The document summarizes the small changes made in ISO 9001:2008 and identifies opportunities organizations can take advantage of through these changes. The changes provide opportunities for organizations to streamline documentation, ensure their quality management system remains relevant to their changing business environment, and use their QMS to ensure compliance in other regulatory areas besides product requirements, though ISO 9001 does not require this. The changes are small but provide big opportunities for organizations to evaluate the effectiveness of their QMS.

1. ISO 9001:2008
Small Changes,
BIG OPPORTUNITIES
Nigel H Croft
Founding Co-chairman, ISO 9000 Advisory Group
Co-Convenor TC176 Conformity Assessment Liaison Group
ISO/TC176 liaison representative to ISO/CASCO
Member, IAF/ILAC/ISO Joint Working Group
Member, ISO/IAF Auditing Practices Group
April 2009 (c) Nigel H Croft 1

2. Small
Aim of the book:
To provide a common platform for organizations,
understand:
Intent of each clause of ISO 9001
Interpretation of the clause
Typical evidence that might be expected in order to
demonstrate conformity
To highlight the changes and opportunities introduced
in the ISO 9001:2008 version
To explain some common misunderstandings
April 2009 (c) Nigel H Croft 2

3. Management System
set of
interrelated or
interacting elements Hardware Software
(equipment) (methods)
to
Interact within processes
establish policy and
objectives
and to Humanware
(people)
achieve those
objectives
April 2009 (c) Nigel H Croft 3

4. ISO 9001 Scope
Clause 1.1 -
requirements for organization to:
demonstrate ability to consistently provide product that
meets customer and applicable regulatory requirements
ISO 14001 and OHSAS 18001 have similar
performance-based objectives
DID WE ALL FORGET THIS???
April 2009 (c) Nigel H Croft 4

5. What is the objective of
a management system audit?
Personal opinion (Nigel Croft)
and/or OHSAS 18001 requirements, and
thereby provide objective evidence of an
Objectives:
May 2005 (c) Nigel H Croft 2005 5

6. What are we looking for? (Case of ISO 9001)
Evidence that the way things are being planned
meets the requirements of
Customers
Applicable legislation
ISO 9001:2000
Evidence that things are being done the way they
were planned
May 2005 (c) Nigel H Croft 2005 6

7. Basic Principles
of good auditing
Concentrate on the processes, not the
documents
Look at the results
System effectiveness
PDCA approach
May 2005 (c) Nigel H Croft 2005 7

8. Cause and Effect
PROCESS
UNDESIRABLE OUTPUTS
Environmental Impacts
Health & Safety risks
May 2005 (c) Nigel H Croft 2005 8

9. Act Plan
How to improve What to do?
next time?
How to do it?
Check Do
Did things happen Do what was
according to plan? planned
May 2005 (c) Nigel H Croft 2005 9

10. HOW TO PROVIDE CONFIDENCE?
(ISO 9001 example)
-promoting activities
Confidence IAF Recognition
(ISO/CASCO) Confidence
ISO 17011
ISO 17021-1 Accreditation Body
ISO 17021-2 Confidence
ISO 17024
Certification Body
ISO/TC176 Confidence
ISO 9001:2008 Organization
Confidence Confidence
National Body Customers
(Translation)
Jan 2009 (C) Nigel H Croft 2009 - All rights reserved 10

11. ISO TC176
Standardization
Confederation of National Standards Bodies
Based in Geneva
Quality management and Quality Assurance
April 2009 (c) Nigel H Croft 11

12. Secretariat: Canada (SCC)
Chair: Dr Gary Cort
Vice-Chair Mr Li Tienan
ISO/TC 176
CALG CSAG
Interpretations WG Spanish Trans TG
Automotive TG Arabic Trans TG
SC 1 SC 2 SC 3
WG1 WG2 WG3 WG18 WG1 WG6 JWG
April 2009
TGx(c) NigelTGy
H Croft
TGz 12

13. Chairman
Strategic
Advisory Group
ISO
ISO/TC 176
CALG CSAG
Interpretations WG Spanish Trans TG
Automotive TG Arabic Trans TG
SC 1 SC 2 SC 3
WG1 WG2 WG3 WG18 WG1 WG6 JWG
April 2009
TGx(c) NigelTGy
H Croft
TGz 13

