The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

Regulation 25

SCHEDULE 22 Amendment of the Lifts Regulations 2016

Introduction

1.  The Lifts Regulations 2016 are amended in accordance with paragraphs 2 to 44.

Amendment to regulation 2

2.—(1) Regulation 2 (interpretation) is amended as follows.

(2) In paragraph (1)—

(a) omit the definition of “accreditation”;

(b) omit the definition of “accreditation certificate”;

(c) after the definition of the “1997 Regulations” insert—

““approved body” has the meaning given to it in regulation 51 (approved bodies);”;

(d) for the definition of “authorised representative” substitute—

““authorised representative” means—

(a)

a person who—

(i)

immediately before exit day was established in the United Kingdom or an EEA state and was appointed by a manufacturer by written mandate to perform specified tasks for that manufacturer, in accordance with regulation 24, as it had effect immediately before exit day; and

(ii)

on or after exit day continues to be so established and appointed by the manufacturer to perform those tasks; or

(b)

a person who, on or after exit day, is appointed in accordance with regulation 24;”;

(e) omit the definition of “CE marking”;

(f) omit the definition of “competent national authority”;

(g) after the definition of “conformity assessment body” insert—

““declaration of conformity” means a declaration of conformity required to be drawn up in accordance with—

(a)

in relation to lifts, regulation 8(1)(a) (declaration of conformity and UK marking: installer); and

(b)

in relation to safety components for lifts, regulation 17(1)(a) (declaration of conformity and UK marking: manufacturer);”;

(h) after the definition of the “Department” insert—

““designated standard” has the meaning given to it in regulation 2A;”;

(i) in the definition of “the Directive” at the end insert “(as it has effect immediately before exit day”);

(j) omit the definition of “European Commission”;

(k) omit the definition of “EU declaration of conformity”;

(l) omit the definition of “harmonised standard”;

(m) for definition of “importer” substitute—

““importer” means a person who—

(a)

is established in the United Kingdom; and

(b)

places a safety component for lifts from a country outside of the United Kingdom on the market;”;

(n) in the definition of “make available on the market” for “EU” substitute “United Kingdom”;

(o) omit the definition of “national accreditation body”;

(p) omit the definition of “notified body requirements”;

(q) omit the definition of “Official Journal”;

(r) in the definition of “place on the market” for “EU” substitute “United Kingdom” in both places it occurs;

(s) in the definition of “safety component for lifts” omit the words after “Schedule 3”;

(t) after the definition of “technical specification” insert—

““UK marking” means the marking in the form set out in Annex 2 of RAMS;

“UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;”.

(3) After paragraph (1) insert—

“(1A) Schedules 11 to 19 reproduce the provisions of Annexes IV to XII to the Directive (respectively) with amendments to correct deficiencies in retained EU law.

(1B) A reference to any provision of Schedules 11 to 19 is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule.”.

(4) Omit paragraphs (3) and (5).

Insertion of regulation 2A

3.  After regulation 2 insert—

“Designated standard

2A.— (1) Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is—

(a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2) For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a) the characteristics required of a product, including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b) production methods and processes relating to the product, where these have an effect on the characteristics of the product.

(3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(c) the European Telecommunications Standards Institute (ETSI);

(d) the British Standards Institution (BSI).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies.

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation, a reference to a “product” is a reference to a lift or a safety component for lifts to which these Regulations apply.

(9) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(10) Regulations made under paragraph (9) are to be made by statutory instrument.

(11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.”.

Amendment to regulation 5

4.  In regulation 5 (lifts where risks are wholly or partly covered by other EU law) and in the heading to that regulation for “EU law” substitute “enactments”.

Amendment to regulation 7

5.  In regulation 7 (technical documentation and conformity assessment)—

(a) in paragraph (b)(i) for “Annex IV to the Directive (as amended from time to time)” substitute “Schedule 11”;

(b) in paragraph (b)(ii) for “Annex XI to the Directive (as amended from time to time)” substitute “Schedule 18”;

(c) in paragraph (b)(iii) for “Annex VIII to the Directive (as amended from time to time)” substitute “Schedule 15”.

Amendment to regulation 8

6.—(1) Regulation 8 (EU declaration of conformity and CE marking) is amended as follows.

(2) In the heading to that regulation—

(a) for “EU declaration” substitute “Declaration”; and

(b) for “CE” substitute “UK”.

(3) In paragraph (1)—

(a) in sub-paragraph (a) omit “EU”; and

(b) in sub-paragraph (c) for “CE”, in both places it occurs, substitute “UK”.

(4) In paragraph (2) omit “EU”.

(5) For paragraph (3) substitute—

“(3) Where a lift is subject to more than one enactment requiring the drawing up of a declaration of conformity, the installer must draw up a single declaration of conformity which identifies each enactment by its title.”.

Amendment to regulation 9

7.  In regulation 9 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 10

8.  In regulation 10 (labelling and instructions)—

(a) for paragraph (2) substitute—

“(2) the information referred to in paragraph (1) must be clear, legible and in easily understandable English.”; and

(b) omit paragraph (3).

Amendment to regulation 12

9.  In regulation 12 (duty to take action in respect of lifts placed on the market which are considered not to be in conformity) in paragraph (2), omit the words from “, and” to “market,”.

Amendment to regulation 16

10.  In regulation 16 (technical documentation and conformity assessment) in paragraph (b)—

(a) in sub-paragraph (i) for “Annex IV to the Directive (as amended from time to time)” substitute “Schedule 11”; and

(b) in sub-paragraph (ii) for “Annex VII to the Directive (as amended from time to time)” substitute “Schedule 14”.

Amendment to regulation 17

11.—(1) Regulation 17 (EU declaration of conformity and CE marking) is amended as follows.

(2) In the heading to that regulation—

(a) for “EU declaration” substitute “Declaration”; and

(b) for “CE” substitute “UK”.

(3) In paragraph (1)—

(a) in sub-paragraph (a) omit “EU”; and

(b) in sub-paragraph (c) for “CE”, in both places it occurs, substitute “UK”.

(4) In paragraph (2) omit “EU”.

(5) For paragraph (3) substitute—

“(3) Where a safety component for lifts is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.”.

Amendment to regulation 18

12.  In regulation 18 (retention of technical documents and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 19

13.  In regulation 19 (labelling and instructions)—

(a) for paragraph (2) substitute—

“(2) The information referred to in paragraph (1) must be clear, legible and in easily understandable English.”; and

(b) omit paragraph (4).

Amendment to regulation 20

14.  In regulation 20 (compliance procedures for series production) in paragraph 2(b)—

(a) for “harmonised” substitute “designated”; and

(b) omit “EU”.

Amendment to regulation 22

15.  In regulation 22 (duty to take action in respect of safety components for lifts placed on the market which are considered not to be in conformity) in paragraph (2) omit the words from “, and” to “market,”.

Amendment to regulation 24

16.  In regulation 24 (appointment of authorised representatives)—

(a) in paragraph (1) after “a person” insert “established in the United Kingdom”;

(b) omit “EU” in each place it occurs; and

(c) for “CE” substitute “UK” in both places it occurs.

Amendment to regulation 26

17.  In regulation 26 (requirements which must be satisfied before an importer places a safety component for lifts on the market) in paragraph (1)(c)—

(a) in paragraph (i) for “CE” substitute “UK”; and

(b) in paragraph (ii), omit “EU”.

