Quality Management With ISO 9001
Quality Management With ISO 9001
Quality Management With ISO 9001
QUALITY MANAGEMENT
WITH ISO 9001
How to implement a smart quality approach
STEFAN LANGHAMMER
Senior Consultant & External Auditor
stefan.langhammer@sqs.com
Stefan Langhammer has been with SQS since 2007. He holds a degree in
Business Administration and is a Certied ISO 9001:2008 External Auditor.
As Senior Consultant in the Process Intelligence Competence Centre, his
responsibilities focus on the implementation of assessments and on the organisation and support of process changes for SQS customers. He has many
years of experience as Project Manager, Process Manager, Quality Manager,
and Banking Auditor, working for military organisations, IT organisations,
as well as shipping and logistics companies. Over the last 15 years, he has
conducted more than 200 quality audits as External Auditor.
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1 MANAGEMENT SUMMARY
Many organisations, even big ones, suffer from
a lack of process transparency and process control: often, process responsibilities and process
interfaces are not clearly dened, and there is
no systematic approach as to how processes are
to be managed. Typically, appropriate process
documentation does not exist, not to mention
the absence of a systematic approach ensuring continual improvement. If there is no process documentation, you automatically have a
lack of transparency since business and process
knowledge is not available to the entire organisation but merely a privilege reserved for a select
group of key players. As a consequence, process
control including the cost and management of
process interfaces is getting rather difcult and
involves taking high risks.
In an attempt to address the aforementioned issues, many organisations started projects documenting their processes and key controls and
establishing quality and process management
systems.
In doing so, organisations can build upon an international standard called ISO 9001. ISO standards
are being developed by technical committees
comprising national delegations of experts from
The elements of ISO 9001 help establish a wellbalanced view of all important processes of an organisation. These processes are documented and
focused on customer needs by identifying drivers
and measures for cost, quality and customer satisfaction. Process controls are clearly identied
including the associated responsibility for conducting and documenting the respective control
activities (see Figure 1).
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Moreover, organisations can improve their external recognition with regard to customers, competitors and external stakeholders by fullling the
ISO 9001 requirements within an external audit
process in order to obtain an ISO 9001 certicate.
In many markets and industrial sectors, ISO 9001
certicates are well-established and recognised
standards of good practice.
WHAT IS ISO?
ISO = International Organization for Standardization is the worlds largest developer
of standards. ISO is a network of the national
standards institutes of 163 countries, on the
basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that
coordinates the system.
This whitepaper gives an overview of the principles of quality management according to ISO
9001, of the implementation strategy for a quality
management system chosen by successful organisations, and of the main steps to obtain certication based on many years experience in consulting and auditing organisations. Furthermore,
practical examples will show how organisations
can improve process transparency and quality
control.
ENT RESPONSIB
GEM
ILIT
NA
Y
MA
Input
Requirements
Customers
REMENT, ANALYS
ASU
ME ND IMPROVEMEN IS
T
A
RCE MANAGEMEN
SOU
T
RE
Customers
PR
ODU
CT REALISATIO
Satisfaction
Output
PRODUCT
Value-adding activities
Information ow
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2 INTRODUCTION
2.1 A BRIEF HISTORY OF ISO 9001
Since 1987, the hour of birth of the ISO 9001 quality management standards, countless organisations have begun to implement quality management systems. Along with the establishment of
certication bodies, a new industry emerged.
Starting with just a handful of organisations
dealing with ISO 9001 certications in Germany,
more than 100 accredited certication bodies are
counted today. (4)
At the very beginning, the ISO 9000 approach
had a controversial reception. Some experts regarded ISO 9000 as too formal, too static and
somehow bureaucratic. Furthermore, the set of
ISO 9000 standards was very much focused on
industrial needs and did not really seem applicable to service organisations.
With the second revision to the ISO 9001 standards conducted by the ISO organisation in the
year 2000, a fundamental breakthrough was
achieved. The ISO 9001 standard received a new
structure suitable for all kinds of organisations including the service sector, and gained a processoriented focus. The requirements of continual
improvement of the quality management system
and of measuring customer satisfaction became
compulsory. Consequently, ISO 9001 became
much more than just a heap of documentations
(which somehow still remains a fundamental misconception): it turned into a rigid and customerfocused approach aimed at improving quality.
1994
2000
1987
2008
1980
1990
2000
Figure 2: Evolution of the ISO 9000 standard for quality management systems
2010
So quality is about fullling requirements. According to ISO 9001, these need to be combined
with the creation and enhancement of customer
satisfaction. In fact, there is a correlation between
the fullment of requirements and customer satisfaction, which was analysed and expressed in
a model by Dr Noriaki Kano, a Japanese quality
expert: (6)
The Kano Model, developed in the early 1980s,
shows the relation between customer satisfaction
and the fullment of requirements (aka quality,
see above) understood as a broader concept. Re-
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quirements converted to offerings can be differentiated into the factors delighter, must be and
more is better:
The factor must be does not help increase
customer satisfaction since it refers to criteria
taken for granted yet, on the other hand,
these criteria are essential preconditions for
any satisfaction.