14. Conformity
Assessment
Liaison
ISO/TC 176
Group
CALG CSAG
Interpretations WG Spanish Trans TG
Automotive TG Arabic Trans TG
SC 1 SC 2 SC 3
WG1 WG2 WG3 WG18 WG1 WG6 JWG
April 2009
TGx(c) NigelTGy
H Croft
TGz 14

15. ISO/TC 176
ISO 9000 CALG CSAG
Interpretations WG Spanish Trans TG
Automotive TG Arabic Trans TG
SC 1 SC 2 SC 3
WG1 WG2 WG3 WG18 WG1 WG6 JWG
April 2009
TGx(c) NigelTGy
H Croft
TGz 15

16. ISO 9001 ISO/TC 176
ISO 9004
CALG CSAG
Interp
Interpretations WG Spanish Trans TG
Automotive TG
omotive Arabic Trans TG
SC 1 SC 2 SC 3
WG1 WG2 WG3 WG18 WG1 WG6 JWG
April 2009
TGx(c) NigelTGy
H Croft
TGz 16

17. ISO 19011
ISO/TC 176
&
ISO 10000
C
CALG CSAG
series
Interpretations WG
pretations Spanish Trans TG
Automotive TG Arabic Trans T
abic TG
SC 1 SC 2 SC 3
WG1 WG2 WG3 WG18 WG1 WG6 JWG
April 2009
TGx(c) NigelTGy
H Croft
TGz 17

18. Overall Scenario of TC176
Generic QMS standards have broad application:
all market sectors
both private and public organizations
+/- 1,000,000 worldwide certifications to ISO 9001
Other guidelines produced by ISO/TC 176 assist
organizations in improving their quality management
processes.
ISO 9000
ISO 9004
Others (ISO 10001/2/3; ISO 19011 etc)
April 2009 (c) Nigel H Croft 18

19. 1979 - BS 5750
1987 ISO 9000 series
1990
1994 Revision to ISO 9000 series
1996 ISO 14000 series published
2000 Major ISO 9000 revision
2002
2002 ISO 19011 published
2004 Revision to ISO 14001
2005 Small revision to ISO 9000 (not ISO 9001)
April 2009 (c) Nigel H Croft 19

20. ISO Review process:
Requires continual review (every 5 years) to keep
standards up to date.
User inputs:
User questionnaire
Suggestions arising from the interpretation process.
Opportunities for increased compatibility with ISO 14001
Current trends:
Keeping up with recent developments in management
system practices.
April 2009 (c) Nigel H Croft 20

21. Key inputs for ISO 9001:2008
Web based User Feedback Survey
conducted by ISO/TC 176/SC2
ISO/TC 176 approved interpretations
See www.tc176.org/ for details
Some interpretation requests indicate need for
clarification of ISO 9001 text
The ISO 9001:2008 Introduction & Support
Package set of documents (www.iso.org)
ISO 14001:2004
April 2009 (c) Nigel H Croft 21

22. Results of User Survey (2003)
Responses from 941 users in 63 countries.
1477 individual comments
All four product categories (Hardware,
Software, Processed Materials and Services)
well represented.
Approx 80% of respondents were satisfied
with the ISO 9001:2000 standard.
April 2009 (c) Nigel H Croft 22

23. Survey responses
229 UNITED STATES
CHINA
337
GERMANY
UNITED KINGDOM
20 MEXICO
25 JAPAN
28
CANADA
COLOMBIA
32
39 AUSTRALIA
70
45 ITALY
58
Other
April 2009 58 (c) Nigel H Croft 23

24. Size of organization
3
271
290
small
medium
large
Blank
377
April 2009 (c) Nigel H Croft 24

25. How long certified?
450 424
400
350
300 264
250
250
200
150
100
50 3
0
0-3 4-10 YEARS 10+ Blank
April 2009 (c) Nigel H Croft 25

26. How well does ISO 9001:2000
meet your needs?
16 42 137 Excellent
167 Good
No comment (or NOT
APPLICABLE)
Needs to be improved
14
Not adequate
Blank
565
April 2009 (c) Nigel H Croft 26

27. Are you happy with the
process approach?
22
70
Yes
No
Blank
849
April 2009 (c) Nigel H Croft 27

28. Most commented clauses /
813 (55%) of total 1477 comments related to:
4.1 General requirements
4.2 Documentation
6.2 Human resources
7.3 Design and development
7.5 Production and Service Provision
8.2 Monitoring and Measurement
8.5 Improvement
April 2009 (c) Nigel H Croft 28

