Directive 2007/23/EC of the European Parliament and of the Council (repealed)Show full title

ANNEX II Conformity assessment procedures

1. MODULE B: EC type-examination

1. This module describes that part of the procedure by which a notified body ascertains and attests that a sample, representative of the production envisaged, meets the relevant provisions of Directive 2007/23/EC (hereinafter referred to as this Directive).

2. The application for EC type-examination must be lodged by the manufacturer with the notified body of his choice.

The application must include:

(a)

the name and address of the manufacturer,

(b)

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

(c)

the technical documents, as described in point 3.

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

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

(a)

a general type-description,

(b)

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

(c)

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

(d)

a list of the harmonised standards referred to in Article 8 of this Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where the harmonised standards referred to in Article 8 of this Directive have not been applied,

(e)

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

(f)

test reports.

4. The notified body must:

(a)

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 harmonised standards referred to in Article 8 of this Directive as well as the components which have been designed without applying the relevant provisions of those harmonised standards,

(b)

perform or have performed the appropriate examinations and necessary tests to check whether, where the harmonised standards referred to in Article 8 of this Directive have not been applied, the solutions adopted by the manufacturer meet the essential safety requirements of this Directive,

(c)

perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant harmonised standards, these have been applied,

(d)

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

5. Where the type meets the relevant provisions of this Directive, the notified body must issue an EC type-examination certificate to the applicant. The certificate must contain the name and address of the manufacturer, the results of the examination and the data necessary for the identification of the approved type.

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

Where the manufacturer 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 must inform the notified body that holds the technical documents concerning the EC type-examination certificate of all modifications to the approved article which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the article. This additional approval must be given in the form of an addition to the original EC type-examination certificate.

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

8. The other notified bodies may receive copies of the EC type-examination certificates and/or any additions thereto. The annexes to the certificates must be kept at the disposal of the other notified bodies.

9. The manufacturer must keep with the technical documents copies of EC type-examination certificates and any additions thereto for a period of at least 10 years after the last date of manufacture of the article concerned.

Where the manufacturer is not established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the market.

2. MODULE C: Conformity to type

1. This module describes that part of the procedure whereby the manufacturer ensures and declares that the pyrotechnic articles 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 marking to each pyrotechnic article and draw up a written declaration of conformity.

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

3. The manufacturer 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 article concerned.

Where the manufacturer is not established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the market.

4. A notified body chosen by the manufacturer must perform or cause to be performed examinations of the article at random intervals. A suitable sample of the finished articles, taken on the spot by the notified body, must be examined and appropriate tests, defined in the applicable harmonised standard referred to in Article 8 of this Directive or equivalent, carried out to check the conformity of the article with the requirements of this Directive. In the event of one or more samples of the articles examined not conforming, the notified body must take appropriate measures.

Under the responsibility of the notified body the manufacturer must affix the identification number of that body during the manufacturing process.

3. MODULE D: Production quality assurance

1. This module describes the procedure whereby a manufacturer who satisfies the obligations set out in point 2 ensures and declares that the pyrotechnic articles concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive. The manufacturer must affix the CE marking to each article and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for the monitoring referred to in point 4.

2. The manufacturer must operate an approved quality system for production, final product inspection and testing as specified in point 3. He must be subject to the monitoring referred to in point 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with the notified body of his choice in relation to the pyrotechnic articles concerned.

The application must include:

(a)

all relevant information for the pyrotechnic article category envisaged,

(b)

the documents concerning the quality system,

(c)

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

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

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.

They must contain in particular an adequate description of:

(a)

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pyrotechnic articles,

(b)

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

(c)

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

(d)

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

(e)

the means of monitoring the achievement of the required quality of the pyrotechnic articles 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 point 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonised standard. 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.

A duly substantiated assessment decision must be notified to the manufacturer. It must contain the results of the examination.

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.

The manufacturer must keep the notified body that has approved the quality system informed of any proposed change to 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 point 3.2 or whether reassessment is required.

A duly substantiated assessment decision must be notified to the manufacturer. It must contain the results of the examination.

4. Monitoring under the responsibility of the notified body

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

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:

(a)

the quality system documents,

(b)

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

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

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

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

(a)

the documents referred to in point 3.1.(b),

(b)

documents relating to the updating referred to in second subparagraph of point 3.4,

(c)

the decisions and reports of the notified body referred to in the fourth subparagraph of point 3.4, and in points 4.3 and 4.4.

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

4. MODULE E: Product quality assurance

1. This module describes the procedure whereby a manufacturer who satisfies the obligations set out in point 2 ensures and declares that the pyrotechnic articles are in conformity with the type as described in the EC type-examination certificate. The manufacturer must affix the CE marking to each article and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for the monitoring referred to in point 4.

2. The manufacturer must operate an approved quality system for final pyrotechnic article inspection and testing as specified in point 3. He must be subject to the monitoring referred to in point 4.

