ISO 9001:2008 Revisions
A new edition of ISO
9001, the quality management system
standard, has been introduced in
November 2008. This will be the fourth edition of the
standard, first published in 1987. As mentioned
before, ISO 9001 was first introduced in 1987.
Revisions were later made in 1994 and 2000.
In terms of changes, ISO
9001:2008 represents fine-tuning, rather than the thorough
overhaul that took place for its update in 2000. ISO
9001:2008 clarifies the requirements that have been in place
since 2000, based on user experience over the last eight
years. It includes changes that are intended to improve
further compatibility with ISO 14001:2004 Environmental
management systems. The new has the same numerical
system as the current version of ISO 9001:2000.
The changes that have been made
are minor representing clarifications and modifications.
Note: Read the table against the ISO
9001:2000 document.
|
Clause number |
Revisions |
|
4.1 |
The new standard
makes it clear that an outsourced process is still part of your QMS. 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. In essence, the the revised clause requires to
you define the
type,
nature, and extent of controls that are effective in ensuring planned
quality levels.
|
|
4.2.1 |
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. And the new standard
requires you 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.
|
|
5.5.2 |
It is a requirement now that the management representative must be a member
of the organization’s own management. Outsiders may no longer
perform this important function.
|
|
6.2.1 |
All QMS personnel must be competent
in any within the QMS which may directly or indirectly affect the
organization’s ability or willingness to meet product requirements.
Personnel competence must be assured. |
|
6.3 |
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. |
|
6.4 |
ISO 9001:2008 says that the term work environment
now refers to
working conditions. These working conditions include physical
and environmental conditions, as well as things like noise,
temperature, humidity, lighting, and weather. All of these conditions need to be managed in order to
help ensure that product requirements are being met. |
|
7.2.1 |
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).
|
|
7.3 |
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. |
|
7.3.3 |
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. |
|
7.6 |
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. |
|
8.2.1 |
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.
|
|
8.2.2 |
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.
|
|
8.2.3 |
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. |
|
8.2.4 |
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 records must now indicate who
releases products for delivery to customers. |
Read more about these revisions at my blog.
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