29. Objectives for ISO 9001
Initial objectives of ISO 9001:2008:
to improve the existing standard;
to provide greater clarity and ease of use,
to improve compatibility with ISO 14001:2004
April 2009 (c) Nigel H Croft 29

30. Impacts and benefits
Changes to ISO 9001 focus on high benefit /
low impact cases
Some high benefit / high impact
improvements that were identified are being
saved for the next revision cycle
Criteria are shown in the following slides
April 2009 (c) Nigel H Croft 30

31. Impact of changes to ISO 9001
Impact Criteria
Category
High Additional or reduced requirements significantly affecting many users
Change in intent of requirement
Need for urgent revision of related QMS standards
Decreased compatibility with ISO 14001
Inconsistency within the ISO 9000 family
Need for recertification or significant transition period
Need for extensive user education or training
Medium Minor additional or reduced requirements for some users
Possible impact on understanding by many users
Need for limited changes of an organizations QMS documentation
Need for eventual revision of other QMS standards
No significant need for additional education or training for users
Creates a minimal requirement for recertification or transition period
Low No increased or reduced requirement
No change in intent of requirement
No impact on most users
No need for additional education or training for users
April 2009 (c) Nigel H Croft 31

32. Benefits of changes to ISO
9001
Benefit Criteria
Category
High Addresses a widely expressed specific user need by improving clarity and
eliminating confusion
Corrects an error in the existing standard
Eliminates inconsistencies within ISO 9001
Eliminates inconsistencies within the ISO 9000 family
Eliminates major problems of translation
Medium Improves clarity in regard to a widely expressed user need but may not eliminate
confusion and/or translation difficulty
Improves clarity in response to needs identified by some users
Increases compatibility with ISO 14001
Demonstrates willingness to respond to the wish to see improvement in compatibility
between ISO 9001 and ISO 14001 even though alignment is not a priority for this
amendment
Reduces problems of translation
Low Improves clarity only in response to low number of requests for improvement
Marginal improvement in clarity where benefit may be offset by risk of unintended
consequences, e.g. with respect to translation, interpretation
Changes not addressing a clear user need
April 2009 (c) Nigel H Croft 32

33. Impact analysis
Impact Benefits
1 2 3
High Medium Low
1 Low 1 2 3
2 Medium 2 4 6
3 High *3 6 9
1-2 Incorporate the change.
3-4 Additional analysis should be conducted prior to making the decision.
6-9 Do not incorporate the change.
- - No change allowed, but we
need to record details of proposed change, to provide input into
future revisions .
April 2009 (c) Nigel H Croft 33

34. Main changes in ISO 9001:2008
-
Changes to the wording of some clauses
-
Organizations need to revisit their QMS to check if
better understanding leads to a need for change.
The changes are small, but they provide BIG
OPPORTUNITIES for organizations to take a step
back & look at the overall effectiveness of their
QMS
April 2009 (c) Nigel H Croft 34

35. WRONG!
April 2009 (c) Nigel H Croft 35

36. SMALL CHANGE, BIG
OPPORTUNITY #1 (Clause 0.1)
Clause 0.1 confirms that the intent of the standard is not to
impose uniformity of documentation
Consider your documentation:
Are you in the driving seat, or are you a slave to your documentation?
Did it make sense to structure your quality documentation in the way that
you have?
Does it really help you to manage your processes more effectively?
Do the people in your organization understand it?
Is it user-friendly?
Is it consistent with other documentation in your company?
Is there any value to making a change now?
Why not take this opportunity to streamline your documentation, and
eliminate those documents that are not adding value?
April 2009 (c) Nigel H Croft 36

37. SMALL CHANGE, BIG
OPPORTUNITY #2 (Clause 0.1)
Clause 0.1 now refers to the organizational environment, changes in that
environment and associated risks.
BIG OPPORTUNITY - check to ensure that your QMS
continues to be relevant to the changing business
environment in which you are operating.
As you grow, your situation may change new technologies,
market opportunities, consumer demands, threats etc.
Is the level of detail of your QMS and associated processes still
appropriate to the risks involved in your activities?
In the current financial climate, you should be looking to your
QMS to guide you through troubled times
Ensure that despite cutbacks etc, your product or service quality
(and with them your reputation) does not suffer.
April 2009 (c) Nigel H Croft 37

