Clin Chem Lab Med 2000; 38(10):10571064 2000 by Walter de Gruyter Berlin New York

Usefulness of EC4 Essential Criteria for Quality Systems of Medical

Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents

European Community Confederation of Clinical

Chemistry (EC4) Working Group on Harmonisation of
Quality Systems and Accreditation

ity Management; FDIS, Final Draft International Standard.

Rob T.P. Jansen1, Desmond Kenny2, Vic Blaton3, David

Burnett4, Wim Huisman5, Mario Plebani6, Josep M.
Queralt7, Simone Zrah8 and Joep van Lieshout9

Introduction

Nederlandse Vereniging voor Klinische Chemie (NVKC),

Department of Clinical Chemistry, St. Anna Hospital,
Geldrop, The Netherlands
2
Association of Clinical Biochemistry in Ireland (ACBI),
Department of Clinical Biochemistry, Our Ladys Hospital for
Sick Children, Crumlin, Dublin, Ireland
3 Belgische Vereniging voor Klinische Chemie (BVKC),
Department of Clinical Chemistry, St. Jan Academic Hospital,
Brugge, Belgium
4 Association of Clinical Biochemists (ACB), Department of
Clinical Biochemistry, St. Albans City Hospital, St. Albans, UK
5
Department of Clinical Chemistry, Westeinde Ziekenhuis,
The Hague, The Netherlands
6
Societ Italiana di Biochimica Clinica e Biologia Molecolare
Clinica (SIBioC), Servizio di Medicina di Laboratorio, Azienda
Ospedaliera di Padova, Padova, Italy
7
Sociedad Espagola de Bioqumica Clinica e Pathologa
Molecular (SEQC), Servei de Bioqumica, Hospital Santa Creu
i Sant Pau, Barcelona, Spain
8
Societ Francaise de Biologie Clinique (SFBC), Laboratoire
danalyse de biologie mdicale, Bagnolet, France
9 European Diagnostic Manufacturers Association (EDMA),
Organon Teknika, Boxtel, The Netherlands

Many medical laboratories have made a start with the

introduction of quality management systems. However, it is still not clear against which standards such
systems should be measured. The existing ISO and
CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential
Criteria has stimulated the development of the
ISO/Draft International Standard 15189. This standard
seems adequate for our type of laboratories. However,
it is not easy to read. The EC4 Essential Criteria could
well serve as a guide, covering additional aspects, e.g.
on total quality management and budget management as required in the EFQM model, that are not (yet)
included in the ISO standard. In the present article the
EC4 Essential Criteria are cross-referenced with two
new international ISO standards, ISO/FDIS 15189 and
ISO/FDIS 17025, the latter being the successor of ISO
guide 25 and EN 45000. Both new ISO documents are
in compliance with the new ISO 9000:2000 standard.
Key words: Quality management; Accreditation; Standards.
Abbreviations: EFQM, European Foundation for Qual-

The issue of quality management systems and accreditation is gaining increasing interest in our profession.
All over Europe laboratories have started to introduce
quality management systems and harmonization of
criteria for accreditation is of increasing importance.
The standards to be used as basis for such systems are
the subject of much discussion. Existing international
standards for general use, like the ISO 9000 series, and
for general laboratories, like ISO guide 25 and the
EN 45000 series, do not seem to fit the specific needs of
medical laboratories. Recently, Essential Criteria for
Quality Systems in the Medical Laboratory have been
published (1, 2) by the European Communities Confederation of Clinical Chemistry (EC4). This publication
has stimulated the development by ISO of the Final
Draft International Standard (FDIS) 15189 Quality
Management in the Medical Laboratory (3). This standard seems better suited for the needs of our laboratories. However, the standard is not easy to read and a
guideline will be of use. The EC4 Essential Criteria can
serve as such a guideline. ISO has produced also a new
FDIS 17025 General Requirements for the Competence of Testing and Calibrating Laboratories(4) for
general laboratories, the successor of ISO guide 25 and
EN 45000. In this article a cross-reference is made between the EC4 Essential Criteria and the two new ISO
documents. Attention is paid to the differences and
omissions are discussed. The EC4 Essential Criteria
and the later published Additional Essential Criteria are
considered as one integral document. In these publications the Essential Criteria refer to the ISO 9000, ISO
guide 25 and EN 45000 documents. In the present paper the Essential Criteria are not cross-referenced with
ISO 9000:2000, the successor document of ISO 9000.
Both ISO FDIS 15189 and ISO FDIS 17025 cover the requirements of ISO 9000:2000, which make them easily
acceptable for the public.