Amendment to regulation 28

18.  In regulation 28 (information identifying importer)—

(a) in paragraph (2) for “competent national authority” to the end substitute “market surveillance authority”;

(b) for paragraph (3) substitute—

“(3) Paragraph (1) does not apply where—

(a) either—

(i) it is not possible to set out the information specified in paragraph (1) on the safety component for lifts; or

(ii) the importer has imported the safety component from an EEA state and places it on the market within the period of 18 months beginning with exit day; and

(b) before placing the safety component for lifts on the market, the importer sets out the information specified in paragraph (1)—

(i) on the packaging; or

(ii) in a document accompanying the safety component for lifts.”.

Amendment to regulation 29

19.  In regulation 29 (instructions)—

(a) for paragraph (1) substitute—

“(1) When placing a safety component for lifts on the market, an importer must ensure that it is accompanied by the instructions referred to in paragraph 7 of Schedule 1 and that they are clear, legible and in easily understandable English.”; and

(b) omit paragraph (2).

Amendment to regulation 33

20.  In regulation 33 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 37

21.  In regulation 37 (requirements which must be satisfied before a distributor makes a safety component for lifts available on the market)—

(a) in paragraph (1)(a)—

(i) in paragraph (i) for “CE” substitute “UK”;

(ii) in paragraph (ii) omit “EU”; and

(iii) for paragraph (iii) substitute—

“(iii) is accompanied by the instructions referred to in paragraph 7 of Schedule 1 and that they are clear, legible and in easily understandable English;”; and

(b) omit paragraph (2).

Amendment to regulation 40

22.  In regulation 40 (duty to take action in respect of safety components for lifts made available on the market which are not in conformity with Part 2) in paragraph (2) omit the words from “, and” to “market,”.

Amendment to regulation 43

23.  Omit regulation 43 (translation of declaration of conformity).

Amendment to regulation 45

24.  In regulation 45 (prohibition on improper use of CE marking), in each place it occurs and in the heading to that regulation, for “CE” substitute “UK”.

Insertion of regulations 45A and 45B

25.  After regulation 45 insert—

“Obligations which are met by complying with obligations in the Directive

45A.— (1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive;

(b) “CE marking” has the meaning given to it in Article 2(21);

(c) “harmonised standard” has the meaning given to it in Article 2(13).

(2) Paragraph (3) applies where, before placing a lift on the market, the installer—

(a) ensures that the lift has been designed, manufactured, installed and tested in accordance with the essential health and safety requirements set out in Annex I;

(b) ensures that the conformity assessment procedure that applies to that lift in accordance with Article 16 has been carried out;

(c) draws up the technical documentation referred to in Article 7(2);

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(e) affixes a CE marking and other markings, in accordance with Articles 18 and 19(1) to (5);

(f) draws up an EU declaration of conformity, in accordance with Article 17; and

(g) ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 6, 7, 8(1) and 8(3) are to be treated as being satisfied;

(b) regulations 2(2)(a), 8(2), 9, 24(2), 24(3) and 45 apply subject to the modifications in paragraph (10);

(c) Part 3 does not apply; and

(d) regulation 68 does not apply.

(4) Paragraph (5) applies where, before placing a safety component for lifts on the market, the manufacturer—

(a) ensures that the safety component has been designed and manufactured in accordance with Article 5(2);

(b) ensures that the conformity assessment procedure that applies to that safety component in accordance with Article 15 has been carried out;

(c) ensures that the relevant technical documentation referred to in Article 8(2) is drawn up;

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(e) affixes a CE marking and other markings, in accordance with Articles 18 and 19(1) to (5);

(f) draws up an EU declaration of conformity, in accordance with Article 17; and

(g) ensures that the EU declaration of conformity is prepared in or translated into English.

(5) Where this paragraph applies—

(a) the requirements of regulations 15, 16, 17(1) and (17)(3) are to be treated as being satisfied;

(b) regulations 2(2)(a), 17(2), 18, 20(2), 24(2), 24(3) and 45 apply subject to the modifications in paragraph (10);

(c) Part 3 does not apply; and

(d) regulation 68 does not apply.

(6) Paragraph (7) applies where, before placing a safety component for lifts on the market, the importer ensures that—

(a) the conformity assessment procedure that applies to that lift in accordance with Article 15 has been carried out;

(b) the manufacturer has drawn up the relevant technical documentation referred to in Article 8(2); and

(c) the safety component for lifts—

(i) bears the CE marking; and

(ii) is accompanied by the EU declaration of conformity drawn up in accordance with Article 17.

(7) Where this paragraph applies—

(a) the requirements of regulation 26(1)(a) to (c)(i) are to be treated as being satisfied;

(b) any requirement of regulation 26(1)(c)(ii), insofar as it relates to the declaration of conformity, is to be treated as being satisfied; and

(c) regulations 2(2)(a), 27(1), 30 and 33 apply subject to the modifications in paragraph (10).

(8) Paragraph (9) applies where, before making a safety component for lifts available on the market, a distributor ensures that the safety component for lifts—

(a) bears the CE marking; and

(b) is accompanied by an EU declaration of conformity drawn up in accordance with Article 17.

(9) Where this paragraph applies—

(a) the requirements of regulations 37(1)(a)(i) are to be treated as being satisfied;

(b) any requirement of regulation 37(1)(a)(ii), insofar as it relates to the declaration of conformity, is to be treated as being satisfied; and

(c) regulations 2(2)(a), 38(1) and 39 apply subject to the modifications in paragraph (10).

(10) The modifications referred to in paragraphs (3)(b), (5)(b), (7)(c) and 9(c) are that—

(a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b) any reference to “UK marking” is to be read as a reference to the CE marking;

(c) any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements referred to in Annex I;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedure that applies to the lift or the safety component for the lift in accordance with Article 15 or Article 16, as the case may be;

(f) any reference to “technical documentation” is a reference to the relevant technical documentation set out in Annexes IV to XII.

Conformity assessment procedure obligation which is met by complying with the Directive

45B.— (1) In this regulation, any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive.

(2) Paragraph (3) applies where, prior to the manufacture of a safety component, the manufacturer ensures that the conformity assessment procedure set out in Annex IV, Part A and referred to in Article 15(a) and (b) as EU-type examination, has been carried out in relation to a model of the safety component in accordance with Article 15(a) or (b).

(3) Where this paragraph applies—

(a) the requirement in regulation 48(a) or (b) to submit the model of the safety component for the conformity assessment procedure referred to in that regulation as Type examination is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 16(a), 17(1), 26(1)(a), 45(1)(b) and 49(b) is to be read as including the conformity assessment procedure referred to in Article 15(a) or (b) as EU-type examination; and;

(c) any reference to “technical documentation” in regulations 16(b), 18, 26(1)(b) and 33(b) is to be read as including the technical documentation relating to the design of the safety component referred to in Annex IV, Part A.

(4) Paragraph (5) applies where, a lift is designed and manufactured in accordance with a model lift that has undergone the conformity assessment procedure set out in Annex IV, Part B, referred to in Article 16(1)(a) as EU-type examination.

(5) Where this paragraph applies—

(a) the condition in regulation 47(1)(a) that the lift is designed and manufactured in accordance with a model lift which has undergone a Type examination set out in Part B of Schedule 11, is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 7(a), 8(1), 45(1)(b) and 49(b) is to be read as including the conformity assessment procedure set out in Annex IV, Part B and referred to in Article 16(1)(a) as EU-type examination; and

(c) any reference to “technical documentation” in regulations 7(b) and 9 is to be read as including the technical documentation relating to the design of the lift referred to in Annex IV, Part B.”.

Amendment of regulation 46

26.  In paragraph (1) of regulation 46 (presumption of conformity)—

(a) for “harmonised” substitute “designated”; and

(b) omit the words from “the reference” to “Journal”.

Amendment to regulation 47

27.—(1) Regulation 47 (conformity assessment procedures for lifts) is amended as follows.