38. SMALL CHANGE, BIG
OPPORTUNITY #3 (Clause 0.1)
ISO 9001:2008 clarifies that only statutory and regulatory requirements
applicable to the product must be addressed (not, for example, those related to
environmental, social, financial or other topics).
You might find it beneficial to use your QMS to ensure regulatory
compliance in these other areas, but ISO 9001 does not require it.
Of course, all statutory and regulatory requirements are important, and a prudent
organization will ensure they are meeting all of these.
BIG OPPORTUNITY - determine which statutory and regulatory
requirements should and could be addressed within your quality
management system, and whether they are being managed to
maximum benefit.
Why not make use of the structure and discipline of your QMS to
allow you to monitor your conformity to other statutory and
regulatory requirements?
April 2009 (c) Nigel H Croft 38

39. SMALL CHANGE, BIG
OPPORTUNITY #4 (Clause 0.2)
Text added to clause 0.2 to emphasize the importance of processes being
capable of achieving desired outcomes.
Probably one of the most subtle but important
changes introduced in the new standard.
Emphasizes that the QMS should be achieving its
primary objective -
Did we all forget this??
Too much focus on documents and records, rather than on
managing processes to achieve desired results.
Take a long, hard look is your system really producing the
desired outcomes for you, your customers, and your
employees? If not, then why not? What needs to be changed?
April 2009 (c) Nigel H Croft 39

40. SMALL CHANGE, BIG
OPPORTUNITY #5 (Clause 0.3)
Reflect on the changes you may need to introduce as a result of the new ISO
9001:2008 standard, and think about using ISO 9004
BIG OPPORTUNITY is to read through ISO
9004 and get a sense of how it might apply to
your business
Make a self-assessment - identify your own
strengths and weaknesses and opportunities
for improvement.
April 2009 (c) Nigel H Croft 40

41. SMALL CHANGE, BIG
OPPORTUNITY #6 (Clause 0.3)
ISO 9001:2008 mentions that ISO 9004 is currently being revised
Once the new ISO 9004 standard is
published, your BIG OPPORTUNITY will be
to use its guidance to determine whether your
QMS is structured in a way that will contribute
to your sustained, long-term success.
April 2009 (c) Nigel H Croft 41

42. SMALL CHANGE, BIG
OPPORTUNITY #7 (Clause 0.4)
Some small editorial changes have been introduced for better alignment with
ISO 14001:2004
No impact on the requirements of ISO 9001, but
intent is to facilitate understanding for
organizations that have chosen to develop an
integrated management system
For organizations that presently maintain
separate systems, your BIG OPPORTUNITY is
to determine whether it makes sense from a
resource standpoint to consider moving toward
an integrated approach.
April 2009 (c) Nigel H Croft 42

43. SMALL CHANGE, BIG
OPPORTUNITY #8 (Clause 1.1)
Re-emphasizes that the aim of the QMS should be to provide confidence in the
As you go through your QMS to check for
changes that might be needed, the BIG
OPPORTUNITY is always to keep in mind
the objectives mentioned in Clause 1.1 as
you do this.
Is your system helping you to achieve these
objectives?
April 2009 (c) Nigel H Croft 43

44. SMALL CHANGE, BIG
OPPORTUNITY #9 (Clause 1.1)
Throughout ISO 9001:2008, the text has been modified (for consistency) to
address statutory and regulatory requirements.
regulatory requirements may sometimes be expressed as legal requirements.
erminology used in ISO 9001 and
(see www.iso.org) provides good dictionary definitions
for these terms.
BIG OPPORTUNITY is to make sure that you understand what is
might affect your product and your liabilities in the markets you
service.
How do you identify these requirements and any changes to them?
Are you currently addressing and meeting them?
Have you considered the risks involved to your image and reputation if
you do not?
April 2009 (c) Nigel H Croft 44

45. SMALL CHANGE, BIG
OPPORTUNITY #10 (Clause 1.1)
9001:2008 it refers to any intended output resulting from the product realization
processes. It is not limited to final product.
Emphasizes that requirements related to the product are
applicable throughout the whole product realization
process, from purchasing through final delivery
(including post-delivery activities).
BIG OPPORTUNITY is for you to ensure that your
system address the requirements of purchased product
and intermediate product as well as final product being
delivered to your customer.
This will help eliminate non-conforming product at an earlier stage, and
reduce your overall costs of quality
April 2009 (c) Nigel H Croft 45