Methods
The Essential Criteria and the Additional Essential Criteria, as
these were published (1, 2), are considered as one integral
document.
A comparison is made of each section and subsection of the
Essential Criteria with the paragraphs and subparagraphs of
the draft documents ISO/FDIS 15189 and ISO/FDIS 17025. In
the ISO documents various items of the EC4 criteria are de-

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Jansen et al.: EC4 essential criteria as guideline to ISO 15189

scribed over several paragraphs. In such cases the different

paragraphs are indicated separated by a slash. When an item
in the Essential Criteria is not clearly addressed in the ISO document, this is indicated as not addressed. In the discussion
attention is paid to the most important of these items.

Discussion
The ISO/FDIS 15189 Quality Management in the Medical Laboratory is an important document for medical
laboratories. It is intended to be the standard which
medical laboratories use in developing their quality
systems in a harmonized context. Its development was
influenced strongly by the EC4 Essential Criteria for
Quality Systems in Medical Laboratories (1, 2), which
are referenced to ISO 9000, ISO guide 25 and EN 45000.
A comparison was made of the EC4 Essential Criteria,
ISO/FDIS 15189 and a third document, the ISO/FDIS
17025, the new standard for general laboratories and
successor of ISO guide 25 and EN 45000. In Table 1 a
cross-reference is given of the EC4 Essential Criteria,
including the Additional Essential Criteria, which were
published later, and the two ISO documents.
Regarding required general information, ISO
17025 does not require that a list of repertoire should
be made available. Both ISO 17025 and 15189 do not
require a list for the STAT repertoire. Other items not
addressed, such as the requirement of a summary of
definitions, terms and abbreviations and stating of

Tab. 1

name and title of the director may seem trivial, but are
according to EC4, essential for a complete quality system.
This also applies to the requirement to refer to the
quality system and the documents of the parent organisation, if they exist.
Criteria for an adequate budget management system are almost completely lacking in ISO 17025 and are
mentioned only partly in ISO 15189. For example requirements for evaluation of investment capital expenditure or the cost per test and workstation are not addressed.
The review of technical aspects in meetings of academic and non-academic staff is needed for maintaining
technical standards as well as motivation of staff. Also
personnel satisfaction monitoring and an appraisal
system are not addressed in the ISO documents. With
respect to personnel management and also budget
management the EC4 criteria include the basic ideas of
European Foundation for Quality Management (EFQM)
(5). These are only to a very limited extent addressed in
the ISO documents.
Also requirements for safety aspects are not mentioned in both ISO documents. However, the ISO TC
212 has produced a Draft document ISO 15190, which
is focussed on safety.
The management of point of care testing and the responsibilities of parties concerned is an increasingly
important subject. Therefore EC4 has produced (additional) essential criteria for this aspect of laboratory

Cross-reference EC4 essential criteria and ISO 15189 and ISO 17025.

EC4 essential criteria

ISO/FDIS 15189

ISO/FDIS 17025

Section

Description

Paragraph

Paragraph

1
1.1
1.1.1
1.2
1.2.1
1.2.2
1.3
1.3.1
1.3.2
1.3.3
1.4
1.4.1
1.4.2
1.4.3
1.4.4
1.5
1.5.1
1.5.2
1.5.3
1.5.4
1.6
1.6.1
1.7
1.7.1
1.7.2

General information
Introduction
Scope of the quality system
Definitions and abbreviations
Used terms
Abbreviations
Legal identity
Legal identity
Name and title of director
Position of laboratory within parent organisation
Clinical advisory service based on analytical facilities
List of activities
List of methodologies
List of repertoire
Types of requesting service users
Research and development
Evaluation of new methodology
Involvement in research
Clinical research
Support to clinical trials
Teaching
Partaking in teaching
Subcontractors
List of activities performed by subcontractors
Selection of subcontractors

Not addressed

4.2.1/4.2.2b

Not addressed
Not addressed

Not addressed
Not addressed

4.1.1
Not addressed
4.1.1/4.1.4.c

4.1.1
Not addressed
(4.1.3) 4.1.4e

4.1.2
5.5.6
5.5.6
Not addressed

4.2.1
Not addressed
Not addressed
Not addressed

5.1.4.m
5.1.4.m
Not addressed
Not addressed

5.4
(5.4.3)
Not addressed
Not addressed

5.1.4.l

Not addressed

4.4.3
4.4.1/4.4.2

4.5.5
4.5.3

Jansen et al.: EC4 essential criteria as guideline to ISO 15189

Tab. 1

Continue.

