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

accreditation of industrial Acalibration and testing
It is now universally recognized by professional laboratoriesB Žthese documents have recently been
bodies, governments, health care administrators and replaced by the new standard ISO 17025 w3x..
other interested parties that accreditation ŽTable 1. of It should be obvious that there is a fundamental
clinicalrmedical laboratories is essential in order to difference between
ensure the high standards of service which patients - testing industrial products to see Žfor example.
and clinicians should be able to take for granted. if they comply with the appropriate regulations and
Until now, accreditation of medical laboratories - the testing of patient samples which constitutes
has been based either on AlocalB standards, e.g. CAP a large part of the role of the clinical laboratory’s
ŽUS., CPA ŽUK., CCKLTest ŽNL., 1 or on interna- service Žand of course there is more to the clinical
tional standards which are not particularly suited for laboratory service than merely performing tests and
the purpose: ISO Guide 25 w1x or its European 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-
)
Tel.: q353-1-409-6434; fax: q353-1-455-9073. cal laboratories, including such aspects as
E-mail address: [email protected] ŽD. Kenny..
1
CAPsCollege of American Pathologists; CPA sClinical
¨
Pathology Accreditation; CCKL sCoordinatie Commissie voor Ø advising on the use of the service,
Kwaliteitsbewaking in Laboratoria in de gezondheidszorg. 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 Table 2
ISO definition of accreditation Structure of ISOrDIS 15189
Accreditation: Contents:
AProcedure by which an authoritative body gives formal Introduction
recognition that a body or person is competent to carry out 1. Scope
specific tasksB ŽISOrIEC Guide 2.. 2. Normative references
3. Terms and definitions
4.Management requirements . . .
5. Technical requirements . . .
Ø contributing to clinical audit, Annexes
Ø organizing the service to meet medical needs, A Žinformative.: Cross reference tables
for example with respect to turnaround times B Žinformative.: Lab Information Systems
C Žinformative.: Ethics in Laboratory Medicine
and responding to medical emergencies,
D Žinformative.: Bibliography
Ø education and training, not only of laboratory
staff but also of medical, nursing and other
professional staff Žthis is not an exhaustive
clinical laboratories. For the first time, there will
list..
be an internationally recognized standard designed
specifically for the accreditation of medical laborato-
To fulfil this need, a newly established ISO Tech-
ries. Work on this document started in 1995 in
nical Committee, ISO TC 212, began work in 1995
Working Group 1 of ISO technical Committee 212
on a draft which is now wDecember 2000x close to ŽISOrTC 212rWG 1.. The text discussed here is
acceptance as an ISO standard: ISO 15189 AQuality
that agreed at the ISOrTC 212 meeting in Philadel-
management in the medical laboratoryB w4x. The
phia in June 2000.
document is also being processed by CEN ŽComité
The uses of 15189 will probably differ in different
´ de Normalisation. as a draft European
Europeen
countries
Standard.
When finalised within ISO, this document will be
Ø as a stand-alone accreditation standard in coun-
circulated by ISO and CEN for final vote as an
tries which currently use AlocalB standards de-
international and European standard. Its adoption as
signed specifically for the accreditation of med-
a European standard ŽEN. will give it the status of a
ical laboratories and in countries which are
national standard in all CEN member countries.
Table 3
ISOrDIS 15189, extract from the Introduction
2. ISO r DIS 2 15189 CQuality management in the
Introduction
medical laboratoryD 3 This International Standard provides requirements relevant to the
quality management of medical laboratories . . . .
The purpose of this standard is to provide a basis Medical laboratory services are essential to patient care and
for Quality systems and Accreditation in medicalr 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,
2
DISs Draft International Standard. transportation, storage, processing and examination of
3
Since the presentation of this paper in October 2000, the title clinical samples with subsequent validation, interpretation,
of this document has been changed to CMedical laboratories— reporting, and advice, as well as safety and ethics of
Particular requirements for quality and competenceD. The Intro- medical laboratory work . . . .
duction and Scope clauses have been slightly modified and Annex Bodies that recognise the competence of medical laboratories may
A has been normative. In all other respects, the text and format of use this International Standard as the basis for their activities.
the document are unchanged as of the date of writing this note If a laboratory seeks accreditation for a part or all of its activities,
ŽJune 2001.. Changes proposed at the meeting of ISOrTC it should select an accreditation body that operates in a manner,
212rWG 1 in Vancouver, March 2001, were withdrawn by which takes into account the special requirements of
resolution w5x at the meeting of ISOrTC 212 in Dublin, June medical laboratories . . . .
2001.
 D. Kenny r Clinica Chimica Acta 309 (2001) 121–125 123

