Directive 2014/33/EU of the European Parliament and of the CouncilDangos y teitl llawn

3. Quality system U.K.

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

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)

the address of the premises where the safety components for lifts are designed, manufactured, inspected and tested;

(c)

all relevant information on safety components for lifts to be manufactured;

(d)

the technical documentation described in point 3 of Annex IV, Part A for one model of each category of safety component for lifts to be manufactured;

(e)

the documentation on the quality system;

(f)

a written declaration that the same application has not been lodged with any other notified body.

3.2. The quality system shall ensure compliance of the safety components for lifts with the conditions referred to in point 1. 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 permit a consistent interpretation of the quality programmes, plans, manuals and records. U.K.

It shall contain in particular an adequate description of:

(a)

the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the design and product quality;

(b)

the technical design specifications, including standards that will be applied and, where the relevant harmonised standards will not be applied or not applied in full, the means, including other relevant technical specifications, that will be used to ensure that the conditions referred to in point 1 will be met;

(c)

the design control and design verification techniques, processes and systematic actions that will be used when designing the safety components for lifts;

(d)

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

(e)

the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(f)

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

(g)

the means of monitoring 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 conformity with those requirements in respect of the elements of the quality systems that comply with the corresponding specifications of the relevant harmonised standard. U.K.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of assessment in the lift technology concerned and knowledge of the essential health and safety requirements set out in Annex I. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in point 3.1(d) to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Annex I and to carry out the necessary examinations with a view to ensuring compliance of the safety components for lifts with those requirements.

The decision shall be notified to the manufacturer and, where appropriate, to his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and maintain it so that it remains adequate and efficient. U.K.

3.5. The manufacturer shall keep the notified body which has approved the quality system informed of any intended change to the quality system. U.K.

The notified body shall assess the modifications proposed and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

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