The Recreational Craft Regulations 1996

Regulation 10(2)

SCHEDULE 9 (Annex IX of the Directive)PRODUCTION QUALITY ASSURANCE(module D)

1.

The manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV)(1). The CE marking shall be accompanied by the distinguishing number of the notified body responsible for the monitoring as specified in point 4.

2.

The manufacturer shall operate an approved quality system for production, final product inspection and testing as specified in paragraph 3 and shall be subject to monitoring as specified in point 4.

3.

Quality system

3.1.

The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the products concerned.

The application shall include:

• all relevant information for the product category envisaged,

• the documentation concerning the quality system,

• where appropriate, the technical documentation of the approved type (see Annex XIII)(2) and a copy of the EC type-examination certificate.

3.2.

The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and 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. The quality system documentation must permit a consistent interpretation of the quality programmes, plan, 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 product quality,

• the 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 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 conformity with these requirements in respect of quality systems that implement the relevant harmonized standard.

The auditing team shall have at least one member with experience of evaluation in the product technology concerned. The evaluation procedure shall include an inspection 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 decisions to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.

Surveillance under the responsibility of the notified body

4.1.

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

4.2.

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

• the quality system documentation,

• the quality records, 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.

4.4.

Additionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality system is functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken place, with a test report.

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:

• 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 decision 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 give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.

(1)

Annex XV is set out in Schedule 14.

(2)

Annex XIII is set out in Schedule 13.