(2) In paragraph (1)(a)—

(a) for “EU-type” substitute “Type”;

(b) for “Annex IV to the Directive (as amended from time to time)” substitute “Schedule 11”;

(c) in paragraph (i) for “Annex V to the Directive (as amended from time to time)” substitute “Schedule 12”;

(d) in paragraph (ii) for “Annex X to the Directive (as amended from time to time)” substitute “Schedule 17”; and

(e) in paragraph (iii) for “Annex XII to the Directive (as amended from time to time)” substitute “Schedule 19”.

(3) In paragraph (1)(b)—

(a) for “Annex XI to the Directive (as amended from time to time)” substitute “Schedule 18”;

(b) in paragraph (i) for “Annex V to the Directive (as amended from time to time)” substitute “Schedule 12”;

(c) in paragraph (ii) for “Annex X to the Directive (as amended from time to time)” substitute “Schedule 17”; and

(d) in paragraph (iii) for “Annex XII to the Directive (as amended from time to time)” substitute “Schedule 19”.

(4) In paragraph (1)(c) for “Annex VIII to the Directive (as amended from time to time)” substitute “Schedule 15”.

(5) In paragraph (1)(d) for “Annex XI to the Directive (as amended from time to time)” substitute “Schedule 18”.

Amendment to regulation 48

28.  Regulation 48 (conformity assessment procedures for safety components for lifts) is amended as follows—

(a) for “EU type” substitute “Type” in both places it occurs;

(b) in paragraph (a)—

(i) for “Annex IV to the Directive (as amended from time to time)” substitute “Schedule 11”; and

(ii) for “Annex IX to the Directive (as amended from time to time)” substitute “Schedule 16”;

(c) in paragraph (b)—

(i) for “Annex IV to the Directive (as amended from time to time)” substitute “Schedule 11”; and

(ii) for “Annex VI to the Directive (as amended from time to time)” substitute “Schedule 13”;

(d) in paragraph (c) for “Annex VII to the Directive (as amended from time to time)” substitute “Schedule 14”.

Amendment to regulation 49

29.  In regulation 49 (EU declaration of conformity)—

(a) in the heading for “EU declaration” substitute “Declaration”;

(b) omit “EU” in both places it occurs; and

(c) in paragraph (b) for “Annexes V to XII to the Directive (as amended from time to time)” substitute “Schedules 12 to 19”.

Amendment to regulation 50

30.—(1) Regulation 50 (CE marking) is amended as follows.

(2) In the heading to that regulation for “CE” substitute “UK”.

(3) For “CE”, in each place it occurs, substitute “UK”.

(4) For “notified”, in each place it occurs, substitute “approved”.

(5) In paragraph (3)—

(a) in sub-paragraph (a) for “Annex V to the Directive (as amended from time to time)” substitute “Schedule 12”;

(b) in sub-paragraph (b) for “Annex VIII to the Directive (as amended from time to time)” substitute “Schedule 15”; and

(c) in sub-paragraph (c) for “Annexes X, XI or XII to the Directive (as amended from time to time)” substitute “Schedules 17, 18 or 19”.

(6) In paragraph (4)—

(a) in sub-paragraph (a) for “Annex VI to the Directive (as amended from time to time)” substitute “Schedule 13”;

(b) in sub-paragraph (b) for “Annex VII to the Directive (as amended from time to time)” substitute “Schedule 14”; and

(c) in sub-paragraph (c) for “Annex IX to the Directive (as amended from time to time)” substitute “Schedule 16”.

Amendment to Part 4

31.  For Part 4, substitute—

“PART 4 Approval of Conformity Assessment Bodies

Approved bodies

51.— (1) An approved body is a conformity assessment body which—

(a) has been approved by the Secretary of State pursuant to the procedure set out in regulation 52 (approval of conformity assessment bodies); or

(b) immediately before exit day was a notified body in respect of which the Secretary of State had taken no action under regulation 57(1) or (2) as they had effect immediately before exit day to suspend or withdraw the body’s status as a notified body.

(2) Paragraph (1) has effect subject to regulation 55 (restriction, suspension or withdrawal of approval).

(3) In this Part—

“notified body” means a body—

(a)

which the Secretary of State had before exit day notified to the European Commission and the member State of the European Union, in accordance with Article 20 of the Directive; and

(b)

in respect of which no objections had been raised, as referred to in regulation 51(1)(b), as it had effect immediately before exit day; and

“approved body requirements” means the requirements set out in Schedule 4.

Approval of conformity assessment bodies

52.— (1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2) A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a) a description of—

(i) the conformity assessment activities that the conformity assessment body intends to carry out;

(ii) the relevant conformity assessment procedure in respect of which the conformity assessment body claims to be competent;

(iii) the product in respect of which the conformity assessment body claims to be competent, where “product” has the meaning given to it in Regulation 2A(8); and

(b) either—

(i) an accreditation certificate; or

(ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body’s compliance with the approved body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may–

(a) have regard to any other matter which appears to the Secretary of State to be relevant; and

(b) set conditions that the conformity assessment body must meet.

(7) For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

Presumption of conformity of approved bodies

53.— (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Monitoring

54.   The Secretary of State must monitor each approved body with a view to verifying that the body—

(a) continues to meet the approved body requirements;

(b) meets any conditions set—

(i) in accordance with regulation 52(6)(b); or

(ii) in the case of an approved body which was a notified body immediately before exit day, in accordance with regulation 52(6)(b) as it applied immediately before exit day; and

(c) carries out its functions in accordance with these Regulations.

Restriction, suspension or withdrawal of approval

55.— (1) Where the Secretary of State determines that an approved body—

(a) no longer meets an approved body requirement, or

(b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 54(b),

the Secretary of State must restrict, suspend or withdraw the body’s status as an approved body under regulation 51 (approved bodies).

(2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 54(b), the Secretary of State may restrict, suspend or withdraw the body’s status as an approved body under regulation 51.

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a) give notice in writing to the approved body of the proposed action and the reasons for it;

(b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c) consider any such representations made by the approved body.

(5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b) keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created.

(6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.

Operational matters in relation to approved bodies

56.— (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures—

(a) in respect of which the body’s approval was given under regulation 51; or

(b) in respect of which the body’s notification as a notified body was made.

(2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6.

(3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body—

(a) to issue a Type-examination certificate referred to in Schedule 11; or

(b) to affix, or cause to be affixed, the body’s identification number pursuant to regulation 50.

Subsidiaries and contractors

57.— (1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a) the assessment of the qualifications of the subcontractor or the subsidiary; and

(b) the conformity assessment activity carried out by the subcontractor or subsidiary.

(4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006(1).

Register of approved bodies

58.— (1) The Secretary of State must—

(a) assign an approved body identification number to each approved body; and

(b) compile and maintain a register of—

(i) approved bodies;

(ii) their approved body notification numbers;

(iii) the activities for which they have been approved; and

(iv) any restrictions on those activities.

(2) The register referred to in paragraph (1) must be made publicly available.

UK national accreditation body

59.   The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a) assessing whether a conformity assessment body meets the approved body requirements;

(b) monitoring approved bodies in accordance with regulation 54; and

(c) compiling and maintaining the register of approved bodies, in accordance with regulation 58.”.

Amendment to regulation 63

32.  In regulation 63 (exercise of enforcement powers) omit paragraph (c).

Amendment to regulation 65

33.  In regulation 65 (enforcement action in respect of lifts and safety components for lifts which are not in conformity and which present a risk)—

(a) in paragraph (2) for “notified” substitute “approved”;

(b) omit paragraphs (4) and (7);

(c) in paragraph (8) for “paragraphs (6) and (7)” substitute “paragraph (6)”.

