Control of externally provided processes, products, and services (ISO 9001:205 clause 8.4)
Besides the various controls, action and processes that will
be firm the operate, there are might be part of the operation that will be
outsourced to other organization.
The ISO 9001 requires all outsources processes to be
identify and control to ensure that those processes, products, and services
conform to the requirements of the organization.
The requirement of controlling the outsources processes is
important because the trend of outsourcing activities is rising worldwide and
because more common for companies outsource operation critical for achieved
customer satisfaction or delivering quality products or services.
Examples for such processes are customer support via call
center, transportation, and production process. Let us see an example for small
production company outsourcing the process production. The company should make
sure that hire company follows their requirements for product such as product
specification and to ensure that the production processes carried out as
required.
To enable to control the outsource company, the production
firm should determine the type and extent of the controls needed to ensure that
the outsource company will be deliver required product then to communicate
requirements and controls with outsourcing company and of course get their
acceptance.
Having the written rules will help the outsource company to
meet requirements and give opportunity to the production company to manage and
control outsourcing operation.
When the process is outsourcing or the product or services are
supplied by external provider, the ability of the company to control them can
vary from direct control to limited or influence especially if the supplier is
big company overseas. So, it is important to take all that into consideration
when defining controls for outsourced processes products or services because in
some cases you will have to exclude some products or services from outsourcing.
The control of outsourced processes should be documented as
any other processes control. The standard says, “to the extent necessary to
achieve confidence that the process is carried out as planned”. Meaning that it
is up to company to decided whether to write the procedure, guidance, or some
other documents but the document must be existing.