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The essential objective of a conformity assessment procedure is to encode the public authorities to ensure that products placed on the market conform to the requirements expressed in the provisions of the directives - particularly with regard to the health and safety of users and consumers. When the EU adopted its "Global Approach to Certification and Testing," it created eight modules to achieve conformity assessment. The modules cover both the design phase and the production phase of manufacturing. The system was put into place in December 1989. All EU New-Approach directives adopted after that date use a combination of these modules to satisfy conformity assessment. For example, the Active Implantable Medical Devices Directive (AIMD) uses four modules while the general Medical Devices Directive (MDD) uses seven modules in its four-part classification system.
While the modular approach has focused on New Approach directives, it is also being reviewed for some application to old approach "sectoral" directives. There are four different process functionalities, which may be employed to achieve "conformity" to the right modules. The four are:
- A. Internal Controls
- B. Type Examination
- C. Unit Verification
- D. Full Quality Assurance
Each process is reviewed below:
A) Internal Control of Production better known as manufacturer self-certification, internal control of production is designed for simple products that pose a minimum risk to health and safety. Manufacturers are required to keep technical documentation on hand for review by national authorities, if requested. The manufacturer self declares conformity with the essential requirements of the directive (such as the Machinery Directive) and affixes the CE mark. Documentation must be kept on hand and be available to national authorities for at least ten years after production of the product. To satisfy the EU Product Liability Directive, documentation should be kept on hand at least ten years after sale of the product. This module also can utilize voluntary Notified Body tests on specific aspects of the product and random product checks. This module also has been designed for manufacturers that choose to produce products in accordance with the essential requirements of a EU directive rather than the European standards issued as a part of the directive. Consequently, a EU Notified Body has to be satisfied that the device is acceptable and satisfies the EU concern about essential health and safety requirements.
B) Five modules are covered by this approach. It is a two-step approach, which first applies Module B (see chart) for the design phase. The manufacturer submits a technical file and an example of the product to a Notified Body. The Notified Body then ascertains conformity to type, carries out tests, if necessary, and issues an EC type examination certificate. After receiving the certificate and depending on the directive, the manufacturer has four choices. Modules C, D, E must supplement module B in the production phase, or F. Conformity to type (C) requires a self Declaration of Conformity to the approved type and may involve Notified Body tests on specific aspects of the product and product checks at random intervals. It depends on the directive. The manufacturer affixes the CE mark and must keep records for at least ten years after the manufacturer of the last product. (The Product Liability Directive requires records be kept for at least ten years after last sale.) Production Quality Assurance (D) is ISO-9002 as described in an Annex of a directive. This includes the entire production process except for design. Only a EU Notified Body for a directive can grant approval of the quality assurance program and permission to affix a CE mark. The Notified Body conducts periodic system surveillance. Product Quality Assurance (E) is ISO-9003 as described in an Annex of a directive. This module covers only inspection and testing. Only a EU Notified Body for a directive can grant approval of the quality assurance program and permission to affix the CE mark. The Notified Body conducts periodic system surveillance. Product verification (F) requires testing and certification of products by a EU Notified Body. The conditions are set forth by an Annex in each directive. The manufacturer assures that their production process meets the requirements of the directive. Often the manufacturer submits product in homogeneous batches to a EU Notified Body, which tests, accepts or rejects, and for those products accepted, issues Certificates of Conformity. The manufacturer then affixes the CE mark.
C) Unit Verification Module G generally applies to unique, one time only products such as the construction of a power plant. The manufacturer submits technical documentation to regulatory authorities. The aim of the technical documentation is to enable conformity with the requirements of the directive to be assessed and the design, manufacture and operation of the product to be understood. Upon approval, the manufacturer manufactures and constructs the product. The EU Notified Body verifies conformity with essential requirements of a directive and grants the manufacturer permission to affix a CE mark.
D) Full Quality Assurance Full Quality Assurance (Module H) requires that a manufacturer operate an approved ISO-9001 quality system for design and production as described by an Annex in a directive. The requirements vary by directive. Approval of the system, the issuing of EU design examination certificates (in accordance with the directive) and permission to affix a CE mark can be granted only by a EU Notified Body for the directive. As with all quality assurance systems, the Notified Body is responsible for periodic surveillance of the system.
NOTE: At present only EU Notified Bodies can approve the quality assurance modules and other modules in accordance with the various EU directives.
However, the European Community in its relations with third countries endeavors to promote international trade. For regulated products, this is achieved - inter alia - through the conclusion of Mutual Recognition Agreements (MRA's).
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