Scope Of The Quality Management System
The ISO 9001 standard requires the quality manual to include the scope of the quality management system
including details of justification for any exclusion. The standard
addresses activities that may not be relevant or applicable to an
organization. The permissible exclusions are explained in section 1.2 of
ISO 9001. Here it states that the organization may only exclude
requirements that neither affect the organization’s ability, nor its
responsibility to provide product that meets customer and applicable
regulatory requirements. The requirements for which exclusion is
permitted are limited to those in section 7 of the standard.
Under
ISO 9001:2008, it was possible for organizations to exclude functions
and processes of their organization that may have been difficult to
control or were not part of the order fulfilment cycle. Organizations
that designed their own products but not for specific customers could
escape bringing these operations into the management system. Marketing
was omitted because it operated before placement of order. Accounting,
Administration, Maintenance, Publicity, Public Relations and After Sales
Support functions were often omitted because there were no requirements
in the standard that specifically dealt with such activities. As there
is no function in an organization that does not directly or indirectly
serve the satisfaction of interested parties, it is unlikely that any
function or process will now be excluded from the quality management system.
It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system
is one area that generates a lot of misunderstanding particularly when
dealing with auditors, consultants and customers. When you claim you
have a management system that meets ISO 9001 it could imply that you
design, develop, install and service the products you supply, when in
fact you may only be a distributor. Why you need to justify specific
exclusions is uncertain because it is more practical to justify
inclusions.
The scope of the quality management system
is the scope of the organization. There is no longer any reason to
exclude locations, activities, functions or processes for which there is
no requirement in the standard. The reason is because the ISO 9000
family now serves customer satisfaction and is not limited to quality
assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It
is not appropriate to address exclusions by inserting pages in the
manual corresponding to the sections of the standard and adding
justification if not within the scope of the management system – such as
‘We don’t do this!’.
It is much more appropriate to use an
appendix as indicated previously in the manual contents list. By
describing the nature of the business, you are establishing boundary
conditions. If in doing so you do not mention that you design products,
it will be interpreted that design is not applicable.
For
exclusions relative to detail requirements, the Compliance Matrix may
suffice but for an unambiguous solution, it is preferable to produce an
exposition that addresses each requirement of the standard.
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ISO 27001 Audit - The OHSAS 18001 standard (may also be mistakenly referred to as ISO 18001) is internationally accepted as a method of assessing and auditing occupational health and safety management systems. Developed by leading trade and international standards bodies, it provides a framework for organisations to instigate proper and effective management of health & safety in the workplace.
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