Quality Management System

2. The revision of ISO 9001:2000 to
ISO 9001:2008 did not bring in drastic
additions.
Its changes seek to make clarification
in relevant clauses based on the vast
application experiences from the
various industrial sectors.
‘Product’ and ‘Service’ will be
used interchangeably as
always in ISO 9001.

3. Paragraph 0.1
A statement about whom and where the
standard is including any statutory
requirements and have the same scale
as any customer or regulatory
requirements. It also clarified that these
requirements are restricted to those
applicable to the product.

4. Paragraph 0.4
A comment that states that the new
standard is made due consideration to
ISO 14001:2004.
(Quite common for organizations that
embarked on ISO 14000 also to have
the ISO 9000 certification)

5. Paragraph 1
Statutory requirements had been referred
in connection with purchased products
and product realization. Second note
explains that a statutory requirement can
be a legal requirement.
(Since statutory requirements have the weight
of statute behind them. It implied that your
suppliers must follow the laws too)

6. Paragraph 2
Normative reference - the ISO 9000
now refers to ISO 9000:2005
Paragraph 3
Explanation on what is a customer
and what is an organization and
what is a supplier had been
removed.

7. Paragraph 4.1
The word "determine” replaced "identify".
Any outsourced process has to be
suitably controlled to ensure product
conformity and, defined in the Quality
Management System.

8. Paragraph 4.2.1
Slight change of words but no change in
meaning from earlier edition.
Note 2 was changed - a single document
may include requirements for more than
one procedure and requirements of one
procedure may appear in more than one
document.

9. Paragraph 4.2.3
clarified that external documentation
are the ones needed for the quality
management system.

10. Paragraph 5.1
The word "statutory" had been
added.
Paragraph 5.5.2
An addition for a demand that the
management representative would
have to be a member of the
organization's management.

11. Paragraph 6.2
Words, "affecting product quality" changed to
"affecting conformity to product requirements”
Paragraph 6.2.2
Sub-clause (b) -"provide training or take other
actions to satisfy these needs" changed to
"where applicable training needs to be
provided to achieve the necessary
competence".
Sub-clause (c) – obligation to ensure that the
staff attained the expected competence.

12. Paragraph 6.3
Sub-clause (c) states that information
systems are included as part of
Infrastructure.
(Good to cover information system, process
software, design software etc under 6.3c as
periodic verification of some design software
was audited under 7.6, which is
not so correct previously.)

13. Paragraph 6.4
A new note mentioning that noise,
humidity, temperatures are part of a
working environment.

14. Paragraph 7.1
Sub-clause (c) - measurement had been
added to the activities.
Paragraph number 7.2.1
Sub-clause (a) - change of words with no
change in the meaning.
Sub-clause (c) - the word 'applicable'
replaced 'related'.
Sub-clause (d) - change of words with no
change in the meaning.
(A note has been added to explain what is
the meaning of "post delivery activities".)

15. Paragraph 7.3.1
A note had been added to clarify
that design review, verification and
validation are separated processes
but they can be conducted together.
Paragraph 7.3.3
A change of wording. A note had
been added clarifying what is
included in "preservation
of product".

16. Paragraph 7.5.3
A requirement added specifying
that product traceability must be
included throughout the product
realization.

17. Paragraph 7.5.4
A change in the note had been amended
to highlight that personal data shall be
included as customer's property.

18. Paragraph 7.5.5
Change of words; from "conformity
of" to "in order to maintain
conformity to requirements"

19. Paragraph 7.6
Change of words; from "devices" to
"equipment" The reference to paragraph
7.2.1 had been removed.
Sub-clause (c) - from "be identified to
enable the” to "identification to enable
their”
Changes in the notes: Note 1 - the reference to
ISO 100012-2 had been removed while Note 3
seeks to explain about situation when
configuration of computer must be applied when
the computer is identified and used for monitor &
measurements processes.

20. Formula for
Delighting
Customers
Paragraph 8.2.1
A note had been added to throw
light on some of the means for
conducting customer satisfaction
evaluation.

21. Paragraph 8.2.2
Requirements for the audit
evidence and results had been
added. It is made clearer now that
the management is responsible to
ensure preventive and corrective
action will be taken.
The reference to the ISO 10011
had been updated to ISO 19011.

22. Paragraph 8.2.3
Minor change of words i.e. "to ensure
conformity of the product" had been
removed.
A note had been added to clarify that the
organization should determine the type of
the monitoring and measuring according
to the processes and, how will this affect
the quality management system.

23. Paragraph 8.2.4
Change of words: "maintain evidence
of conformity with acceptance
criteria" had been removed but it is
still a perceived requirement.

24. Paragraph number 8.3
An addition sub-clause (d) that
specifies how to deal with a
nonconforming product that was
discovered after delivery.
(Nothing new as it had always been
addressed under Warranty or After-sales
protocol.)

25. kaizenplus88@yahoo.co.uk