The European Union is keen to ensure that all products entering and used within the Union are such as not to impose a threat to consumers or the environment.
The European Community aims to ensure that industrial products made available on the Community market respect a high level of protection of public interests such as health and safety, protection of consumers and the environment.
A common indication of a product's fitness for placement within the Community is the affixing of a CE Mark.
The client shall forward the application to the SVS with organization details, Manufacturing setup, etc.,
This activity is a top level review conducted by the SVS at the premises of the manufacturer. This is necessary because of the combined complexity of the CE Marking and Authorised Representative processes. It can be likened to a pre-Stage One review. The Readiness Review will indicate to the manufacturer the likelihood of achieving CE Mark status for their product, the probable timescale and whether or not specialist help may be necessary. Manufacturers should note that a common circumstance is that products will have developed during a period of several years. Moreover, the level of sophistication of a manufacturer's management practices and personnel will have developed in similar manner. Data regarding the excellence of the design of the product may not therefore be currently available. Often the requirement 'in the early days' was either non-existent or unappreciated. Nonetheless, today's European Community requirement is that products should posses known qualities and data relating to their health and safety properties. Collating such data may not be an easy or rapid task and for this reason a Readiness Review is considered essential in order to ascertain realistic project milestones and costs for CE marking.
Technical Construction File
The manufacturer must prepare a technical construction file for the products intended for the European market. The file will contain evidence as to why the product, when installed, maintained and used in accordance with specified instructions, will not present an unreasonable hazard or risk to health and safety or to the environment. The Technical Construction File will contain product information, especially relating to the design evaluation and the risks and hazards evaluated. It will also address the manufacturing capability of the manufacturer and its ability to achieve the quality of design in a manufacturing environment. Typically a certificated quality management system such as ISO 9001 will be of assistance in demonstrating this. However ISO 9001 certification will not necessarily, on its own, contain sufficient evidence of the safeguard the potential of design. Other information may be necessary and should be expected to be forthcoming on most occasions. Typically this will be information and data arising from the manufacturing process.
This activity is conducted by the SVS. It is done in five stages:-
(i) Stage One, Document Review. This is done on site.
(ii) Stage Two, On-site assessment.
(iii) Stage Three, CE Mark certification. This is done at the SVS premises.
(iv) Stage Four, Product Release. (i.e. issue of appropriate certificates).
(v) Surveillance. Typically this would be on a two year cycle but may be more frequent if necessary.
It is the responsibility of the manufacture to advise the SVS of such changes in business structure, product design, or manufacturing systems that could impact upon the basic characteristics, fit, form or function of the product. Failure to advise of relevant changes may invalidate their CE mark status and relationship with the Authorised Representative.
The assignment process is that whereby the SVS assigns ASCB(E) to the manufacturer as their Authorised Representative in Europe. Notification to ASCB(E) has to be done within a defined period of time. Reference numbers are allocated and where not previously performed, all technical documentation and documentation pertaining to stages three and four, shall be put into electronic format and copies submitted to ASCB(E) for secure and confidential retention in Europe.
Documents expected to be submitted are as follows:
Technical Construction File
Declaration of Conformity
Following receipt of submission, SVS shall review documentation as appropriate and shall retain registries within Europe of the CE marked products. A register shall be maintained for public access subject to the provisions of legislation requiring data security.