S.I. No. 83/1999 - European Communities (Equipment and Protective Systems Intended For Use in Potentially Explosive Atmospheres) Regulations, 1999

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold the system so that it remains adequate and efficient. The manufacturer or his authorised representative shall inform the notified body which has approved the quality system of any intended updating of the quality system. The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required. It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.1 The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2 The manufacturer shall, for inspection purposes, allow the notified body access to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular — the quality system documentation — the quality records, such as inspection reports and text data, calibration data, reports on the qualifications of the personnel concerned, etc.

4.3 The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4 Furthermore, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may carry out tests, or arrange for tests to be carried out, to check that the quality system is functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken place with a test report.

— the documentation referred to in the second of paragraph 3.1;

— the updating referred to in the second subparagraph of paragraph 3.4;

— the decisions and reports from the notified body which are referred to in paragraph 3.4, last subparagrph, paragraph 4.3 and paragraph 4.4.

FIFTH SCHEDULE

Regulation 7

Module: Product Verification

The manufacturer or his authorised representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last piece of equipment was manufactured.

4.1 All equipment shall be individually examined and appropriate tests as set out in the relevant standard referred to in these Regulations or equipment tests shall be carried out in order to verify their conformity with the type as described in the EC-type-examination certificate and the relevant requirements of these Regulations.

4.2 The notified body shall affix or have affixed its identification number to each approved item of equipment and shall draw up a written certificate of conformity relating to the the tests carried out.

4.3 The manufacturer or his authorised representative shall ensure that he is able to supply the notified body's certificates of conformity on request.

SIXTH SCHEDULE

Regulation 7

Module: Conformity to Type

For each piece of equipment manufactured, tests relating to the anti-explosive protection aspects of the product shall be carried out by the manufacturer or on his behalf. The tests shall be carried out under the responsibility of a notified body, chosen by the manufacturer. On the responsibility of the notified body, the manufacturer shall affix the forger's identification number during the manufacturing process.

SEVENTH SCHEDULE

Regulation 7

Module: Product Quality Assurance

3.1. The manufacturer shall lodge an application for assessment of his quality system for the equipment and protective systems, with a notified body of his choice.

The application shall include:

— all relevant information for the product category envisaged;

— documentation on the quality system;

— technical documentation on the approved type and a copy of the EC-type-examination certificate.

3.2. Under the quality system, each piece of equipment shall be examined and appropriate tests as set out in the relevant standard referred to in these Regulations or equivalent tests shall be carried out in order to ensure its conformity with the relevant requirements of these Regulations.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instruments. This quality system documentation must permit a consistent intepretation of the quality programmes, plans, manuals and records.

It shall contain, in particular, an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

— the examinations and tests which will be carried out after manufacture;

— the means to monitor the effective operation of the quality system;

— quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2. It shall presume conformity with these requirements in respect of quality systems which implement the relevant harmonised standard.

The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The assessment procedure shall include an assessment visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer shall undertake to discharge the obligations arising from the quality system as approved and to maintain it in an appropriate and efficient manner.

The manufacturer or his authorised representative shall inform the notified body which has approved the quality system of any intended updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.1. The purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall for inspection purposes allow the notified body access to the inspection, testing and storage premises and shall provide it with all necessary information, in particular:

— quality system documentation;

— technical documentation;

— quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

4.3. The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4. Furthermore, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or arrange for tests to be carried out in order to check the proper functioning of the quality system, where necessary; it shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.

— the documentation referred to in the third indent of paragraph 3.1;

— the updating referred to in the second paragraph of paragraph 3.4;

— the decisions and reports from the notified body which are referred to in paragraph 3.4, last subparagraph, paragraph 4.3 and paragraph 4.4.

EIGHTH SCHEDULE

Regulation 7

Module: Internal Control of Production

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the equipment on the Community market.

— a general description of the equipment;

— conceptual design and manufacturing drawings and schemes of components, sub-ssemblies, circuits, etc.;

— descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the equipment;

— a list of the standards applied in full or in part, and descriptions of the solutions adopted to meet the safety aspects of these Regulations where the standards have not been applied;

— results of design calculations made, examinations carried out, etc.;

— test reports.

NINTH SCHEDULE

Regulation 7

Module: Unit Verification

The notified body shall affix, or cause to be affixed, its identification number on the approved equipment or protective system and shall draw up a certificate of conformity concerning the tests carried out.

The documentation shall contain:

— a general description of the product;

— conceptual design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;

— descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the equipment or protective system;

— a list of the standards referred to in these Regulations, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of these Regulations where the standards referred to have not been applied;

— results of design calculations made, examinations carried out, etc.;

— test reports.

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations implement Council Directive 94/9/EC on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres. They apply to equipment, protective systems, devices and components intended for use in potentially explosive atmospheres and going on the market for the first time after the 1st March 1996. The Regulations require compliance with the essential health and safety requirents (Schedule 2) and the affixing of the CE marking. The CE marking can only be affixed if the equipment has undergone the appropriate conformity assessment procedure (Regulation 7) and in respect of which an EC declaration of Conformity has been drawn up.

The aim of the Directive is to remove barriers to trade in the area of equipment and protective systems which are intended for use in potentially explosive atmospheres.

There is a transitional period up to the 30th June 2003 whereby the Regulations do not apply to equipment or a protective system which complies with the health and safety provisions, in respect of it, which were in force in Ireland on 23rd of March 1994. Also, electrical equipment which complies with Directives 76/117/EEC and 79/196/EEC may continue to be marketed until the 30th June 2003.

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