46. SMALL CHANGE, BIG
OPPORTUNITY #11 (Clause 1.2)
When reviewing the requirements of ISO 9001:2008, think about the scope of
When you first implemented your QMS, did it
include all the products and services you
provide, or only a small part of these?
BIG OPPORTUNITY is to look at the
advantages of extending your system to include
other parts of your business that could benefit
from better organization and discipline, even
though certification might not be needed.
April 2009 (c) Nigel H Croft 46

47. SMALL CHANGE, BIG
OPPORTUNITY #12 (Clause 1.2)
Think about the application of the ISO 9001:2008 requirements in your
organization
As you review your QMS in the light of ISO 9001:2008,
there is a BIG OPPORTUNITY to check and make sure
it is properly applied throughout your organization.
Have you excluded any ISO 9001 requirements that maybe you
Have a long, hard look at the concept of product design and
Can you really justify excluding all the requirements of clause 7.3, or
What is the impact on your ability to provide confidence in your
products and services?
April 2009 (c) Nigel H Croft 47

48. SMALL CHANGE, BIG
OPPORTUNITY #13 (Clause 2)
ISO 9001:2008 now refers to the ISO 9000:2005 version
understand? The BIG OPPORTUNITY is for you to
consult the principles and terminology given in ISO
9000:2005 and the many guidance documents produced
by ISO/TC176
then either you have misunderstood the requirement or
you are probably doing it wrong!
April 2009 (c) Nigel H Croft 48

49. SMALL CHANGE, BIG
OPPORTUNITY #14 (Clause 3)
As you review the changes in ISO 9001:2008, think about the various
components of the product you provide
Are you applying your system to all of your intended
products?
Many organizations only think about the tangible products they
provide (particularly when it comes to design and development)
and forget about the service component of their product.
The BIG OPPORTUNITY is to consider very carefully
whether you have included all the different product
categories (hardware, software, service and processed
materials) that apply to your organization, and their
April 2009 (c) Nigel H Croft 49

50. SMALL CHANGE, BIG
OPPORTUNITY #15 (Clause 4.1)
Note 1 to Clause 4.1 clarifies that the processes needed for the QMS include
not only processes for management activities, provision of resources and
product realization, but also those needed for measurement, analysis and
improvement.
The BIG OPPORTUNITY is for you to check and
make sure you are managing your
measurement, analysis and improvement
processes in terms of this clause 4.1.
Have you identified the intended outputs?
Have you allocated adequate resources?
Are you monitoring these processes to ensure they
are effective?
April 2009 (c) Nigel H Croft 50

51. SMALL CHANGE, BIG
OPPORTUNITY #16 (Clause 4.1)
Clause 4.1 (e) now clarifies that process measurement may not be applicable in
all cases (though all processes must be monitored).
Do you know the difference between monitoring and
measuring?
In some cases, you may have been induced by consultants
and/or auditors to come up with process measurements that are
not practical, meaningful or useful, simply because ISO 9001 was
understood to require them.
Your BIG OPPORTUNITY through ISO 9001:2008 is to
re-evaluate the need for such measurements, and to
ensure that any measurements that are necessary really
do add value to your organization
April 2009 (c) Nigel H Croft 51

52. SMALL CHANGE, BIG
OPPORTUNITY #17 (Clause 4.1)
Notes have been added to explain more about outsourcing what is meant by
The BIG OPPORTUNITY is for you to review the way
you manage your outsourced processes.
Are they being carried out in line with the requirements of ISO
9001:2008?
Can you introduce greater efficiencies by considering alternate
sourcing or imposing more meaningful monitoring initiatives?
Are there any indications of customer dissatisfaction with these
processes?
Could you benefit from outsourcing other processes?
Might it be appropriate to bring some outsourced processes back
in-house?
April 2009 (c) Nigel H Croft 52

53. SMALL CHANGE, BIG
OPPORTUNITY #18 (Clause 4.2.1)
ISO 9001:2008 now clarifies that a single document may address the
requirements for one or more procedures. Equally, an ISO 9001 requirement for
a documented procedure may be covered by more than one document
You may choose, for example, to address corrective and preventive action
in a single procedure (provided that the procedure covers all the
requirements of clauses 8.5.2 and 8.5.3).
For some processes like internal audit, it might be convenient to develop
two or three separate procedures (e.g. planning, execution and reporting)
that cover all the requirements of clause 8.2.2.
BIG OPPORTUNITY is to re-evaluate all your documentation.
Is it used?
Is it useful?
-
Can it be pruned down to be more readable?
Maybe use some figures, drawings or photographs to substitute words?
April 2009 (c) Nigel H Croft 53

