ISOManagement Systems December 2001 37

p to now, I SO had developed

separate gui del i nes for audi ti ng
qual i ty and envi ronmental manage-
ment systems (Figure 1). The three
parts of I SO 10011 provi di ng gui d-
ance on the audi ti ng of qual i ty man-
agement systems were i ssued i n 1991.
The three separate gui del i nes for the
audi ti ng of envi ronmental manage-
ment systems I SO 14010, I SO 14011
and I SO 14012, were publ i shed i n
1996.
Duri ng the devel opment of the
I SO 14010 series, due attention was
paid to I SO 10011 and, therefore, the
two sets of standards do not di ffer
fundamentally from each other. I n
particular, I SO 10011-1 and I SO 14011
on audit procedures, and I SO 10011-2
and I SO 14012 on audi tor qual i fi ca-
ti ons, show great si mi l ari ti es. Of
course, I SO 14012 requires that envi-
ronmental audi tors have knowl edge
of environmental management, envi -
ronmental sci ence and technol ogy,
and envi ronmental l egi sl ati on that i s
different from the knowledge require-
ments i n I SO 10011-2. Nevertheless,
the framework of qual i fi cati on cri te-
ri a i n terms of educati on, trai ni ng,
and work and audi t experi ence i s
basi cal l y the same.
I N T E R N A T I O N A L
I SO develops uni que standard
forauditing ISO 9000
and ISO14000 systems
As part of ISOs response to ISO 9000 and ISO 14000 users requirement for maximum
compatibility between the two families of standards, the organization is developing a
unique guideline for the auditing of both quality and environmental management systems.
The draft International Standard ISO/ DIS 19011, Guidelines for quality and/ or environmen-
tal management systems auditing, was published on 31 May 2001 and has been distributed
to ISOs members for a five-month ballot, closing on 31 October 2001. Its publication as an
International Standard is expected in the second half of 2002. ISO 19011 will complete the
ISO 9000 core series also comprising the revised ISO 9000, ISO 9001 and ISO 9004,
published in December 2000. It is being developed by a joint working group set up by sub-
committees of two of the most well known ISO technical committees: ISO/ TC 176, Quality
management and quality assurance, and ISO/ TC207, Environmental management. The
development of ISO 19011 is a unique project for ISO as is it the first document to bridge
the gap between the famous ISO 9000 and ISO 14000 families of standards. This article
describes the background to this project and highlights the major features of the future
standard.
U
D i ck H ortensi us i s Seni or
Standardization Consultant
wi th the N etherlands
Standardization I nstitute
N EN ) . Closely involved
with the development
of the I SO 1 4000 seri es on
envi ronmental management,
he serves as Secretary
of the Joint Working G roup
on Audi ti ng set by
Subcommi ttees 3 and 2,
respectively, of I SO Technical
Committee ISO /TC 1 76 ISO 9000)
and ISO /TC 207 ISO 1 4000) .
Dick Hortensius, NEN,
P.O. Box 5059, NL-2600 GB Delft,
Netherlands.
Tel. + 31 15 2 69 03 90.
Fax + 31 15 2 69 01 90.
E-mail Dick.Hortensius@ nen.nl
Web www.nen.nl
B Y DICK HORTENSIUS
38 ISOManagement Systems December 2001
More recent was the devel op-
ment of a gui del i ne descri bi ng the
general pri nci pl es of envi ronmental
audi ti ng, I SO 14010. However, i t was
not consi dered necessary to devel op
a document on managi ng envi ron-
mental audi ti ng programmes and,
therefore, the I SO 14010 seri es does
not i ncl ude a counterpart to I SO
10011-3.
Focus on compatibility and
alignment
At the beginning of 1997, I SO/TC
176 and I SO/TC 207 paid renewed
attention to their cooperation and the
way in which they managed the devel-
opment of compati-
bl e standards, i .e.
standards that are
easy to use in a com-
bi ned or i ntegrated
manner. The reason
for thi s revi val of the
c o m p a t i b i l i t y
debate was the
fi nal i zati on of the
fi rst i mportant set of
I SO 14000 standards
i n the second hal f of
1996 and, at the same time, the start
of the revi si on process of both the
I SO 9000 series and I SO 10011.