More is better is a one-dimensional factor
since it will only increase customer satisfaction
as long as an over-fullment of requirements
is ensured.
The category delighter, however, includes the
criteria that make the difference. Delighter
comprises the innovative and unexpected factors of quality. This means you should surprise
the customer in a manner that is perceived as
positive, and not achieve satisfaction only but
create enthusiasm and customer loyalty.
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MORE
satisfied
More is better
CUSTOMER SATISFACTION
Delighter
included
omitted
Must be
dissatisfied
OFFERINGS
MORE
In this context, it is important to dene the expectations and deliverables regarding quality
management. This should be done by the senior
management and take into account the involvement of respective stakeholders for quality (see
Section 4.4).
For some organisations, obtaining and keeping an
ISO 9001 certicate is still the one and only target. In this case, the quality management system
is more or less limited to producing just this one
deliverable.
On the other hand, an increasing number of organisations expect to get more value from a
quality management system than just obtaining
a certicate. Regular surveys conducted by the
ISO organisation indicate that both the motivation and the expectations for quality management are rising. The following section will explain
this in more detail.
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Customer satisfaction
3689
Market need
3290
Self-declared conformance
500
Other
0
Figure 4: Factors inuencing ISO 9001 certication (7)
4500
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Aligning ourselves with the most competent base of suppliers available in the
industry. The ability of our suppliers to
provide us with quality services is critical
to our success. We will strive to achieve
excellence in our supply chain with a
common vision in the areas of quality,
continuous improvement and excellence
in customer service.
Increasing process effectiveness and efciency. Quality must provide and deliver
measurable results and benets for our
organisation.
Figure 6: Quality policy example
5889
5821
4125
4112
3975
3577
2289
It is a customer requirement
2262
2216
1241
Other
354
No benefit at all
161
0
Figure 5: Benets of applying 9001 (7)
1000
2000
3000
4000
5000
6000 7000
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China:
257076
Japan:
68484
Russian Fed.:
53152
Italy:
130066
Spain:
59576
UK:
41193
Germany:
47156
USA:
28935
India:
37493
Rep. of Korea:
23400
2004
2005
2006
2007
2008
2009
660132
773867
896929
951486
982832
1064785
31443
48327
71438
78910
73104
77408
17016
22498
29382
39354
39940
36551
49962
59663
61436
47600
47896
41947
Europe
320748
377196
414232
431479
455332
500319
Far East
220966
247091
300851
345428
356559
398288
19997
19092
19590
8715
10001
10272
TOTAL
North America
Figure 8: Trend of absolute numbers of ISO 9001 certicates between 2004 and 2009 (9)
+ 61 %
+ 56 %
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In order to provide a practical view on the requirements of ISO 9001, the ISO Technical Committee
ISO/TC 176, which is responsible for developing
and maintaining the ISO 9000 standards, derived
eight quality management principles.
THE EIGHT ISO PRINCIPLES
1 Customer focus
2 Leadership
3 Involvement of people
4 Process approach
5 System approach to management
6 Continual improvement
7 Factual approach to decision making
8 Mutually benecial supplier relationship
Figure 10: Quality management principles (2)
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5 MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.2 Customer
focus
5.4 Planning
6 RESOURCE MANAGEMENT
5.5 Responsibility,
authority and
communication
5.6 Management
review
8 MEASUREMENT, ANALYSIS,
IMPROVEMENT
6.3 Infrastructure
6.4 Work
environment
8.4 Analysis
of data
8.5 Improvement
7 PRODUCT REALISATION
7.1 Planning of product realisation
7.2 Customer-related
processes
7.4 Purchasing
These principles can be used by senior management as a guidance to navigate their organisations towards an improved performance.
4.2 MAIN STEPS FOR IMPLEMENTATION
In order to realise the ISO 9001 principles in practice, the implementation of a quality management
system according to ISO 9001 should be planned
and organised as a project including corresponding project roles and responsibilities. The top
management (e.g. a board member) should act as
project sponsor.
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Depending on the size of the organisation, complexity of processes, and available resources, the
project time for achieving ISO certication readiness will require a minimum of between six and
nine months. SQS experience shows that most
ISO 9001 projects take between twelve and 15
months. Usually, creating the process documentation will require the most time, so there should
be special focus on the methods and approaches
for doing so (see Section 4.3).
The following 14 steps describe the main activities SQS recommends to perform in the proposed
sequence in order to implement a QM system and
establish readiness for external certication.