Amendment to regulation 66

34.  Omit regulation 66 (EU safeguard procedure).

Amendment to regulation 67

35.  In regulation 67 (enforcement action in respect of lifts and safety components for lifts which are in conformity but present a risk)—

(a) omit paragraph (3);

(b) in paragraph (4) for “notices referred to paragraphs (2) and (3)” substitute “notice referred to in paragraph (2)”.

Amendment to regulation 68

36.  Regulation 68 (enforcement action in respect of formal non-compliance) is amended as follows—

(a) for “CE”, in each place it occurs, substitute “UK”;

(b) in paragraph (1)(b)—

(i) for “a notified” substitute “an approved”; and

(ii) for “the notified” substitute “the approved”;

(c) in paragraph (1)(c) omit “EU” in each place it occurs.

Amendment to regulation 82

37.  In regulation 82 (transitional provisions) at the end insert—

“(3) In paragraphs (4), (5) and (6)—

“pre-exit period” means the period beginning with the commencement date and ending immediately before exit day;

“product” means a lift or a safety component to lifts to which these Regulations apply.

(4) Subject to paragraph (5), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 22 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019(2), any obligation to which a person was subject under these Regulations as they had effect immediately before exit day, continues to have effect as it did immediately before exit day, in relation to that product.

(5) Paragraph (4) does not apply to—

(a) any obligation of any enforcing authority to inform the European Commission or the member States of any matter; or

(b) any obligation to take action outside of the United Kingdom in respect of that product.

(6) Where during the pre-exit period—

(a) a product has not been placed on the market; and

(b) a manufacturer has taken any action under regulations 47 or 48 as they had effect immediately before exit day in relation to that product,

that action has effect as if it had been done under regulations 47 or 48 as they have effect on and after exit day.”.

Amendment to regulation 83

38.  In regulation 83 (consequential revocations, savings and amendments)—

(a) in paragraph (2) for “The” substitute “Subject to the modifications made in paragraph (3A), the”;

(b) in paragraph (3) after “effect” insert “, subject to the modifications made in paragraph (3A),”;

(c) after paragraph 3 insert—

“(3A) The modifications referred to in paragraphs (2) and (3) are as follows—

(a) any reference to the “Community” is to be read as including the United Kingdom;

(b) any reference to a “member State” is to be read as including the United Kingdom;

(c) in regulation 11(3) omit paragraph (a);

(d) in Schedule 5 in Part A and in Part B—

(i) in paragraph (5) omit the words from “The Commission” to “carried out.”; and

(ii) in paragraph (7) omit the words after “issued”;

(e) in Schedules 7, 8, 11,12 and 13—

(i) in paragraph (5), for “national” substitute “enforcement”; and

(iv) in paragraph (6) omit “and withdrawn”;

(f) in paragraph (6) of Schedule 15, omit “with a view to this information being passed by him to the Commission”.”.

Amendment to Schedule 1

39.—(1) Schedule 1 (essential health and safety requirements) is amended as follows.

(2) In paragraph 1(2), for “the Directive” substitute “this Schedule”.

(3) In the italic heading before paragraph 2, for “Directive 2006/42/EC” substitute “the Supply of Machinery (Safety) Regulations 2008/1597”.

(4) In paragraph 2—

(a) for “Annex 1 to Directive 2006/42/EC of the European Parliament and of the Council” substitute “Schedule 2 to the Supply of Machinery (Safety) Regulations 2008/1597; and

(b) for “1.1.2 of Annex I to Directive 2006/43/EC” substitute “paragraph 1.1.2 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008/1597”.

(5) In paragraph (6)(1) for “1.7.3 of Annex I to Directive 2006/42/EC” substitute “paragraph 1.7.3 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008/1597”.

Amendment to Schedule 3

40.  In Schedule 3, in the heading omit the words “referred to in Article 1(1) of the Directive”.

Amendment to Schedule 4

41.  In Schedule 4—

(a) in the heading for “Notified” substitute “Approved”;

(b) in paragraph 5 for “notified” substitute “approved”;

(c) in paragraph 8 for “notified” substitute “approved”;

(d) in paragraph 9(b) for “a notified” substitute “an approved”;

(e) in paragraph 11(a) for “notified” substitute “approved”; and

(f) in paragraph 17 for “the Coordination Group of Notified Bodies for Lifts established under the Directive” substitute “any coordination group of approved bodies for lifts established by the Secretary of State”.

Amendment to Schedule 5

42.—(1) Schedule 5 (EU declaration of conformity) is amended as follows.

(2) In the heading omit “EU”.

(3) For “notified”, in each place it occurs, substitute “approved”.

(4) In the heading of Part 1, omit “EU”.

(5) In paragraph (1)—

(a) omit “EU”;

(b) in sub-paragraph (f) for “the relevant Union harmonisation legislation” substitute “relevant enactments”;

(c) in sub-paragraph (h)—

(i) for “EU-type”, in both places it occurs, substitute “Type”; and

(ii) for “Annex IV to the Directive (as amended from time to time)” substitute “Schedule 11”;

(d) in sub-paragraph (i) for “Annex VIII to the Directive (as amended from time to time)” substitute “Schedule 15”;

(e) in sub-paragraph (j) for “Annex V to the Directive (as amended from time to time)” substitute “Schedule 12”; and

(f) in sub-paragraph (k) for “Annex X, XI or XII to the Directive (as amended from time to time)” substitute “Schedules 17, 18 or 19”.

(6) In the heading of Part 2, omit “EU”.

(7) In paragraph (2)—

(a) omit “EU”;

(b) in sub-paragraph (i)—

(i) for “EU-type”, in both place it occurs, substitute “Type”; and

(ii) for “Annex IV and Annex VI to the Directive (as amended from time to time)” substitute “Schedule 11 and Schedule 13”;

(c) in sub-paragraph (j) for “Annex IX to the Directive (as amended from time to time)” substitute “Schedule 16”; and

(d) in sub-paragraph (k) for “Annex VI or VII to the Directive (as amended from time to time)” substitute “Schedule 13 or 14”.

Amendment to Schedule 6

43.  Schedule 6 (operational obligations of notified bodies) is amended as follows—

(a) in the heading for “notified” substitute “approved”;

(b) for “A notified”, in each place it occurs, substitute “An approved”;

(c) in paragraphs 7 and 9, in each place it occurs, for “the notified” substitute “the approved”;

(d) in paragraph 12 for “notified under the Directive” substitute “approved by the Secretary of State”; and

(e) in paragraph (13) for the words “the Coordination Group of Notified Approved Bodies for Lifts established under the Directive” substitute “any coordination group of approved bodies for lifts established by the Secretary of State”.

New Schedules 11 to 19

44.  After Schedule 10 (Compliance, withdrawal and recall notices) insert—

Regulations 47 and 48

“SCHEDULE 11 TYPE EXAMINATION FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS (Annex IV to the Directive)

MODULE B

A. Type examination of safety components for lifts

1.   Type examination is the part of a conformity assessment procedure in which an approved body examines the technical design of a safety component for lifts and verifies and attests that the technical design of the safety component for lifts satisfies the applicable essential health and safety requirements of Schedule 1 and will enable a lift in which it is correctly incorporated to satisfy those requirements.

2.   The application for Type examination shall be lodged by the manufacturer, or his authorised representative, with a single approved body of his choice.

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 and the place of manufacture of the safety components for lifts;

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

(c) the technical documentation;

(d) a representative specimen of the safety component for lifts or details of the place where it can be examined. The approved body may request further specimens if needed for carrying out the test programme;

(e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents, including other relevant technical specifications, that have been used, in particular where the relevant designated standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

3.   The technical documentation shall make it possible to assess whether the safety component for lifts meets the conditions referred to in point 1 and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the safety component for lifts.

