Clinica Chimica Acta 309 Ž2001.

121–125
www.elsevier.comrlocaterclinchim

ISO and CEN documents on quality in medical laboratories

Desmond Kenny )
Department of Clinical Biochemistry, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland

Abstract

The forthcoming international standard ISO 15189 AQuality management in the medical laboratoryB is a document of
great importance for the development of quality systems and accreditation for medicalrclinical laboratories. For the first
time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories.
The document takes into account the special requirements imposed by the medical environment and by the essential
contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only
testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form
ŽISOrDIS 15190., deals with safety management for medical laboratories. ISO 15189 Žand probably 15190 also. are
expected be adopted by CEN as a European Standard ŽEN.. q 2001 Elsevier Science B.V. All rights reserved.

Keywords: Medical laboratories; Clinical laboratories; Quality management; Accreditation; Standards

1. Introduction equivalent, EN 45001 w2x, which were designed for

It is now universally recognized by professional
bodies, governments, health care administrators and
other interested parties that accreditation ŽTable 1. of
clinicalrmedical laboratories is essential in order to
ensure the high standards of service which patients
and clinicians should be able to take for granted.
Until now, accreditation of medical laboratories
has been based either on AlocalB standards, e.g. CAP
ŽUS., CPA ŽUK., CCKLTest ŽNL., 1 or on interna-
tional standards which are not particularly suited for
the purpose: ISO Guide 25 w1x or its European
)
Tel.: q353-1-409-6434; fax: q353-1-455-9073.
E-mail address: deskenny@iol.ie ŽD. Kenny..
1
CAPsCollege of American Pathologists; CPA sClinical
¨
Pathology Accreditation; CCKL sCoordinatie Commissie voor
Kwaliteitsbewaking in Laboratoria in de gezondheidszorg.
accreditation of industrial Acalibration and testing
laboratoriesB Žthese documents have recently been
replaced by the new standard ISO 17025 w3x..
It should be obvious that there is a fundamental
difference between
- testing industrial products to see Žfor example.
if they comply with the appropriate regulations and
- the testing of patient samples which constitutes
a large part of the role of the clinical laboratory’s
service Žand of course there is more to the clinical
laboratory service than merely performing tests and
issuing results.; this testing is an integral part of
medical treatment, especially with regard to diagno-
sis and monitoring.
There is a need for an international standard
which takes into account the special nature of medi-
cal laboratories, including such aspects as
Ø advising on the use of the service,
Ø interpretation of results,