14 STEPS
1. ESTABLISH ISO STEERING
COMMITTEE
Ensure top management buy-in
Ensure availability of resources
Conduct regular project meetings and
progress report
2. BUILD UP QM KNOWLEDGE
Select quality staff and ensure
appropriate training
Inform all staff about project goals and
motivation for quality improvement
3. APPOINT QUALITY REPRESENTATIVE
Dene role and tasks of a quality
representative
Ensure direct reporting line to top
management
Select a strong character with
excellent communication and
management skills
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QUALITY CLASSES
Targets &
Strategy
Business
Map
Plans
Contracts
Standards Methods
& Policies
Customers
Prospective
Customers
Employees
QUALITY
ITEM
STAKEHOLDER TYPES
Shareholders
Governance
Bodies
Outsourcing
Organisation
Corporate
Audit
External
Regulators
Auditors
Suppliers
Professional
Bodies
Competitors
Public /
Media
How do we do a quality
activity?
What are the costs / efforts?
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In fact, almost all known industrial methodologies for process analysis and improvement work
for service businesses as well. Their employment
is mainly dependent on appropriate training and
the availability of respective tools. Successful organisations clearly recognised that the dedicated
training of staff in quality methods is a key factor for quality improvement. Just having a quality department and making them responsible for
quality denitely is not enough. Ultimately, in an
organisation, each and every one is responsible
for quality.
So once again, there is a mind change. Quality
no longer is just expert knowledge represented
by a few colleagues in the quality department. It
needs to become common knowledge, part of the
way people think and how they interact with each
other and with their customers.
4.6 OBTAINING VALUE FROM EXTERNAL
CERTIFICATION
The nal step (see Section 4.2, Step 14) for implementing a quality management system is about
external certication. And as already outlined
above, most organisations take this step.
On the other hand, SQS experience shows that
some organisations decide to establish a quality
management system but do not target certication. These organisations do not have any external requirements or incentives to seek certication. They are just convinced of the value of a
quality management system in itself and do not
want to focus too much on an external certicate
or external audits.
These concerns are understandable as there is
a risk that quality might be reduced to a mere
certicate as a matter of fact, there are organ-
isations that do have rather limited quality objectives, only focused on obtaining the certicate.
Nevertheless, SQS strongly recommends doing
both: implementing a quality management system and obtaining external certication. This is
for the following reasons:
An external audit can strongly support the
quality objectives of an organisation. External
auditors may deliver valuable input. They are
well-trained experts in their eld, have a neutral view on the organisation and usually have
broad experience regarding good practices.
Audit results provide a good overview of the
QMS's implementation status, conveying information about the strengths and weaknesses
of an organisation.
External audits are conducted on a regular
(yearly) basis and thus support the process of
continual improvement.
External audits enforce management and staff
commitment regarding the quality objectives
of an organisation.
Finally, the ISO certicate is a visible result
and achievement not only for external stakeholders but for internal ones as well.
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Inform and train all staff members everyone should understand the external auditors
approach and be happy to present his / her
process and how to manage it.
After successfully passing the external audit:
plan and conduct internally and externally focused marketing measures (i.a. press releases,
internal newspaper, Internet, intranet, business paper with certication logo, brochures).
And last but not least: celebrate your success
with all employees and selected customers
and suppliers.
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Bibliographical References
ISO, International Organization for Standardization, 2011. About us, ISO Org.
[Online] 23/11/2011. [Cited: 23/11/2011.] http://www.iso.org/iso/about.htm.
4 Deutsche Akkreditierungsstelle GmbH (DAkkS), List of Accredited Organisations for Quality Management Systems (2011). www.dakks.de. [Online]
03/11/2011. [Cited: 03/11/2011.] http://www.dakks.de/content/verzeichnisseakkreditierterstellen.
5 British Standard Institution (BSI Group), 2011. www.bsigroup.com. [Online]
[Cited: 21/11/2011.] http://www.bsigroup.com/en/Assessment-and-certication-services/management-systems/Standards-and-Schemes/ISO-9001/.
6 Wikipedia and Noriaki Kano, 2011.en.wikipedia.org/wiki/Noriaki_KanoIm
Cache- hnliche Seiten. Wikipedia, the free encyclopedia.
[Online] 2011. [Cited: 23/11/2011.] 7.
7
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Bibliographical References
13 Der Qualittsmanager aktuell, 2010. Gesellschaft fr Wirtschaftsinformation. Der Qualittsmanager aktuell. [Online] 2010. [Cited: 23/11/2011.] http://
www.qm-aktuell.com/newsletterarticle.asp?his=2833.2233.7104&id=13001&y
ear=0.
14 Wikipedia and 2011. de.wikipedia.org/wiki/ISO/TS_16949. Wikipedia, the free
encyclopedia. [Online] [Cited: 23/11/2011.]
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