422
to the uncertainty budget. As an obvious
requirement, bias correction should be
rewarded by lower residual uncertainty,
that is, in case of significance the bias
should be larger than its standard uncer-
tainty. However, the significance criterion
according to Eq. (6) only requires that
the bias is larger than its expanded uncer-
tainty, with a coverage factor of two.
Therefore it may be better, for the sake
of compatibility, to use another decision
rule in the Sect. Testing for bias, where
the coverage factor of two is replaced by
unity. If this is done, a harmonized sys-
tem of bias handling cases results as fol-
lows.
First, an estimate a of additive bias,
and its standard uncertainty u(a) are de-
termined, and the bias estimate is tested
for significance: bias is significant if
hah 1 u(a), otherwise insignificant.
For insignificant bias, no correction is
applied, and the standard uncertainty on
the bias estimate is added to the uncer-
tainty budget.
2 2 2
xestpxmeas, u(xest) pu(xmeas) cu(a) . (17)
Significant bias is corrected if appro-
priate, and the standard uncertainty on
the bias estimate is added to the uncer-
tainty budget.
xestpxmeasca, u(xest) 2pu(xmeas) 2cu(a) 2 .
(18)
If not appropriate, no correction is ap-
plied, and the bias estimate is added to
the uncertainty budget.
xestpxmeas , u(xest) 2pu(xmeas) 2ca 2
A flow diagram of bias handling is given
in Fig. 1.
Conclusions
As an alternative, and complement, of
the step-by-step approach, uncertainty of
analytical methods may be determined di-
rectly by analysis of reference samples
and comparison of results with the known
reference values. Equivalently, the meth-
od under investigation may be applied in
parallel with an established reference
method to appropriate samples. As the
key item in this approach, handling of
bias and estimation of bias-related uncer-
tainty have been discussed. Further work
on this topic is currently in progress as a
CITAC 1 project.
1
) CITAC denotes the Co-operation on
International Traceability in Analytical
Chemistry that was established in 1993,
see [7] for a recent account.
References
1. Guide to the Expression of Uncertain-
ty in Measurement (1993) ISO, Gene-
va
2. Quantifying Uncertainty in Analytical
Measurement (1995) EURACHEM
Laboratory of the Government Chem-
ist, London
3. Williams A (1996) Accred Qual Assur
1 : 1417
4. ISO 5725 : 1994 Accuracy (trueness and
precision) of measurement methods
and results. ISO, Geneva
5. Ellison S, Williams A (1998) Accred
Qual Assur 3 : 610
LEGISLATION AND NORMS
Relevant legislation, legislation plans and related initiatives in different countries
and continents
Accred Qual Assur 3 : 422425
Q Springer-Verlag 1998
Herfried Kohl
The new ISO 17025
(19)
basic idea
Abstract This paper offers a concise
overview of the recent draft of ISO
17025, which is expected to replace EN
45001 in 1999. Reference is made to the
general area of related ISO standards for
management systems. The main changes
compared with EN 45001 are discussed
for testing laboratories.
Key words ISO 17025 7 Quality assu-
rance 7 Quality management 7 Laborato-
ry management
Introduction
ISO 17025 (General requirements for the
competence of testing and calibration la-
boratories) designed to replace EN 45001
(General criteria for the operation of
testing laboratories) and ISO Guide 25
(General requirements for the compe-
tence of calibration and testing laborato-
ries) is now converging rapidly towards
its final version. The intent of the current
6. Heydorn K (1993) Anal Chim Acta
283 : 494499
7. Walker R (1997) Accred Qual Assur
2 : 4043
Presented at: Analytica Conference 98,
Symposium 2: Uncertainty budgets in
chemical measurements, Munich,
2124 April 1998
W. Hsselbarth (Y)
Federal Institute for Materials Research
and Testing (BAM),
D-12200 Berlin, Germany
Tel.: c49-30-6392 5861
Fax: c49-30-6392 5577
e-mail: werner.haesselbarth6bam.de
note is to give the reader a basic idea of
the recent draft of ISO 17025 published
by the working group ISO/CASCO WG
10/40 in February 1998.
