Process Control - Quality Systems:
Any organization that provides a product or a service needs some
controls on the processes involved. It is apparent that completely uncontroled processes usually result
in highly variable quality of service/product and definitely result in higher costs.
Organizations that make products that fall within the scope of the EU "CE
Marking" directives must have a means of "ensuring compliance during series production", which means some form of
controls and appropriate record keeping. It is also true that such Organizations require controls on documentation
since this is the primary method of demonstrating compliance... technical documentaion that is wrong or out-of-date
is not a lot of use!
We have extensive experience in helping Organizations adopt appropriate levels of
control, such methods are based on "best practice" and can easily be further enhanced to allow compliance with
Formal Quality Management Systems to be demonstrated.
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Informal
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Formal Quality
Management Systems
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Appropriate process and document controls based on "best practice"

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General
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ISO 9001:2008 |

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Medical
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ISO 13485:2003
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Other
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ISO 80079-34 |

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We have experience of applying these informal and formal
quality systems across 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.

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