0009-8981r01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved.
PII: S 0 0 0 9 - 8 9 8 1 Ž 0 1 . 0 0 5 0 8 - 3
122 D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 1
ISO definition of accreditation
Accreditation:
AProcedure by which an authoritative body gives formal
recognition that a body or person is competent to carry out
specific tasksB ŽISOrIEC Guide 2..
Ø contributing to clinical audit,
Ø organizing the service to meet medical needs,
for example with respect to turnaround times
and responding to medical emergencies,
Ø education and training, not only of laboratory
staff but also of medical, nursing and other
professional staff Žthis is not an exhaustive
list..
To fulfil this need, a newly established ISO Tech-
nical Committee, ISO TC 212, began work in 1995
on a draft which is now wDecember 2000x close to
acceptance as an ISO standard: ISO 15189 AQuality
management in the medical laboratoryB w4x. The
document is also being processed by CEN ŽComité
´ de Normalisation. as a draft European
Europeen
Standard.
When finalised within ISO, this document will be
circulated by ISO and CEN for final vote as an
international and European standard. Its adoption as
a European standard ŽEN. will give it the status of a
national standard in all CEN member countries.
2. ISO r DIS 2 15189 CQuality management in the
medical laboratoryD 3
The purpose of this standard is to provide a basis
for Quality systems and Accreditation in medicalr
2
DISs Draft International Standard.
3
Since the presentation of this paper in October 2000, the title
of this document has been changed to CMedical laboratories—
Particular requirements for quality and competenceD. The Intro-
duction and Scope clauses have been slightly modified and Annex
A has been normative. In all other respects, the text and format of
the document are unchanged as of the date of writing this note
ŽJune 2001.. Changes proposed at the meeting of ISOrTC
212rWG 1 in Vancouver, March 2001, were withdrawn by
resolution w5x at the meeting of ISOrTC 212 in Dublin, June
2001.
Table 2
Structure of ISOrDIS 15189
Contents:
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4.Management requirements . . .
5. Technical requirements . . .
Annexes
A Žinformative.: Cross reference tables
B Žinformative.: Lab Information Systems
C Žinformative.: Ethics in Laboratory Medicine
D Žinformative.: Bibliography
clinical laboratories. For the first time, there will
be an internationally recognized standard designed
specifically for the accreditation of medical laborato-
ries. Work on this document started in 1995 in
Working Group 1 of ISO technical Committee 212
ŽISOrTC 212rWG 1.. The text discussed here is
that agreed at the ISOrTC 212 meeting in Philadel-
phia in June 2000.
The uses of 15189 will probably differ in different
countries
Ø as a stand-alone accreditation standard in coun-
tries which currently use AlocalB standards de-
signed specifically for the accreditation of med-
ical laboratories and in countries which are
Table 3
ISOrDIS 15189, extract from the Introduction
Introduction
This International Standard provides requirements relevant to the
quality management of medical laboratories . . . .
Medical laboratory services are essential to patient care and
therefore should be available to meet the needs of all patients and
clinical personnel . . . .
These services include arrangements for requisition, patient
preparation, patient identification, collection of samples,
transportation, storage, processing and examination of
clinical samples with subsequent validation, interpretation,
reporting, and advice, as well as safety and ethics of
medical laboratory work . . . .
Bodies that recognise the competence of medical laboratories may
use this International Standard as the basis for their activities.
If a laboratory seeks accreditation for a part or all of its activities,
it should select an accreditation body that operates in a manner,
which takes into account the special requirements of
medical laboratories . . . .
 D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 4
ISOrDIS 15189, subclause headings of clause 4
4 Management requirements:
4.1 Organization and management
4.2 Quality management system
4.3 Document control
4.4 Examination by referral laboratories
4.5 External services and supplies
4.6 Identification and control of nonconformities
4.7 Corrective action
4.8 Advisory services and resolution of complaints
4.9 Continuous improvement process
4.10 Quality and technical records
4.11 Internal audits
4.12 Management review
establishing new medical laboratory accredita-
tion systems;
Ø as a guidance document for the application of
ISOrIEC 17025 Žthe successor to Guide 25
and EN 45001. in medical laboratories in some
countries which currently use the Acalibration
and testing laboratoryB standards for accredita-
tion of medical laboratories.
Table 5
ISOrDIS 15189, selected subclauses from clause 4 Management
requirements
4.1.2 Medical laboratory services, including . . . interpretation and
advisory services, shall be designed to meet the needs of patients
and . . . clinical personnel . . . .
4.4.4 The referring laboratory and not the referral laboratory shall
report . . . results and findings. The report shall include all essential
elements . . . without alterations that could effect clinical
interpretation.
Note: This does not mandate that the laboratory report every word
and the exact format of the referral lab report unless required by
nationalrlocal laws . . . may provide additional interpretative