3. Quality system

3.1. The manufacturer must lodge an application with the notified body of his choice for the assessment of the quality system in relation to his pyrotechnic articles.

The application must include:

(a)

all relevant information for the pyrotechnic category envisaged,

(b)

the quality system documents,

(c)

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

3.2. Under the quality system, each pyrotechnic article must be examined and appropriate tests, as defined in the relevant harmonised standard(s) referred to in Article 8 of this Directive or equivalent, carried out in order to verify the conformity of the article with the relevant requirements of this 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. The quality system documents must permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

They must in particular contain an adequate description of:

(a)

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

(b)

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

(c)

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

(d)

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

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

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.

A duly substantiated assessment decision must be notified to the manufacturer. It must contain the results of the examination.

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.

The manufacturer must keep the notified body which has approved the quality system informed of any proposed change to 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 point 3.2 or whether a reassessment is required.

A duly substantiated assessment decision must be notified to the manufacturer. It must contain the results of the examination.

4. Monitoring under the responsibility of the notified body

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

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:

(a)

the quality system documents,

(b)

the technical documents,

(c)

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

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.

4.4. Additionally, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may, if necessary, carry out tests or have them carried out to verify that the quality system is functioning correctly. The notified body 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 date of manufacture of the article keep at the disposal of the national authorities:

(a)

the documents referred to in point 3.1.(b),

(b)

documents relating to the updating referred to in the second subparagraph of point 3.4,

(c)

the decisions and reports of the notified body referred to in the fourth subparagraph of point 3.4, and in points 4.3 and 4.4.

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

5. MODULE G: Unit verification

1. This module describes the procedure whereby the manufacturer ensures and declares that the pyrotechnic article which has been issued with the certificate referred to in point 2 conforms with the relevant requirements of this Directive. The manufacturer must affix the CE marking to the article and draw up a declaration of conformity.

2. The notified body must examine the pyrotechnic article and carry out the appropriate tests as set out in the relevant harmonised standard(s) referred to in Article 8 of this Directive, or equivalent tests, to ensure the conformity of the article with the relevant requirements of this Directive.

The notified body must affix, or cause to be affixed, its identification number to the approved pyrotechnic article 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 this Directive to be assessed and the design, manufacture and operation of the pyrotechnic article to be understood.

Where necessary for the assessment, the documents must contain:

(a)

a general description of the type,

(b)

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

(c)

the descriptions and explanations necessary for the understanding of the conceptual design and manufacturing drawings, the schemes of components, sub-assemblies and circuits and the operation of the pyrotechnic article,

(d)

a list of the harmonised standards referred to in Article 8 of this Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where the harmonised standards referred to in Article 8 of this Directive have not been applied,

(e)

results of design calculations made and examinations carried out,

(f)

test reports.

6. MODULE H: Full quality assurance

1. This module describes the procedure whereby the manufacturer who satisfies the obligations set out in point 2 ensures and declares that the articles concerned meet the requirements of this Directive. The manufacturer or his importer must affix the CE marking to each article and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for the monitoring referred to in point 4.

2. The manufacturer must operate an approved quality system for the design, production, final product inspection and testing as specified in point 3 and must be subject to the monitoring referred to in point 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.

The application must include:

(a)

all relevant information for the pyrotechnic article category envisaged,

(b)

the documents concerning the quality system.

3.2. The quality system must ensure the conformity of the article with the requirements of this 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. The quality system documents must permit a consistent interpretation of the quality programmes, plans, manuals and quality records.

They must contain in particular an adequate description of:

(a)

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

(b)

technical construction specifications including the standards applicable and, if the standards referred to in Article 8 of this Directive have not been fully applied, the means of ensuring that the relevant basic requirements of this Directive have been met,

(c)

techniques to control and assess the development results, processes and systematic actions that will be used to develop products belonging to the product category in question,

(d)

the manufacturing, quality control and quality assurance techniques and the processes and systematic actions applied,

(e)

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

(f)

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

(g)

the means of monitoring the achievement of the required design and quality of the product 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 point 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonised standard.

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

A duly substantiated assessment decision must be notified to the manufacturer. It must contain the results of the examination.

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.

The manufacturer must keep the notified body that has approved the quality system constantly informed of any proposed update of 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 point 3.2 or whether reassessment is required.

A duly substantiated assessment decision must be notified to the manufacturer. It must contain the results of the examination.

4. EC monitoring under the responsibility of the notified body

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

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:

(a)

the quality system documents,

(b)

the quality records required under the quality system for the development field such as the results of analyses, calculations and tests,

(c)

the quality records required under the quality system for the manufacturing field such as inspection reports and test data, calibration data, and qualification reports of the personnel concerned.

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

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

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

(a)

the documents referred to in point 3.1.(b),

(b)

documents relating to the updating referred to in second subparagraph of point 3.4,

(c)

the decisions and reports of the notified body referred to in the fourth subparagraph of point 3.4, and in points 4.3 and 4.4.

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