The Telecommunications Terminal Equipment Regulations 1992

Production quality assurance

The production quality assurance part of the procedure

27.  Regulations 28 to 35 below shall have effect in relation to a manufacturer who chooses to carry out the EC declaration of conformity to type procedure pursuant to the production quality assurance part of the procedure, that is to say, that part of the procedure provided for in Annex III of the TTE Directive whereby the manufacturer who operates a production quality assurance approved quality system ensures and declares pursuant to that Annex that the applicable terminal equipment concerned fulfils the relevant conditions.

Manufacturer’s duty

28.  The manufacturer shall operate a production quality assurance approved quality system.

Application for approval of a production quality assurance quality system

29.—(1) The manufacturer shall lodge an application for approval of his quality system with a notified body of his choice, for the products concerned.

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

(a) all relevant information for the product category envisaged;

(b) the documentation concerning the quality system; and

(c) if applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate, and, where the application relates to the production of a modification, the additional technical documentation and the additional approval.

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

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

(a) it ensures that products fulfil the relevant conditions;

(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 permits a consistent interpretation of the quality programmes, plans, manuals and records;

(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 product quality;

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

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

(iv) the quality records; and

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

Assessment of quality systems by a United Kingdom notified body

31.—(1) 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 30 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 III of the TTE Directive(1) .

(3) The auditing team shall have at least one member with experience of evaluation in the product technology concerned.

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

(5) Subject to regulation 54 below, 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

32.  Where a United Kingdom notified body informs the manufacturer pursuant to regulation 31(5) 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 quality systems

33.—(1) Where a manufacturer intends to update a production 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 30 above or whether a re-assessment pursuant to regulation 31 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 32 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

34.—(1) The notified body shall carry out surveillance as provided for in the procedure set out in paragraph (2) below (“the production 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 manufacture, inspection and testing, and storage;

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

(2) The purpose of the production quality assurance surveillance procedure is to make sure that the manufacturer duly fulfils the obligations arising out of the production 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 verify that the quality system is functioning correctly, 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 a United Kingdom notified body acting pursuant to paragraph (1) above that the manufacturer is not fulfilling his obligations under the production quality assurance approved quality system, it shall report the matter—

(a) to the notified body (if not itself) which issued the EC type-examination certificate or additional approval, as the case may be;

(b) where the products are manufactured, or the body is aware that products manufactured in accordance with the type or modification 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;

(c) where the products are manufactured, or the body is aware that products manufactured in accordance with the type or modification 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;

(d) where the body is aware that products manufactured in accordance with the type or modification 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—

(a) the notified body shall suspend the approval, and where it granted the EC type examination certificate, it shall suspend that certificate; and

(b) where another notified body granted the EC type-examination certificate, it shall report the matter to that other body for appropriate action and, where that other body is a United Kingdom notified body, that other body shall suspend the certificate;

and a certificate or 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

35.  Subject to regulation 54 below, where a United Kingdom notified body which approved a production 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 fulfil the relevant conditions, that body may withdraw the approval;

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

(c) in order for the system to ensure that products to which it relates fulfil the relevant conditions, 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.

(1)

EN 29002 supplemented if necessary to take into account the specific nature of the procedure for which it is implemented.