Professional Documents
Culture Documents
Full Issue PDF
Full Issue PDF
Full Issue PDF
July-August 2005
IMS
ISSN 1680-8096
Auditing
ISO 9001
at the
sharp end
Services in
Singapore
EDITORIAL
by Roger Frost
Option B
Option A
I take the strategic view. My goal is sustainable business without polluting or depleting the
environment. I save money by cutting waste and
making efficient use of resources. I respect the
environmental concerns of customers, shareholders, employees, regulators, local communities, and
society as a whole.
CONTENTS
VIEWPOINT
SPECIAL REPORT
ISO MANAGEMENT
SYSTEMS is published
six times a year
by the Central
Secretariat of ISO (International
Organization for Standardization)
and is available in English,
French and Spanish editions.
Publisher : ISO Central Secretariat,
1, rue de Varemb, Case postale 56,
CH-1211 Geneva 20, Switzerland.
Tel.
+ 41 22 749 01 11.
Fax
+ 41 22 733 34 30.
E-mail central@iso.org
Web
www.iso.org
Editor in Chief : Roger Frost.
Contributing Editor : Garry Lambert.
Artwork : Pascal Krieger,
Pierre Granier.
A one-year subscription
(six issues) to ISO MANAGEMENT
SYSTEMS costs 128 Swiss francs.
Subscription enquiries : Sonia
Rosas-Friot, ISO Central Secretariat.
Tel.
+ 41 22 749 03 36.
Fax
+ 41 22 749 09 47.
E-mail sales@iso.org
Advertising enquiries :
SOGI Communication, 103, rue La
Fayette, 75481 Paris cedex 10, France.
Contact : Martin de Halleux.
Tel.
+ 33 (0)1 42 81 94 00.
E-mail halleux@qualite-references.com
and
ISO Central Secretariat,
Case postale 56, CH-1211 Geneva 20,
Switzerland.
Contact : Ms. Gisela Helberling.
Tel.
+ 41 22 749 02 58.
E-mail helberling@iso.org
Auditing
ISO INSIDER
28
ISO 22000 standard for safe food supply chains Get me the money ! How quality
management systems can yield financial and economic benefits Guidance on the role
of QMS in product certification New edition of influential ISO/IEC standard on
competence of laboratories
INTERNATIONAL
35
44
NEXT ISSUE
48
in 5
n
o
ti 200
a
c
i
l ber
b
u
P tem
Se p
Failures
in food
safety can
be dangerous
and cost you plenty !
VIEWPOINT
Dean Oestreich
Wounded
police officers
perspective
on
ISO 9001:2000
by Matt Morgan
VIEWPOINT
Photo credits
seem like it would affect me
in any way.
Saves lives
I couldnt have been more
wrong. Not only is the ISO 9000
philosophy important to many
of my daily tasks, it probably has, and will continue to
save my life, and the lives of
my fellow officers across the
country.
The photos illustrating this Viewpoint were staged by the members of Officer Matt Morgans
squad, Phoenix Police Department (PPD), Arizona, to illustrate the types of situation that
police officers may be faced
with when checking vehicles
and their drivers. They also
show the information interface,
examination of data and report
writing to which ISO 9001:2000
can add value. The photos were
taken by Kevin DeNomie, of
the PPD.
Dangerous situations
I should preface the preceding
paragraph with the fact that the
traffic stop is one of the most
dangerous situations a police
officer can encounter while on
patrol. I know this at first hand
as I was shot three times during
a routine traffic stop.
In reality, there is no routine
traffic stop as one never knows
what may happen on approach
to a vehicle. That is why accurate
information is critical to give
law enforcement every advantage over the bad guys .
In my situation, I checked, or
ran , a license plate on my
Mobile Data Terminal in my
patrol car. When the information came back to me, I discovered that the license plate was
fictitious, or in other words did
not belong on the vehicle that
I was stopping.
This tells me many things, such
as that it could be a person
VIEWPOINT
Model for law
enforcement agencies
Investigative management is an
important part of law enforcement. Cases are delayed when
information and physical evidence are not readily availa-
Every aspect
ISO 9001:2000 can be applied
to every aspect of criminology,
from securing the crime scene
VIEWPOINT
On the road to
recovery
SPECIAL REPORT
by Nigel Bauer
Nigel Bauer has over 25 years
of practical management systems
and audit experience gained
initially in major high technology industries, and over the last
15 years as an independent
advisor and trainer to a diverse
range of manufacturing and
service sector organizations, in
both public and private sectors.
Based in the United Kingdom,
Nigel Bauer and Associates
operates internationally providing
a range of consultancy and
training services to a broad
range of clients, including regulatory agencies, directly and
through partner organizations
located throughout the world.
E-mail nigel@nigelbauer.co.uk
Web www.nigelbauer.co.uk
SPECIAL REPORT
An end in itself
Auditing does appear to be
pursued as an end in itself, with
many organizations employing
auditors who assume that they
know what to do and get on
and do it in such a manner that
the organizations systems are
maintained and improved.
However, the fact that the
auditors are often left to get
on with the job with senior
management taking little or
no interest, let alone becoming involved with the process
themselves, is worrying and
indicative of a lack of understanding of the true purpose
of auditing and how it and the
auditors should be managed.
The mystique, misunderstandings and preconceptions relating to auditing are rife and it
is hardly surprising, therefore,
to find that in the majority
of organizations, auditing is
viewed as a necessary evil to
maintain certification.
