§5.1.6 Modules based on quality assurance

— The use of quality assurance systems for the purpose of conformity assessment in the Union harmonisation legislation is described in modules D, E and H and their variants. — For the purpose of complying with the applicable legislation the manufacturer must ensure that the quality system is implemented and applied in such a way that it ensures full compliance of the products with the legislative requirements in question. — Compliance of the manufacturer with standards EN ISO 9000, EN ISO 9001, gives a presumption of conformity with the corresponding quality assurance modules as regards the legislative provisions covered by these standards. — In addition the quality system must take into consideration the specificities of the concerned products. Some modules and their variants are based on quality assurance techniques and are derived from the EN ISO 9000 (244), EN ISO 9001 (245) standards. The modules based on quality assurance techniques (modules D, E, H and their variants) describe the elements a manufacturer must implement in his organisation in order to demonstrate that the product fulfils the essential requirements of the applicable legislation. This means that a manufacturer is given the possibility of using an approved quality system for the purpose of demonstrating compliance with regulatory requirements. The quality system is assessed by the notified body. A quality system implemented on the basis of the EN ISO 9000, EN ISO 9001 gives a presumption of conformity with the respective modules with regard to the provisions in the modules that these standards cover, provided that the quality system takes into consideration the specificities of the concerned products. However, the manufacturer is free to apply other quality system models than those based on EN ISO 9001 for the purpose of complying with these modules. In any case the manufacturer must specifically address all regulatory provisions while applying its quality system, in particular: — The quality objectives, quality planning and quality manual must fully take on board the objective of delivering products that conform to the essential requirements. — The manufacturer must identify and document the essential requirements that are relevant for the product and the harmonised standards or other technical solutions that will ensure fulfilment of these requirements. — The identified standards or other technical solutions must be used as design input, and as verification that design output ensures that the essential requirements will be met. — The measures taken to control manufacturing must ensure that the products conform to the identified essential requirements. — Quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, must be suitable to ensure the fulfilment of the applicable essential requirements.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07