The ISO world of standards
The two standards ISO 9001 (Quality sys-
tems model for quality assurance in de-
sign, development, production, installa-
tion and servicing) and ISO 14001 (Envi-
ronmental management systems, specifi-
cation with guidance for use) have re-
ceived enormous attention and accept-
ance in all kinds of business. Compared
with these two standards, EN 45001 has
some serious drawbacks. First, it is only a
European standard and second, some
standard modules of quality management
standards are lacking. Roughly speaking,
EN 45001 focuses mainly on the technical
competence of the testing laboratory,
whereas new quality management stand-
ards have more explicit requirements on
how to deal with customers.
The new standard ISO 17025 will be
more in line with the philosophy of ISO
9001 and, as a rule, laboratories now op-
erating a management system conforming
with ISO 9001 and EN 45001 will have
no difficulties in conforming with ISO
17025. In practice this is especially true
for those laboratories which are part of
large organizations which run quality
management systems according to ISO

9001 and which have been accredited ac-
cording to EN 45001.
The fact that ISO 17025 will become
accepted worldwide means there will be a
big step forward in the area of interna-
tional standardization. Laboratories ob-
taining accreditation according to this
standard by an accreditation body which
has signed an international agreement of
recognition with other bodies will find
their testing and calibration results ac-
cepted in a much larger number of coun-
tries.
Scope of ISO 17025
In contrast to EN 45001, ISO 17025 now
covers testing, sampling and calibration
activities. It addresses all kinds of labora-
tories like first, second and third party as
well as laboratories where testing and cal-
Fig. 1 Tables of contents of ISO 17025 and EN 45001
ibration activities form part of inspection
or certification. Laboratories complying
with ISO 17025 will easily be able to de-
monstrate that their quality management
system in the area of testing, sampling
and calibration also meets the require-
ments of ISO 9001 or ISO 9002. Howev-
er, accreditation according to ISO 17025
by an accreditation body will not include
certification of the laboratory according
to ISO 9001/2.
Of course, ISO 17025 does not cover
compliance with regulatory health or sa-
fety or other legal requirements which
may be, and mostly are, specific to the
scope of the laboratory as well as to the
country where the laboratory operates.
ISO 17025 defines general require-
ments for the operation of testing, sam-
pling and calibration laboratories. It is
the responsibility of each laboratory to
meet the requirements of the standard in
423
such a way that regulatory, safety and le-
gal requirements are met as well as those
defined or expected by clients. The labo-
ratory should run one all-encompassing
quality and laboratory management sys-
tem, the optimal design of which is a
masterpiece.
Structure of ISO 17025
A first insight into the structure and gen-
eral requirements of ISO 17025 may be
gained by comparing the table of con-
tents of this standard with that of EN
45001 (Fig. 1).
The most important additional requi-
rements compared to EN 45001 for many
laboratories which do not already work in
an ISO 9001 or comparable environment
come from module 4 (Management requi-
rements) of ISO 17025. Few changes will
be found in module 5 (Technical require-
ments) for testing and calibration labora-
tories. During the final years of applica-
tion of the EN 45001 standard EAL (Eu-
ropean Accreditation of Laboratories),
now EA, and the national accreditation
bodies worked out specific interpretations
of EN 45001. The reader will find many
of them now implemented in ISO 17025.
Therefore, accredited laboratories will
find them folklore.
The final publication of ISO 17025 is
expected in late 1999. It will then take
the accreditation bodies some time to ap-
ply the new requirements in accreditation
and surveillance audits. Still, the reader
may find it useful to conduct a diagnostic
audit in his/her laboratory now to identify
possible problem areas and to eliminate
them in good time. The following
abridged checklist could be helpful in a
first attempt. We will concentrate mainly
on the requirements for testing laborato-
ries.
Management requirements
Organization and management
Either the laboratory or the organization
of which it is a part is a legal entity. The
laboratory is required to fulfil all require-
ments of ISO 17025 as far as they are ap-
plicable. There should be no conflict of
interest resulting from organization or
other dependencies; the laboratory and
its personnel are required to have suffi-
cient independence. The laboratory is re-
quired to have clear organizational struc-
ture with respect to its activities as well
as with respect to the duties of its staff.
There will be quality managers with suffi-
cient authority and know-how.
424
Quality system
The laboratory shall establish, implement
and maintain a quality management sys-
tem which is appropriate to its scope of
activities. This quality management sys-
tem will be documented in a manual, pro-
cedures, calibration instructions, job de-
scriptions and similar documents. The
quality policy statement must be relevant
and consistent with the scope of activities.
Document control
There will be an all-encompassing system
of document control addressing issues
like document approval and issuing as
well as changes to documents. Of course,
documents may be written on paper or
they may be in electronic form.
Request, tender and contract review
The laboratory will run a documented
system for dealing with requests, tenders
and contract reviews. This will include
feasibility studies where necessary.
Subcontracting of tests and calibrations
Subcontracting is very relevant to quality,
so the laboratory will have procedures to
make sure subcontractors (e. g. laborato-
ries) are competent. The laboratory must
maintain a register of its subcontractors.
The client of the laboratory will be in-
formed and has to approve the subcon-
tracting of tests.
Purchasing services and supplies
There must be procedures in the labora-
tory which ensure that quality-relevant
products and services are supplied by
companies meeting predefined standards.
Service to the client
There will be procedures in the laborato-
ry which regulate cooperation with its
clients.
Complaints
The laboratory will have procedures for
dealing with complaints. Laboratories are
encouraged to acquire feedback from
their clients and to use it for continuous
improvement of their services.
Control of nonconforming testing and/or
calibration work
The laboratory is required to introduce
general procedures for dealing with non-
conforming services. These procedures
should be sufficiently detailed to cover
remedial action as well as recalling work
already released.
Corrective action
Procedures for corrective action will in-
clude cause analysis as well as standard
paths. Special system or product audits
are required if they seem necessary to get
problem areas under control.
Preventive action
Procedures will be maintained which fo-
cus on preventive action in all relevant
areas of activity of the laboratory.
Records
The laboratory will run a system for iden-
tification, collection, indexing, distribu-
tion and storage of records. Special requi-
rements are defined for technical records
which are accumulations of data and for
other information on tests and calibra-
tions which have been performed.
Internal audits
The laboratory will plan and conduct in-
ternal audits on a regular basis. These au-
dits are required to address all elements
of the quality management system. The
results of the audits will be clearly re-
ported and corrective action will be made
within an acceptable period.
Management reviews
The management of the laboratory is re-
quired to conduct management reviews of
all elements of the quality management
system. The results of audits, incoming
complaints and other sources of informa-
tion as well as corrective action taken
and other issues of relevance will be re-
ferred to in the review.
Technical requirements
General
This clause of ISO 17025 describes gener-
al requirements for testing and calibra-
tion laboratories. It must be adequately
interpreted and applied by the laboratory
depending on the field in which it works
and depending on its scope of activities.
It is understood that legal requirements
or requirements defined by accreditation
bodies or clients are fulfilled by the labo-
ratory.
Personnel
The personnel of the laboratory will be
sufficiently competent for the work to be
done. There will be procedures to identi-
fy training needs of the personnel and
there will be job descriptions or similar
regulations to describe the competence
and duties of the personnel. The relation
between management and subordinate
staff will be suitable. Records of the qual-
ification of personnel must be kept up to
date.
Accommodation and environmental
conditions
The laboratory must keep accomodation
and environmental conditions under con-
trol. Adequate monitoring is part of this.
Procedures will describe the activities and
regulations taken.
Test and calibration methods
This is the longest clause in ISO 17025.
Laboratories are required to use appro-
priate methods and procedures in per-
forming testing and calibration work. La-
boratories will also have instructions for
running equipment if the absence of such
instructions could jeopardize the results.
It is understood that international or oth-
er recognized specifications do not neces-
sarily need to be supplemented or rewrit-
ten if they can be applied by the labora-
tory staff. In the event of the laboratory
developing new testing or calibration
methods the laboratory is required to im-
plement methods for validation. These
methods also include aspects of statistical
control.
The laboratory performing internal
calibrations will have methods to deter-
mine the best measurement capability.
Furthermore it is required that the labo-
ratory be able to estimate the uncertainty
of its measurements where possible and
when required by the client. Calculations
and electronic data transfer will be con-
trolled by the laboratory. This is not such
a trivial point since ISO 17025 requires
that computer software, especially that
developed by the laboratory, is docu-
mented in sufficient detail and has
proved to be suitable for use. The reader
should ask his/her accreditation body how
it will interpret this point.

Equipment
There are no essential changes in this
clause compared to the requirements of
EN 45001. It is required that the labora-
tory be furnished with all items needed
for sampling and testing. There is ade-
quate maintenance for all items and there
are procedures to cover all relevant as-
pects of dealing with them. Records will
be accessible for all relevant aspects and
working with the equipment will be in ac-
cordance with the procedures. Personnel
will receive sufficient training.