The auditors themselves are
viewed as strange, pedantic and
often uncontrollable beasts
who demand and dictate. In
particular, when so-called
nonconformities are found,
er themselves as an expert or
higher authority and quickly
become imbued with their own
self-importance.
Opinions
It should be remembered at
all times that managers manage and that auditors audit at
the request and on behalf of
management. If opinions are
sought, they may be freely given, but it should not be regarded as an integral part of auditing that auditors express their
opinions and demand actions
of managers.
If managers require opinions
and identification of good/bad
practices or opportunities for
improvement, then this must
be communicated clearly to the
auditors together with the form
of reporting to be adopted.
The majority of audits undertaken in professional organizations reveals little by way
of earth-shattering news for
the business world, but merely
indicate the level of noise in
the organization, which may
actually be tolerable to senior
management and worth little
attention in the overall scheme
of things.
Putting audit results into perspective is thus very necessary if an organization is to
avoid tying itself up in knots
constantly responding to trivial audit findings although it
must be recognized that trend
analysis could reveal something of value in this noise .
It is not the job of the auditors
to make decisions regarding
the importance of audit findings. However, it is the task
SPECIAL REPORT
Example A:
how managements
attitude to internal
auditing evolved from
scorn to respect
The first example concerns
a very large, internationally active organization that
undertakes engineering work to
exacting standards and must be
able to demonstrate full control
of its operational processes.
This organization was certified
for a number of years to ISO
9001, mainly due to the need
to satisfy potential customers
that it had an effective quality management system and so
attract new business.
The quality function comprised
a relatively large number of
technically competent staff,
many of whom were required
to undertake routine audits
throughout the organization,
including overseas operations,
and of key suppliers of products and services.
The audit team was not particularly well respected, had not
been provided with appropriate audit training and conse-
The retrained auditors and quality managers began to undertake audits in a much more
planned and systematic manner, responding to the needs of
senior and middle management
by focusing the audits on operational aspects that management
had concerns over.
Audits of overseas operations
were directed to areas of greater perceived risk, and audits
of suppliers and contractors
became more focused on specific and relevant operational
activities.
The audit reporting become
more factual and objective
and the results were viewed by
management as much more relevant, helpful and adding value
to their operations. There was
a quantum leap in the respect
for and perceived usefulness
of the auditors.
Audit issues raised at management meetings were welcomed and actively discussed
and where necessary, process improvements made. The
auditors felt valued and eventually it was agreed that this
professional audit team was
far surpassing the benefits of
third-party auditing and so subsequently, third-party certification was discontinued.
Key points : Competent
auditors, effective management
of the audit process,
management involvement.
Example B:
how management
puts little in...and gets
little out
The second example is of a
large organization providing
a range of products and services. Separate divisions of the
organization are responsible
for their own local quality
management system with each
being independently certified
to ISO 9001.
The organization had a history
of quality related complaints
and investigations into its product and service delivery activities, with the consequence that
there had been several quality initiatives resulting in large
numbers of staff being trained,
both in management systems
and auditing techniques.
SPECIAL REPORT
A very important auditor ability is that of being able to conduct the audit in a professional manner without upsetting,
offending or intimidating those
being audited. Auditor arrogance should certainly not be
tolerated.
It is also necessary for auditors to be able to write comprehensive reports to communicate meaningful information
to management. This is another problematic area for many
auditors, who do not seem to
possess this important ability.
Appropriate training
The lack of appropriate training is a very significant failing. In many organizations,
there has been an over reliance on the so-called certified auditor training courses
which, whilst providing baseline auditor training, cannot
possibly provide sufficient time
SPECIAL REPORT
Senior management
and the audit process
have effectively become
decoupled
An effective management-led
audit process will likely be of
far more value than the type of
routine auditing often encountered utilizing inappropriate
audit staff, or the various random efforts of external, thirdparty auditors.
SPECIAL REPORT
SPECIAL REPORT
First step
My first step is to examine the
contract review that the CRB
has carried out for certification of an applicant organization. This, amongst other things,
should have resulted in a profile being created for the organization to be audited, especially
in terms of the proposed scope
of certification activities to be
considered for a particular IAF
scope code. I then expect to see
an auditor/audit team profile
from the existing CRB pool of
auditors that matches the corresponding IAF scope code.
The two profiles should match.
In the event that they do not,
then consideration needs to
be given to acquiring additional specialist external auditor resources or making use
Personal attributes
Dealing firstly with the nine
personal attributes I would
expect individual auditor
records to show that these have
been addressed and evaluated. The evaluation can range
from simple observation to
more complex methods such
as psychometric testing. What
is more important than the
method selected is the recognition that any shortfall is
either corrected through further development, or can be
safely mitigated and managed
by assigning the auditor to situations where the audit will not
be compromised.
Generic knowledge
and skills
What is expected here is that
the CRB has assigned quantitative or qualitative criteria for
each of the following criteria
for a generic audit situation
and that resulting individual
conformity and performance
has been demonstrated, tested and accepted.