54. SMALL CHANGE, BIG
OPPORTUNITY #19 (Clause 4.2.1)
Clause 4.2.1 (c) and (d) mention that records are a type of documentation that
are required for the quality management system.
Although this change should have no impact,
here is another BIG OPPORTUNITY.
Have you considered developing check-lists to
control your processes instead of heavy
procedures - when complete, the check-list can
be used as a record?
You might want to try to eliminate duplicate
information on different records (time-consuming,
costly, and may introduce inconsistencies).
April 2009 (c) Nigel H Croft 54

55. SMALL CHANGE, BIG
OPPORTUNITY #20 (Clause 4.2.3)
Explains that the only external documents that need to be identified and have
controlled distribution are those that are deemed necessary by the
organization for the planning and operation of the QMS.
Does not apply to all external documents that might be
used by your organization.
BIG OPPORTUNITY is to allow you more flexibility in the
way you control documents of external origin, based on
their impact on your QMS.
You might also want to consider bringing (or leaving) all
externally-generated documents under your document
control process, if you find this to be beneficial.
April 2009 (c) Nigel H Croft 55

56. SMALL CHANGE, BIG
OPPORTUNITY #21 (Clause 4.2.4)
The sequence of this clause has been changed for greater clarity and better
alignment with ISO 14001.
No real implications, but the BIG
OPPORTUNITY would be for you to look at how
you might achieve better integration of the
records generated by your quality,
environmental and other management systems
in order to achieve greater efficiency.
April 2009 (c) Nigel H Croft 56

57. SMALL CHANGE, BIG
OPPORTUNITY #22 (Clause 5.5.2)
The new version of the standard clarifies that the management representative
If you are currently using a part-time consultant as your
management representative the BIG OPPORTUNITY
yourselves and integrate the QMS into your day-to-day
work routine.
The consultant can still have an important role in helping
your MR to carry out his/her functions, but the subtle
and obliges you to take charge of your own destiny.
April 2009 (c) Nigel H Croft 57

58. SMALL CHANGE, BIG
OPPORTUNITY #23 (Clause 6.2)
ISO 9001:2008 makes an important clarification that competence requirements
relate not only to personnel whose work directly affects product quality, but
also where it indirectly affects product quality via the operation of the QMS
(e.g. purchasing, supplier evaluations, internal audits etc).
If you have previously limited your attention to
competence requirements for personnel directly involved
in production or service delivery processes, the BIG
OPPORTUNITY is to assess where you may need to
include other activities such as those mentioned above,
among others.
This might mean an extra work-load in the short-term,
but it is likely to bring long-term benefits.
April 2009 (c) Nigel H Croft 58

59. SMALL CHANGE, BIG
OPPORTUNITY #24 (Clause 6.2)
The change in sequence of the title of this clause to bring it in line with the
equivalent clause of ISO 14001 may have gone un-noticed.
Although the change is trivial, it does provide a
BIG OPPORTUNITY for you to think about the
ways in which you address the requirements of
your quality and environmental management
system (if you have one).
Do you use a common, integrated approach?
If not, then why not?
April 2009 (c) Nigel H Croft 59

60. SMALL CHANGE, BIG
OPPORTUNITY #25 (Clause 6.3)
This clause now recognizes the importance of information technology (IT) in
modern organizations and the effect that information systems can have on
product conformity.
Not a new requirement, but the specific inclusion of IT as
an example of infrastructure provides you with a BIG
OPPORTUNITY to review your dependence on IT
Risk analysis of potential problems should a failure occur (system
crash, computer virus, loss of confidential data, file corruption
etc).
No requirement to use IT in your QMS (many
organizations can operate quite effectively without it), but
where it is used, the risks must be understood and
mitigation measures put in place as appropriate.
April 2009 (c) Nigel H Croft 60

61. SMALL CHANGE, BIG
OPPORTUNITY #26 (Clause 6.4)
This does not change any requirement (the note is
simply a partial repetition of the ISO 9000:2005 definition
BIG OPPORTUNITY is for you to consider the
implications of the work environment on your ability to
provide conforming products
Although not mentioned in the note, the ISO 9000:2005 definition
also includes psychological and ergonomic factors that can be
particularly relevant in a service provision situation.
You should look at the ISO 9000:2005 definition, for a better
understanding.
April 2009 (c) Nigel H Croft 61