remarks wauthor must be identifiedx.
4.6.1.c The medical significance of the nonconforming
examinations is considered, and where appropriate, the requesting
clinician informed.
4.8.2 Appropriate laboratory professional staff shall provide
advice on choice of examinations and use of the service . . . where
appropriate, interpretation of the results of examinations shall
be provided.
4.12.1 . . . management shall review the laboratory’s quality
management system and all of its medical services, including
examination and advisory activities to ensure continuing
suitability and effectiveness in support of patient care.
123
Table 6
ISOrDIS 15189, subclause headings of clause 5
5 Technical requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment
5.4 Pre-examination process
5.5 Examination procedures
5.6 Assuring the quality of examination procedures
5.7 Post-examination process
5.8 Reporting of results
5.9 Alterations and amendments of reports
ISOrDIS 15189 includes cross-reference tables
showing the correspondence between sub-clauses of
15189 and ISO 9001:2000 w6x and between 15189
and ISOrIEC 17025.
ISO 15189 incorporates a large part of the EC4
AEssential criteria for quality systems of medical
laboratoriesB w7x and AAdditional essential crite-
ria . . . B w8x. A recent paper, also from EC4, gives
details of the correspondences between the AEssen-
tial criteriaB documents and ISO 15189 and 17025
w9x.
The structure of the draft standard is shown in
Table 2.
An Introduction followed by clauses 1–3: Scope,
NormatiÕe references and Terms and definitions
is the usual structure for an ISO standard. The
main normative text is in sections 4 and 5 and there
are four annexes, which are designated as Ainforma-
tive.B 4 Division of the normative text into Manage-
ment and Technical requirements parallels the struc-
ture of ISOrIEC 17025.
The Introduction ŽTable 3. clearly places the ac-
tivities of the medical laboratory in the context of
patient care and emphasizes that medical laboratories
have special requirements which must be taken into
4
ANormativeB and AinformativeB are terms used in interna-
tional standards work to distinguish two kinds of text in standards
documents. NormatiÕe text is the core of the standard, and
contains requirements, which must be satisfied in order to claim
compliance with the standard. InformatiÕe text does not contain
requirements, and is given for information only. The informative
text of a standard includes the Introduction, all text in Notes, and
any annexes which are stated to be Informative.
124 D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
Table 7
ISOrDIS 15189, selected subclauses from clause 5 Technical
requirements
5.1.3 The laboratory shall be directed by a person or persons . . .
who have the competence to assume responsibility for the
service provided.
Note 1: Competence is here understood as the product of basic
academic, postgraduate, and continuing education, as well as
training and experience of several years in a medical laboratory.
5.1.4 The responsibilities of the laboratory director or
designees shall include professional, scientific, consultative
or advisory, organisational, administrative, and educational
matters . . . .
5.1.10 There shall be a continuing education programme available
for all levels of staff.
5.1.13 The personnel making professional judgements with
reference to examinations shall have applicable theoretical and
practical background as well as recent experience. They shall
take part in regular professional development or other
professional liaison.
5.4.1 The request form shall contain sufficient information to
identify the patient and the authorised requester, as well as
providing pertinent clinical data . . . .
5.4.2 Specific instructions for the proper collection and
handling of primary samples . . . shall be contained in a primary
sample collection manual.
5.5.1 The laboratory shall use examination procedures . . . which
meet the needs of the users of laboratory services . . . Procedures
published in peer-reviewed texts or journals or as international,
national or regional recommended guidelines are preferred.
In-house procedures shall be appropriately validated . . . .
5.6.4 The laboratory shall participate in . . . external quality
assessment . . . .
5.6.5 wwhere EQA is not available, the laboratory shall develop
alternatives such as exchange of samples with other laboratoriesx.
5.7.1 Authorized personnel shall systematically review and
authorize the release of results of examinations.
5.8.1 The laboratory management shall be responsible for the
formatting of reports . . . to be determined in discussion with the
users of the service
5.8.6 wprocedures for notification of results falling within
AalertB or AcriticalB intervalsx
5.8.7 . . . turnaround time shall reflect clinical needs.
account when they are being assessed for accredita-
tion.
The structure of clause 4, Management require-
ments, is shown in Table 4. The clause includes all
the essential points which are also found in other
accreditation standards, but emphasizes the impor-
tance and special nature of the patient care environ-
ment in which medical laboratories operate ŽTable
5..
The structure of clause 5, Technical requirements,
is shown in Table 6. Here again, the clause covers
the requirements of other accreditation standards, but
gives the necessary attention to the realities of the
medical environment, including the requirements of
the pre- and post-examination phases of the medical
laboratory process ŽTable 7..
