The deadline for the transition to ISO 9000:2000 is now well behind us but
to what extent was it successful, how was success measured and what
indeed was the original objective?
What was the original objective?
When the external audits were taking place, did you
feel that you were demonstrating the capability of your organization
to satisfy its customers or did it feel no different than usual – a
hike through the documentation, a tour round the facility and a look
at the quality policy and a customer satisfaction survey? This may
appear harsh but in our experience it is very near the truth. Not that
any organization having such an audit would complain – they achieved
their goal. They retained the badge. But what about their customers?
They want to see improved communication, better response and delivery
and far more occasions when the product or service actually meet their
needs and expectations. They are unlikely to want customer
The objective was to move
organizations from A to B, where A was a system for producing
conforming product and B a system for satisfying customers and other
interested parties. Perhaps many feel this a play on words because
they believed that they were doing it already – not necessarily so!
What was the success criteria?
Whatever one’s view of the changes in the standard,
the assessment criteria have changed. Millions of Euros weren’t spent
to produce only trivial changes. The change had to be radical because
it was reflecting what industry leaders were doing in the 1990s just
as the 1987 version reflected current practice in the 1970s. It’s the
way standards are set. The 2000 family now consists of definitions
(ISO 9000), design guidelines (ISO 9004) and measurement criteria (ISO
9001). None can be taken in isolation.
Was it successful?
The answer depends upon who is asking the question -
organizations or certification bodies – customers are oblivious!
Organizations had the opportunity to review their approach to quality
management, certification bodies had to rethink their assessment
approach. Over the last three years we have engaged with organizations
and certification bodies through our book sales, seminars, training
and consultancy and based on our observation we raise a number of
Use of ISO 9001
Has ISO 9001 been used as a design tool rather than a measurement
We have no doubt that most
organizations applied ISO 9001:2008 just the same way as they applied
ISO 9001:1994; they designed their system to look like the standard
and not like the business.
The opportunity was there to
break the mould. Gone was the requirement for the supplier to “prepare
a quality manual covering the requirements of this International
Standard” and replaced by a requirement for the quality manual to
include a “description of the interaction between the processes of the
quality management system.” An American school
posted its Quality Manual on the Internet and rather than describing
the processes needed in managing the school, the manual mirrors the
standard and has policies on nonconforming product, calibration and
product realization. How absurd! A document specifying the QMS
must surely be one that describes the processes for accomplishing the
organization’s purpose and how these processes are managed.
ISO 9004 clearly states “it is
not the intent… to imply uniformity in the structure of quality
management systems”. From our research very few in the ISO ‘94
fraternity had read the definitions in ISO 8402 or read ISO 9004 and
it does appear that this situation has not changed. Had ISO merged
9000, 9001 and 9004 into one document, many of these misconceptions
would not have arisen – however, we reap what we sow!
ISO 9000:2000 clause 2.3 is very
clear on the approach that should be adopted in
developing and implementing a quality management system - it
beggars belief that this fundamental approach to system design has
been ignored by so many.
Using the 8 principles
Have organizations and certification bodies used the 8 quality
When we ran IQA seminars in 1999
and 2000, we showed people how to test system robustness using the
principles. This revealed many opportunities clause based auditing
fails to do.
Most auditors know of the
principles and weave them into the audit but only superficially. IRCA
training requirements require auditors to be able to explain the
principles but this is not the same as using them. When observing a
process, do auditors ascertain how Customer Focus is applied or look
for evidence that the process is being managed according to the
Process and Systems Approach principles? Few, if any auditors validate
the policy statements by seeking the processes that will deliver the
policy. “You have a policy of continually reviewing your processes to
improve your competitiveness –can you show me a recent process review
and what changes related to competitiveness were made as a result?”
Were the policies challenged or simply registered by a tick in the
Has the organization been viewed as one system of interconnected
business processes and the quality management system processes
perceived as being synonymous with these?
The ISO 9000:2000 family was
billed as enabling full integration of quality systems into normal
business operations i.e. one system.
those organizations we have worked with all perceived they only had
one management system, once we had opened their eyes to the reality.
Organisations have only one purpose, one mission, one organizational
structure. It works together to produce outputs. There is no part that
only serves quality and another serving only environment, safety,
profit etc. The outputs and therefore the processes have to simultaneously
fulfil all needs and expectations of all the stakeholders. ISO 9000
defines a system as set of interrelated or interacting elements. This
appears to have led to diagrams of ISO 9001 clause headings in boxes
with connecting lines and called the ‘management system’. Perhaps this
was caused by a lack of ‘perception’. If you have ever been shown a
picture which, at first appears to be just random shapes you will know
that after someone points out the animal within the picture, you will
never see that picture again without seeing the animal. And so it is
here, once the ‘one system’ picture is pointed out, never again can
the organization be perceived as many separate systems. It is sad that
many have not had the opportunity to see the animal!
