April 2009 (c) Nigel H Croft 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
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April 2009 (c) Nigel H Croft 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
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
April 2009 (c) Nigel H Croft 3
Management System
set of
interrelated or
interacting elements
to
establish policy and
objectives
and to
achieve those
objectives
Hardware
(equipment)
Software
(methods)
Humanware
(people)
Interact within processes
April 2009 (c) Nigel H Croft 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???
May 2005 (c) Nigel H Croft 2005 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 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 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 8
Cause and EffectPROCESS
UNDESIRABLE OUTPUTS
Environmental Impacts
Health & Safety risks
May 2005 (c) Nigel H Croft 2005 9
PlanWhat to do?
How to do it?
DoDo what was
planned
CheckDid things happen
according to plan?
ActHow to improve
next time?
10
HOW TO PROVIDE CONFIDENCE?
(ISO 9001 example)
Accreditation Body
IAF Recognition
Organization
Certification Body
Customers
Confidence
ISO 9001:2008
ISO/TC176
(Translation) National Body
Confidence
Confidence
ConfidenceConfidence
-promoting activities
(ISO/CASCO)ISO 17011
ISO 17021-1
ISO 17021-2
ISO 17024
Confidence
Jan 2009 (C) Nigel H Croft 2009 - All rights reserved
April 2009 (c) Nigel H Croft 11
ISO TC176
Standardization
Confederation of National Standards Bodies
Based in Geneva
Quality management and Quality Assurance
April 2009 (c) Nigel H Croft 12
CSAG
SC 1 SC 2 SC 3
ISO/TC 176
CALG
WG1 WG2 WG3 WG18
TGx TGy TGz
WG1 WG6 JWG
Secretariat: Canada (SCC)
Chair: Dr Gary Cort
Vice-Chair Mr Li Tienan
Automotive TG
Interpretations WG Spanish Trans TG
Arabic Trans TG
April 2009 (c) Nigel H Croft 13
CSAG
SC 1 SC 2 SC 3
ISO/TC 176
WG1 WG2 WG3 WG18
TGx TGy TGz
WG1 WG6 JWG
ISO
Chairman
Strategic
Advisory Group
CALG
Automotive TG
Interpretations WG Spanish Trans TG
Arabic Trans TG
April 2009 (c) Nigel H Croft 14
SC 1 SC 2 SC 3
ISO/TC 176
WG1 WG2 WG3 WG18
TGx TGy TGz
WG1 WG6 JWG
Conformity
Assessment
Liaison
Group
CSAGCALG
Automotive TG
Interpretations WG Spanish Trans TG
Arabic Trans TG
April 2009 (c) Nigel H Croft 15
SC 1 SC 2 SC 3
ISO/TC 176
WG1 WG2 WG3 WG18
TGx TGy TGz
WG1 WG6 JWG
ISO 9000 CSAGCALG
Automotive TG
Interpretations WG Spanish Trans TG
Arabic Trans TG
April 2009 (c) Nigel H Croft 16
SC 1 SC 2 SC 3
ISO/TC 176
WG1 WG2 WG3 WG18
TGx TGy TGz
WG1 WG6 JWG
CSAGCALG
Automotive TG
Interpretations WG Spanish Trans TG
Arabic Trans TGomotive
Interp
ISO 9001
ISO 9004
April 2009 (c) Nigel H Croft 17
SC 1 SC 2 SC 3
ISO/TC 176
WG1 WG2 WG3 WG18
TGx TGy TGz
WG1 WG6 JWG
CSAGCALG
Automotive TG
Interpretations WG Spanish Trans TG
Arabic Trans TG
C
pretations WG
abic Trans T
ISO 19011
&
ISO 10000
series
April 2009 (c) Nigel H Croft 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 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 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 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 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 23
337
70
5845
3932
28
25
20
229
58
UNITED STATES
CHINA
GERMANY
UNITED KINGDOM
MEXICO
JAPAN
CANADA
COLOMBIA
AUSTRALIA
ITALY
Other
Survey responses
April 2009 (c) Nigel H Croft 24
Size of organization
271
377
290
3
small
medium
large
Blank
April 2009 (c) Nigel H Croft 25
How long certified?
250
424
264
30
50
100
150
200
250
300
350
400
450
0-3 4-10 10+ BlankYEARS
April 2009 (c) Nigel H Croft 26
How well does ISO 9001:2000
meet your needs?
137
565
14
167
16 42Excellent
Good
No comment (or NOT
APPLICABLE)Needs to be improved
Not adequate
Blank
April 2009 (c) Nigel H Croft 27
Are you happy with the
process approach?
849
22
70
Yes
No
Blank
April 2009 (c) Nigel H Croft 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 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 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 31
Impact of changes to ISO 9001
Impact
Category
Criteria
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 32
Benefits of changes to ISO
9001
Benefit
Category
Criteria
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 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 .
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
WRONG!
April 2009 (c) Nigel H Croft 35
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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