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- Original (As adopted by EU)
Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles (Text with EEA relevance) (repealed)
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This is the original version (as it was originally adopted).
The application must include:
all relevant information for the pyrotechnic article category envisaged,
the documents concerning the quality system.
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:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product design and quality,
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,
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,
the manufacturing, quality control and quality assurance techniques and the processes and systematic actions applied,
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, and qualification reports of the personnel concerned,
the means of monitoring the achievement of the required design and quality of the product and the effective operation of the quality system.
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.
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.
the quality system documents,
the quality records required under the quality system for the development field such as the results of analyses, calculations and tests,
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.
the documents referred to in point 3.1.(b),
documents relating to the updating referred to in second subparagraph of point 3.4,
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.
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