The Telecommunications Terminal Equipment Regulations 1992

PART IV EC DECLARATION OF CONFORMITY PROCEDURE

Application of Part IV

38.—(1) This Part shall have effect for providing for the manner in which the conformity assessment requirements may be complied with where the manufacturer or his authorised representative chooses the EC declaration of conformity procedure.

(2) The EC declaration of conformity procedure shall consist of full quality assurance, that is to say, the procedure provided for in Annex IV of the TTE Directive whereby the manufacturer who operates a full quality assurance approved quality system ensures and declares pursuant to that Annex that the products concerned satisfy the requirements of the TTE Directive that apply to them.

The conformity assessment requirements pursuant to the EC declaration of conformity procedure

39.  The conformity assessment requirements are complied with in relation to applicable terminal equipment pursuant to the EC declaration of conformity procedure if the manufacturer has, having carried out full quality assurance, drawn up, subject to regulation 48, an EC declaration of conformity (which it is hereby declared for the avoidance of doubt may relate to any number of items of applicable terminal equipment).

Full quality assurance

Manufacturer’s duty

40.  The manufacturer shall operate a full quality assurance approved quality system.

Application for approval of a quality system

41.—(1) The manufacturer shall lodge an application for approval of his quality system with a notified body of his choice.

(2) An application for approval of a quality system made to a United Kingdom notified body shall include—

(a) all relevant information for the products envisaged; and

(b) the quality system’s documentation.

Requirements for the approval of quality systems by a United Kingdom notified body

42.  A United Kingdom notified body shall not approve a quality system unless—

(a) it ensures compliance of the products with the requirements of the TTE Directive that apply to them;

(b) all the elements, requirements and provisions of the quality system are documented in a systematic and orderly manner in the form of written policies, procedures and instructions;

(c) the quality system documentation ensures a common understanding of the quality policies and procedures;

(d) the quality system documentation contains an adequate description of—

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

(ii) the technical specifications, including the harmonized standards and common technical regulations as well as relevant test specifications that will be applied and, where the harmonized standards will not be applied in full, the means which will be used to ensure that the essential requirements that apply to the products will be met;

(iii) the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered;

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

(v) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, as well as the results of the tests carried out before manufacture where appropriate;

(vi) the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary tests;

(vii) the design quality records and production quality records; and

(viii) the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.

Assessment of quality systems by a United Kingdom notified body

43.—(1) Subject to regulation 54 below, a United Kingdom notified body with which an application has been lodged for the approval of a quality system shall assess the quality system to determine whether it satisfies the requirements of regulation 42 above, and the following provisions of this regulation shall have effect in relation to the conduct of the assessment.

(2) The United Kingdom notified body shall presume conformity with those requirements in respect of quality systems that implement a standard which is for the time being a relevant harmonized standard for the purposes of point 3.3 of Annex IV of the TTE Directive(1) .

(3) The United Kingdom notified body shall assess in particular whether the quality control system ensures conformity of the products with the requirements of the TTE Directive in the light of the relevant documentation supplied pursuant to regulations 41(2) and 42 above including, where relevant, test results supplied by the manufacturer.

(4) The auditing team shall have at least one member experienced as an assessor in the product technology concerned.

(5) The evaluation procedure shall include an inspection visit to the manufacturer’s premises concerned.

(6) The United Kingdom notified body shall inform the manufacturer by notice in writing of the decision on whether to approve the quality system, and such notice shall contain the conclusions of the examination and the reasoned assessment decision.

Manufacturer’s undertaking

44.  Where a United Kingdom notified body informs the manufacturer pursuant to regulation 43(6) above that it has decided to approve the quality system, the approval shall not have effect until the manufacturer has deposited with that body a written undertaking to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and effective.

Modifications to approved quality systems

45.—(1) Where a manufacturer intends to update a full quality assurance approved quality system approved by a United Kingdom notified body, the manufacturer or his authorised representative shall apply to that body for the approval of the quality system as modified in accordance with the proposed modifications.