Audit principles, procedures
and techniques. Knowledge of
SPECIAL REPORT
Specific knowledge
and skills
Quality related methods and
techniques. In order to audit
effectively in a QMS context, it
is vital that the CRB has clearly set the levels needed. It is
expected that these relate to
modern quality management
tools and their applications
and are maintained and updat-
This does not have to be complicated and in some situations it may be satisfactory as a
coarse filter to identify simply
in broadest possible terms by
discipline, such as mechanical
engineer, electrical engineer,
industrial engineer, metallurgist. In other situations it may
be considered that a scientific discipline such as a chemist,
physicist, or materials scientist
may be more appropriate.
Migration of competence
It is a well established fact
that many auditors are able to
acquire satisfactory levels of
knowledge and develop satisfactory levels of skill to audit
effectively in other IAF scope
codes that are sometimes quite
different from their mainstream industrial or commercial disciplines.
This should be neither dismissed, nor accepted at face
value. What needs to be considered is that the grounds and
justification have been satisfactorily provided by the CRB.
This is perhaps the time when
criteria such as Table 1 in section 7 of ISO 19011:2002 may
be useful and assist the CRB
in setting the levels which, if
attained, may lead to the requisite auditor competence.
However, it needs to be emphasized again that there is no single Table 1 to suit all situations.
The accompanying notes in the
standard are quite clear that
depending on the scope and
nature of the specific audit,
that the levels can be higher
or lower.
Experience has shown that
outdated work place experience is often more dangerous
than having none at all. Claims
of having gained product and
SPECIAL REPORT
Generic knowledge
and skills of audit team
leaders
This is no different to the
generic knowledge and skills
for auditors with provision
for the CRB to set the levels
needed to develop the competence needed by QMS audit
Evaluation processes
ISO 19011:2002 Section 7 Figure 5 shows the relationship
between the stages of the evaluation process and then goes
on to describe four main steps
that are needed. As an accreditation auditor, I expect to
Development
of competence
Better approaches
Criteria
not met
Auditor certification
This is now required to be taken into account, but consideration needs to be given about
the credibility of the auditor
certification body. Members
of associations such as the
International Personnel Certification Association (IPC
formerly IATCA www.iatca.org), linked by multilateral agreements and subject to
regular peer review, and bodies accredited by IAF accreditation bodies to provide auditor certification to ISO/IEC
17024, Conformity assessment
General requirements for
bodies operating certification
of persons, should inspire confidence.
see that use of this or a similar model has been documented and implemented by
the CRB.
Initial evaluation
(7.6)
Criteria
met
Continual evaluation
of performance
(7.6)
Criteria
met
Auditor
Not
selected
Criteria
not met
Maintenance and
improvement of competence
(7.5)
Care was taken when preparing this article to maintain confidentiality and not to divulge
any unique techniques that
have been developed by an
individual CRB. What has been
cited is strictly a generalization
of what is considered as being
some of the better approaches
that have been seen to be used
around the world and would
be acceptable to accreditation
body members of the IAF.
Research is confirming
that many auditors do
not really understand
the standards
Audit team
selection
(6.2.4)
SPECIAL REPORT
by Simon Feary
Simon Feary has been Director
and CEO of IRCA since 1994. He
currently serves on the Board of
IPC, the successor to IATCA.
E-mail sfeary@irca.org
Web www.irca.org
SPECIAL REPORT
Concern
But there are negatives and
these are of sufficient magnitude to cause concern. The
growth in 2003 was supported
almost entirely by two economies, China and Japan, while
all the other majors were at
best flat with some showing a
retraction in percentage terms
of double figures.
One high-profile manufacturing industry, automotive,
has declared no confidence in
mainstream certification
although maintaining its confidence in ISO 9001: 2000 and
has walked away to create its
own sector-specific structure
for accreditation and certification. Another major sector, the aerospace industry
now requires having auditors
accompanied in order to ensure
confidence in their findings.
China, a rare bright spot, has
seen fit to impose some severe
caveats in the way it allows
certification to operate within
its borders. While some argue
their action is no more than a
clever expression of the Chinese way , where legitimate
competition is kept at arms
length, others recognize it to
be a reasonable response to
damaging and out of control
practices that are symptomatic of a malaise within the
industry.
So what has caused the brakes
to be applied so abruptly ?
Expressed in business jargon,
diplomatically, the reasons are
that demand has outstripped
the ability of the infrastructure to control the quality of
output.
Interpretations
Interpretations of standards
differ from one accreditation
body to the other, sometimes
significantly, depending to an
extent on the lobbying skills
of the petitioning certification body, and often they vary
within an accreditation body,
depending on the extent of
assessment competence of the
accreditation personnel.
So wheres the solution? Apparently, it lies with the accreditation industrys governing body,
the International Accreditation Forum (IAF). Nothing
is ever simple, or speedy with
governing bodies that are consensus-oriented and composed
of a membership approaching
50 from across the very broad
spectrum of economic situations and cultures.
Certification is now
global, with few if any
regions of the world
exempt from its
influence
Simple in concept but in
practice it is not working well
enough. Accreditation bodies,
invariably monopolies within
their own countries, are often
accused of lacking the commercial and technical competence found within the certification bodies they are tasked
with controlling.
SPECIAL REPORT
Cause
But from the perspective of
auditor certification and it is
from this direction that this critique comes there is unease.
There is a fear that the focus
of the IAF and other initiatives will be on the symptom,
leaving the cause unaddressed.
The culprit will be determined
to be the auditor, or more precisely, the incompetent auditor
and recommendations will lean
toward addressing this aspect
rather than structurally, where
this article argues the problems
originate.
