Directive 1999/5/EC of the European Parliament and of the Council (repealed)Dangos y teitl llawn

ANNEX V U.K. CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10Full quality assurance

1. Full quality assurance is the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned satisfy the requirements of the Directive that apply to them. The manufacturer must affix the marks referred to in Article 12(1) to each product and draw up a written declaration of conformity. U.K.

2. The manufacturer must operate an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4. U.K.

3. Quality system U.K.

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body. U.K.

The application must include:

• all relevant information for the products envisaged,

• the quality system's documentation.

3.2. The quality system must ensure compliance of the products with the requirements of the Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records. U.K.

It must contain in particular an adequate description of:

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

• the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in Article 5(1) will not be applied in full, the means that will be used to ensure that the essential requirements of the Directive that apply to the products will be met,

• 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,

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

• 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,

• the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test,

• the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,

• the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It must presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard. U.K.

The notified body must assess in particular whether the quality control system ensures conformity of the products with the requirements of the Directive in the light of the relevant documentation supplied in respect of points 3.1 and 3.2 including, where relevant, test results supplied by the manufacturer.

The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure must include an assessment visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient. U.K.

The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.

The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. EC surveillance under the responsibility of the notified body U.K.

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular: U.K.

• the quality system documentation,

• the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,

• the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body must carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer. U.K.

4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report. U.K.

5. The manufacturer must, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities: U.K.

• the documentation referred to in the second indent of point 3.1,

• the updating referred to in the second paragraph of point 3.4,

• the decisions and reports from the notified body which are referred to in the final paragraph of point 3.4 and in points 4.3 and 4.4.

6. Each notified body must make available to the other notified bodies the relevant information concerning quality system approvals including references to the product(s) concerned, issued and withdrawn. U.K.