Council Directive 93/15/EEC (repealed)Dangos y teitl llawn

ANNEX II U.K.

1. MODULE B: EC type-examination U.K.

1. This module describes that part of the procedure by which a notified body ascertains and attests that an example, representative of the production envisaged, meets the relevant provisions of the Directive. U.K.

2. The application for EC type-examination is lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice. U.K.

The application must include:

• the name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address in addition,

• a written declaration that the same application has not been lodged with any other notified body,

• the technical documents, as described in Section 3.

The applicant must place at the disposal of the notified body an example representative of the production envisaged, hereinafter called ‘type’. The notified body may request further examples if needed for carrying out the test programme.

3. The technical documents must enable the conformity of the appliance with the requirements of the Directive to be assessed. They must, as far as is relevant for such assessment, cover the design, manufacture and operation of the appliance and contain as far as is relevant for assessment: U.K.

• a general type-description,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the product,

• a list of the standards referred to in Article 4, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports.

4. The notified body must: U.K.

4.1. examine the technical documents, verify that the type has been manufactured in conformity with those documents and identify the elements which have been designed in accordance with the relevant provisions of the standards referred to in Article 4 as well as the components which have been designed without applying the relevant provisions of those standards; U.K.

4.2. perform or have performed the appropriate examinations and necessary tests to check whether, where the standards referred to in Article 4 have not been applied, the solutions adopted by the manufacturer meet the essential requirements of the Directive; U.K.

4.3. perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied; U.K.

4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out. U.K.

5. Where the type meets the relevant provisions of this Directive, the notified body issues an EC type-examination certificate to the applicant. The certificate contains the name and [X1 address] of the manufacturer, the conclusion of the examination and necessary data for identification of the approved type. U.K.

Editorial Information

X1 Substituted by Corrigendum to Council Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses (Official Journal of the European Communities No L 121 of 15 May 1993).

A list of the relevant parts of the technical documents is annexed to the certificate and a copy kept by the notified body.

If the manufacturer or his authorized representative established in the Community is refused a type certificate, the notified body must provide detailed reasons for such refusal.

Provision must be made for an appeals procedure.

6. The applicant informs the notified body that holds the technical documents concerning the EC type-examination certificate of all [X1 modifications] to the approved appliance which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the product. This additional approval is given in the form of an addition to the original EC type-examination certificate. U.K.

7. Each notified body must communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and additions issued and withdrawn. U.K.

8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The Annexes to the certificates must be kept at the disposal of the other notified bodies. U.K.

9. The manufacturer or his authorized representative established within the Community must keep with the technical documents copies of EC type-examination certificates and their additions for a period of at least 10 years after the last date of manufacture of the product concerned. U.K.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market.

2. MODULE C: Conformity to type U.K.

1. This module describes that part of the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the explosives concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive that apply to them. The manufacturer must affix the CE mark to each explosive and draw up a written declaration of conformity. U.K.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process assures the conformity of the manufactured product with the type as described in the EC type-examination certificate with the essential safety requirements of the Directive. U.K.

3. The manufacturer or his authorized representative must keep a copy of the declaration of conformity for a period of at least 10 years after the last date of manufacture of the product concerned. U.K.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market.

4. A notified body chosen by the manufacturer must perform or have performed examinations of the product at random intervals. A suitable sample of the finished products, taken on the spot by the notified body, is examined [X1 and appropriate tests,] defined in the applicable standard or standards referred to in Article 4 or equivalent tests are carried out to check the conformity of the product with the requirements of the corresponding Directive. In the event of one or more samples of the products examined not conforming, the notified body must take the appropriate measures. U.K.

Under the responsibility of the notified body the manufacturer shall affix the identification symbol of that body during the manufacturing process.

3. MODULE D: Production quality assurance U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive. The manufacturer affixes the CE mark to each explosive and draws up a written declaration of conformity. The CE mark is accompanied by the identification symbol of the notified body responsible for the checks referred to in Section 4. U.K.

2. The manufacturer must operate an approved quality system for production, final product inspection and testing as specified in Section 3. He is subject to the checks referred to in Section 4. U.K.

3. Quality system U.K.

3.1. The manufacturer lodges an application for assessment of his quality system with a notified body of his choice, for the explosives concerned. U.K.

The application must include:

• all relevant information for the explosive category envisaged,

• the documents concerning the quality system,

• the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.

3.2. The quality system must ensure conformity of explosives with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them. U.K.

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. The quality system documents must permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the explosives,

• the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

• the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means of monitoring the achievement of the required quality of explosive and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure includes an inspection visit to the manufacturer's premises. U.K.