The reasons for this unease lie
with the considerable interest
shown in ISO/IEC 17024:2003,
Conformity assessment General requirements for bodies
operating certification of persons, for the approval of auditors. It is almost as if this is
seen as the what weve been
waiting for solution. And that
would be incongruous, as ISO/
IEC 17024 implies a third-party
determination of auditor competence, in other words, auditor
certification, and auditor certification has historically been
relegated to the periphery of
accredited certification.
While it is understandable
that there is interest in ISO/
IEC 17024:2003 it is a new
and an International Standard
the danger is that it will be
seen as the answer: not just part
of the answer, but the answer.
Already, one major auditor certification body is presenting it
as exactly that.
Competent
The message this organization is promoting is that only
accredited certified auditors
are properly competent. All
others, it says, are suspect and
the current criteria and methods for evaluating auditors
count for little. This is dangerous nonsense.
It is nonsense because there
are thousands of extremely
competent, certified auditors
exercising their profession to
good effect, and dangerous
because it distracts from the
root cause of the industrys
loss of credibility the lack of
effective control at the accreditor level.
SPECIAL REPORT
Critical
About IRCA
The London-based International Register of Certificated Auditors (IRCA) began certifying auditors in 1984. It was set up
as part of an initiative by the United Kingdom Government
to make business and industry more competitive.
The aim of this initiative, which was in effect accredited certification, was to achieve efficiencies by reducing the costs
of supplier audits by replacing them with a fewer number
of third-party audits. Each third-party audit of a supplier
would then be accepted and recognized by all customers of
that supplier.
This quality infrastructure proved to be extremely successful and is now recognized worldwide to be the most effective and most commonly used method for assuring the quality of supplier organizations. This same structure is now used
in other contexts, e.g. to assure the compliance of organizations management systems to occupational health & safety,
food safety and environmental requirements. But whatever
the context, because the structure relies heavily on competent auditors and consultants, the role played by IRCA has
been essential.
The evaluation and certification methods developed and used
by IRCA have been adopted by most other auditor certification bodies. Although most countries now offer alternatives
to IRCA through their own national auditor certification
programmes, IRCA certification has achieved international
recognition.
Programmes
The majority of auditors on IRCAs register are certified to
audit ISO 9001:2000. In addition to providing certification
services to quality management system auditors, IRCA also
offers certification programmes for environmental management, occupational health and safety, food safety, information
security, social systems and sustainability assurance.
Under development is a programme certifying the competence of auditors who audit greenhouse gas emissions under
the European Unions carbon emissions trading initiative.
IRCA also certifies auditor training courses and, in addition,
now certifies an increasing range of training organizations and
training courses as independent activity. Originally designed
for auditors intending to become certified, the range of such
courses has expanded to meet the needs of students seeking
information on quality, environmental and health & safety
management for a variety of reasons. Now, only a small minority of students attending these courses are auditors.
Training organizations in many parts of the world seek IRCA
certification for their courses. Around 50 000 students a year
attend IRCA-certified training in all parts of the world.
SPECIAL REPORT
Auditor certification
provides an indication
of generic auditing
competence only
Value-adding
Attempting to resolve these
aspects through an artificial,
third-party process only serves
to add a layer of complexity, cost and mystique to what
Determining competence
requirements of a specific
audit and matching these with
individual auditors competences is a responsibility that
lies entirely within the remit
of those who manage the audit
process. That it is too often
neglected is neither an indictment of auditor competence,
nor of auditor certification. It
is a reflection that certification
bodies are cutting corners and
the accreditation process is not
picking this up.
Identifying the remedy is simple. Accreditation must be
made to work properly. The
key to credible certification
does not lie with auditor certification bodies adding complexity, cost and gimmickry to
what ought to be a simple process. There are aspects of competence that are best addressed
SPECIAL REPORT
by Gary L. Johnson
+
19011S-2004
E
Q
Q
S
A
/
O
S
I
/
I
S
AN
0 Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 Principles of Auditing
Description
The structure of ANSI/ISO/
ASQ QE 19011-2004 follows
the same order as the ISO
standard:
5 Managing an Audit
Programme
6 Audit Activities
7 Competence and
Evaluation of Auditors
SPECIAL REPORT
Clause 1 Scope
The ISO text focuses on the
applicability of the standard
to quality management systems (QMS) and environmental management systems
(EMS), and notes that it may
be applied to other types of
management systems as well.
The US Supplement
is not intended
to supplant
ISO 19011:2002
The Supplement emphasizes the
particular differences in how
internal and external audits
are conducted. For example,
an opening meeting may be
less formal for an internal audit
and communication during the
audit can be simpler. The Supplement notes, however, that
a formal meeting is always
appropriate in supplier (second-party) audits.
The ISO standard and the Supplement provide specific guidance for audit completion and
follow-up as needed to confirm
that all nonconformities have
been addressed. In most cases, the audit will be completed
when all activities described in
the audit plan have been completed; however, there may be
SPECIAL REPORT
More effective
While ISO 19011:2002 provides
new and more effective guidance for auditing QMS and
EMS, its value for the full scope
of auditing activities may be
fully realized by an organization through the use of ANSI/
ISO/ASQ QE 19011S-2004.
The Supplement contains the
full text of the ISO standard
and provides the added guidance necessary to manage
audit programmes, plan and
conduct individual audits, and
select and evaluate competent
auditors.
The Supplement expands the
applicability of ISO 19011
beyond its emphasis on external (third -party) audits to
more effectively encompass
internal (first-party) audits,
supplier (second-party) audits,
and use by small organizations.
SPECIAL REPORT
E-mail l.thione@sincert.it
Web www.sincert.it
E-mail Alex.Ezrakhovich@sai-global.
com
Web www.sai-global.com
Documenting nonconformities.
Reviewing and closing nonconformities.
Auditing the effectiveness
of internal audits.
Third party auditor impartiality and conflicts of interest.
Auditing of electronic based
management systems.
Auditing service organizations.
The modules making up the
APGs auditing kit are avail-
SPECIAL REPORT
Expanded scope
As a result, the IAF Technical Committee has decided to
expand the groups scope and
membership to cover accreditation audits (office and witness audits) of certification
bodies.
This has led to the formation
of the Accreditation Auditing
Practices Group (AAPG)
administratively related to the
APG which will hold joint
meetings with the APG, follow
The AAPG has already developed a number of draft publications which are currently
being reviewed prior to release,
including the following :
Auditing competence of
QMS certification/registration body auditors and audit
teams.
Accreditation witness
audits.
Process approach based
accreditation audit.
New ideas
We are delighted that IAF
has extended the scope of our
work to include accreditation
practices, and we are working on ideas for new papers to
help enhance the effectiveness
of the accreditation process,
and the value and credibility
of accredited QMS certifications.
We would encourage all accreditation and certification bodies to make use of the guideline papers, and urge auditors
around the world to read them
and benefit from the insights
they provide. And as part of
our continual improvement
ISO INSIDER
Food chain
Thus, food safety is a joint
responsibility that is principally
assured through the combined
efforts of all the parties participating in the food chain.
ISO 22000 specifies the requirements for a food safety management system in the food
chain where an organization
needs to demonstrate its ability to control food safety hazards in order to provide consistently safe end products that
meet both the requirements
handle or supply food recognize that customers increasingly want them to demonstrate
and provide adequate evidence
of their ability to identify and
control food safety hazards and
the many conditions impacting
food safety.
Complemented
The publication of ISO 22000
will be complemented by an
ISO Technical Specification
(ISO/TS 22004) giving guidance on the implementation
of the standard, with a particular emphasis on small
and medium-sized enterprises. In the following months,
another Technical Specification ((ISO/TS 22003) will be
published explaining certification requirements applicable when third-party certification is used.
These documents are being
developed by working group
WG 8, Food safety management systems, of ISO technical committee ISO/TC 34,
Food products. Experts from
23 countries are participating and organizations with
liaison status include the following: Confederation of the
Food and Drink Industries of
the European Union (CIAA),
Codex Alimentarius Commission, International Hotel and
Restaurant Association, CIES/
Global Food Safety Initiative,
and World Food Safety Organization (WFSO).
Th e g r o w i n g n u m b e r o f
national standards for food
safety management has led
to confusion. Consequently,
there is a need to harmonize
the national standards at an
international level.
The standard can be applied
on its own, or in combination
with other management system standards such as ISO
ISO INSIDER
Swedenbased management
consultant
Tommie J.
Johansson
specializes
in quality,
project and competence management, and is convener of the
ISO working group reviewing
ISO 10014.
Paul C.
Palmes is
the project
secretary
and US Lead
delegate for
the development of the
ISO 10014 guideline, Vice Chair
of the US TC 176, and Quality
Assurance Director for Northern
Pipe Products Inc. in Fargo,
North Dakota, USA. He has been
a Certified Quality Manager and
member of the American
Society for Quality (ASQ) since
1992. His new book, Process
Driven Comprehensive Auditing
(ISBN 0-87389-641-6) was
recently published by ASQ Press
(http://qualitypress.asq.org/).
Paul Palmes is also a member
of the Steering Committee of
the Open Compliance and Ethics
Group (OCEG) participating in
the development of ethical systems design and management.
He represents the US TC 176 on
the Quality Board of the ANSIASQ National Accreditation
Board (ANAB), the US accreditation
body for management systems,
and as liaison to the International
Accreditation Forum (IAF).
E-mail tommie@sighard.com
Web www.sighard.com
E-mail paulp@northernpipe.com
ISO INSIDER
definition for the quality community. Many of these financial tools resisted application
to a single quality principle or
function.
Several share similar features,
but have significantly different investment requirements.
Some are identical, but have
different names in different
countries.
Clause 5 addresses these obstacles by listing the most appropriate financial tools and
reports beneath each management principle. Early drafts
struggled with what goes
where and whether the repeatability of a particular tool warranted an expanded definition
in a separate annex.
DO
CHECK
ACT
Market
appraisal
Product
realization
Assessment
Improvement
Customer Relationship
Management (CRM)
Market surveys and analysis
Strategic planning
Strengths, Weaknesses, Opportunities, Threats (SWOT)
Customer
requirements
identification
Quality Function Deployment
(QFD)
Service agreements
Bottleneck management
Electronic Data Interchange
(EDI)
Materials Requirement
Planning (MRP)
(See Annex A)
Balanced Scorecard (BSC)
Increased efficiency
Benchmarking
Improved effectiveness
Dashboard
Improved performance
in processes, activities and
products
Design of Experiments
(DOE)
Trend analysis
Call centres
Customer Relationship Management (CRM)
Customer satisfaction surveys
Help desks
Response and complaints handling
New/rened objectives
Recognition and reward
Self-assessment
A unique self-assessment tool,
developed specially for ISO
10014, is an integral part of
Annex A. In the form of a questionnaire, it comprises three
questions per principle in a
condensed version, plus a
detailed 68-question version
for a more comprehensive evaluation, scored on a scale of 1
to 5, to assess an organizations
level of maturity.
