Directive 2007/23/EC of the European Parliament and of the Council (repealed)Show full title

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.