• The technical documentation shall contain, where applicable, the following:

  (a)

  a description of the safety component for lifts, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements);

  (b)

  design and manufacturing drawings and diagrams;

  (c)

  explanations necessary for the understanding of those drawings and diagrams and the operation of the safety component for lifts;

  (d)

  a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to enable the safety component for lifts to meet the conditions referred to in point 1, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied;

  (e)

  results of design calculations performed by or for the manufacturer;

  (f)

  test reports;

  (g)

  a copy of the instructions for the safety components for lifts;

  (h)

  steps taken at the manufacturing stage to ensure that series-produced safety components for lifts conform to the safety component for lifts examined.

4.   The approved body shall:

(a) examine the technical documentation and the supporting evidence to assess the adequacy of the technical design of the safety component for lifts;

(b) agree with the applicant on a location where the examinations and tests will be carried out;

(c) verify that the representative specimen(s) has(have) been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

(d) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the specifications of the relevant designated standards, these have been applied correctly;

(e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the specifications of the relevant designated standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications enable the safety component for lifts to meet the conditions referred to in point 1.

The approved body shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

5.   Where the type of the safety component for lifts meets the conditions referred to in point 1, the body shall issue a type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer the conclusions of the Type examination, any conditions of validity of the certificate and the particulars necessary to identify the approved type.

• The Type examination certificate may have one or more annexes attached.

• The Type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured safety components for lifts with the examined type to be evaluated and to allow for in-service control.

• Where the type of the safety component for lifts does not satisfy the conditions referred to in point 1, the approved body shall refuse to issue a type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

• The approved body shall keep a copy of the Type examination certificate, its annexes and additions, as well as the technical documentation and the evaluation report, for 15 years from the date of issue of that certificate.

6.   The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer meet the conditions referred to in point 1 and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

7.   The manufacturer shall inform the approved body that holds the technical documentation relating to the Type examination certificate of any modification to the approved type that may affect the conformity of the safety component for lifts with the conditions referred to in point 1 or the conditions of validity of the Type examination certificate.

The approved body shall examine the modification and inform the applicant whether the Type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate, the approved body shall issue an addition to the original Type examination certificate or ask for a new application for a type examination to be submitted.

8.   Each approved body shall inform the Secretary of State concerning the Type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended or otherwise restricted.

Each approved body shall inform the other approved bodies concerning the Type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

9.   The other approved bodies may, on request, obtain a copy of the Type examination certificates and additions thereto.

10.   The manufacturer shall keep with the technical documentation a copy of the Type examination certificates, its annexes and additions at the disposal of the enforcing authorities for 10 years after the safety component for lifts has been placed on the market.

11.   Authorised representative

The manufacturer’s authorised representative may lodge the application referred to in point 2 and fulfil the obligations set out in points 7 and 10, provided that they are specified in the mandate.

B. Type examination of lifts

1.   Type examination of lifts is the part of a conformity assessment procedure in which an approved body examines the technical design of a model lift, or a lift for which there is no provision for an extension or variant, and verifies and attests that the technical design of the model lift or the lift meets the applicable essential health and safety requirements set out in Schedule 1.

Type examination of a lift includes an examination of a representative specimen of a complete lift.

2.   The application for Type examination shall be lodged by the installer or his authorised representative with a single approved body of his choice.

The application shall include:

(a) the name and address of the installer; 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 technical documentation;

(d) details of the place where the specimen lift can be examined. The specimen lift submitted for examination shall include the terminal parts and be capable of serving at least three levels (top, middle and bottom);

(e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents, including other relevant technical specifications that have been used, in particular where the relevant designated standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the installer, or by another testing laboratory on his behalf and under his responsibility.

3.   The technical documentation shall make it possible to assess the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1.

• The technical documentation shall contain, where applicable, the following:

  (a)

  a description of the model lift indicating clearly all the permitted variations of the model lift;

  (b)

  design and manufacturing drawings and diagrams;

  (c)

  explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift;

  (d)

  a list of the essential health and safety requirements taken into consideration;

  (e)

  a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied;

  (f)

  a copy of the declarations of conformity of the safety components for lifts incorporated in the lift;

  (g)

  results of design calculations performed by or for the installer;

  (h)

  test reports;

  (i)

  a copy of the instructions referred to in point 7.2 of Schedule 1;

  (j)

  steps taken at the installation stage to ensure that the series-produced lift conforms to the essential health and safety requirements set out in Schedule 1.

4.   The approved body shall:

(a) examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the model lift or of the lift for which there is no provision for an extension or variant;

(b) agree with the installer on a location where the examinations and tests will be carried out;

(c) examine the specimen lift to check that it has been manufactured in accordance with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

(d) carry out appropriate examinations and tests, or have them carried out, to check whether, where the installer has chosen to apply the specifications of the relevant designated standards, these have been applied correctly;

(e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the specifications of the relevant designated standards have not been applied, the solutions adopted by the installer applying other relevant technical specifications meet the corresponding essential health and safety requirements of these Regulations.

5.   The approved body shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the installer.

6.   Where the type meets the essential health and safety requirements set out in Schedule 1 applicable to the lift concerned, the approved body shall issue a Type examination certificate to the installer. That certificate shall contain the name and address of the installer, the conclusions of the Type examination, any conditions of validity of the certificate and the particulars necessary to identify the approved type.

• The Type examination certificate may have one or more annexes attached.

• The Type examination certificate and its annexes shall contain all the information necessary to enable the conformity of lifts with the approved type to be assessed during the final inspection.

• Where the type does not comply with the essential health and safety requirements set out in Schedule 1, the approved body shall refuse to issue a Type examination certificate and shall inform the installer accordingly, giving detailed reasons for its refusal.

• The approved body shall keep a copy of the Type examination certificate, its annexes and additions, as well as the technical documentation and the evaluation report for 15 years from the date of issue of that certificate.

7.   The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the essential health and safety requirements set out in Schedule 1, and shall determine whether such changes require further investigation. If so, the approved body shall inform the installer accordingly.

8.   The installer shall inform the approved body of any modifications to the approved type, including variations not specified in the original technical documentation, that may affect the conformity of the lift with the essential health and safety requirements set out in Schedule 1 or the conditions of validity of the Type examination certificate.

The approved body shall examine the modification and inform the installer whether the Type examination certificate remains valid or whether further examinations, verifications or tests are needed. As appropriate the approved body shall issue an addition to the original Type examination certificate or ask for a new application for a Type examination to be submitted.

9.   Each approved body shall inform the Secretary of State concerning the Type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended or otherwise restricted.

Each approved body shall inform the other approved bodies concerning the Type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and additions thereto which it has issued.

10.   The other approved bodies may, on request, obtain a copy of the Type examination certificates and additions thereto.

11.   The installer shall keep with the technical documentation a copy of the Type examination certificate, including its annexes and additions, at the disposal of the enforcing authorities for 10 years after the lift has been placed on the market.

12.   Authorised representative

The installer’s authorised representative may lodge the application referred to in point 2 and fulfil the obligations set out in points 8 and 11, provided that they are specified in the mandate.

Regulations 47 and 50

SCHEDULE 12 FINAL INSPECTION FOR LIFTS (Annex V to the Directive)

1.   Final inspection is the part of a conformity assessment procedure whereby an approved body ascertains and certifies that a lift subject to a Type examination certificate or designed and manufactured according to an approved quality system satisfies the essential health and safety requirements set out in Schedule 1.