(2) Subject to regulation 54 below, the United Kingdom notified body shall, on application made pursuant to paragraph (1) above, evaluate the proposed modifications and decide whether the amended quality system will satisfy the requirements of regulation 42 above or whether a re-assessment pursuant to regulation 43 would be required to evaluate the system as modified in accordance with the proposals.

(3) The United Kingdom notified body shall inform the manufacturer by notice in writing of the decision on whether to approve the proposed modifications to the quality system, and such notice shall contain the conclusions of the examination and the reasoned assessment decision.

(4) Where a United Kingdom notified body informs the manufacturer pursuant to paragraph (3) above that it has decided to approve the proposed modifications to an approved quality system—

(a) the approval of the quality system shall have effect as if the modifications were made; and

(b) the written undertaking referred to in regulation 44 shall have effect as if it were an undertaking to fulfil the obligations arising out of the quality system as approved as so modified and to uphold it as so modified so that it remains adequate and effective.

Surveillance procedure

46.—(1) The notified body shall carry out surveillance as provided for in the procedure set out in paragraph (2) below (“the full quality assurance surveillance procedure”) and the manufacturer shall permit that notified body to carry out that procedure, and, without prejudice to the generality of the foregoing, he shall—

(a) allow the notified body access for the purpose of inspection to the location of design, manufacture, inspection and testing, and storage;

(b) provide the notified body with such information (including the quality system documentation, the design quality records and the production quality records), facilities and assistance as it may reasonably require in carrying out that procedure.

(2) The purpose of the full quality assurance surveillance procedure is to make sure that the manufacturer duly fulfils the obligations arising out of the full quality assurance approved quality system, and the procedure shall consist of—

(a) the carrying out by the notified body of audits at reasonable intervals to make sure that the manufacturer maintains and applies the approved quality system and the provision of an audit report to the manufacturer; and

(b) should the notified body consider it necessary, the paying of unexpected visits to the manufacturer, during which the notified body may carry out, or cause to be carried out, tests to check the proper functioning of the quality system, and, where such a visit has been paid, the provision of a visit report and a report upon any such tests.

(3) Where it appears to the United Kingdom notified body acting pursuant to paragraph (1) above that one or more of the products checked do not conform with the relevant requirements of the TTE Directive, it shall report the matter—

(a) where the products concerned are to be or have been supplied or put into service or connected to the public telecommunications network in the United Kingdom, to the enforcement authority;

(b) where the products concerned are to be or have been supplied or put into service or connected to a public telecommunications network in a member State other than the United Kingdom, to the appropriate authorities in that other member State; or

(c) where the body is aware that the products concerned are to be or have been connected to a public telecommunications network in the United Kingdom or another member State, to the operator thereof.

(4) If the manufacturer fails to comply with his obligations under paragraph (1)(a) and (b) above the notified body shall suspend the approval of the quality system; and an approval suspended pursuant to this paragraph shall remain suspended until the manufacturer complies with the requirements of paragraph (1)(a) and (b) above.

Withdrawal and compulsory modification of approved quality systems

47.  Subject to regulation 54 below, where a United Kingdom notified body which approved a full quality assurance approved quality system is satisfied that—

(a) the manufacturer is not fulfilling his obligations under the system or that one or more products to which the system relates do not conform with the relevant requirements of the TTE Directive, that body may withdraw the approval;

(b) the system does not ensure, when operated as intended, that products to which it relates so conform, that body shall withdraw the approval;

(c) in order for the system to ensure that products to which it relates so conform, it is necessary to modify the system, that body shall require the manufacturer to modify the system accordingly, and the approval of the system shall have effect in accordance with the modification.

Final provisions

EC declaration of conformity to type where quality system approved by a United Kingdom notified body

48.  Where the quality system is approved by a United Kingdom notified body, the manufacturer shall draw up the EC declaration of conformity in English, or in another language acceptable to the notified body.

Interpretation

49.  In this Part—

• “design quality records” includes the result of analyses, calculations and tests;

• “production quality records” includes inspection reports and test data, calibration data and qualification reports of the personnel concerned; and

• “quality policies and procedures” include quality programmes, plans, manuals and records.

(1)

EN 29001 supplemented if necessary to take into account the specific nature of the products for which it is implemented.