Regulation 42 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—
it ensures compliance of the products with the requirements of the TTE Directive that apply to them;
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;
the quality system documentation ensures a common understanding of the quality policies and procedures;
the quality system documentation contains 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 harmonized standards and common technical regulations as well as relevant test specifications that will be applied and, where the harmonized standards will not be applied in full, the means which will be used to ensure that the essential requirements 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 tests;
the design quality records and production quality records; and
the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.