PCL - Formal 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	Medical	Others
ISO 9001:2008	ISO 13485:2003	Various
Generally applicable, simple, non-prescriptive, can be moulded to suit the organization, relatively small "overhead", limited documentation. Covers all aspects of an operation. Links into H&S, product regulatory, environmental etc. Major emphasis on continual improvement.	Based on ISO 9001:2000 but is a standard in it own right. Focussed on maintaining the process and keeping records. Fairly prescriptive. Increased burden of documentation. Satisfying the a vast majority of 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 the new EN ISO 80079-34:2011 (replacing EN 13980:2002) which provides additional requirements for organizations involved in the production of products for use in potentially explosive environments.

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.