The Council Resolution of 21 December 1989 on a global approach to conformity assessment states the guiding principles for the conformity assessment:
- A consistent approach is developed at Community level based on the identification of modules each corresponding to various conformity assessment procedures, on defining the criteria for the use of these procedures, for the designation of the bodies operating on these procedures and for the use of the CE marking.
- Generalization of the use of the European standards on quality assurance (EN ISO 9000 series) and on the requirements to be fulfilled by the conformity assessment bodies quality assurance (EN 45000 series).
- Promotion in Member States and at Community level setting up of accreditation systems and using of inter-comparison techniques.
- Promotion of mutual recognition agreements concerning testing and certification in the non-regulatory sphere.
- Definition of programs aimed at reducing the differences between the Member States and industrial sectors in relation to existing quality infrastructures (such as calibration and metrology systems, testing laboratories, certification and insoection bodies, accreditation bodies, etc.).
- Promotion of international trade between the Community and third countries by means of mutual recognition agreements, cooperation and technical assistance programmes.
Scope of the Global Approach is not only make the conformity assessment process consistent, but also sufficiently flexible to be adapted to the needs of the each individual operator.
That is the source of the modular approach concept.
Each module is defined based on:
- Stage of product development:
> design,
> prototype,
> full production.
- Type of assessment:
> documental check,
> type approval,
> quality assurance
- Person carrying out the assessment:
> manufacturer, or
> a third party.
The Global Approach was completed by Council Directive 90/683/EEC, later on supersede by the Decision 93/465/EEC.
These documents states the general guidelines and kay down the detail procedures for conformity assessment that are to be used in New Approach Directives.
The conformity assessment is based on:
- Manufacturer’s internal design and internal production control activities;
- Third party examination in combination with manufacturer’s internal production control activities;
- Third party type or design examination in combination with third party approval of product or production quality assurance systems, or third party product verification;
- Third party unit verification of design and production;
- Third party approval of the whole quality assurance system.
The Decision 93/465/EEC also defines the rules for the affixing and use of CE marking.