Annex C ŽTable 8., Ethics in Laboratory Medi-
cine, although it is not part of the normative text,
provides further illustration of the special nature of
medical laboratories. In particular, it emphasizes that
the patient’s welfare is paramount ŽC.2.1. and that
the laboratory has responsibilities to the patient,
which do not end with the issuing of a test result
ŽC.6.3.. When ethical problems are considered, ac-
count must be taken not only of legal considerations
but also of the patient’s best interests ŽC.9.1..
Table 8
ISOrDIS 15189, extracts from Annex C, Ethics in Laboratory
Medicine
C.1.1 . . . professional personnel are bound by the ethical codes
of their respective profession. Each country may have
specific rules or requirements . . . .
C.2.1 The general principle . . . is that the patient’s welfare is
paramount . . . .
C.4.1 All procedures . . . require informed consent . . . .
C.6 Reporting of results
C.6.1 Results will normally be reported to the requesting
physician and may be reported to other parties with the
patient’s consent, or as required by law. Results . . . that
have been separated from all patient identification may
be used for such purposes as epidemiology, demography,
or other statistical analysis.
C.6.3 . . . the laboratory has an additional responsibility to ensure
that as far as possible, the examinations are correctly interpreted
and applied in the patient’s best interest. Specialist
advice with regard to the selection and interpretation of
examinations is part of the laboratory service.
C.9 Use of samples for examination purposes other than those
requested
C.9.1 The use of samples for purposes other than those requested
without prior consent should occur only if the residual
samples are made anonymous or have been pooled.
Laboratoriesrinstitutions should have documented policies
on how to handle unrequested information Že.g. follow-up
examinations to clarify previous results. from identifiable
samples taking into account the legal implications and the
patient’s best interests. Relevant national, regional, and
local regulatory requirements should be observed.
 D. Kenny r Clinica Chimica Acta 309 (2001) 121–125
3. ISO r DIS 15190 Csafety management for medi-
cal laboratoriesD 5
This draft standard w10x, also produced by ISOrTC
212rWG 1, has been circulated by ISO for comment
and voting, with a deadline of 23 April 2001. As
DIS, it will then be subject to modification in re-
sponse to the comments received. This document
may be regarded as a supplement to 15189, covering
the safety issues which must also be considered in
the accreditation of medical laboratories.
In addition to the normative text, the document
has three Informative annexes.
Annex A: Outline plan for the implementation
of the standard
Annex B: Laboratory Safety Audit wmodel ques-
tionnairex
Annex C: Decontamination, cleaning and disin-
fection of medical laboratory equipment.
4. What next?
It is expected that new versions of nationalrlocal
accreditation standards will be revised so that accred-
ited laboratories will satisfy the requirements of ISO
15189. CPA ŽUK. have already produced a new
version of their accreditation standards, based on
15189 and also cross-referenced to ISO 17025 w3x
and the EC4 AEssential requirementsB w7,8x.
Two new work items for ISOrTC 212rWG 1
have now been approved:
Ø AGuidance document on the application of ISO
15189, Quality management in the medical lab-
oratoryB and
Ø AQuality Management of point of care testing
ŽPOCT.B.
5
Renamed CMedical laboratories—Requirements for safetyD in
June 2001 w5x.
125
Criteria for quality systems of Point of Care Testing
are included in the EC4 AAdditional essential crite-
riaB document w7x, which can be used as a source of
material for the new draft on this subject.
Acknowledgements
Text quoted from ISOrDIS 15189 is used here by
permission of ISO, which holds the copyright.
References
w1x ISOrIEC Guide 25, General requirements for the compe-
tence of calibration and testing laboratories, 3rd edn. Interna-
tional Organization for Standardization, Geneva, 1990.
w2x EN 45001, General criteria for the operation of testing
laboratories. European Committee for Standardization, Brus-
sels, 1991.
w3x ISOrIEC 17025, General requirements for the competence
of testing and calibration laboratories. International Organiza-
tion for Standardization, Geneva, 1999.
w4x ISOrDIS 15189, Quality management in the medical labora-
tory. International Organization for Standardization, Geneva,
2000.
w5x ISOrTC 212 N90 Resolutions of the seventh meeting,
Dublin, Ireland, 6 and 8 June 2001. International Organiza-
tion for Standardization, Geneva, 2001.
w6x ISO 9001:2000, Quality management systems—Require-
ments. International Organization for Standardization, Gene-
va, 2000.
w7x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM,
´ S, Allman B. Essential criteria for quality systems of
Zerah
medical laboratories. Eur J Clin Chem Clin Biochem
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w8x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM,
´ S, Allman B. Essential criteria for quality systems of
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w9x Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W,
Plebani M, Queralto JM, Zerah´ S, van Lieshout J. Usefulness
of EC4 essential criteria for quality systems of medical
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w10x ISOrDIS 15190, Clinical laboratory medicine—Safety man-
agement for medical laboratories. International Organization
for Standardization, Geneva, 2000.