Division 3 Quality systemF1

The manufacturer shall lodge an application for the assessment of his quality system with the F2approved body of their choice, for the product concerned.

The application shall include:

1. (a)

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

2. (b)

   the technical documentation for each type of product intended to be manufactured, containing the elements set out in Part 10 where applicable;

3. (c)

   the documentation concerning the quality system;

4. (d)

   a written declaration stating that the same application has not been lodged with any other F3approved body.

The quality system shall ensure compliance of the product with the requirements of this Regulation.

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.

The documentation shall, in particular, contain an adequate description of:

1. (a)

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

2. (b)

   the technical design specifications, including standards, that will be applied and, where the relevant F4designated standards will not be applied in full, the means that will be used to ensure that the requirements of this Regulation are met;

3. (c)

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

4. (d)

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

5. (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;

6. (f)

   the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, etc.;

7. (g)

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

The F5approved 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 elements of the quality system that comply with the corresponding specifications of the relevant F6designated standard.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit on the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3(1)(b) to verify the manufacturer’s ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring the product’s compliance with these requirements.

The manufacturer or his authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

The manufacturer shall keep the F7approved body that has approved the quality system informed of any intended change to the quality system.

The F8approved body shall evaluate any proposed changes 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.

The approved body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.