Directive 2007/23/EC of the European Parliament and of the Council (repealed)Show full title

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.