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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.
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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. |