The decision is notified to the manufacturer. The notification must contain the [X1 conclusions] of the examination and the duly substantiated assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level. U.K.

The manufacturer or his authorized representative must keep the notified body that has approved the quality system informed of any proposed change in the quality system.

The notified body must assess the changes proposed [X1 and] decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment is required.

It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.

4. Monitoring under the responsibility of the notified body U.K.

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

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

• the quality system documents,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and provides an audit report to the manufacturer. U.K.

4.4. Additionally the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report. U.K.

5. The manufacturer must, for a period of at least 10 years after the last date of manufacture of the product, keep at the disposal of the national authorities: U.K.

• the document referred to in the second indent of 3.1,

• the updating referred to in second paragraph of 3.4,

• the decisions and reports [X1 from] the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn. U.K.

4. MODULE E: Product quality assurance U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives are in conformity with the type as described in the EC type-examination certificate. The manufacturer must affix the CE mark to each explosive and draw up a written declaration of conformity. The CE mark must be accompanied by the identification symbol of the notified body responsible for the checks referred to in Section 4. U.K.

2. The manufacturer must operate an approved quality system for final explosive inspection and testing as specified in Section 3. He must be subject to the checks referred to in Section 4. U.K.

3. Quality system U.K.

3.1. The manufacturer lodges an application with a notified body of his choice for the assessment of the quality system for his explosives. U.K.

The application must include:

• all relevant information for the explosive category envisaged,

• the quality system's documentation,

• the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.

3.2. Under the quality system, each explosive is examined and appropriate tests as defined in the relevant standard(s) referred to in Article 4 or equivalent tests are carried out in order to verify its conformity with the relevant requirements of the Directive. 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 enable the quality programmes, plans, manuals and records to be interpreted in a uniform manner. U.K.

It must in particular contain an adequate description of:

• the quality objectives and the organizational structure, [X1 responsibilities] and powers of the management with regard to product quality,

• the examination and tests that will be carried out after manufacture,

• the means of monitoring the effective operation of the quality system,

• quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. It must presume conformity with these requirements in respect of quality systems that implement the relevant harmonized standard. U.K.

The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure must include an inspection visit to the manufacturer's premises.

The manufacturer must be notified of the decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level. U.K.

The manufacturer or his authorized representative must keep the notified body which has approved the quality system informed of any proposed change in the quality system.

The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.

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

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

• the quality system documentation,

• the technical documents,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

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

4.4. Additionally, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified body must provide the manufacturer with a visit report and, if a test has been carried out, [X1 with a test report.] U.K.

5. The manufacturer must for a period of at least 10 years after the last date of manufacture of the product keep at the disposal of the national authorities: U.K.

• the documents referred to in the second indent of 3.1,

• the changes referred to in the second paragraph of 3.4,

• the decisions and reports [X1 from] the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn. U.K.

5. MODULE F: Product verification U.K.

1. This module describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the explosives subject to the provisions of 3 are in conformity with the type as described in the EC type-examination certificate and satisfy the relevant requirements of the Directive. U.K.

2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the explosives with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them. He shall affix the CE mark to each explosive and shall draw up a declaration of conformity. U.K.

3. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the explosive with the relevant requirements of the Directive by examination and testing of every explosive as specified in 4. U.K.

The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last explosive has been manufactured.

4. Verification by examination and testing of every explosive U.K.

4.1. All explosives shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in Article 4 or equivalent tests shall be carried out in order to verify their conformity with the relevant type and requirements of the Directive. U.K.

4.2. The notified body [X1 shall affix,] or cause to be affixed, its identification symbol to each approved explosive and draw up a written certificate of conformity relating to the tests carried out. U.K.

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

6. MODULE G: Unit verification U.K.

1. This module describes the procedure whereby the manufacturer ensures and declares that the explosive which has been issued with the certificate referred to in Section 2 conforms to the relevant requirements of the Directive. The manufacturer must affix the CE mark to the explosive and draw up a declaration of conformity. U.K.

2. The notified body must examine the explosive and carry out the appropriate tests as set out in the relevant standard(s) referred to in Article 4, or equivalent tests, to ensure its conformity with the relevant requirements of the Directive. U.K.

The notified body must affix, [X1 or cause] to be affixed, its identification symbol on the approved explosive and draw up a certificate of conformity concerning the tests carried out.

3. The aim of the technical documents is to enable conformity with the requirements of the Directive to be assessed and the design, manufacture and operation of the explosive to be understood. U.K.

The documents must contain, in so far as is necessary for the assessment:

• a general description of the type,

• conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of the said drawings and schemes and the operation of the explosive or protection system,

• a list of the standards referred to in Article 4, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 4 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports.