QMS CERTIFICATION

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					ASB(L)01.1                                                                          Page 01.1


                                        QMS CERTIFICATION
     Certification & Accreditation: Independence & Public
                            Service


FOREWORD
This presentation discusses aspects associated with management
systems certification. It is intended to be somewhat provocative.
It encompasses the purpose of certification, specified
methodologies and the responses adopted by the certification
industry or profession. It implies that the Quality Certification
profession has a long way to go in order to fully understand
itself, its products, its customers and the needs of the
marketplace. It is suggested that the quality profession is in a
state of growth and self understanding but is nonetheless
confused. It often mistakes or fails to appreciate, that there is a
significant difference between standards of quality and the
quality of standards. The profession is perhaps delusional, and
the sadness of this is that those who turn to it for guidance are
presented with misinformation.
The quality profession has yet to come to terms with the reality
that most standards at the date of publication have ceased to be
the latest „word‟ on the subject. By the very nature of the writing
and review process all standards are deemed to be a minimal set
of requirements that are seen to be insufficient, or even
inappropriate, in the fullness of time. One of the worst and most
damaging aspect of the review and rewrite process is the
technical caution of the committees tasked with writing them. It
has become the norm that standards become more and more

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comprehensive and seek to become „bigger and better‟ than their
predecessors. Seldom is material that was written in the past left
in the past. The ideal of „simplicity‟ escapes most standards. The
consequence is that the standards documents of today become a
consensual mix causing least offence. Often standards will
combine the flawed premises of the past with the mediocrity of
consensual agreement of the present.
QMS Certification therefore must be a flawed process. It is
retrospective in that it looks at a current practice and compares it
to a set of requirements that are becoming at worst obsolete1, and
at best superseded.2 And yet, it is the best we have within the
field of third party certification. For this reason, it is purported
that QMS certification should be the minimum, or even an
ancillary, level of confidence within the procurement chain or
even just an internal organisational toolkit. It should not be
utilised as the only arbiter of appropriateness.
PURPOSE
Third party certification is a new industry. It has developed for
the following purposes:
        Badge on the wall
        Internal confidence
        Identify strengths
        Identify weakness
        Identify opportunities
        Identify threats.
        Procurement hurdle or gateway.

1 Obsolete: A document is obsolete if it has gone out of use. Obsolete documents shall be prevented from inadvertent use.
2 Superseded: A document is superseded if there is a later version available. Superseded documents may be used if a later
version is available in order to cope with local contingencies or to make full use of existing stocks of forms or documents etc.
As a general rule, most documents will be superseded by an update rather than be made obsolete.

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Sadly, in my opinion, the least occurring motivation for quality
management certification is that of self-improvement. It has, by-
and-large, become a marketing and a procurement tool.
Procurers use the requirement of a certificated management
system as a gateway. Suppliers need to enter this in order to
achieve listing on an approved supplier list. Suppliers use it as an
advertising addendum that gives a momentary sound-bite when
they are extolling the excellence of their products and services.
Often, procurement and sales professionals fail to appreciate or
understand the true advantages of management systems in
themselves. They see only that certification is the goal, rather
than conscientious implementation of a management system in
accordance with its underlying principles.
The sadness of this situation is that third party certification in
such situations fails to deliver the service that it set out to do.
Were it not for the calibre of some auditors it could be a poor
situation.
METHODOLOGY
The quality assurance discipline is one that requires consistency
and order so that confidence may be had in our conclusions. This
is obtained by observing common standards of behaviour, or
methods, in the way we conduct ourselves. A hierarchy has
developed and this is represented by the following bullet points:
        ISO 17011          For Accreditation Bodies
        ISO 17021          For Certification Bodies
        ISO 9001 et al For Organisations
        ISO 19011          For all organisations who audit

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The commonality of these standards is that they are mimics of
each other. They define management system requirements that in
general are based upon principles3 rather than rules4 (or hard and
fast requirements). This is a point that is worth emphasising
because there may be a potential conflict in the approach
adopted for third party certification. Whilst there may be a
general awareness of the principles versus rules situation, its
impact is not such as to have been fully appreciated at the
auditing coalface. In consequence, auditors are being pulled in
diverse directions by the necessity of having to be aware (or
politically correct), of many aspects not necessarily related to the
audit function.
On this point, is it worth discussing the terms Auditor and
Assessor? ISO 17000:2004 defines an „audit‟ but not an
„assessment‟, although it does define ‟conformity assessment‟
An audit is a process that obtains records and statements of fact
to determine objectively the extent to which specified
requirements are met. (Note also the word “extent”).
Conformity assessment is a demonstration that specified
requirements relating to …a system… are fulfilled.


For all practical purposes I can not see much difference between
these two definitions except they both use fine words to say what
they say. Although a personal view, I feel that the above
definition of audit is a fine one (except that the word “extent”
3 Principles: statements of general requirement defined in subjective terms and not readily lending themselves to
measurement.
4 Rules: Statements of specific requirement defined in objective terms that readily lend themselves to measurement

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implies that less than 100% may be an acceptable outcome but it
seems that the quality profession seems reluctant to countenance
this possibility when it comes to certification). The definition of
assessment is a bit woolly. For me I feel that „assessment‟
permits a degree of subjectivity, and developing practices within
the certification industry seem to support this view.
I do feel that the much emphasised word “objectivity” is a bit
misleading when the certification professional (I don‟t know
whether to call them auditors or assessors), is so imprecise in
what it expects to see. Moreover, it is my perception that (other
than a count of non-conformities), the need to ascertain the
“extent” to which requirements are met is seldom achieved.
Typically, results of third party certification are black & white, it
is „pass / fail‟ and the extent of conformity is not addressed. (Has
anybody ever heard of an organisation‟s quality management
system being 88% compliant with requirements? I have, but it is,
sadly, a minor practice at the moment, but it does indicate
“extent”).
APPROACHES
Our approach to management systems certification is primarily
from two directions and there are principally two responses.
These are through the definition of requirements and how they
are answered:
          Requirements
          Principle based:                                 Subjective -Broad spectrum
          Rules based:                                     Objective -Narrow spectrum



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          Responses
          Excellence with the „The System‟ – i.e. the certification
          system to ISO 17021 - Accreditation
          Excellence with „The Professional‟ – i.e. Personal qualities
          of Auditor – Auditor Registration
The ideal situation is that a Principle based standard has a
Professional to assess compliance with it, and a Rules based
standard uses a System to audit it. The reason for this is that if
principles are subjectively defined then they will, of necessity,
require a person with high levels of experience, skill,
competence, personal qualities and integrity in order to conduct
an assessment. On the other hand, Rules based requirements that
are defined in objective and measurable terms may be assessed
for compliance using systematic methods. (Databases and
computer algorithms play a strong role in this field and
oftentimes we, as individuals have been blocked from making
further progress during a process because a computer has
determined that our input parameters do not meet its rules.)
The current practice is that Principle based standards are being
addressed by attempting to use objective led system
methodologies and Rules based standards are being audited
subjectively. The end result is that the profession and its clients
intuitively feel that „something is not quite right here‟, but
precisely defining it has escaped many until now.
Principle based standards are typically those like ISO 9001.
They define broad goals as „requirements‟ but allow a
tremendous amount of leeway and flexibility in the manner that
organisations may implement a management system in order to
comply. Principle based requirements have their uses and have
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made a significant contribution to industry worldwide. They
have introduced organisations to a systematic approach to
organising their affairs in order to achieve customer satisfaction.
(Although Customer satisfaction was only introduced as a
requirement in the version before last in 2000). ISO 9001 has
therefore been a good thing, but has it been good enough?
In recent years there has been a move towards sector specific
management system requirements and now many industries
typically those with inherent levels of risk such as Automotive,
Aerospace, Medical Devices etc have developed their own
variants of standards. These are hybrids in that they retain the
principle driven format of ISO 9001 but have added further
requirements special to their industry. These requirements are
becoming more and more specific in their definition and
therefore requiring of less skill in ascertaining compliance. Yes,
I said less skill. The moment a certification professional relies
upon his judgement or discernment regarding compliance is
when the standard has defined itself as „principle based‟. If the
certification professional has no need to use their experience,
skill, judgement and discernment to ascertain compliance but
merely relies upon their knowledge of fact and procedure then it
is probably because the standard has defined a requirement as an
attribute which is not capable of discussion. The requirement is
either met or it is not. It is as simple as that. Such a standard is
ideal.
Should not the aim of industry be the production of items or
services from within a management system that is „simplicity
itself‟? And should not the implementation be incapable of
varying degrees of interpretation? Such a desired situation is
manifested in the expression “Excellence with the System”
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above.
It is the variance in interpretation that gives rise to a lot of
dialogue within the quality profession at this time.
Where a management system is not simple, and where a
requirement is principle based then the opportunity for
significant degrees of interpretation of requirements arise. Such a
situation is manifested in the expression “Excellence with the
Professional”. In this respect no doubt, most of you reading this
would consider yourselves Professionals in that you have the
experience, skill, competence and discernment to incisively
examine and objectively appraise, in a systematic manner, all
that is put before you. But, for all of your excellent skills and
qualifications can you guarantee to each arrive at identical
conclusions if you each survey the same scenario? I presume that
the answer will be in three parts (i) generally yes, (ii) perhaps
not in fine detail, (iii) and anyway, we may each have taken a
different sample! Well that is OK then is it not? But is it really
the level of assurance that the lay person is expecting when a
fancy logo entreats them to believe in the excellence of a product
or service? It also follows that the question is indeed, quite
legitimate: “Does a certificate provide any degree of public
service in such circumstances?”
This situation leads us to the developing world of the
„Excellence with the Professional‟. We have experienced for
some while that management systems certification require
auditors skilled not just in management systems but skilled in
products. Patently, one should not find it appropriate if a skilled
agriculturist is allocated to a management system for the nuclear
medicines industry. There needs to be some degree of matching,