Measurement traceability
All test and calibration equipment will be
verified or calibrated at regular intervals.
It is assumed that these are planned ac-
tivities of the laboratory. It is also as-
sumed that the laboratory runs suitable
programme and has procedures for deal-
ing with reference materials and stand-
ards.
Sampling
If sampling is carried out by the laborato-
ry the remarks made above for test and
calibration methods apply.
Handling of test and calibration items
The laboratory is required to have proce-
dures for the receipt, handling, protection
etc. of testing and calibration equipment.
MEETING REPORT
Accred Qual Assur (1998) 3 : 425426
Q Springer-Verlag 1998
Werner Hsselbarth
EURACHEMs Annual
Meeting in Budapest
2125 April 1998
On invitation from EURACHEM-Hunga-
ry, EURACHEMs Annual Meeting was
held on 2125 April 1998 in Budapest at
Hotel Agro which, located uphill, pro-
vided a panoramic view of the former
Assuring the quality of test and
calibration results
The laboratory will run suitable pro-
grammes for internal and external quality
control schemes. These will include statis-
tical techniques, participation in profi-
ciency testing programmes, etc.
Reporting the results
The requirements of test reports mainly
follow those of EN 45001. An important
change is, however, that opinions and in-
terpretations may now be part of the test
report if they are clearly separated from
the test results.
Presented at: Analytica Conference 98,
Symposium 1: Trends of accreditation
and licensing of laboratories, Munich,
2124 April 1998
H. Kohl
LGA InterCert
Zertifizierungsgesellschaft mbH
Umweltgutachterorganisation,
Tillystrasse 2,
D-90431 Nrnberg, Germany
e-mail: intercert6gw.lga.de
Tel.: c49-911-6554160
Fax: c49-911-6554170
twin cities Buda and Pest. The pro-
gramme included meetings of the Execu-
tive Committee, the Full Committee, the
working groups (WGs) on Measurement
Uncertainty and Education and Training,
and a concluding Puszta tour.
The meeting was attended by 50 regis-
tered participants from 25 countries, pre-
dominantly from Europe, but with a no-
ticeable transcontinental flavour from
Australia, Japan and the United States.
Invitees included Ronald Christensen,
Executive Director of AOAC Interna-
tional, Wiktor Raldow, Head of the Eu-
ropean Commissions Standards, Meas-
urement and Testing (SMT) Programme,
and Alan Squirrell, Chairman of CITAC.
425
New Chair and Vice Chair
The EURACHEM Chair, held by Maire
Walsh from the State Laboratory, Ire-
land, was handed over to Veikko Komp-
pa from VTT Chemical Technology, Fin-
land, the former Vice Chair person. Ed
de Leer from The Netherlands Measure-
ment Institute took on the position of
Vice Chair person.
New guides
The Full Committee approved two new
guidance documents prepared by EURA-
CHEM WGs:
A EURACHEM guide on method vali-
dation entitled The fitness for purpose
of analytical methods A laboratory
guide to method validation and related
topics
A joint EURACHEM/CITAC guide
on quality assurance beyond routine
analysis, entitled EURACHEM/CI-
TAC Guide 2 Quality assurance for
research and development and non-
routine analysis
The draft documents will be processed
for final editing and publication by the
end of 1998.
In addition, EURACHEM approved
the final draft of the IUPAC guide on re-
covery factors, entitled Harmonized
guidelines for the use of recovery infor-
mation in analytical measurement, that
was recently the subject of a vote among
IUPAC, AOAC International, ISO/
REMCO and other contributing organi-
zations.
Forthcoming workshops
The current programme of workshops in
preparation, organized or co-organized by
EURACHEM includes:
Quality Assurance in Computerized
Laboratories, Copenhagen, 1112 June
1998 (jointly with AOAC Europe Sec-
tion)
Accreditation and/or Certification,
Delft, 2526 June 1998 (jointly with
EUROLAB)
Quality Assurance in Research and
Development (R&D), Basle, 9 Septem-
ber 1998 (at Euroanalysis 10)
The 2nd EURACHEM Workshop on
Education and Training, Geesthacht,
2729 September 1998
The 3rd EURACHEM Workshop on
Measurement Uncertainty, Helsinki,
1315 June 1999
The 3rd EURACHEM Workshop on
Traceability, Bratislava, 68 September
1999.