We have observed that many
organizations have retained the notion of separate systems. Having now
achieved ISO 9001:2008 some have expressed a need to integrate their
systems – suggesting that they failed to realise that a response to a
particular standard is not a system. The system is the organisation.
Identifying stakeholder needs
Have organizations identified needs and
expectations of all stakeholders and derived measurable objectives
Because ISO 9001 focuses on
customers, and manuals are written around the clauses, it is
understandable that the only stakeholder whose needs have been
identified is the customer. Therefore, most organizations have not met
the intent of the standard because clause 2.3 of
ISO 9000 clearly states that the development
of a QMS “consists of several steps including determining the needs
and expectations of customers and other interested parties”.
Most organizations have defined
measurable objectives, but the word ‘quality’ got in the way again.
The standard calls for quality objectives and is vague about what
these are. This has resulted
in a wide range of objectives - some that look like corporate
objectives, others inappropriately focused such as “reducing time to
respond to complaints.
question is - were they derived from
stakeholder needs? At recent IQA branch meetings where we asked this
question to people from certificated organizations. Few could answer
yes. There is no doubt that ISO 9001 is unclear on this point.
However once you make the linkages within ISO 9001, what becomes clear
is that, “the quality policy has to be appropriate to the purpose of
the organization” and the
“purpose of an organization is to identify and meet the needs and
expectations of its customers and other interested parties” and the
quality objectives have to be “consistent with the quality policy”–
therefore it follows that the objectives should be derived from
Have organizations identified and mapped end-to-end processes that
deliver business outputs?
Having made the link between
stakeholder needs and objectives, the need to link processes to
objectives is obvious – isn’t it? We were surprised
by the many organizations that have not done this. They have
objectives. They have processes. But they have not linked processes to
objectives. We also found no auditors testing this linkage.
Some organisations have taken the main ISO 9001 headings and called
them ‘processes’, so their system comprises a Management
Responsibility process, Resource Management process, etc.
One organization we visited early in 2001 did not
have defined objectives but gained certification. However, we know
organizations that have defined end-to-end processes that
deliver business outputs. For example some use the three processes of
Demand Creation, Demand Fulfilment and Business Management – clearly
they understand the connection between results and enablers.
Perhaps the biggest change is that
many organizations have lurched into process mapping without a clear
idea of what they are trying to achieve. We have seen the ‘clause
maps’, ‘departmental activity’ maps, maps that link the four elements
of the standard and thankfully some maps of true business processes.
Most we have seen are simply context diagrams of procedures and called
processes. Instead of starting with the top level objectives and
identifying the key stages that needed to achieve them, some have
started with their existing procedures, flowcharted the tasks and
sometimes added objectives to them. In reality they have only made
cosmetic changes. Others have built their system from the bottom up
and failed to achieve a clear line of sight between the activities at
the bottom and the corporate objectives.
Have organizations identified the competences required to deliver
Clause 2.3 links resources
necessary to achievement of objectives.
Although ISO 9000 does not define what resources are,
most people would regard people as a resource but they might think of
numbers of people rather than the competences needed to deliver
objectives. Few organizations have defined this link but when pointed
out, no one disagreed that it would be beneficial to make it.
ISO 9001 is unclear when it comes to the identification of competences
(clause 6.1). However, as objectives should be derived from
stakeholder needs it follows that competences should also be traceable
to satisfying stakeholder needs – but we believe few have done this.
measuring performance relative to the objectives?
There is no doubt that most
organizations are now measuring performance – a positive benefit.
However, many need to focus on determining the right measures and once
again the problem appears to be in the linkages. Performance measures
are in place but do not necessarily relate to the organization’s
objectives and less so to process objectives. There is also confusion
between measures of process efficiency and measures of process
Is the concept of testing measurement integrity fully understood?
From our observations the
conclusion must be no. Many organisations and auditors seem to think
that clause 7.6 is only about calibration of measuring instruments.
The requirements are just as applicable to the measurement of customer
satisfaction as they are to crankshaft measurement. If we use a
customer survey to measure customer satisfaction, or a teacher to
examine a pupil how do we calibrate these? How do we know that the
results we get are repeatable, reproducible, stable, reliable and
without bias? Enough said.
Do organizations have plans in place to improve efficiency and
This issue has always generated
However, let us adopt the popular meanings of efficiency as doing
things right and effectiveness as doing the right things. If processes
have been designed to deliver conforming product, fixing problems when
it fails to do so can hardly be called an improvement in effectiveness
- it is process control. Restoring the status quo after process
variation beyond specified limits is corrective action but for many
organizations, it is deemed an improvement action. It is only when the
specification is changed as a result of determining it is no longer
the right specification that an improvement in effectiveness can be
claimed. Many organizations had, in effect corrective action plans to
bring about process control rather than plans for improving process
efficiency and effectiveness. There is little evidence to indicate
that they checked that their objectives remained relevant to
stakeholder needs even though ISO 9001 clause 5.3 requires the quality
policy to be reviewed for continuing suitability.
problem is not just confined to those managing the system, third party
auditors are equally susceptible to mistaking corrective action for
Approach to auditing
Have certification body auditors changed their approach?
