The Lifts Regulations 1997

3.    Quality assurance system

(3.1) The manufacturer of the safety component must lodge an application for assessment of his quality assurance system for the safety components concerned with a notified body of his choice.

The application must include:

• all relevant information for the safety components envisaged,

• the documentation on the quality assurance system,

• the technical documentation of the approved safety components and a copy of the EC type-examination certificates.

(3.2) Under the quality assurance system, each safety component must be examined and appropriate tests as set out in the relevant standards referred to in Article 5 or equivalent tests must be carried out in order to ensure its conformity to the relevant requirements of the Directive.

• All the elements, requirements and provisions adopted by the manufacturer of the safety components must be documented in a systematic and orderly manner in the form of written measures, procedures and instructions. This quality assurance system documentation must ensure a common understanding of the quality programmes, plans, manuals and records.

• It must contain in particular an adequate description of:

  (a)

  the quality objectives;

  (b)

  the organizational structure, responsibilities and powers of the management with regard to safety component quality;

  (c)

  the examinations and tests that will be carried out after manufacture;

  (d)

  the means to verify the effective operation of the quality assurance system;

  (e)

  quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

(3.3) The notified body must assess the quality assurance system to determine whether it satisfies the requirements referred to in Section 3.2. It must presume conformity with these requirements in respect of quality assurance systems that implement the relevant harmonized standard(1).

• The auditing team must have at least one member with experience of assessment in the lift technology concerned. The assessment procedure must include a visit to the premises of the safety component manufacturer.

• The decision must be notified to the manufacturer of the safety components. The notification must contain the conclusions of the examination and the reasoned assessment decision.

(3.4) The manufacturer of the safety components must undertake to discharge the obligations arising from the quality assurance system as approved and to ensure that it is maintained in an appropriate and efficient manner.

• The manufacturer of the safety components or his authorized representative established in the Community must keep the notified body which has approved the quality assurance system informed of any intended updating of the quality assurance system.

• The notified body must assess the modifications proposed and decide whether the modified quality assurance system still satisfies the requirements referred to in Section 3.2 or whether a reassessment is required.

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

(1)

This harmonised standard will be EN 29003, supplemented where necessary to take account of the specific features of safety components.