I t was cl ear that both revi si ons
woul d l ead to fundamental changes
i n the standards, for exampl e, I SO
9001 and I SO 9004 were to be based
on the process model and I SO 10011
woul d i ncorporate a new approach to
the qual i fi cati on of audi tors. There-
fore, the establ i shment of new mech-
ani sms to ensure compati bi l i ty was
consi dered i mportant. The Joi nt Co-
ordi nati on Group of I SO/TC 176
and I SO/TC 207 i ni ti ated vari ous
l i ai son groups, amongst whi ch the
Common Study Group on Audi ti ng
between the subcommi ttees (SCs)
I SO/TC 176/SC 3 and I SO/TC 207/
SC 2.
Thi s Common Study Group had
the task of i nvesti gati ng opti ons to
further al i gn the I SO standards on
audi ti ng up to ful l i ntegrati on and to
assess the market need, support for,
and the feasi bi l i ty of these opti ons.
The group met for twi ce i n 1997 and
1998. I ts most
i mportant recom-
mendati on to the
respecti ve parent
commi ttees was to
consi der the devel -
opment of one com-
mon I SO document
on envi ronmental
and qual i ty audi ti ng,
i f necessary wi th
add-ons for speci fi c
qual i ty and envi ron-
mental aspects.
I n March 1998, thi s recommenda-
ti on was fol l owed-up by the i ssui ng
of a joi nt new work i tem proposal for
the devel opment of a common I SO
standard on qual i ty and envi ronmen-
tal audi ti ng. Thi s proposal was
accepted by both I SO subcommi ttees
and a joi nt worki ng group (JWG)
I N T E R N A T I O N A L
Figure 1
Current ISO guidelines
for auditing
At the beginning of 1997,
ISO/ TC 176 and ISO/ TC 207
paid renewed attention
to the way in which they
managed the development
of compatible standards
ISOManagement Systems December 2001 39
ronmental ) regul atory compl i ance
audits, product audi ts and process
audi ts are not covered by I SO
19011. Of course, performance, regu-
l atory compl i ance, prod-
uct and processes are el e-
ments of system audi ts,
for exampl e, where the
capabi l i ty of a manage-
ment system to assi st the
company i n compl yi ng
wi th appl i cabl e l egi sl a-
ti on, or i n achi evi ng per -
formance objecti ves, i s
assessed. However, i t was
deci ded to focus I SO
19011 on those qual i ty
and envi ronment rel ated
audi ts that are cl osest to
each other and can most readi l y be
combi ned i n a standard, as wel l as
actual practi ce. At the same ti me,
thi s provi des a good opportuni ty to
use I SO 19011 as a basi s for other
management system audi ts, such as
those for occupati onal heal th and
safety.
Figure 3 (overleaf) i ndi cates how
the vari ous el ements of the current
audi ti ng standards are merged i n
I SO 19011.
Thi s does not mean that I SO
19011 i s si mpl y a combi nati on of the
current documents.
was establ i shed that met for the fi rst
ti me i n November 1998 to devel op
the si ngl e audi ti ng standard.
This JWG (Figure 2) is chaired by
two co-conveners: Alistair Dalrymple,
from the French certification body,
AFAQ, on behalf of I SO/TC 176/
SC 3 and Andrew Gri ffi ths, from
Degussa Metal s Catal ysts Cerdec,
Germany, on behal f of I SO/TC
207/SC 2. Duri ng the enti re process,
the Netherl ands Standardi zati on
I nsti tute (NEN) pl ayed a key rol e as
i t i s responsible for the secretariats
of both the I SO subcommi ttees
involved, as wel l as of the Common
Study Group and the Joi nt Worki ng
Group.
Breaking new ground with
ISO19011
I SO/DI S 19011, Guidelines for
quality and/or environmental man-
agement systems auditing, i s the
product of seven meeti ngs of the
Joi nt Worki ng Group and three
i nternal Commi ttee Drafts. The num-
ber 19011 the fi rst XX011 number
avai l abl e was speci al l y granted to
thi s project by I SO. The i dea behi nd
thi s choi ce of number was to avoi d
l i nki ng the standard excl usi vel y to
ei ther the I SO 9000 or the I SO 14000
fami l y of standards, but on the other
hand to mai ntai n the rel ati onshi p
wi th the current audi ti ng standards
(I SO 10011 and 14011). The number
19011 can al so be l ooked upon as a
symbol that thi s project goes beyond
the current gap between qual i ty and
envi ronmental management.
