sec_1_1_3__para__11

On the basis of ISO/IEC documentation, the Council in its Decisions developed consolidated conformity assessment procedures and the rules for their selection and use in directives (the modules). The modules are set out in a manner to favour their selection from the lightest (‘internal control of production’) for simple products or products not necessarily presenting serious risks, moving to the most comprehensive (full quality assurance with EU-design examination), where the risks are more severe or the products/technologies more complex. In order to face up to modern manufacturing processes, the modules foresee both product conformity assessment processes and quality management assessment, leaving the legislator to decide which are the most appropriate in each sector, as it is not necessarily effective to provide for individual certification for each mass produced product, for example. To reinforce the transparency of the modules and their effectiveness, at the request of the Commission, the ISO 9000 series of standards on quality assurance were harmonised at the European level and integrated into the modules. Thus, economic operators who use these tools in their voluntary quality management policies to reinforce their quality image on the market, can benefit from the use of the same tools in the regulated sectors.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.