Table 4 Table 6
ISOrDIS 15189, subclause headings of clause 4 ISOrDIS 15189, subclause headings of clause 5
4 Management requirements: 5 Technical requirements
4.1 Organization and management 5.1 Personnel
4.2 Quality management system 5.2 Accommodation and environmental conditions
4.3 Document control 5.3 Laboratory equipment
4.4 Examination by referral laboratories 5.4 Pre-examination process
4.5 External services and supplies 5.5 Examination procedures
4.6 Identification and control of nonconformities 5.6 Assuring the quality of examination procedures
4.7 Corrective action 5.7 Post-examination process
4.8 Advisory services and resolution of complaints 5.8 Reporting of results
4.9 Continuous improvement process 5.9 Alterations and amendments of reports
4.10 Quality and technical records
4.11 Internal audits
4.12 Management review

ISOrDIS 15189 includes cross-reference tables

showing the correspondence between sub-clauses of
15189 and ISO 9001:2000 w6x and between 15189
establishing new medical laboratory accredita-
and ISOrIEC 17025.
tion systems;
ISO 15189 incorporates a large part of the EC4
Ø as a guidance document for the application of
AEssential criteria for quality systems of medical
ISOrIEC 17025 Žthe successor to Guide 25
laboratoriesB w7x and AAdditional essential crite-
and EN 45001. in medical laboratories in some
ria . . . B w8x. A recent paper, also from EC4, gives
countries which currently use the Acalibration
details of the correspondences between the AEssen-
and testing laboratoryB standards for accredita-
tial criteriaB documents and ISO 15189 and 17025
tion of medical laboratories. w9x.
The structure of the draft standard is shown in
Table 2.
Table 5
An Introduction followed by clauses 1–3: Scope,
ISOrDIS 15189, selected subclauses from clause 4 Management
requirements NormatiÕe references and Terms and definitions
4.1.2 Medical laboratory services, including . . . interpretation and
is the usual structure for an ISO standard. The
advisory services, shall be designed to meet the needs of patients main normative text is in sections 4 and 5 and there
and . . . clinical personnel . . . . are four annexes, which are designated as Ainforma-
4.4.4 The referring laboratory and not the referral laboratory shall tive.B 4 Division of the normative text into Manage-
report . . . results and findings. The report shall include all essential ment and Technical requirements parallels the struc-
elements . . . without alterations that could effect clinical
interpretation.
ture of ISOrIEC 17025.
Note: This does not mandate that the laboratory report every word The Introduction ŽTable 3. clearly places the ac-
and the exact format of the referral lab report unless required by tivities of the medical laboratory in the context of
nationalrlocal laws . . . may provide additional interpretative patient care and emphasizes that medical laboratories
remarks wauthor must be identifiedx. have special requirements which must be taken into
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
4
advice on choice of examinations and use of the service . . . where ANormativeB and AinformativeB are terms used in interna-
appropriate, interpretation of the results of examinations shall tional standards work to distinguish two kinds of text in standards
be provided. documents. NormatiÕe text is the core of the standard, and
4.12.1 . . . management shall review the laboratory’s quality contains requirements, which must be satisfied in order to claim
management system and all of its medical services, including compliance with the standard. InformatiÕe text does not contain
examination and advisory activities to ensure continuing requirements, and is given for information only. The informative
suitability and effectiveness in support of patient care. 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 The structure of clause 5, Technical requirements,

