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.

Application

The client can forward the application to IsoBeacon with organization details, Manufacturing setup, etc.,

Readiness Review

A top level review will be conducted by the IsoBeacon at the manufacturer's premises. This is necessary because of the combined complexity of the CE Marking and Authorised Representative processes. It can be likened to a 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 not necessarily, on its own, contain sufficient evidence of safeguards in 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.

Product Release

AQMS does this in five stages:-

• Stage one, on site Document Review.
• Stage Two, On-site assessment.
• Stage Three, CE Mark certification. This is done at the IsoBeacon premises.
• Stage Four, Product Release. (i.e. issue of appropriate certificates).
• 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 IsoBeacon 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 advice of relevant changes may invalidate their CE mark status and relationship with the Authorized Representative.

The assignment process is that whereby the IsoBeacon assigns a CE certifiying agency to the manufacturer as their Authorised Representative in Europe. Notification to CE certifiying agency 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 CE certifiying agency for secure and confidential retention in Europe.

Documents expected to be submitted are as follows:

• Technical Construction File
• Declaration of Conformity
• Release Certificate

Acceptance

Following receipt of AQMS submission, CE certifying agency reviews documentation as appropriate and retains registries within Europe of the CE marked products. A register is maintained for public access subject to the provisions of legislation requiring data security.

Accreditations

IsoBeacon is striking a balance between providing popular accreditation to its customers at the same time providing cost effective service. AQMS as required can organize other accreditation like ANAB, ANSI-ASQ National Accrediation Board,US;Dutch Accreditation Council, RVA Netherland; DAR, T.G.A Gmph German; & NABCB (National Accreditation Board for Certifying Bodies)India; Through respective Accredited CB's.