62. SMALL CHANGE, BIG
OPPORTUNITY #27 (Clause 7.1)
ISO 9001:2008 now strengthens the requirement for product realization
planning to include measurement (as appropriate).
BIG OPPORTUNITY during product realization planning
is to think about and define what measurements you
need to make in order to ensure control over your
processes and conformity of the resulting product.
All processes have to be monitored, but it is not always feasible,
meaningful or cost-effective to establish measurements for
everything.
Think about the reasons measurements might be needed (eg for
evidence of conformity to requirements, or to provide process
control data for subsequent action) and the potential
consequences of not making measurements for every process.
April 2009 (c) Nigel H Croft 62

63. SMALL CHANGE, BIG
OPPORTUNITY #28 (Clause 7.2.1)
The standard now clarifies that post-delivery activities may include actions
under warranty provisions, contractual obligations such as maintenance
services, and supplementary services such as recycling or final disposal.
BIG OPPORTUNITY is to think about the whole range of
characteristics of your product that can affect customer satisfaction.
As global environmental awareness increases, considerations such
as unnecessary packaging or end-of-life product disposal
(particularly for electronic and electrical items) become a concern
Take a positive and proactive approach to these issues, and you will not
only be meeting the intent of ISO 9001:2008 you may be able to use
them as a strategic marketing tool to gain an advantage over your
competitors.
April 2009 (c) Nigel H Croft 63

64. SMALL CHANGE, BIG
OPPORTUNITY #29 (Clause 7.3.1)
A note has been added to explain that design and development review,
verification and validation have distinct purposes. As such, they may be
conducted and recorded separately or in any combination as suitable for the
product and the organization.
BIG OPPORTUNITY is the greater flexibility in the way
you address design review, verification and validation.
If you have large, complex design and development projects for
high-risk equipment or services, you are likely to need formal and
distinct processes for these activities, which might be carried out
in various phases over a range of time.
For simple design and development process and low-risk
projects, it might be acceptable to carry out all activities at the
same time.
April 2009 (c) Nigel H Croft 64

65. SMALL CHANGE, BIG
OPPORTUNITY #30 (Clause 7.3.3)
In addition to minor editorial changes in the body of Clause 7.3.3, a new note
has been added to explain that design and development outputs can also
include details for the preservation of product.
BIG OPPORTUNITY do the design outputs
provide sufficient confidence that your product
will not be damaged prior to delivery to its
intended point of use?
Should you be addressing product packaging or
handling information as an important output of
your design and development process?
April 2009 (c) Nigel H Croft 65

66. SMALL CHANGE, BIG
OPPORTUNITY #31 (Clause 7.5.3)
The wording of this clause has been changed to clarify that identification may
be needed throughout the product realization process not only for the final
product
BIG OPPORTUNITY is to think about the ways in which
you identify your products (and services) during the
product realization process.
Are there benefits to be obtained by improving identification?
You might want to consider making temporary changes during
periods where non-conformities are occurring with a greater
frequency (to facilitate identification of nonconforming product, or
for enhanced problem-solving).
April 2009 (c) Nigel H Croft 66

67. SMALL CHANGE, BIG
OPPORTUNITY #32 (Clause 7.5.4)
The note to this clause now explains that both intellectual property and
personal data should be considered customer property
There is a BIG OPPORTUNITY here, particularly
if you are working in the service sector.
Your customers are no doubt worried about fraud and
identity theft, so if you can demonstrate that you are
controlling this in an effective way, that should give
you a competitive advantage.
Such data might include credit card information
(internet purchases), address or passport details
(hotel check-in) or confidential medical information
(health service).
April 2009 (c) Nigel H Croft 67

68. SMALL CHANGE, BIG
OPPORTUNITY #33 (Clause 7.6)
has been added regarding the use of computer software. The note describes
verification and configuration management as typical methods of satisfying the
intended application and maintaining suitability for use.
The editorial changes should have no impact.
BIG OPPORTUNITY is to consider the extent to which
computer software is used in the course of your
monitoring and measuring activities.
Do you know the impact of this software on the accuracy of your
results?
Are you confident that the software is up-to-date and suitably
protected against virus, memory loss, system crashes etc?
If not, then you might well be vulnerable!
April 2009 (c) Nigel H Croft 68