The self-assessment process is
designed to help identify the
priority areas for improvement
and to indicate methods and
tools to realize benefits. An
important link between the
self-assessment findings and
achievable benefits is cross-referenced in Annex B, to assist
top management rank and prioritize actions.
Here are examples of how the
guidelines elaborate on two of
the key principles, Customer
focus and Continual improvement :
Customer focus
Clause 5 examines each of the
management principles and
describes the financial and economic benefits that can be
achieved by applying them.
Once you have identified and
prioritized the principle
improvement actions to be taken, the next step is to identify
ISO INSIDER
Nevertheless, it is important to
take a holistic view of the needs
of all interested parties to
ensure an organization is capable of effecting the sort of
changes that lead to continual
improvement.
by Germn Lombana
Working towards
a common goal
ISO 10014 was written to define
the common ground and a common language between top
management and quality professionals. Both levels need to
achieve positive financial return
for their work, but often struggle to understand each others
perspectives, terminology and
reports. The success of ISO
10014 will be measured by how
far they succeed in communicating and working together
towards a common goal.
Customer feedback
Financial performance
Self-assessment results
Audit results
Yield
Value of goods and services
Human resources
Appraisal
Satisfaction feedback
Suggestions
Recommendations for improvement
Problem solving (corrective action)
External factors
Regulatory
Emerging technologies
Changes in the marketplace
Environmental/social
Guidance on
the role of QMS
in product
certification
Process steps
Review of action
INPUTS
Data analysis
Trend identification
Self-assessments
Results evaluation
Identication of action items
Prioritisation
Set and cascade objectives
Application of all principles and
selected tools
Action plan development
Allocation of resources
Re-conducting self-assessment
and evaluations
Projected sales
Budget allocations
Performance target levels
Strategic plan
Cost reduction targets
Cash flow
Capital
expenditure
OUTPUT
ISO INSIDER
Product certification
schemes incorporating
an organizations quality
management system
can be beneficial
This is consistent with ISO
9001:2000 which specifies
requirements for a QMS where
an organization :
Scope
In scope, Guide 53 outlines
a general approach by which
certification bodies can develop and apply product certification schemes utilizing the
Benefits
ISO/IEC Guide 53:2005 is
intended to make product
supplier organizations aware
of the benefits of access to
product conformity assessment
schemes offered by certification bodies, which include verification of QMS requirements.
This can lead to increased confidence in fulfilling product
requirements, and to reduced
risks related to certification.
Simplification of some stages
of product conformity assessment can also yield corresponding reductions in cost
and time.
In certification of services,
there is still much to
accomplish
Guide 53 is based on the
assumption that an organization that has implemented a
ISO INSIDER
Good alternative
In the certification of services,
there is still much to accomplish, although service certification schemes have been
established that include some
QMS requirements, for example, those related to the competence of personnel providing
the service (see ISO 9001:2000
clause 6.2.2 C o m p e t e n c e,
awareness and training), and
the necessary infrastructure
supporting the service (clause
6.3 Infrastructure), among
others.
Some national service standards have been established
following this approach in
sectors such as tourism, dangerous goods transportation,
moving, and cleaning. However, establishment of QMS
requirements based on ISO
9001:2000 provides a good
alternative for the service
industry, particularly due to
the standards responsiveness
to changing customer needs.
Confidence in the
competence of laboratories
is frequently needed
by businesses and by
government regulators and
trade officials
However, the influence of
ISO/IEC 17025 is even greater
than this figure suggests since
many countries make its use
a legal requirement. In addition, documents derived from
it are used by laboratories in
specific sectors such as medicine and microbiology.
ISO Secretary-General Alan
Bryden commented : ISO/
IEC 17025 benefits business,
ISO INSIDER
Worldwide
Dependable testing and calibration laboratories are ones
that have been duly accredited as competent and ISO/
IEC 17025:2005 is the laboratory accreditation standard
that, like the edition it replaces, will be counted on by business and governments worldwide, declared Peter van de
Leemput, who led the ISO
group of experts that carried
out the work.
The new, 2005 edition results
from the amendment of ISO/
IEC 17025:1999 to ensure its
compatibility with the requirements of ISO 9001:2000, Quality management systems
Requirements. This became
necessary because of the generalized adoption of quality
management systems conforming to ISO 9001:2000, including
many of the organizations that
testing and calibration laboratories serve.
It also seeks to clarify that
while compatible, the two
standards are not inter-changeable. Although both standards
can be used by laboratories as a
framework for providing their
customers with confidence that
The International Laboratory Accreditation Cooperation (ILAC) has set a transition period of two years from
date of publication of the new
edition 12 May 2005 for
accredited laboratories to comply with the standards requirements.
There are no essential changes to the technical requirements. The modifications relate
mainly to the management
requirements in the document
to reflect the content of ISO
9001:2000, especially in a greater emphasis on the responsibilities of top management,
on the need to demonstrate
a commitment to continually
improve the effectiveness of
the management system, on
customer satisfaction, and on
internal and customer communication about the management system.