2.    Obligations of the installer

The installer shall take all measures necessary to ensure that the lift being installed complies with the applicable essential health and safety requirements set out in Schedule 1 and with one of the following:

(a) an approved type described in a Type examination certificate;

(b) a lift designed and manufactured in accordance with a quality system pursuant to Schedule 18 and the design examination certificate if the design is not wholly in accordance with the designated standards.

3.    Final inspection

An approved body chosen by the installer shall carry out the final inspection of the lift about to be placed on the market in order to check the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1.

The installer shall lodge an application for final inspection with a single approved body of his choice and shall provide to the approved body the following documents:

(a) the plan of the complete lift;

(b) the plans and diagrams necessary for final inspection, in particular control circuit diagrams;

(c) copy of the instructions referred to in Schedule 1, point 7.2;

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

• The approved body may not require detailed plans or precise information not necessary for verifying the conformity of the lift.

• The appropriate examinations and tests set out in the relevant designated standard(s) or equivalent tests shall be carried out in order to check the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1.

The examinations shall include at least one of the following:

(a) examination of the documents referred to in point 3.1 to check that the lift conforms with the approved type described in the Type examination certificate pursuant to Schedule 11, Part B;

(b) examination of the documents referred to in point 3.1 to check that the lift conforms with the lift designed and manufactured in accordance with an approved quality system pursuant to Schedule 18 and if the design is not wholly in accordance with the designated standards, with the design examination certificate.

The tests of the lift shall include at least the following:

(a) operation of the lift both empty and at maximum load to ensure correct installation and operation of the safety devices (end stops, locking devices, etc.);

(b) operation of the lift at both maximum load and empty to ensure the correct functioning of the safety devices in the event of loss of power;

(c) static test with a load equal to 1.25 times the rated load.

• The rated load shall be that referred to in Schedule 1, paragraph 6.

• After these tests, the approved body shall check that no distortion or deterioration which could impair the use of the lift has occurred.

If the lift satisfies the essential health and safety requirements set out in Schedule 1, the approved body shall affix or have affixed its identification number adjacent to the UK marking in accordance with regulation 8 (declaration of conformity and UK marking) and regulation 50 (UK marking) and shall issue a final inspection certificate which mentions the examinations and tests carried out.

• The approved body shall fill in the corresponding pages in the logbook referred to in Schedule 1, paragraph 7(2).

• If the approved body refuses to issue the final inspection certificate, it shall state the detailed reasons for refusal and indicate the necessary corrective measures to be taken. Where the installer again applies for final inspection, he shall apply to the same approved body.

5.    UK marking and declaration of conformity

The installer shall affix the UK marking in the car of each lift which satisfies the essential health and safety requirements of these Regulations, and, under the responsibility of the approved body referred to in point 3.1, the latter’s identification number adjacent to the UK marking in the car of each lift.

The installer shall draw up a written declaration of conformity for each lift and keep a copy of the Declaration of conformity and the final inspection certificate at the disposal of the enforcing authorities for 10 years after the placing on the market of the lift. A copy of the Declaration of conformity shall be made available to the relevant authorities upon request.

6.    Authorised representative

The installer’s obligations set out in points 3.1 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Regulation 48

SCHEDULE 13 CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS (Annex VI to the Directive)

MODULE E

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.

2.    Obligations of the manufacturer

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.

3.    Quality system

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.

• 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.

• 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.

• 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.

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.

• 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.

4.    Surveillance under the responsibility of the approved 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 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:

(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.

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.

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.

5.    UK marking and Declaration of conformity

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.

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.

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:

(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.

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.

8.    Authorised representative

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.

Regulation 48

SCHEDULE 14 CONFORMITY BASED ON FULL QUALITY ASSURANCE FOR SAFETY COMPONENTS FOR LIFTS (Annex VII to the Directive)

MODULE H

1.   Conformity based on full quality assurance for safety components for lifts is the conformity assessment procedure whereby an approved body assesses the quality system of a manufacturer to ensure that the safety components for lifts are designed, manufactured, inspected and tested in order to satisfy the applicable requirements of Schedule 1 and to enable a lift to which they are correctly incorporated to satisfy those requirements.

2.    Obligations of the manufacturer

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

3.    Quality system

3.1.   The manufacturer shall lodge an application for assessment of his quality system with a single approved body of his choice. 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) 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 Schedule 11, 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 approved 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.

• 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 designated 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 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.

• 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(d) to verify the manufacturer’s ability to identify the applicable essential health and safety requirements set out in Schedule 1 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.

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

• 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 assessment and the reasoned assessment decision.

4.    Surveillance under the responsibility of the approved 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 for assessment purposes allow the approved body access to the design, manufacture, inspection and testing, and storage locations, and shall provide it with all necessary information, in particular:

(a) the quality system documentation;

(b) the quality records provided for in the design part of the quality system such as results of analyses, calculations, tests;

(c) the technical documentation for the safety components for lifts manufactured;

(d) the quality records provided for in the manufacturing part of the full quality system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

4.3.   The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.   Additionally, the approved body may pay unexpected visits to the manufacturer. 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 tests have been carried out, with a test report

5.    UK marking and Declaration of conformity

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.

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.

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:

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

(b) the technical documentation referred to in point 3.1(d);

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

(d) the decisions and reports from the approved body 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.

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

• The approved body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.

8.    Authorised representative

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.

Regulation 47 and 50

SCHEDULE 15 CONFORMITY BASED ON UNIT VERIFICATION FOR LIFTS (Annex VIII to the Directive)

MODULE G

1.   Conformity based on unit verification is the conformity assessment procedure whereby an approved body assesses whether a lift complies with the applicable essential health and safety requirements set out in Schedule 1.

2.    Obligations of the installer

2.1.   The installer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1.

2.2.   The installer shall apply to a single approved body of his choice for unit verification.

• The application shall contain:

  (a)

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

  (b)

  the location where the lift is installed;

  (c)

  a written declaration to the effect that a similar application has not been lodged with another approved body;

  (d)

  the technical documentation.

3.   The technical documentation shall allow an assessment of the conformity of the lift with the applicable essential health and safety requirements set out in Schedule 1.

• The technical documentation shall contain at least the following elements:

  (a)

  a description of the lift;

  (b)

  design and manufacturing drawings and diagrams;

  (c)

  explanations necessary for the understanding of those drawings and diagrams and of the operation of the lift;

  (d)

  a list of the essential health and safety requirements taken into consideration;

  (e)

  a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied;

  (f)

  a copy of the Type examination certificates of the safety components for lifts incorporated in the lift;

  (g)

  results of design calculations performed by or for the installer;

  (h)

  test reports;

  (i)

  a copy of the instructions referred to in point 7.2 of Schedule 1.

4.    Verification

The approved body chosen by the installer shall examine the technical documentation and the lift and carry out the appropriate tests as set out in the relevant designated standard(s), or equivalent tests, to check its conformity with the applicable essential health and safety requirements set out in Schedule 1. The tests shall include at least the tests referred to in point 3.3 of Schedule 12.

• If the lift meets the essential health and safety requirements set out in Schedule 1 the approved body shall issue a certificate of conformity relating to the tests carried out.

• The approved body shall fill in the corresponding pages of the logbook referred to in point 7.2 of Schedule 1.

• If the approved body refuses to issue the certificate of conformity, it shall state in detail its reasons for refusal and indicate the necessary corrective measures to be taken. When the installer reapplies for unit verification he shall apply to the same approved body.

• On request, the approved body shall provide the Secretary of State with a copy of the certificate of conformity.

