the revision to ISO 9001:2000, ISO
9001:2008 was published. While the changes represent
no new requirements, it does serve to clarify and place emphasis on
requirements inherent in the 2000 revision that may not have been
fully understood or incorporated in many implementations. Below, we
have provided a clause-by-clause description of the changes that are
now part of ISO 9001:2008. ISO 9001:2000 certifications will remain
valid until November 2010, but organizations are urged to study the
changes and evaluate their current degree of compliance and address
deficiencies sooner rather than later.
standard provides the ability to meet any statutory requirements
along with regulatory requirements.
It's also clarified
that these requirements are restricted to those which are applicable
to the product.
0.2 – Process
Text added to identify a process as "an activity or
set of activities"
0.3 - Relationship with
Revised to emphasize
continual improvement. Now specifies that ISO 9004 can be used "to
move beyond the requirements of ISO
0.4 - Compatibility with
other management systems
Added reference to Annex
A, which compares ISO 9001:2008 and ISO
1.1 and 1.2 -
First note clarifies
that the term product can be any intended output from the product
realization process. A second note explains that a statutory
requirement can also be a legal requirement.
2 - Normative
current reference - the ISO 9000:2000 is now replaced by ISO
3 - Terms and
"customer," "organization" and "supplier" terms have been
Clause a -
The word "determine" replaces the word "identify" for
Notes cover definition of outsourced process and types
of control that may be applied to these processes. Reference to
clause 7.4 has been added.
4.2.1 – Documentation
Clarification that QMS
documentation also includes records. Note 1 was changed - a
single document may address the requirements for one or more
procedures, and a requirement for a documented procedure may be
covered by more than one document.
4.2.3 (f) - Control of
Clarification that only
external documents determined by the organization to be necessary
for the planning and operation of the QMS need to be identified and
have their distribution controlled.
4.2.4 - Control of
Editorial changes to
better align with ISO 14001.
5.5.2 - Management
that the management representative be a part of the organization’s
6.2.2 - Competence,
training and awareness
Clause b – "provide
training or take other actions to satisfy these needs" changed to
"where applicable, provide training or take other action to achieve
the necessary competence"
Clause c – Clarification
that "information systems" are included as part of the
6.4 - Work
Clarification of "work
environment" to include conditions under which work is
performed. These conditions include noise, temperature,
humidity, lighting, and weather as part of the working environment.
7.1 (c) - Planning of product
The term "measurement" had been added to the
7.2.1 - Determination of
requirements related to the product
clarification of the meaning of "post delivery
7.3.1 - Design and
A note has been added
clarifying that design and development review, verification and
validation have distinct purposes. However, they can be conducted
and recorded separately or in any combination, as suitable for the
product and the organization.
7.3.3 - Design and
Note added to clarify
that information needed for production and service provision may
include details for preservation of the
7.5.3 - Identification
Added/clarified that the
organization shall identify product status with respect to
monitoring and measuring requirements throughout product
7.5.4 - Customer
Slight wording change in
the requirement to inform the customer of any problem regarding his
note has been amended to specify that personal data is "customer
Preservation of product
– Added "in order to maintain conformity to
– Addition of the term "As applicable,"
preservation shall include …”
Control of monitoring and measuring
changed from monitoring and measuring “devices” to
The reference to paragraph 7.2.1 has been
Clause a – Changed "and/or" to "or," so it now reads "be
calibrated or verified, or both."
Clause c – from "be identified
to enable the" to "have identification in order to"
Note 1 – the
references to ISO 10012-1 and ISO 10012-2 have been removed
added – Confirmation of the ability of computer software to satisfy
the intended application would typically include its verification
and configuration management to maintain its suitability for
8.2.1 - Customer
Note added to explain
that monitoring of customer perception can include input from
sources such as customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, lost business
analysis, compliments, warranty claims, and dealer
8.2.2 - Internal
responsible for the area being audited shall ensure that any
necessary corrections and corrective actions are taken without undue
delay to eliminate detected nonconformities and their
Records of audits include audit
The references to ISO 10011-1, ISO 10011-2, and ISO
10011-3 are now changed to ISO 19011.
Monitoring and measurement of processes
A change of
words: "to ensure conformity of the product" was removed at the end
of the last sentence.
Note added: "When
determining suitable methods, it is advisable that the organization
should consider the type and extent of monitoring or measurement
appropriate to each of its processes in relation to their impact on
the conformity to product requirements and on the effectiveness of
the quality management system."
Control of nonconforming product
Editorial changes only – rearrangement of the
Analysis of data
to other clauses updated in items b), c), and
updated to read "reviewing the effectiveness of the corrective
updated to read "reviewing the effectiveness of the preventative
Need more information on the details
of the 2008 revision, or help implementing changes,
training staff, auditing, etc.?
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