We wish that we could be
positive here but in our experience the certification body auditors
have not materially changed their approach. This is increasingly being
confirmed by reports we receive from other organisations. IRCA claim
that QMS 2000 qualified auditors have the “ability to conduct
process-based audits against ISO 9001:2000 for clients worldwide” but
we have yet to witness a third party audit in which the auditor has
covered the issues raised in this paper. The clause approach still
taken by many auditors puts clauses on a timetable and looks for
evidence of compliance during the tour of the department. We still
have too many industrial tourists.
In our paper to QW in January
2001 we posed the question “will
the Certification Bodies rise to the challenge?” The evidence suggests
that they have not. At the grass roots it is the lonely auditors who
must make the call. If they have not had the appropriate guidance,
training, mentoring and competence assessment, one cannot blame them.
Understanding the process approach
Have certification body auditors understood the
For many auditors, the process
approach appears to mean following a trail through departments or
selecting a contract and chasing it through the system to verify that
all the right connections were made. This isn’t the process approach
or process auditing but transaction auditing. Processes are different.
They produce results, measurable against process objectives that are
derived from stakeholder needs. It is these linkages that the auditors
should be checking rather than following trails. The one thing that
the process approach makes an auditor do is to hold his or her focus
on the goals so as to avoid being dragged down holes that lead nowhere
In 2000 we published ‘ISO
9000:2000 Auditor Questions using the Process Approach’. It was
adopted and translated by the Japanese, Italian and Spanish Standards
organisations and continues to sell well, particularly to auditors. It
is not a set of questions based on the clauses but a methodology for
establishing whether an organization is managing its processes
effectively. The essence of the process approach is ’linkage’ between
purpose, objectives, processes and results but few auditors in the UK
have understood this simple concept.
TC 176 has recently completely
rewritten their guide on the use of the process approach, which in
principle now aligns with the approach we have been promoting for many
We had pointed out to TC 176 in
February 2002 that the 2000 version of the guide was misleading. At
last we feel vindicated but the message from ISO came too late for the
transition programme. We repeat our question “Will certification
bodies rise to the challenge” and now change their approach.
In her December Quality World
Editorial, Nicky Farmer questioned whether those successfully
achieving the transition “have embraced the standard to improve
processes and continually improve”. From our experience we wonder
whether the report that 95% of organizations successfully made the
transition is masking reality.
An international survey we
carried out relative to these questions showed than up to 50% of
auditors did not explore how processes were being managed – they
seemed to stop the questioning once they had established that there
were a set of objectives and few flow charts. Fewer than 10% of
auditors followed through and sought evidence of performance and
From our perspective there are
two main conclusions. Firstly the certification bodies may have made
it too easy by adopting a lenient interpretation designed to retain
clients rather than challenge, raise standards and add value. As a
result, some organizations believe that the certification bodies have
lost their credibility. For those organizations using ISO 9001
certification to achieve a competitive advantage there is little
solace in knowing that their less able competitors did not have to
change a thing to win a place on the tender list. Secondly, many
organizations may have failed to take the opportunity to genuinely
improve the manner in which the organization is managed and therefore
Three years ago we placed a page
on our web site titled the “Most important Clause” in the family of
standards. Through this article we have referred to this clause
because it does hold the essence of intent – what ISO 9000 is all
about. ISO 9000 Clause 2.3 Quality management systems approach says it
At the start of
the transition period we wrote in QW suggesting that mindsets had to
change – we believe there is still some way to go! We are convinced
that many organizations and certification bodies don’t understand what
it is all about. For certification bodies and their respective
accreditation bodies they have to review their position as their
credibility may be at risk. For organizations there is one
consolation. The one thing about management system is that the
description of the how the organization operates can be changed. As
Kofi Anan said recently changing words on paper is easy and changes
nothing, changing action is what counts. Therefore those organizations
that have jumped into the documentation and described processes before
establishing their objectives or linking these to stakeholder needs
need not be depressed. In practice very little may have changed on the
ground. They can start again and adopt a goal driven approach that
will bring more clarity. It involves and helps people to understand
what they are trying to do and how they make it happen. They will
therefore be more committed and equipped to undertake meaningful
improvements that will bring real business benefits.
Transition to ISO 9001:2000 Guidance on ISO 90001:2000 Quality
Management Systems - Requirements
[ii] ISO/TC 176/SC2/N544R2 Guidance on the concept and
use of the process approach for management systems. 4 December 2003
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