http://www.legislation.gov.uk/eudr/1994/25/annex/XII/division/3/2008-12-11Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (repealed)Directive 94/25/EC of the European Parliament and of the Council (repealed)Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft (repealed)2020-12-12King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01994L0025-20081211texttext/xmlen2008-12-11 ANNEX XII FULL QUALITY ASSURANCE (module H) 3. Quality system 3.1.

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

The application shall include:

all relevant information for the product cagetory envisaged, the quality system's documentation.

3.2.

The quality system shall ensure compliance of the products with the requirements of the Directive that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.

It shall contain in particular an adequate description of:

the quality objectives and the organizational structure, responsibilities and powers of the management with regard to design and product quality, the technical design specifications, including standards, that will be applied and, where the standards referred to in Article 5 will not be applied in full, the means that will be used to ensure that the essential requirements of the Directive that apply to the products will be met, the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered, the corresponding 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 to monitor the achievement of the required design and product quality and the effective operation of the quality system.

3.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonized standard (EN 29001).

The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.4.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.

The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.

The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.

It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

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<Number>ANNEX XII</Number>
<TitleBlock>
<Title>FULL QUALITY ASSURANCE</Title>
<Title>(module H)</Title>
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<ScheduleBody>
<Division DocumentURI="http://www.legislation.gov.uk/eudr/1994/25/annex/XII/division/3/2008-12-11" IdURI="http://www.legislation.gov.uk/id/eudr/1994/25/annex/XII/division/3" id="annex-XII-division-3" RestrictStartDate="2008-12-11" RestrictEndDate="2016-01-17" RestrictExtent="E+W+S+N.I.">
<Number>3.</Number>
<Title>Quality system</Title>
<Division DocumentURI="http://www.legislation.gov.uk/eudr/1994/25/annex/XII/division/3/division/3.1/2008-12-11" IdURI="http://www.legislation.gov.uk/id/eudr/1994/25/annex/XII/division/3/division/3.1" id="annex-XII-division-3-division-3.1" RestrictStartDate="2008-12-11" RestrictEndDate="2016-01-17" RestrictExtent="E+W+S+N.I.">
<Number>3.1.</Number>
<P>
<Text>The manufacturer shall lodge an application for assessment of his quality system with a notified body.</Text>
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<P>
<Text>The application shall include:</Text>
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<Text>all relevant information for the product cagetory envisaged,</Text>
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<Text>the quality system's documentation.</Text>
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<Division DocumentURI="http://www.legislation.gov.uk/eudr/1994/25/annex/XII/division/3/division/3.2/2008-12-11" IdURI="http://www.legislation.gov.uk/id/eudr/1994/25/annex/XII/division/3/division/3.2" id="annex-XII-division-3-division-3.2" RestrictStartDate="2008-12-11" RestrictEndDate="2016-01-17" RestrictExtent="E+W+S+N.I.">
<Number>3.2.</Number>
<P>
<Text>The quality system shall ensure compliance of the products with the requirements of the Directive that apply to them.</Text>
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<P>
<Text>All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.</Text>
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<P>
<Text>It shall contain in particular an adequate description of:</Text>
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<Text>the quality objectives and the organizational structure, responsibilities and powers of the management with regard to design and product quality,</Text>
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<Text>the technical design specifications, including standards, that will be applied and, where the standards referred to in Article 5 will not be applied in full, the means that will be used to ensure that the essential requirements of the Directive that apply to the products will be met,</Text>
</Para>
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<Para>
<Text>the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered,</Text>
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<Para>
<Text>the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,</Text>
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<Para>
<Text>the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,</Text>
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<Text>the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,</Text>
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<Text>the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.</Text>
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<Division DocumentURI="http://www.legislation.gov.uk/eudr/1994/25/annex/XII/division/3/division/3.3/2008-12-11" IdURI="http://www.legislation.gov.uk/id/eudr/1994/25/annex/XII/division/3/division/3.3" id="annex-XII-division-3-division-3.3" RestrictStartDate="2008-12-11" RestrictEndDate="2016-01-17" RestrictExtent="E+W+S+N.I.">
<Number>3.3.</Number>
<P>
<Text>The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonized standard (EN 29001).</Text>
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<P>
<Text>The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises.</Text>
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<P>
<Text>The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.</Text>
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<Division DocumentURI="http://www.legislation.gov.uk/eudr/1994/25/annex/XII/division/3/division/3.4/2008-12-11" IdURI="http://www.legislation.gov.uk/id/eudr/1994/25/annex/XII/division/3/division/3.4" id="annex-XII-division-3-division-3.4" RestrictStartDate="2008-12-11" RestrictEndDate="2016-01-17" RestrictExtent="E+W+S+N.I.">
<Number>3.4.</Number>
<P>
<Text>The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.</Text>
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<P>
<Text>The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.</Text>
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<P>
<Text>The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.</Text>
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<P>
<Text>It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.</Text>
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