The Lifts Regulations 2016

[F1 MODULE E E+W+S

Textual Amendments

F1 Schs. 11-19 inserted (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. 22 para. 44 (with Sch. 22 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

1.   Conformity to type based on product quality assurance for safety components for lifts is the part of the conformity assessment procedure whereby an approved body assesses the quality system of a manufacturer in order to ensure that the safety components for lifts are manufactured and monitored in conformity with the type described in the Type examination certificate, satisfy the applicable requirements of Schedule 1 and will enable a lift to which they are correctly incorporated to satisfy those requirements. E+W+S

Obligations of the manufacturer E+W+S

2.   The manufacturer shall operate an approved quality system for final inspection and testing of the safety components for lifts as specified in point 3, and shall be subject to surveillance as specified in point 4.

Quality system E+W+S

3.1.   The manufacturer shall lodge an application for assessment of his quality system for the safety components for lifts concerned with a single approved body of his choice. E+W+S

The application shall include:

(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) a written declaration that the same application has not been lodged with any other approved body;

(c) the address of the premises where final inspection and testing of the safety components for lifts are carried out;

(d) all relevant information on the safety components for lifts to be manufactured;

(e) the documentation concerning the quality system;

(f) the technical documentation of the approved safety components for lifts and a copy of the Type examination certificate.

3.2.   Under the quality system, each safety component for lifts shall be inspected and appropriate tests as set out in the relevant designated standards or equivalent tests shall be carried out in order to ensure that it meets 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. E+W+S

It shall contain in particular an adequate description of:

(a) the quality objectives;

(b) the organizational structure, responsibilities and powers of the management with regard to product quality;

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

(d) the means of monitoring the effective operation of the quality system; and

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

3.3.   The approved 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 designated standard. E+W+S

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 Schedule 1.

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(f), in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations 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. 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 to maintain it so that it remains adequate and efficient. E+W+S

3.5.   The manufacturer or his authorised representative shall keep the approved body which has approved the quality system informed of any intended changes of the quality system. E+W+S

The approved 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 examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body E+W+S

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

4.2.   The manufacturer shall for assessment purposes allow the approved body access to the premises where final inspection, testing and storage are carried out and provide it with all necessary information, in particular: E+W+S

(a) the quality system documentation;

(b) the technical documentation;

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

4.3.   The approved body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. E+W+S

4.4.   Additionally, the approved body may pay unexpected visits to the manufacturer's premises where final inspection and testing of safety components for lifts are carried out. E+W+S

At the time of such visits, the approved body may, where necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer, with a visit report and, if a test has been carried out, with a test report.

UK marking and Declaration of conformity E+W+S

5.1.   The manufacturer shall affix the UK marking, and, under the responsibility of the approved body referred to in point 3.1, the latter's identification number to each individual safety component for lifts that meets the conditions referred to in point 1. E+W+S

5.2.   The manufacturer shall draw up a written declaration of conformity for each safety component for lifts and keep a copy of it at the disposal of the enforcing authorities for 10 years after the safety component for lifts has been placed on the market. The Declaration of conformity shall identify the safety component for lifts for which it has been drawn up. E+W+S

6.   The manufacturer shall for a period ending 10 years after the safety component for lifts has been placed on the market, keep at the disposal of the enforcing authorities: E+W+S

(a) the technical documentation referred to in point 3.1(f);

(b) the documentation referred to in point 3.1(e);

(c) the information relating to the change referred to in point 3.5;

(d) the decisions and reports from the approved body which are referred to in the third paragraph of point 3.5 and in points 4.3 and 4.4.

7.   Each approved body shall inform the Secretary of State of quality system approval decision(s) issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of approval decisions refused, suspended or otherwise restricted. E+W+S

Each approved body shall inform the other approved bodies of quality system approval decision(s) which it has refused, suspended or withdrawn and, upon request, of approval decision(s) which it has issued.

Authorised representative E+W+S

8.   The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.]