5.    UK marking and Declaration of conformity

5.1.   The installer shall affix the UK marking in the car of each lift which satisfies the essential health and safety requirements of these Regulations, and, under the responsibility of the approved body referred to in point 2.2, the latter’s identification number adjacent to the UK marking in the car of each lift.

5.2   The installer shall draw up a written declaration of conformity for each lift and keep a copy of the Declaration of conformity at the disposal of the enforcing authorities for 10 years after the placing on the market of the lift. A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

6.   The installer shall keep with the technical documentation a copy of the certificate of conformity at the disposal of the enforcing authorities for 10 years from the date on which the lift is placed on the market.

7.    Authorised representative

The installer’s obligations set out in points 2.2 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Regulation 48

SCHEDULE 16 CONFORMITY TO TYPE WITH RANDOM CHECKING FOR SAFETY COMPONENTS FOR LIFTS (Annex IX to the Directive)

MODULE C2

1.   Conformity to type with random checking is the part of the conformity assessment procedure whereby an approved body carries out checks on safety components for lifts to ensure that they are in conformity with the approved type as described in the Type examination certificate and satisfy the applicable requirements of Schedule 1 and will enable a lift in which they are correctly incorporated to satisfy those requirements.

2.    Manufacturing

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure that the manufactured safety components for lifts meet the conditions referred to in point 1.

The manufacturer shall lodge an application for random checking with a single approved body of his choice.

• 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)

  all relevant information on the safety components for lifts manufactured;

  (d)

  the address of the premises where the sample of the safety components for lifts can be taken.

The approved body shall carry out or have carried out checks on safety components for lifts at random intervals. An adequate sample of the final safety components for lifts, taken on site by the approved body, shall be examined and appropriate tests set out in the relevant designated standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to check whether the safety components for lifts meets the conditions referred to in point 1. In cases where one or more of the safety components for lifts checked do not conform, the approved body shall take appropriate measures.

• The points to be taken into account when checking the safety components for lifts will be defined by joint agreement between all the approved bodies responsible for this procedure, taking into consideration the essential characteristics of the safety components for lifts.

• The approved body shall issue a certificate of conformity to type with respect to the examinations and tests carried out.

• On request the approved body shall provide the Secretary of State with a copy of the certificate of conformity to type.

5.    UK marking and Declaration of conformity

5.1.   The manufacturer shall affix the UK marking, and, under the responsibility of the approved body referred to in point 3, the latter’s identification number to each individual safety component for lifts that meets the conditions referred to in point 1.

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.

6.    Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative shall not fulfil the manufacturer’s obligations set out in point 2.

Regulation 47

SCHEDULE 17 CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE FOR LIFTS (Annex X to the Directive)

MODULE E

1.   Conformity to type based on product quality assurance is the part of the conformity assessment procedure whereby an approved body assesses the product quality system of an installer to ensure that the lifts are in conformity with the approved type as described in the Type examination certificate or with a lift designed and manufactured under a full quality system approved in accordance with Schedule 18, and satisfy the applicable essential health and safety requirements set out in Schedule 1.

2.    Obligations of the installer

The installer shall operate an approved quality system for final inspection and testing of the lift as specified in point 3, and shall be subject to surveillance as specified in point 4.

3.    Quality system

3.1.   The installer shall lodge an application for assessment of his quality system for the lifts concerned with a single approved body of his choice.

• The application shall include:

  (a)

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

  (b)

  all relevant information on the lifts to be installed;

  (c)

     ”.

  the documentation on the quality system;

  (d)

  the technical documentation of the lifts to be installed;

  (e)

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

3.2.   Under the quality system, each lift shall be examined and appropriate tests as set out in the relevant designated standards or equivalent tests shall be carried out in order to ensure its conformity with the applicable essential health and safety requirements set out in Schedule 1.

• All the elements, requirements and provisions adopted by the installer 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 quality records.

• It shall contain in particular an adequate description of:

  (a)

  the quality objectives;

  (b)

  the organisational structure, responsibilities and powers of the management with regard to product quality;

  (c)

  the examinations and tests that will be carried out before placing on the market, including at least the tests laid down in point 3.3 of Schedule 12;

  (d)

  the means of monitoring the effective operation of the quality system;

  (e)

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

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.

• 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 premises of the installer and a visit to the installation site.

• The decision shall be notified to the installer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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

3.4.1.   The installer shall keep the approved body which has approved the quality system informed of any intended change to the system.

3.4.2.   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 its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

• The approved body shall affix, or cause to be affixed, its identification number adjacent to the UK marking in accordance with regulation 50.

4.    Surveillance under the responsibility of the approved body

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

4.2.   The installer shall, for assessment purposes, allow the approved body access to the installation, inspection and testing locations, and shall provide it with all necessary information, in particular:

(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, etc.

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

4.4.   Additionally, the approved body may pay unexpected visits to the lift installation sites.

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 and of the lift. It shall provide the installer with a visit report and, if tests have been carried out, with a test report.

5.   The installer shall, for 10 years after the last lift has been placed on the market, keep at the disposal of the enforcing authorities:

(a) the documentation referred to in point 3.1(c);

(b) the technical documentation referred to in point 3.1(d);

(c) the information relating to the changes referred to in point 3.4.1;

(d) the decisions and reports from the approved body which are referred to in the second paragraph of point 3.4.2 and in points 4.3 and 4.4.

6.   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.

• 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.

• On request, the approved body shall provide the Secretary of State with a copy of the quality system approval decision(s) issued.

7.    UK marking and declaration of conformity

7.1.   The installer shall affix the UK marking in the car of each lift which satisfies the essential health and safety requirements of these Regulations, and, under the responsibility of the approved body referred to in point 3.1, the latter’s identification number adjacent to the UK marking in the car of each lift.

7.2.   The installer shall draw up a written Declaration of conformity for each lift and keep a copy of the Declaration of conformity at the disposal of the enforcing authorities for 10 years after the placing on the market of the lift. A copy of the Declaration of conformity shall be made available to the relevant authorities upon request.

8.    Authorised representative

The installer’s obligations set out in points 3.1, 3.4.1, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Regulation 47

SCHEDULE 18 CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION FOR LIFTS (Annex XI to the Directive)

MODULE H1

1.   Conformity based on full quality assurance plus design examination for lifts is the conformity assessment procedure whereby an approved body assesses the quality system of an installer and, where appropriate, the design of the lifts, to ensure that the lifts satisfy the applicable essential health and safety requirements set out in Schedule 1.

2.    Obligations of the installer

The installer shall operate an approved quality system for the design, manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the lifts shall have been examined in accordance with point 3.3.

3.    Quality system

3.1.   The installer shall lodge an application for assessment of his quality system with a single approved body of his choice.

• The application shall include:

  (a)

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

  (b)

  all relevant information on the lifts to be installed, in particular information which makes for an understanding of the relationship between the design and operation of the lift;

  (c)

  the documentation on the quality system;

  (d)

  the technical documentation described in point 3 of Schedule 11, Part B;

  (e)

  a written Declaration that the same application has not been lodged with any other approved body.

3.2.   The quality system shall ensure compliance of the lifts with the applicable essential health and safety requirements set out in Schedule 1. All the elements, requirements and provisions adopted by the installer 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 quality records.