ISOrDIS 15189, selected subclauses from clause 5 Technical is shown in Table 6. Here again, the clause covers
requirements
the requirements of other accreditation standards, but
5.1.3 The laboratory shall be directed by a person or persons . . .
gives the necessary attention to the realities of the
who have the competence to assume responsibility for the
service provided. medical environment, including the requirements of
Note 1: Competence is here understood as the product of basic the pre- and post-examination phases of the medical
academic, postgraduate, and continuing education, as well as laboratory process ŽTable 7..
training and experience of several years in a medical laboratory. Annex C ŽTable 8., Ethics in Laboratory Medi-
5.1.4 The responsibilities of the laboratory director or
cine, although it is not part of the normative text,
designees shall include professional, scientific, consultative
or advisory, organisational, administrative, and educational provides further illustration of the special nature of
matters . . . . medical laboratories. In particular, it emphasizes that
5.1.10 There shall be a continuing education programme available the patient’s welfare is paramount ŽC.2.1. and that
for all levels of staff. the laboratory has responsibilities to the patient,
5.1.13 The personnel making professional judgements with
which do not end with the issuing of a test result
reference to examinations shall have applicable theoretical and
practical background as well as recent experience. They shall
ŽC.6.3.. When ethical problems are considered, ac-
take part in regular professional development or other count must be taken not only of legal considerations
professional liaison. but also of the patient’s best interests ŽC.9.1..
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 Table 8
sample collection manual. ISOrDIS 15189, extracts from Annex C, Ethics in Laboratory
5.5.1 The laboratory shall use examination procedures . . . which Medicine
meet the needs of the users of laboratory services . . . Procedures C.1.1 . . . professional personnel are bound by the ethical codes
published in peer-reviewed texts or journals or as international, of their respective profession. Each country may have
national or regional recommended guidelines are preferred. specific rules or requirements . . . .
In-house procedures shall be appropriately validated . . . . C.2.1 The general principle . . . is that the patient’s welfare is
5.6.4 The laboratory shall participate in . . . external quality paramount . . . .
assessment . . . . C.4.1 All procedures . . . require informed consent . . . .
5.6.5 wwhere EQA is not available, the laboratory shall develop C.6 Reporting of results
alternatives such as exchange of samples with other laboratoriesx. C.6.1 Results will normally be reported to the requesting
5.7.1 Authorized personnel shall systematically review and physician and may be reported to other parties with the
authorize the release of results of examinations. patient’s consent, or as required by law. Results . . . that
5.8.1 The laboratory management shall be responsible for the have been separated from all patient identification may
formatting of reports . . . to be determined in discussion with the be used for such purposes as epidemiology, demography,
users of the service or other statistical analysis.
5.8.6 wprocedures for notification of results falling within C.6.3 . . . the laboratory has an additional responsibility to ensure
AalertB or AcriticalB intervalsx that as far as possible, the examinations are correctly interpreted
5.8.7 . . . turnaround time shall reflect clinical needs. 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
account when they are being assessed for accredita- requested
C.9.1 The use of samples for purposes other than those requested
tion. without prior consent should occur only if the residual
The structure of clause 4, Management require- samples are made anonymous or have been pooled.
ments, is shown in Table 4. The clause includes all Laboratoriesrinstitutions should have documented policies
the essential points which are also found in other on how to handle unrequested information Že.g. follow-up
accreditation standards, but emphasizes the impor- examinations to clarify previous results. from identifiable
samples taking into account the legal implications and the
tance and special nature of the patient care environ- patient’s best interests. Relevant national, regional, and
ment in which medical laboratories operate ŽTable local regulatory requirements should be observed.
5..
 D. Kenny r Clinica Chimica Acta 309 (2001) 121–125 125

3. ISO r DIS 15190 Csafety management for medi- Criteria for quality systems of Point of Care Testing
cal laboratoriesD 5 are included in the EC4 AAdditional essential crite-
riaB document w7x, which can be used as a source of
This draft standard w10x, also produced by ISOrTC material for the new draft on this subject.
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 Acknowledgements
may be regarded as a supplement to 15189, covering
the safety issues which must also be considered in Text quoted from ISOrDIS 15189 is used here by
the accreditation of medical laboratories. permission of ISO, which holds the copyright.
In addition to the normative text, the document
has three Informative annexes.

Annex A: Outline plan for the implementation References

of the standard
Annex B: Laboratory Safety Audit wmodel ques- w1x ISOrIEC Guide 25, General requirements for the compe-
tionnairex tence of calibration and testing laboratories, 3rd edn. Interna-
Annex C: Decontamination, cleaning and disin- tional Organization for Standardization, Geneva, 1990.
fection of medical laboratory equipment. 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-
4. What next? tion for Standardization, Geneva, 1999.
w4x ISOrDIS 15189, Quality management in the medical labora-
It is expected that new versions of nationalrlocal tory. International Organization for Standardization, Geneva,
2000.
accreditation standards will be revised so that accred- w5x ISOrTC 212 N90 Resolutions of the seventh meeting,
ited laboratories will satisfy the requirements of ISO Dublin, Ireland, 6 and 8 June 2001. International Organiza-
15189. CPA ŽUK. have already produced a new tion for Standardization, Geneva, 2001.
version of their accreditation standards, based on w6x ISO 9001:2000, Quality management systems—Require-
15189 and also cross-referenced to ISO 17025 w3x ments. International Organization for Standardization, Gene-
va, 2000.
and the EC4 AEssential requirementsB w7,8x. w7x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM,
Two new work items for ISOrTC 212rWG 1 ´ S, Allman B. Essential criteria for quality systems of
Zerah
have now been approved: medical laboratories. Eur J Clin Chem Clin Biochem
1997;35:121–32.
w8x Jansen RTP, Blaton V, Burnett D, Huisman W, Queralto JM,
Ø AGuidance document on the application of ISO
´ S, Allman B. Essential criteria for quality systems of
Zerah
15189, Quality management in the medical lab- medical laboratories. Clin Chem Lab Med 1998;36:249–52.
oratoryB and w9x Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W,
Ø AQuality Management of point of care testing Plebani M, Queralto JM, Zerah´ S, van Lieshout J. Usefulness
ŽPOCT.B. of EC4 essential criteria for quality systems of medical
laboratories as guidelines to the ISO 15189 and ISO 17025
documents. Clin Chem Lab Med 2000;38:1057–64.
w10x ISOrDIS 15190, Clinical laboratory medicine—Safety man-
5
Renamed CMedical laboratories—Requirements for safetyD in agement for medical laboratories. International Organization
June 2001 w5x. for Standardization, Geneva, 2000.