Regulation 14 Quality system approval

(1)

Where an application for approval of—

(a)

a quality system relating to production quality as provided in paragraph 3.3 of Annex II of the Directive; or

(b)

a quality system relating to product quality as provided in paragraph 4.3 of the said Annex II,

is made to a notified body (whether the relevant EC type-examination certificate was issued by it or by another notified body), the application shall be made in writing and shall be accompanied by an undertaking by the manufacturer—

(i)

to carry out the obligations arising from the approved quality system;

(ii)

to maintain the approved quality system to ensure its continuing suitability and effectiveness; and

(iii)

to pay the appropriate fee,

and such systems shall be designed to secure that appliances and fittings comply with the essential requirements which apply to them.

(2)

The manufacturer shall make available to the notified body—

(a)

a copy of the EC type-examination certificate;

(b)

all relevant information including in particular the documentation of the quality system; and

(c)

the design documentation of the appliances or fittings.

(3)

The documentation of the quality system shall be systematic and shall permit a clear interpretion to be made of the manufacturer’s quality programme, plans, manuals and records and shall include, in particular, descriptions of—

(a)

the manufacturer’s quality objectives relating to production of the appliances or fittings;

(b)

the manufacturer’s management structures and the responsibilities of managers within that structure which are relevant to the quality of production;

(c)

in the case of an application under paragraph (1)(a) above,—

(i)

the manufacturing process, quality control and quality assurance techniques and systems employed in production of the appliances or fittings, and

(ii)

the nature and frequency of examinations and tests carried out before, during and after the manufacture of appliances or fittings;

(d)

in the case of an application under paragraph (1)(b) above, the nature of examinations and tests carried out after the manufacture of each appliance or fitting;

(e)

the method employed to monitor attainment of the quality objectives referred to in subparagraph (a) above; and

(f)

the method employed to monitor the effectiveness of the examinations and tests referred to in subparagraph (d) above.

(4)

On an application made to it under paragraph (1) above the notified body shall take all necessary steps to examine and evaluate the quality system.

(5)

If the notified body is minded to refuse to approve the quality system, it shall give the applicant the opportunity, within a reasonable period, of making representations as to why it should not be refused.

(6)

The notified body shall, in writing,—

(a)

inform the manufacturer of—

(i)

the results of the examination, and

(ii)

the reasons for the decision;

(b)

if it is satisfied that the quality system satisfies the relevant provisions of Annex II of the Directive, on payment of the appropriate fee,—

(i)

notify the applicant of its approval of the quality system; and

(ii)

inform all other notified bodies of its decision.

(7)

Where—

(a)

an approval of a quality system under this regulation is in force; and

(b)

the manufacturer proposes to make modifications or additions to the approved quality system,

the manufacturer (instead of making an application under paragraph (1) above) may make an application in writing to the notified body which gave the approval for approval of modifications or additions to the quality system; and the foregoing provisions of this regulation shall have effect in relation to such an application as they have effect in relation to an application for approval of a quality system.