From a fi rst l ook at I SO 19011, i t
becomes i mmedi atel y cl ear that:
an expl i ci t choi ce has been made
to l i mi t the scope of the standard
to management system audi ts;
al l el ements of the current I SO
10011 and the I SO 14010 seri es are
embodi ed i n the new standard.
The fi rst poi nt means that vari -
ous types of audi ts, such as envi ron-
mental performance audi ts, (envi -
I N T E R N A T I O N A L
Figure 2 Position of the
JWG on Auditing
Proof that quali ty and
envi ronmental cultures can
si t down at the same table :
co-conveners of the Joi nt
Worki ng G roup on Audi ti ng
whi ch i s developi ng
I SO 1 901 1 Left, Andrew
G ri ffi ths, from D egussa
Metals Catalysts Cerdec,
G ermany, on behalf of
I SO /TC 207/ SC 2 I SO 1 4000) ,
and right, Ali stai r D alrymple
from the French certi fi cati on
body, AFAQ, on behalf of
I SO / TC 1 76/ SC 3 I SO 9000) .
40 ISOManagement Systems December 2001
Key i mprovements are:
the cl ear set of defi ni ti ons cover-
i ng the rel evant concepts of man-
agement system audi ti ng;
the conci se des-
cri pti on of the
essenti al charac-
teri sti cs and pri n-
ci pl es of audi ti ng
and the audi ti ng
professi on;
the provi si on of
the key aspects
of managi ng an
audi t programme
i ncl udi ng cl ear
l i nkages wi th the conduct of i ndi -
vi dual audi ts and the process of
eval uati on of audi tor compe-
tence;
the cl ear descri pti on of al l el e-
ments of an audi t process, and
the competence approach to audi -
tor qual i fi cati on.
I n addi ti on to these, vari ous prac-
ti cal hel p boxes are i ncl uded i n the
text to provi de addi ti onal detai l and
to assi st, for exampl e, smal l and
medi um si zed enterpri ses, al ong wi th
a number of fi gures presenti ng the
key concepts of I SO 19011 vi sual l y.
Potential users of the standard
I SO 19011 i s i ntended to be appl i -
cabl e to i nternal as wel l as external
management system audi ts. There-
fore, the mai n target group are
organi zati ons havi ng i mpl emented a
qual i ty and/or envi ronmental man-
agement system and thus havi ng a
need to conduct i nternal system
audi ts. Another i mportant target
group are certi fi cati on/regi strati on
bodi es that conduct external system
audi ts as a basi s for the deci si on
whether or not to i ssue a certi fi cate
of conformi ty to a management sys-
tem standard.
Other potenti al users of the stan-
dard i ncl ude organi zati ons i nvol ved
i n audi tor trai ni ng or regi strati on,
organi zati ons that provi de consul -
tancy i n management systems, and
accredi tati on bodi es.
The gui dance i n I SO 19011 can be
used to conduct
audi ts on ei ther an
envi ronmental man-
agement system or a
qual i ty management
system separatel y, or
to conduct combi ned
audi ts on both sys-
tems (whether i n-
tegrated or not) at
the same time. This
choi ce i s at the di s-
creti on of the user
and i s not at al l i mposed by I SO
19011 i tsel f. However, I SO 19011
refl ects the market devel opment that
many organi zati ons i mpl ement both
qual i ty and envi ronmental manage-
ment systems and want to opti mi ze
thei r audi ti ng efforts.
The concept of auditing
Accordi ng to the defi ni ti on i n I SO
19011 an audi t i s a systematic, inde-
pendent and documented process for
obtaining audit evidence and evaluat-
ing it objectively to determine the
extent to which audit criteria are ful-
filled. Audi t evi dence i s based on
records, statements of fact or other
I N T E R N A T I O N A L
Figure 3 Merging
of the ISO 10011
and the ISO 14010 series
The number 19011
can be looked upon as a
symbol that this project
goes beyond the current
gap between quality and
environmental management
ISOManagement Systems December 2001 41
i nformati on that the audi tor gathers
and that can be verified. The audit
cri teri a may be, for exampl e, the
requi rements of a management sys-
tem standard such as I SO 9001 or
I SO 14001. The eval uati on of the
audi t evi dence agai nst the audi t cri te-
ri a l eads to fi ndi ngs of conformi ty or
nonconformity with the criteria, i.e.
somethi ng does or does not conform
to the applicable requirements.
After consi derati on of al l the fi nd-
ings, the auditor can draw conclu-
si ons such as whether the manage-
ment system of an organi zati on does
or does not conform to a manage-
ment system standard.
These basi c steps of gatheri ng and
sel ecti ng i nformati on and l ogi cal rea-
soning are shown in Figure 4 below.
l Ethical conduct the foundation of
professionalism
l Fair presentation the obligation
to report truthfully and accurately
l Due professional care the appli-
cation of diligence and judgment to
auditing.
Two further principles relate to
the audi t process:
l
Independence the basis for the
impartiality and objectivity of the
audit conclusions
l Evidence the rational basis for
reaching reliable and reproducible
audit conclusions in a systematic
audit process.
Adherence to these pri nci pl es i s a
prerequi si te for provi di ng a rel i abl e
and rel evant audi t outcome and the
remai nder of the gui dance gi ven i n
I SO 19011 i s therefore based on
them.
Management of audit programmes
Accordi ng to I SO 19011, an audi t
programme i s a set of one or more
audits planned for a specific time
frame and directed towards a specific
purpose. For many organi zati ons,
the audi t programme wi l l consi st of
the set of i ndi vi dual audi ts whi ch
are carri ed out to cover al l el ements
of the management system i n al l
parts of the organi zati on duri ng an
audi t cycl e. The programme may
al so consi st of the set of i ni ti al and
survei l l ance audi ts carri ed out by a
thi rd party duri ng the contractual
peri od of a management system cer-
ti fi cate of conformi ty. Management
of an audi t programme i ncl udes al l
rel evant acti vi ti es that are necessary
to faci l i tate the conduct of i ndi vi d-
ual audi ts, such as appropri ate pl an-
ni ng, provi di ng resources (fi nanci al ,
human) and establ i shi ng proce-
dures.
Fi gure 5 (overleaf) shows the
vari ous el ements of an audi t pro-
gramme and the appl i cati on of the
Pl an-Do-Check-Act cycl e to i t.
I N T E R N A T I O N A L
Figure 4 Basic steps
in an audit process
Principles of auditing
I SO 19011 descri bes the pri nci pl es
of audi ti ng that make audi ts di fferent
from other types of assessment, and
that make them a rel i abl e tool i n sup-
port of management pol i ci es and con-
trol s, and i n the provi si on of i nforma-
tion to interested parties.
Three of these pri nci pl es rel ate to
the audi tors themsel ves:
42 ISOManagement Systems December 2001
I N T E R N A T I O N A L
Conduct of audits
The guidance that I SO 19011 pro-
vi des for the conduct of i ndi vi dual
audi ts does not di ffer fundamental l y
from the gui dance gi ven i n the cur-
rent auditing standards.
Figure 6 below shows the parties
i nvol ved i n the conduct of an audi t.
I n the I SO 10011 and I SO 14010
seri es the rol es and responsi bi l i ti es of
each actor were descri bed i n detai l .
I n I SO 19011, these rol es and respon-
si bi l i ti es are i ncl uded i n the descri p-
tion of the audit process.
The various stages in this audit
process are given in Figure 7 on the
next page and, for each element, I SO
19011 provides the necessary guidance.
Auditor competence
The most i nnovati ve part of I SO
19011 i s the cl ause whi ch addresses
the competence of auditors. I n I SO
10011-2, as well as in I SO 14012, the
qual i fi cati on cri teri a for audi tors are
defi ned i n terms of mi ni mum l evel of
educati on and number of years of
work experi ence and hours of audi tor
trai ni ng and experi ence. I n I SO
19011, the focus i s on audi tor compe-
tence: to be a competent audi tor a
person shoul d demonstrate the pos-
sessi on of a number of personal
attri butes and the abi l i ty to appl y the
knowl edge and ski l l s that are neces-
sary to conduct a successful audi t and
achi eve the audi t objecti ves.
Knowl edge and ski l l s can be acqui red
by an appropri ate combi nati on of
educati on, work experi ence and audi t
training and experience. This concept
Figure 5 Management of
an audit programme
Figure 6 Parties involved
in an audit
ISOManagement Systems December 2001 43
I N T E R N A T I O N A L
of audi tor competence i s portrayed i n
Figure 8 opposite.
The knowl edge and ski l l s speci -
fi ed i n I SO 19011 are subdi vi ded i nto
those that appl y to al l management
system auditors, those that only apply
to audi tors of qual i ty or envi ronmen-
tal management systems and those
that apply to audit team leaders.
The generic knowledge and skills
i ncl ude those rel ated to:
audi t pri nci pl es, procedures and
techni ques;
management systems and refer-
ence documents;
organizational situations, and
appl i cabl e l aws, regul ati ons and
other relevant requirements.
Figure 7 Overview of
audit activities
Figure 8 Auditor
competence
ISO 19011 can be used
to conduct audits on
either an environmental
management system or
a quality management
system separately, or to
conduct combined audits
on both systems
44 ISOManagement Systems December 2001
Knowl edge and ski l l s speci fi c to
qual i ty management system audi tors
are those rel ated to:
qual i ty-rel ated methods and tech-
niques, and
products, i ncl udi ng servi ces and
operational processes.
Speci fi c to envi ronmental manage-
ment system audi tors are:
envi ronmental management meth-
ods and techni ques;
envi ronmental sci ence and tech-
nology, and
techni cal and envi ronmental
aspects of ope-
rations.
As far as audi t
team l eaders are
concerned, I SO
19011 states that
they shoul d have
the knowl edge
and l eadershi p
ski l l s necessary
to enabl e the
team to conduct
the audi t effi ci entl y and effecti vel y.
I n addi ti on to the above, the audi -
tor shoul d posses a number of per-
sonal attri butes that contri bute to the
successful performance of audi ts.
Accordi ng to I SO 19011, an auditor
shoul d be ethi cal , open mi nded,
di pl omati c, observant, percepti ve,
versatile, tenacious, decisive and self-
reliant.
The necessary knowl edge and
ski l l s and the personal attri butes to
appl y them effecti vel y can be
acqui red by an appropri ate combi na-
tion of education, work experience,
audi tor trai ni ng and audi t experi -
ence. I n I SO 10011-2 and I SO 14012,
these bui l di ng bl ocks are quanti-
fi ed by, for example, specifying the
minimum level of education, the nec-
essary number of years work experi-
ence and the mi n-
imum amount of
audit experience.
The authors of
I SO 19011, how-
ever, consi dered
i t not appropri ate
to set generi c
r e c o mme n d e d
l evel s that shoul d
appl y to al l audi-
tors i n al l audi t
situations. I t was
acknowl edged that the appropri ate
l evel s wi l l vary accordi ng to such fac-
tors as the size, nature and complexi-
ty of the organi zati on to be audi ted
and the objecti ves and extent of the
audit programme.
I t i s up to the organi zati on to
defi ne the appropri ate l evel s.
Therefore, I SO 19011 cl earl y
descri bes an audi tor eval uati on
process that i ncl udes the setti ng of
l evel s of knowl edge and ski l l s that
are needed and the educati on, audi-
tor trai ni ng and work and audi t expe-
rience necessary to acquire them.
Auditor evaluation
The evaluation of auditors occurs
at di fferent stages:
an i ni ti al eval uati on of persons
who wi sh to become audi tors wi th-
in the framework of an audit pro-
gramme (for example, the internal
audi t programme of a company, or
ISO 19011 represents a first
collaborative effort between
two ISO communities
qualityand the environment
with their own history, culture
and ways of interacting
I N T E R N A T I O N A L
Figure 9 Stages of auditor
evaluation
ISOManagement Systems December 2001 45
the external audi t programmes of a
regi strati on/certi fi cati on organi za-
ti on);
the eval uati on of audi tors as part
of the sel ecti on of an audi t team to
conduct a speci fi c audi t wi thi n the
audit programme, or
the on-goi ng eval uati on of audi tor
performance i n the audi t pro-
gramme to i denti fy, for example,
trai ni ng needs to mai ntai n and
i mprove the necessary knowl edge
and skills.
