What is new in ISO9001:2008
Outsourced Processes
The process approach continues to be of central importance to
ISO 9001. And since outsourcing has become increasingly common
during the last few years, the new ISO 9001 standard has expanded
its discussion of outsourced processes (see ISO 9001 Part 4.1).
The new standard makes it clear that an outsourced process is
still part of your QMS even though it is performed by a party that
is external to your organization. The new standard emphasizes
the need to ensure that outsourced processes comply with all
customer and legal requirements. While the responsibility for
a process may have been outsourced, your organization is,
nevertheless, still responsible for ensuring that it meets all
customer, regulatory, and statutory requirements.
….
Documentation
ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentation
includes not only the records required by the standard but also the
records that your organization needs to have in order to be able to
plan, operate, and control its QMS processes. So the new standard
has expanded the definition of documentation to include all QMS
process records.
Part 4.2.1 makes it clear that a single document may contain several
procedures or several documents may be used to describe a single
procedure. While this has always been an option, the new standard
makes this possibility explicit.
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