ISO/IEC 17025
will be counted on by
business and governments
worldwide
INTERNATIONAL
by Timothy Wan
INTERNATIONAL
Greatest threat
Firstly, Chinese organizations
set a higher priority on reducing the impacts of pollution
and waste generation (see
Figure 1). Given the dramatic rate of urban and economic development in China, it is
not surprising that these are
the two key issues on the governments environmental agenda. This is increasingly apparent in the run up to the 2008
Olympic Games, particularly for organizations based in
Chinas major cities.
Secondly, many Chinese companies had no environmental
policy before implementing
Others
Waste
generation
29
20
United Kingdom
14
60
Resource
scarcity
29
20
Prosecution
29
20
Pollution
29
China
60
Exceeding requirements
Fourthly, a higher percentage
of Chinese companies claimed
they could obtain the same
environmental improvements
without ISO 14001 (see Figure 2). There are two possible
explanations. In the first place,
many Chinese companies form
part of a supply chain to multi-national organizations that
already have a stringent EMS
in place, and are expected to
apply best environmental practice to meet customer requirements, regardless of being ISO
14001-certified or not. A similar trend can be seen in other
labour-intensive countries such
as Vietnam and Mexico.
United Kingdom
China
Hard to say
43
Yes
57
20
%
80
In the second place, expectations of auditors and certification bodies in China may be
lower than those in the United Kingdom. This finding could
indicate that the average level of environmental performance management constantly
evolves as a result of continual improvement.
Opportunities
Overall, the findings indicated
superior environmental performance management from
the ISO 14001-certified organizations. In terms of goal setting,
uncertified companies tended to direct corporate policies
towards compliance alone. They
saw little real business opportunity from environmental
changes apart from the greenwashing effect, and considered
environmental issues irrelevant
to their future and profitability. Those who had implemented ISO 14001 said the opposite
(see Figure 3, overleaf)
Certified companies identified
environmental aspects that were
relevant to their future operations, tended to stay ahead of
regulatory requirements and
found more innovative and
INTERNATIONAL
75
Improved publicity
17
0
Reduced
costs
33
New business
opportunities
0
42
50
58
0
10
20
30
Innovation
40
50
60
70
80
Certified companies also benefited from having both internal and external environmental auditing which increased
the reliability and transparency of the exercise. Evidence
of continual improvement
was reported in 75 % of certified companies, but in none
of the uncertified respondents.
This contrast in commitment
reflects the stronger drive of
the ISO 14001 review process, with its central concept of
improvement.
Measuring performance
ISO 14001-certified companies
often utilize formal performance indicators that are not
evident in uncertified companies, and their environmental
performance suggests a greater ability to measure, evaluate and improve. In addition,
most uncertified organizations
did not carry out environmental or sustainability reporting,
while 80 % of those implementing ISO 14001 did.
The best
ISO 14001 thrives by being
the best and most generic tool
available to improve environmental performance management. It offers a degree of flexibility not seen in its closest
competitor the Eco-Management Audit Scheme (EMAS).
It is adaptable to an existing
environmental management
system, or to companies establish an EMS for the first time.
It provides solid framework for
improving corporate environmental performance.
A possible weakness of ISO
14001 is its non-requirement
for organizations to report
environmental performance
to the public, since the decision to do so or not is left to
the organization.
Geographical location
has little effect on
ISO 14001 implementation
INTERNATIONAL
INTERNATIONAL
An essential principle is to
ensure that all employees
feel a sense of ownership
in the QMS
Translation
In the case of HCSL, there
were obstacles to overcome
before this could be achieved.
Many employees find English
difficult to understand, particularly in sentences and paragraphs. ISO 9001:2000 documentation was seen as the
foundation of the QMS but
not as the foundation of a
course to learn English.
So, with the help of consultants Mrs. Madhavi and Mrs.
Raghu Jyothi, of the Professional Quality Management
Centre (PQMC), Hyderabad,
the system work instructions
were re-written in simplified
English, supported by translation into the local Telegu language, and by pictorial representation where feasible.
The result of this effort was a
work force that became highly
motivated to implement the
ISO 9001:2000-based QMS
culminating in many benefits
to the company.
INTERNATIONAL
A production
supervisor monitors
process
parameters on
the HCSL
production line.
Monitoring QMS
performance
HCSL set a number of parameters for measuring the effect of
its QMS. These included :
increases in turnover and
yield,
customer satisfaction,
vendor performance,
employee satisfaction,
reduction of waste including
solvent losses in storage
tanks,
inventory reduction,
training of employees,
Impressive benefits
In the two years since ISO
9001:2000 certification, HCSL
has seen some impressive benefits. Customer complaints have
fallen dramatically from ten
to one per month, while the
percentage of on-time deliveries has increased from 85 %
to 99,9 %.
Equipment downtime has
dropped from 5 % to only
0,1 %, linked with a reduction
in process losses from 10 % to
1 % despite an increase in the
number of product introductions. And during the period
annual turnover has increased
from USD 10 million to USD
44 million, without adding
manpower.
INTERNATIONAL
Santander Serfin is headquartered in Mexico City, a metropolis of almost 24 million inhabitants. Environmental pollution
is one of the citys biggest problems, exacerbated by its location in a valley 2 240 metres
above sea level.