• It shall contain in particular an adequate description of:

  (a)

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

  (b)

  the technical design specifications, including standards that will be applied and, where the relevant designated standards will not be applied in full, the means, including other relevant technical specifications that will be used to ensure that the applicable essential health and safety requirements set out in Schedule 1 will be met;

  (c)

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

  (d)

  the examinations and tests that will be carried out on acceptance of the supplies of materials, components and sub-assemblies;

  (e)

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

  (f)

  the examinations and tests that will be carried out before (inspection of installation conditions: shaft, housing of machinery, etc.), during and after installation (including at least the tests laid down in point 3.3 of Schedule 12);

  (g)

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

  (h)

  the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

3.3.   Design examination

3.3.1.   When the design is not entirely in accordance with designated standards, the approved body shall ascertain whether the design conforms to the essential health and safety requirements set out in Schedule 1 and, if it does, issue a design examination certificate to the installer, stating the limits of the certificate’s validity and giving the details required for identification of the approved design.

3.3.2.   Where the design does not satisfy the applicable essential health and safety requirements set out in Schedule 1, the approved body shall refuse to issue a design examination certificate and shall inform the installer accordingly, giving detailed reasons for its refusal.

The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the essential health and safety requirements set out in Schedule 1, and shall determine whether such changes require further investigation. If so, the approved body shall inform the installer accordingly.

3.3.3.   The installer shall keep the approved body that has issued the design examination certificate informed of any modification to the approved design that may affect the conformity with the essential health and safety requirements set out in Schedule 1 or the conditions for validity of the certificate. Such modifications shall require additional approval — from the approved body that issued the design examination certificate — in the form of an addition to the original design examination certificate.

3.3.4.   Each approved body shall inform the Secretary of State of the design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of design examination certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each approved body shall inform the other approved bodies of the design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.

3.3.5.   The installer shall keep a copy of the design examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authorities for 10 years after the lift has been placed on the market.

3.4.   Assessment of the quality system

• 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.

• 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 installer’s premises and a visit to an installation site.

• The auditing team shall review the technical documentation referred to in point 3.1(d), to verify the installer’s ability to identify the applicable essential health and safety requirements set out in Schedule 1 and to carry out the necessary examinations with a view to ensuring compliance of the lift with those requirements.

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

3.5.   The installer shall undertake to fulfil the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

• The installer shall keep the approved body that has approved the quality system informed of any intended change to the system.

• 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 its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

• The approved body shall affix, or cause to be affixed, its identification number adjacent to the UK marking in accordance with regulation 50.

4.    Surveillance under the responsibility of the approved body

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

4.2.   The installer shall, for assessment purposes, allow the approved body access to the design, manufacture, assembly, installation, inspection, testing and storage locations, and shall provide it with all necessary information, in particular:

(a) the quality system documentation;

(b) the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests;

(c) the quality records provided for in the part of the quality system concerning acceptance of supplies and installation, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned.

4.3.   The approved body shall carry out periodic audits to make sure that the installer maintains and applies the quality system and shall provide the installer with an audit report.

4.4.   Additionally, the approved body may pay unexpected visits to the premises of the installer or to the installation site of a lift. 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 installer with a visit report and, if tests have been carried out, with a test report.

5.   The installer shall, keep at the disposal of the enforcing authorities for a period ending 10 years after the lift has been placed on the market:

(a) the documentation referred to in point 3.1(c);

(b) the technical documentation referred to in point 3.1(d);

(c) the information relating to the changes referred to in the second paragraph of point 3.5;

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

6.   Each approved body shall inform the Secretary of State of full 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.

• 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 decisions which it has issued.

• The approved body shall keep a copy of the approval decision issued, its annexes and additions, as well as the technical documentation for 15 years from the date of their issue.

• On request, the approved body shall provide the Secretary of State with a copy of the quality system approval decision(s) issued.

7.    UK marking and Declaration of conformity

7.1.   The installer shall affix the UK marking in the car of each lift which satisfies the essential health and safety requirements of these Regulations, and, under the responsibility of the approved body referred to in point 3.1, the latter’s identification number adjacent to the UK marking in the car of each lift.

7.2.   The installer shall draw up a written declaration of conformity for each lift and keep a copy of the Declaration of conformity at the disposal of the enforcing authorities for 10 years after the placing on the market of the lift. A copy of the Declaration of conformity shall be made available to the relevant authorities upon request.

8.    Authorised representative

The installer’s obligations set out in points 3.1, 3.3.3, 3.3.5, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

Regulation 47

SCHEDULE 19 CONFORMITY TO TYPE BASED ON PRODUCTION QUALITY ASSURANCE FOR LIFTS (Annex XII to the Directive)

MODULE D

1.   Conformity to type based on production quality assurance for lifts is the part of the conformity assessment procedure whereby an approved body assesses the production quality system of an installer to ensure that the lifts installed are in conformity with the approved type as described in the Type examination certificate or with a lift designed and manufactured under a quality system approved in accordance with Schedule 18 , and satisfy the applicable essential health and safety requirements set out in Schedule 1.

2.    Obligations of the installer

The installer shall operate an approved quality system for manufacture, assembly, installation, final inspection and testing of the lifts as specified in point 3, and shall be subject to surveillance as specified in point 4.

3.    Quality system

3.1.   The installer shall lodge an application for assessment of his quality system with a single approved body of his choice.

• The application shall include:

  (a)

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

  (b)

  all relevant information for the lifts to be installed;

  (c)

  the documentation on the quality system;

  (d)

  the technical documentation of the lifts to be installed;

  (e)

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

3.2.   The quality system shall ensure compliance of the lifts with the applicable essential health and safety requirements set out in Schedule 1.

• All the elements, requirements and provisions adopted by the installer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

• 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 product quality;

  (b)

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

  (c)

  the examinations and tests that will be carried out before, during and after installation;

  (d)

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

  (e)

  the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

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 system that comply with the corresponding specifications of the relevant designated standard.

• 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 installer’s premises and a visit to an installation site.

• The decision shall be notified to the installer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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

3.4.1.   The installer shall keep the approved body that has approved the quality system informed of any intended change to the system.

3.4.2.   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 its decision to the installer or, where appropriate, to his authorised representative. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

• The approved body shall affix, or cause to be affixed, its identification number adjacent to the UK marking in accordance with regulation 50.

4.    Surveillance under the responsibility of the approved body

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

4.2.   The installer shall, for assessment purposes, allow the approved body access to the manufacture, assembly, installation, inspection, testing and storage locations, and shall provide it with all necessary information, in particular:

(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 carry out periodic audits to make sure that the installer maintains and applies the quality system and shall provide the installer with an audit report.

4.4.   Additionally, the approved body may pay unexpected visits to the installer. During such visits the approved body may, where necessary carry out tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the installer with a visit report and, if tests have been carried out, with a test report.

5.   The installer shall, keep at the disposal of the enforcing authorities for a period ending 10 years after the lift has been placed on the market:

(a) the documentation referred to in point 3.1(c);

(b) the technical documentation referred to in point 3.1(d);

(c) the information relating to the changes referred to in point 3.4.1;

(d) the decisions and reports from the approved body which are referred to in the second paragraph of point 3.4.2, and in points 4.3 and 4.4.

6.   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.

• 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.

• On request, the approved body shall provide the Secretary of State with a copy of the quality system approval decision(s) issued.

7.    UK marking and Declaration of conformity

7.1.   The installer shall affix the UK marking in the car of each lift which satisfies the essential health and safety requirements of these Regulations, and, under the responsibility of the approved body referred to in point 3.1, the latter’s identification number adjacent to the UK marking in the car of each lift.

7.2.   The installer shall draw up a written Declaration of conformity for each lift and keep a copy of the Declaration of conformity at the disposal of the enforcing authorities for 10 years after the placing on the market of the lift. A copy of the Declaration of conformity shall be made available to the relevant authorities upon request.

8.    Authorised representative

The installer’s obligations set out in points 3.1, 3.4.1, 5 and 7 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.”.

(1)

2006 c.46.

(2)

S.I. 2019/696.