These stages are represented i n
Figure 9 on the preceding page.
I n each case, the eval uati on
process i nvol ves the fol l owi ng steps:
1. i denti fi cati on of the types and l ev-
el s of knowl edge and ski l l s neces-
sary to meet the needs;
2. setti ng of i ndi cators of educati on,
work experience, auditor training
and audi t experi ence to acqui re the
l evel s i denti fi ed i n step 1;
3. sel ecti on of the appropri ate
method to eval uate whether the
i ndi cators i denti fi ed i n step 2 are
satisfied, and
4. compl eti on of the eval uati on by
compari ng the resul ts for a per-
son/audi tor (by appl i cati on of the
sel ected method) agai nst the i ndi -
cators i denti -
fi ed i n step 2.
On compl e-
tion of thi s pro-
cess, persons/
audi tors i denti -
fi ed as not
meeti ng the cri-
teri a may need
further educa-
tion, training and/
or experi ence.
The necessary knowl edge and
skills can vary for each stage. For
example, a person may qualify as an
audi tor i n the i nternal audi t pro-
gramme of a chemi cal company, but
not qual i fy as member of a team to
conduct a speci fi c audi t i n a busi ness
unit with special hi-tech processes,
unl ess supported by appropri ate
techni cal expert-
ise.
As menti on-
ed above, the
requi red knowl -
edge and ski l l s
wi l l vary for
each organi za-
ti on havi ng the
need to conduct
audi ts and, as a
co n s e q u e n ce ,
the necessary
educati on, audi tor trai ni ng and work
and audi t experi ence to acqui re the
competence wi l l vary as wel l .
However, I SO 19011 i ncl udes a tabl e
i l l ustrati ng i ndi cators of these
bui l di ng bl ocks of competence
I N T E R N A T I O N A L
ISO 19011 includes a table
illustrating indicators of the
building blocks of competence
which are typical for auditors
conducting certification audits
Figure 10 Auditor
evaluation process
Example of internal audit programme
46 ISOManagement Systems December 2001
whi ch are typi cal for audi tors con-
ducti ng certi fi cati on audi ts, or audi ts
of si mi l ar compl exi ty. I SO 19011 al so
i ncl udes a tabl e wi th exampl es of the
appl i cati on of the audi tor eval uati on
process i n an i nternal audi t pro-
gramme.
Figure 10 on the
preceding page rep-
resents the audi tor
eval uati on process,
as wel l as gi vi ng
some examples of its
appl i cati on i n an
i nternal audi t pro-
gramme.
Conclusion
After three Commi ttee Drafts,
I SO/DI S 19011 has clearly emerged
as cl ose to the fi nal versi on of the
I SO standard on management system
audi ti ng. The project i s runni ng
smoothl y and swi ftl y: from start to
finish, it will take less than four years.
On the one hand, it can be argued
that good starti ng materi al was avai l -
able, but, on the other hand, I SO
19011 represents a fi rst col l aborati ve
effort between two I SO communi-
ti es qual i ty and the envi ronment
wi th thei r own hi story, culture and
ways of interacting.
Regardi ng thi s l ast poi nt, the
spi ri t of cooperati on
and teamwork i n the
Joint Working Group
i s remarkabl e and,
after seven meet-
i ngs, i t i s hard to tel l
whi ch member ori gi -
nates from the qual -
i ty or envi ronmental
si de. At the l ast
meeti ng i n Sydney,
the JWG members
were compared wi th the Austral i an
pl atypus a perfect combi nati on of
two rather di sti nct ani mal s!
Qual i ty and the envi ronment are
good partners and I SO 19011 i s per-
haps onl y the fi rst project i n a new
seri es of I SO standards. The cata-
l ogue number I SO 19001 i s sti l l
avai l abl e for an ambi ti ous new
project...
Quality
and the environment are
good partners and
ISO 19011 is perhaps only
the first project in a new
series of ISO standards
I N T E R N A T I O N A L
The Joi nt Worki ng G roup of TC 1 76 and TC 207 experts whi ch developed
I SO 1 901 1 has been compared wi th the Australi an platypus
a perfect combi nati on of two rather di sti nct ani mals!