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but how far do we go before the Certification Bodies are being
taken down a path where they need as many auditors as there are
standard industrial classifications? How far do we have to go
before a management systems certification becomes a product
line certification? At this stage I reserve my position on the
perceived convergence of product certification and management
systems certification, but I do claim the right to wave a warning
flag.
Surely a balance needs striking here. Are we dealing with
management systems or product lines? Third party certifiers and
their accrediting bodies should have a clear perception of what
their service is and what the output is. In this respect, I feel that
they do not. They are trying to portray the epitome of excellence
but lack the courage to say “almost”, or “nearly” or “on
balance”.
The output of third party certification is a certificate. This is
supported with a report and it is justified by the adherence to a
management system the meets ISO 17021. The certificate is a
statement of activity and an opinion. It is not a warranty or a
guarantee of quality; it is an indication of expected quality and
customer satisfaction but it is not a promise. Does this therefore
meet the public need and does the outcome of the certification
process meet the public‟s expected outcome? Or have the public
learned not to care?
DISCUSSION
A situation is developing within the certification industry
whereby the professionals are trying hard to be precise and yet
also endeavouring to cast their net wide. Three and a half
decades ago there was a move to avoid a situation whereby a

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separate standard was necessary for each conceivable scenario.
Principle based standards such as BS 5750 were developed in
response. During the intervening period shortfalls have become
apparent and to redress the situation our industry has been
sucked into being more and more specific. The practice of
generic and principle driven standards is still maintained but in
addition there has been a huge amount of further information,
guides, instructions and interpretations from many sources, none
of which in their own right are authoritative, notwithstanding
some influence. That has tended to confuse the situation.
No standard that requires another standard to interpret it is a
good standard. A requirement should be self explanatory on its
first pass. It should say what it wants. In addition, all too
frequently we see creeping into standards, not what the standards
want but what they do not want. Is this a healthy situation? Is it
really a sound basis for industrial and commercial growth to
define more and more aspects in terms of undesirable features
rather than desired ones? One should be concerned about this
apparent trend in negativity within standards and the impact it
will have on the quality profession. It was four decades ago that
I first heard the joke that the definition of a Quality Manager was
the person who had a perfectly good reason why one should not
be doing something! Have we now reached the stage within the
quality profession where standardisation is a list of „Shall nots‟
rather than „Shalls‟? I thought we had moved away from the old
Inspection driven mantra of “That‟s not right”, but if our
standards are containing more and more „Shall nots‟ what else is
the quality professional going to have to say?
The Certification industry says that more and more emphasis
should be put upon the attributes, skills, experience and
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qualification of individuals within the quality profession. Table 1
in the draft ISO 17021-2 indicates some of the desirable feature
in an auditor but I have a feeling that this will ultimately be a
flawed process even though I recognise its high intent. For
example, the most highly regulated and legislated industry in the
world is that of the Finance Industry. And yet, for all of the
professional bodies, the qualifications, the charter-ships,
watchdogs and what-have-you, we have a global recession not
because of all of these institutions and their measures but
because of the failure of them. I am apprehensive that the quality
profession is moving in a similar direction. We are putting ever
increasing attention into control via certification and
qualification and yet there are ever more examples of these
measures, or systems, failing. Why is this? If the Finance
Industry has failed in implementing independent services for the
public good how then is the quality profession any different?
In the UK, our legislature has created about 5000 new criminal
offences during the last ten years and yet our newspapers are
ever full of reported injustices and infringements upon society as
a whole and individuals as well. Patently more rules and
documentation is not helping society, it just builds a
bureaucracy. Is this not being paralleled within the Management
Systems certification business where there is an ever increasing
amount of standards plus all the paraphernalia of guides and
technical notes that are developed to support them? My wish is
that a good starting position, within Quality as well as society as
a whole, is that no new requirement document should be
introduced unless a further two are withdrawn. Let us all move
towards simplicity.
In case you feel that the tone of this discourse is unduly
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pessimistic please be assured that it is not how I feel. It is my
perception that the certification industry is populated by some
very well qualified practitioners of the highest technical and
moral fibre. If you feel that you know people in the industry who
do not match that description then you must ask yourselves why
that is. Is it because they are just a „bad sort‟ or is it that the
standards and systems that are trumpeted so loudly, are so poorly
written as a vehicle for certification, that they permit a diverse
and sometimes conflicting number of responses. And yet, whilst
perhaps viewed in a poor light by some, the State finds no
quarrel (or no quarrel that it wishes to take action upon), with
these diverse approaches. The action therefore lies with you, and
that gives me great hope.
Whenever a group of quality professionals are gathered together
there is always a deal of discussion on improvement needed
within the professionals themselves, the standards and the
systems within which they operate. Is this just not a totally
positive situation? There is a level of critical analysis and
introspection that has escaped many other professions. Ours has,
because of the very nature of quality assurance the ability to see
every incident and perceived shortfall as an opportunity, an
indicator within a growth curve and a measure of attainment.
This is good news. My advice is to keep it simple, and when
introducing new requirements, consolidate a few old ones, and
even throw some away. Achieve this and we will enhance the
degree of public service currently offered by the certification
profession.


                                                                                  Stephen Feltham
                                                                                Chairman and CEO
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           Accreditation Service for Certifying Bodies (Europe) Ltd.




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