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Quality Management Systems

Quality Management Systems:

Increasingly businesses are finding that there are major benefits to be had by working to a Quality Management System that ensures that their work processes will consistently provide the same end product or service. A well-implemented system reduces the need for constant checking and supervision and can free up staff for more productive work.

In certain industries compliance to a formal Quality Management System is effectively mandatory and increasingly notified bodies involved in process of CE marking products are expecting to be able to audit the organization processes against a recognised standard.  

General Environmental Medical Others

ISO 9001:2000

ISO 14001:2004

ISO 13485:2003

Various
Generally applicable, simple, non-prescriptive, can be moulded to suit the organization, limited "overhead", limited documentation. Covers all aspects of an operation. Links into H&S, product regulatory, environmental etc. Major emphasis on continual improvement. Focussed on reducing the environmental impact of the organization, non-prescriptive, can be moulded to suit the organization, limited "overhead", limited documentation. Can use existing management systems to leverage the benefits Based on ISO 9001:200 but is a standard in it own right. Focussed on maintaining the process and keeping records. Fairly prescriptive. Increased burden of documentation. Satisfying the requirements of this standard is effectively mandatory for CE marking of medium and high risk medical products - although certification is not. There are a range of industry specific systems that can be stand-alone or add-ons to ISO9001.

Example of an add-on is EN 13980:2002 which provides additional requirements for organizations involved in the production of products for use in potentially explosive environments.

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We have experience of applying these quality management systems in a range of organizations and can assist you to implement your system in the most efficient and cost-effective manner, in addition, our experience and background in continuous improvement will ensure that your system will provide real benefits to your business.

Quality Management Systems
 

ISO 9001

ISO14001

ISO13485

 

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