ISO 9001 2008 versus ISO 9001 2000

ISO 9001 2008 and ISO 9001 2000 use the same numbering system
to organize the standard. As a result, the new standard looks much
like the old standard. However, some important clarifications and
modifications were made. These changes are summarized below.

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.

While the old standard said that outsourced processes must be
controlled, the new standard goes further by expecting you also
to specify the type, nature, and extent of control. ISO 9001 2008
also wants you to think carefully about how you’re going to control
outsourced processes. How you choose to control an outsourced
process should be influenced by the potential impact it could have
on your products, whether or not process control will be shared
with the process supplier, and whether or not adequate controls
can be contractually established using your purchasing process.

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.

ISO 9001 2000 Part 4.2.3 gave the impression that all external
documents needed to be identified and controlled. This has now
been clarified. The new standard says that you need to identify and
control the distribution of only those external documents that you
need in order to be able to plan and operate your QMS. In other
words, only relevant external QMS documents need to be
controlled, not all of them.

Management Representative

ISO 9001 2000, Part 5.5.2, allowed you to appoint any member
of management to oversee the organization’s QMS. Since the old
standard did not explicitly say that the management representative
must be a member of the organization’s own management, outsiders
were sometimes appointed, instead. This loophole has now
been closed.

ISO 9001 2008 now makes it clear that the management representative
must be a member of the organization’s own management. Outsiders
may no longer perform this important function.

Competence

While both old and new standards stress the importance of
competence, the old standard wasn’t very clear about who they
were talking about. Now it’s pretty clear that all QMS personnel must
be competent. ISO 9001 2008, Part 6.2.1, makes it clear that any task
within the QMS may directly or indirectly affect the organization’s
ability or willingness to meet product requirements. Since any
QMS task could directly or indirectly influence product quality,
the competence of anyone and everyone who carries out
any QMS task must be assured.

Infrastructure

For ISO 9001 2000 (Part 6.3) the term infrastructure includes
buildings, workspaces, equipment, software, utilities, and support
services like transportation and communications. ISO 9001 2008
has now added information systems to the previous list of support
services. Both old and new standards expect you to provide the
infrastructure (including information systems) that your
organization needs in order to ensure that product
requirements are being met.

Work Environment

According to ISO 9001 2000, Part 6.4, you are expected to
manage the work environment that your organization needs
in order to be able to ensure that all product requirements are
being met. However, it failed to indicate exactly what they were
talking about. This problem has now been solved. ISO 9001 2008
says that the term work environment refers to working conditions.
These working conditions include physical and environmental
conditions, as well as things like noise, temperature, humidity,
lighting, and weather. According to the new standard, all of
these conditions need to be managed in order to help
ensure that product requirements are being met.

Customer Requirements

According to ISO 9001 2000, Part 7.2.1, you are expected to identify
your customers’ specific delivery and post delivery requirements.
Since some people weren’t sure about what post delivery meant,
the new standard has tried to clarify this.

According to ISO 9001 2008, post delivery requirements include
things like warranty provisions, contractual obligations (such as
maintenance), and supplementary services (such as recycling
and final disposal).

Design and Development Planning

Both old and new standards expect organizations to plan and
perform product design and development review, verification,
and validation activities (Part 7.3.1).

While each of these three activities serves a different purpose,
ISO 9001 2008 makes it clear that these three activities can be
carried out and recorded separately or in any combination as
long as it makes sense for the product and the organization.

Design and Development Outputs

Part 7.3.3 of ISO 9001 2000 wants you to make sure that the
design and development process generates information
(outputs) that your purchasing, production, and service
provision processes need to have.

ISO 9001 2008 now also says that design and development
outputs could include information that explains how products
can be preserved during production and service provision.

Monitoring and Measuring Equipment

While ISO 9001 2008, Part 7.6, refers to the need to control
monitoring and measuring equipment, the old standard talked
about controlling devices. Since the term device can refer to
almost anything from a literary contrivance to a machine, its
meaning wasn’t exactly clear. The new ISO 9001 standard
has removed this ambiguity by using the term equipment.

Both the old and the new standard wants you to confirm that
monitoring and measuring software is capable of doing the job
you want it to do. In addition to this requirement, the new standard
suggests (in a note) that configuration management and well
established verification methods can be used to ensure the
ongoing suitability of monitoring and measuring software.
However, this is not a requirement, just a statement that
explains how the ongoing suitability of software can
be maintained.

Customer Satisfaction

Both old and new standards want you to monitor and
measure customer satisfaction (perceptions). A new note to
ISO 9001 2008, Part 8.2.1, explains that there are many ways
to monitor and measure customer satisfaction. You could use
customer satisfaction and opinion surveys. And you could collect
product quality data (post delivery), track warranty claims, examine
dealer reports, study customer compliments and criticisms, and
analyze lost business opportunities.

Internal Audit Records

Both old and new standards refer to the need to establish
a procedure to define how internal audits should be planned,
performed, reported, and recorded (Part 8.2.2). However, the old
standard did not explicitly state that audit records must actually be
maintained. This oversight has now been corrected. ISO 9001 2008
now explicitly says that you must maintain a record of your internal
audit activities and results.

Process Monitoring and Measurement

Both old and new standards expect you to monitor and
measure your QMS processes. A new note to ISO 9001 2008,
Part 8.2.3, wants you to consider the impact each process has
on the overall effectiveness of your QMS and the impact it has
on your ability to meet product requirements (when you’re
making decisions about what kinds of process monitoring
and measurement methods should be used).

Release of Product

According to ISO 9001 2000, Part 8.2.4, you must make sure
that product monitoring and measuring records indicate who
was responsible for authorizing the release of products. However,
the old standard did not specify who must be on the receiving end.
This has now been clarified.

ISO 9001 2008 now makes it clear that products are released for
delivery to customers. Records must now indicate who releases
products for delivery to customers.

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