ISO 9000 family of standards and SMEs
The
ISO 9000 quality management system
is generic in nature and applicable to all companies, regardless of the
type and size of the business, including small and medium enterprises
(SMEs), and they are applicable to all categories of products, whether
hardware, software, processed materials or services.
ISO 9001:2008 specifies
what is required to be done by an organization but does not indicate
how it should be done, thus giving the enterprise a lot of flexibility
to run its business.
It is simple to use, clear in language and
easily understandable. The new standard is also appropriate for small
companies, as it does not demand the type of paper bureaucracy needed
for the implementation of the 1994 version. Only six documented
procedures are now required and need for other procedures/documents can
be decided by the company. Companies will, however, be required to
provide objective evidence that the QMS has been effectively
implemented. A small company may find it appropriate to include the
description of its entire QMS within a single Quality Manual, including
all the documented procedures required by the standard.
The
process-based approach given in the new standard will tend to ensure
that systems are documented and implemented in a manner that suits a
SME’s own way of doing business. This approach makes it easier for SMEs
to implement, instead of just taking over an artificial structure of
QMS
imposed from outside. It will also be easier for SMEs managed by their
owners to demonstrate “top management commitment” towards QMS.
Furthermore, in a SME, it is easier to ensure effective internal
communication, better utilization of resources, people clearly
understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain
product realization processes included in section 7 of the standard.
For example, if the SME has no responsibility for the design and
development of the product it provides, the SME may say so, giving the
reasoning behind it, in the Quality Manual; the certification body,
being satisfied that this corresponds, would then award it certification
to ISO 9001:2008. Similarly, other product realization processes such
as purchasing, product identification and traceability, control of
measuring devices may also be excluded if these are not applicable for
the type of products or services being provided by the company.
It
is also possible that SMEs may not have adequate in-house expertise or
there may be other constraints to perform all processes on their own. In
such cases, the new standard also permits the outsourcing of any of the
QMS processes, providing the company has control over such processes.
The nature of this control will depend on the nature of the outsourced
or subcontracted processes and the risk involved. For example, the
design and development process may be subcontracted to an expert or a
specialized agency, inspection/verification of goods purchased may be
subcontracted to an inspection agency, internal audit of QMS can be
outsourced, etc. However, overall responsibility for ensuring control on
all outsourced processes as per requirements of the standard would
remain with the company’s management.