Regulation 30 Requirements for the approval of quality systems by a United Kingdom notified body

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.