INTERNATIONAL
Santander Serfins ISO 14001-certified Santa Fe Corporate Centre building in Mexico City 1).
their waste collection, handling
and elimination systems. However, there is less obligation on
service companies to reduce
the emission of pollutants or
consumption of non-renewable materials. Instead, they are
expected to take action voluntarily in the context of social
responsibility. Santander Serfin
was the first financial institution in Mexico to take up the
challenge.
Reducing pollution
is top of the governmental,
corporate and social
agendas in Mexico
The company, together with
Grupo Santander, decided to
implement an EMS as part of
its Corporate Social Responsibility and Environmental Pol-
Environmentally smart
Constructed in 1994 and housing some 1 800 employees, the
companys corporate centre
was designed as an environmentally smart building from
the outset. This in itself was a
good starting point for staff
members directly involved in
the implementation and certification process. However, further measures were required
to reduce the environmental
impact still more.
According to the ISO 14001
approach, all business activity involves the possibility
of generating environmental impacts, such as the consumption of raw materials
Legal
In charge of adapting the existing legislation and standards, to
comply with the banks established provisions and objectives, and to ensure that the
system is kept up to date.
Quality
Responsible for implementing
the EMS and monitoring the
system by coordinating internal audits.
Maintenance
In charge of maintaining the
buildings equipment in good
condition to reduce polluting
emissions. Also responsible
for installing devices to reduce
the consumption of water and
electricity.
Services
Responsible for managing
the buildings non-renewable
resources, such as water, electricity and paper.
INTERNATIONAL
Medical Service
The Medical Service collaborates by coordinating the
handling and elimination of
medicines, infectious biological waste and sharp medical
implements, outsourced to a
specialized company.
Economic advantages
Although the main objective of
implementing ISO 14001 was
to reduce the companys environmental impact, Santander
Serfin has achieved economic
advantages as well.
In 2004, the year of implementation, the corporation reduced
consumption of photocopy
paper by 60 %, energy use by
38 % and water by almost 5
%. These savings have been
reflected in the lower cost of
these services.
Training
Provides training for all company personnel and supplier
company staff, tailored to their
particular EMS activity.
Communication
Disseminates EMS information through the Intranet to
all who work in the building
and reinforces the message via
a monthly magazine and regular campaigns.
Human Resources
Coordinates the participation
of all head office employees
in the EMS.
It was all
about team
work : the
ISO-14001
implementation
team at
Santander
Serfin proudly
display their
certificate.
Structured approach
Singapores journey towards
the development of service standards began in 1998
when it hosted the first of four
regional seminars, organized
standards for property management agents and for the cleaning of commercial premises.
Exhibition management
Today, it is significant that
ISO has decided to develop
an International Standard on
exhibition terminology, using
one of the Singapore standards
as the initial draft.
ISOs Technical Management
Board (TMB) formally accept-
Making headway
Besides the exhibition service
standards, Singapore has also
launched service standards in
e-supply chain management,
cleaning services and pest management.
Logistics
Singapores connectivity to
the world enables the quick
exchange of goods, capital,
information and ideas, so
there is a continuous need to
strengthen our logistics infrastructure.
There is increased
emphasis on security to
boost the tourism sector
This will provide the framework for hotels to set up a
security management system,
thus, enabling them to provide
a higher level of safety, security and assurance to guests
and staff.
Retail
E-business messaging
Singapore supports the widespread adoption of the e-business messaging standards,
developed by EAN Inter-
NEXT ISSUE
ISO INSIDER
Lessons of the ISO
14001 SME survey
There are more than 72 million registered small and
medium-sized enterprises (SMEs) in the world,
although as most businesses of this type are not registered, the actual figure
may be in the hundreds of
millions. Therefore, their
impact on the environment
is huge and a sustainable
future without their involvement is inimaginable. This
article examines the results
and lessons of the recent
online survey carried out
by ISO to gather feedback
on the use of ISO 14001 by
SMEs.
SPECIAL REPORT
For example, ISO 9001:2000
primarily affects the certified
firm and its customers, but is
not something that end consumers, nongovernmental
organizations, or governments
have much interest in, while
the ISO 14000 family is more
tied obviously linked to a
broader subsection of global,
societal interests.
How do standards
become global supply
chain pressures or
cultural convergence ?
It is clear that standards such
as the ISO 9000 and ISO 14000
families have been adopted at
different rates by countries
across the world. Likely, the
same will be true for the
recently launched ISO guidance for social responsibility,
and for trade-facilitating
standards such as those disseminating RFID (radio identification frequency) technology. It is also clear that a range
of factors contribute to the
global diffusion of these standards : supply chain pressures,
word-of-mouth, personal contacts, etc.
STANDARDS
FOR SERVICES
Improved
ISO/IEC 17799 for
secure information
INTERNATIONAL
The impact of ISO 14001
certification on Israeli
exports
al.
v
i
n.
v
o
r
i
t
u
c
s
ote
ns
r
o
i
p
t
a
t
es
niz
b
a
g
e
r
s th
ur o
e
o
y
v
r
ese
al to
t
d
i
v
t
is
se
s
n
a
o
i
s
at
u
o
m
i
r
c
o
e
f
In
pr
a
h
Suc
05
0
2
:
79 9
7
1
ion
l
C
t
a
E
a
I
n
/
m
o
I SO ternati or infor nt
f
e
in
T h e c h m a r ka n a g e m
ben urity m
sec