The Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

3.3.  It must contain in particular an adequate description of: E+W+S

• — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality

• — the technical documentation to be drawn up for each product, containing at least the information indicated in point 3.1 for the technical documentations mentioned there

• — the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the equipment category covered

• — the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used

• — the examinations and test 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 assurance system.

The [F1 approved] body must assess the quality assurance 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 assurance systems that implement EN ISO 9001.

The auditing team must have at least one member with experience as an assessor in the equipment technology concerned. The assessment procedure must include an assessment visit to the manufacturer’s premises.

The decision must be notified to the manufacturer. The notification must contain the conclusion of the examination and the reasoned assessment decision.

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Word in Sch. 11 para. 3.3 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 24(d) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.3.  It must contain in particular an adequate description of: N.I.

• — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality

• — the technical documentation to be drawn up for each product, containing at least the information indicated in point 3.1 for the technical documentations mentioned there

• — the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the equipment category covered

• — the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used

• — the examinations and test 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 assurance system.

The notified body must assess the quality assurance 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 assurance systems that implement EN ISO 9001.

The auditing team must have at least one member with experience as an assessor in the equipment technology concerned. The assessment procedure must include an assessment visit to the manufacturer’s premises.

The decision must be notified to the manufacturer. The notification must contain the conclusion of the examination and the reasoned assessment decision.

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only