69. SMALL CHANGE, BIG
OPPORTUNITY #34 (Clause 8.2.1)
A note has been 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 reports.
No new requirement, but you have a BIG OPPORTUNITY to review
the way in which you go about obtaining this information.
Are you obtaining valid, actionable information that will help give you the
meet the requirements of ISO 9001?
You might find it useful to consult the guidance given in ISO/TS
10004 Monitoring and measuring customer satisfaction.
refer exclusively to the contractual customer. It may include both
internal and external customers as well as consumers, clients, end
users, retailers, beneficiaries and purchasers.
April 2009 (c) Nigel H Croft 69

70. SMALL CHANGE, BIG
OPPORTUNITY #35 (Clause 8.2.2)
This clause now expects management responsible for the area being audited to
ensure that both correction and corrective actions are addressed as
appropriate with respect to detected nonconformities.
The BIG OPPORTUNITY is that you can now consider
the need for correction of detected nonconformities and
recognize that it might not be necessary or appropriate
to take corrective action for all nonconformities found
during internal audits.
After a root cause analysis of the situation and based on a
number of factors, including the risk and probability of a
recurrence
correct the problem, without the need for corrective action.
April 2009 (c) Nigel H Croft 70

71. SMALL CHANGE, BIG
OPPORTUNITY #36 (Clause 8.2.3)
A note has been added here to clarify that when deciding on appropriate
monitoring and/or measurement methods, you should consider both the impact
on product conformity and on the effectiveness of your quality management
system.
When QMS processes do not achieve planned results,
you must now evaluate the need to make corrections
and/or take corrective action, regardless of the direct
impact on product conformity.
BIG OPPORTUNITY is for you to emphasize to all in
your organization that it is not only product realization
processes that are important.
If system processes such as document control, management review,
internal audits and others are not achieving planned results, corrections
and/or corrective actions will also be needed.
April 2009 (c) Nigel H Croft 71

72. SMALL CHANGE, BIG
OPPORTUNITY #37 (Clause 8.5.2)
The standard now makes it clear that it is the effectiveness of the corrective
action that must be reviewed, not just the corrective action itself.
This provides a BIG OPPORTUNITY for you to
look carefully at the corrective actions you have
initiated, and to make sure they are achieving
the intended results.
If the corrective actions are to address specific
nonconformities (in product, process or the
quality management system), have they
successfully eliminated (or significantly reduced)
the problem?
April 2009 (c) Nigel H Croft 72

73. SMALL CHANGE, BIG
OPPORTUNITY #38 (Clause 8.5.3)
The standard now makes it clear that it is the effectiveness of the preventive
action that must be reviewed, not just the preventive action itself.
This provides you with a BIG OPPORTUNITY to look
carefully at the preventive actions you have initiated, and
to make sure they are achieving the intended results.
If the preventive actions are to address unfavourable
trends or specific potential nonconformities (in product,
process or the QMS), have they successfully prevented
the nonconformity from occurring? Were they successful
in terms of cost/benefit?
April 2009 (c) Nigel H Croft 73

74. ISO 9001:2008 Implementation
Policy
(Joint communiqué published by ISO and IAF)
November 15th 2008 Publication of ISO
9001:2008
Before publication of ISO 9001:2008 no accredited
certificates to new standard were allowed
New certificates only after a routine surveillance
or recertification audit against ISO 9001:2008.
April 2009 (c) Nigel H Croft 74

75. ISO 9001:2008 Implementation
Policy (continued)
Up to Nov 15th 2009 certification /
renewal to ISO 9001:2000 still permitted
Beginning Nov 15th 2009, no new
certificates to ISO 9001:2000 allowed all
audits to be conducted to ISO 9001:2008
From Nov 15th 2010 ISO 9001:2000
certificates will no longer be valid
April 2009 (c) Nigel H Croft 75

76. Implications
No additional audits should be required
Auditors need to be aware of changes
Use ISO 9001:2008 Annex B
Organizations should take advantage of the changes to
re-assess the value of their QMS and make the most of
this BIG OPPORTUNITY
April 2009 (c) Nigel H Croft 76

77. Summary
The details of the quality management
OUTPUT MATTERS!
9001 Clauses 4.1 8.5.3!!
April 2009 (c) Nigel H Croft 77

78. THANK YOU
nigelhcroft@sapo.pt
April 2009 (c) Nigel H Croft 78