The Recreational Craft Regulations 2004

Regulation 10(2)

SCHEDULE 12 U.K. (Annex XII of the Directive)

FULL QUALITY ASSURANCE U.K. (module H)

1.  This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 2 ensures and declares that the products concerned satisfy the requirements of the Directive that apply to them. The manufacturer or his authorised representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV). M1 The CE marking shall be accompanied by the distinguishing number of the notified body responsible for the surveillance as specified in point 4. U.K.

2.  The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4. U.K.

3.  Quality system U.K.

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

The application shall include:

• — all relevant information for the product category 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. U.K.

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 organisational 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 M2 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 harmonised standard (EN 29001). U.K.

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. U.K.

The manufacturer or his authorised 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.

4.  EC surveillance under the responsibility of the notified body U.K.

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

4.2.  The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, in particular: U.K.

• — the quality system documentation,

• — the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

• — the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

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

4.4.  Additionally the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report. U.K.

5.  The manufacturer shall, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities: U.K.

• — the documentation referred to in the second indent of the second subparagraph of point 3.1,

• — the updating referred to in the second subparagraph of point 3.4,

• — the decisions and reports from the notified body which are referred to in the final subparagraph of point 3.4, point 4.3 and point 4.4.

6.  Each notified body shall forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn. U.K.