ISO 9000 Quality Management Systems

ISO 9001:2008 is no more just QMS, it is now a Business Management System that requires you to do RISK Management when designing the QMS. You have to understand the Risks to the business, and determine the Processes to be develoed. This may require you to do HACCP studies, if you are a food processor, and understand Product liability and the implications of Product Recall as in ISO/PC 240. For guidance in designing your QMS, you must refer to ISO 9004:2009.

Wednesday, May 26, 2010

CE Marking - useful LINKS

Useful links

1. Standardisation related websites

New Approach Standardisation in the Internal Market

This website represents the joint efforts of CEN, CENELEC and ETSI together with both the European Commission and EFTA. This common entry point provides access to information on standards and routes into the standardisation process, irrespective of which of the three European Standards Organisations is responsible for the standards applicable to the products.

Guide to the Implementation of Directives Based on New Approach and Global Approach

This Guide is intended to contribute to better understanding of Directives based on the New Approach and the Global Approach, and to their more uniform and coherent application across different sectors and throughout the Single Market.

2. Participants in the standardisation process

Co-operating partner

EFTA: European Free Trade Association

European Standards Organisations

European organisations and associations representing SMEs and societal stakeholder interests

International Standards Organisations

ISO: International Organization for Standardization
IEC: International Electrotechnical Commission
ITU: International Telecommunication Union

3. Other useful links

European Union legislation: EUR-Lex
New Approach directives and standards-receptive directives: List of directives and subjects
European SME portal
Enterprise Europe Network
Enterprise policy magazine

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Manufacturer's Responsibility

Responsibility of manufacturers

The CE marking must be affixed by the manufacturer or his agent established within the Community. The manufacturer bears ultimate responsibility for the conformity of the product.

Conformity assessment relates to the design and production phases of the product. Depending on the conformity assessment procedures applied, a notified body may be involved in these two phases. If the notified body is involved in the production control phase, its identification number will follow the CE marking.

If a product falls within the scope of a directive that provides for the CE marking, this should be affixed:

to all new products, whether manufactured in the Member States or in third countries;
to used and second hand products imported from third countries.