality system to the Agency or conformity assessment body.
The application must include:
- all relevant information for the certain product,
- the documentation pertaining to the quality system.
3.2. The quality system must ensure compliance of the product with the requirements of this Ordinance. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
It must contain, in particular, an adequate description of:
- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
- the technical specifications, including the harmonised standards and technical regulations, as well as relevant test specifications that will be applied and, where the harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements that apply to the product will be met,
- the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered,
- 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, as well as the results of the tests carried out before manufacture, where appropriate,
- the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test,
- the quality records, such as supervision reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
- the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.
3.3. The Agency or the conformity assessment body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. of this Appendix. It must presume compliance with these requirements with respect to quality systems that implement the relevant harmonised standard.
The Agency or the conformity assessment body must assess, in particular, whether the quality control system ensures conformity of the products with the requirements of this Ordinance, in lieu of the relevant documentation supplied with respect to points 3.1 and 3.2 of this Appendix, including test results supplied by the manufacturer.
The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure must include an assessment visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and an explanation of the assessment decision.
3.4. The manufacturer must undertake the fulfilment of the obligations arising from the approved quality system, and to uphold it so that it remains adequate and efficient.
The manufacturer or its authorised representative in the Republic of Croatia must keep the Agency or the conformity assessment body that has approved the quality system, informed of any intended updating of the quality system.
The Agency or the conformity assessment body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 of this Appendix, or whether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and an explanation of the assessment decision.
4. Surveillance of the quality system:
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising from the approved quality system.
4.2. The manufacturer must allow the Agency, the conformity assessment body and the inspector referred to in Article 17 of this Ordinance, access for supervision purposes to the locations of design, manufacture, supervision and testing, and storage, and must provide it with all necessary information, in particular:
- the quality system documentation,
- the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
- the quality records as foreseen by the manufacturing part of the quality system, such as supervision reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The Agency or the conformity assessment body must carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system, and must provide an audit report to the manufacturer.
4.4. The Agency or the conformity assessment body may pay unexpected visits to the manufacturer. At the time of such visits, the Agency or the conformity assessment body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.
5. The manufacturer must, for a period of at least 10 years after the last product has been manufactured, keep at the disposal of the Agency:
- the documentation referred to in the second indent of point 3.1 of this Appendix,
- the updating referred to in the second paragraph of point 3.4 of this Appendix,
- the decisions and reports from the conformity assessment bodies which are referred to in paragraph 4 of point 3.4 and in points 4.3 and 4.4. of this Appendix.
6. The Agency and each conformity assessment body must make available to other conformity assessment bodies the relevant information concerning quality system approvals including the approvals issued and withdrawn.