EC4 essential criteria

ISO/FDIS 15189

ISO/FDIS 17025

Section

Description

Paragraph

Paragraph

2
2.1
2.1.1
2.2
2.2.1
2.2.2
2.2.3
2.3
2.3.1
2.3.2
2.3.3
2.3.4
2.3.5
2.3.6
2.3.7
2.3.8
2.3.9
2.3.10
2.4
2.4.1
2.5
2.5.1

Quality policy and strategy

Quality policy of the parent organisation
References to documents of parent organisation
Quality policy of the laboratory
General quality policy
Safety for personnel and environment
Measures for protection for personnel and environment
Quality strategy of the laboratory
Quality manual
Quality goals
General structure of documents
General format of procedures
Document control
Document identification
Valid versions
Accessibility of quality manual
Active involvement of personnel in the system
Evaluation of procedures
Confidentiality
Patient information
Improper influence
Measures against improper influence

Not addressed

Not addressed

4.1.2/4.2.3
5.1.4.o/5.2.2
5.1.4.o/5.2.2

4.2.2
Not addressed
Not addressed

4.2.5
4.1.5
4.2.4
Not addressed
4.3.1
4.3.3
4.3.1/4.3.2
4.2.1/4.2.4
4.2.3.b
4.3.2.d

4.2.2/4.2.3/4.2.4
Not addressed
4.2.1
Not addressed
4.3.1
4.3.2.3
4.3.2.1
4.3.2.2a
4.2.1
4.3.2.2b

C.6.1

Not addressed

C.10.1/C.10.2

4.1.3/4.1.4b/4.1.4d

3
3.1
3.1.1
3.2
3.2.1
3.2.2
3.3
3.3.1
3.3.2
3.3.3
3.3.4
3.3.5
3.3.6
3.3.7
3.4
3.4.1
3.4.2
3.5
3.5.1
3.5.2
3.5.3
3.5.4
3.5.5
3.5.6
3.5.7
3.5.8
3.5.9
3.5.10

Organisation and management

External relationship
Position of laboratory within parent organisation
Internal organisation structure
Management diagram
List of functions
Budget management
Report of strategy and production
Budgeting and debiting system
Responsibilities for budget and efficiency
Budget responsibility of head of the laboratory
Investment matching with aims of parent organisation
Management information system
Documentation on number of tests
Head of the laboratory
Education of head of the laboratory
Overall responsibility of head of the laboratory
Professional staff and other staffing
Professional staff training
Professional staff responsibility
Quality officer
Safety advisor
Appropriate number of staff
Staff meetings to review services
Staff meetings to review technical aspects
Overall responsibility for point of care testing
Establishing clinical need for point of care testing
Management of point of care testing service

4.1.4.c

4.1.3/4.1.4e

4.1.4.c
5.1.1/5.1.2/5.1.7

4.1.4e
4.1.4f

Not addressed
5.1.4.k
5.1.4.k
5.1.4.k
Not addressed
Not addressed
Not addressed

Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed

5.1.3
4.1.4/5.1.4

Not addressed
Not addressed

5.1.2/5.1.4/5.1.13
5.1.4.a/5.1.4.d
4.1.4.f/4.2.4
Not addressed
5.1.4.i/5.1.5
4.12.4
Not addressed
Not addressed
Not addressed
Not addressed

Not addressed
4.1.4f
4.1.4i
Not addressed
4.1.4a
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed

4
4.1
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.1.7

Personnel
Job descriptions, duties and responsibilities
Job descriptions
Copy of job description for staff
Specification of duties and responsibilities
Liability of staff
Personnel satisfaction monitoring
Allocation of point of care testing responsibilities
Definition of point of care testing responsibilities

5.1.1/5.1.2
Not addressed
4.1.4.d/5.1.1/5.1.7
Not addressed
Not addressed
Not addressed
Not addressed

5.2.4
Not addressed
4.1.4f/5.2.5
Not addressed
Not addressed
Not addressed
Not addressed

1059

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Tab. 1

Continue.

EC4 essential criteria

ISO/FDIS 15189

ISO/FDIS 17025

Section

Description

Paragraph

Paragraph

4.2
4.2.1
4.3
4.3.1
4.3.2
4.3.3
4.3.4
4.3.5
4.3.6
4.3.7
4.3.8
4.4
4.4.1

Service and leave planning; sickness substitution

Time scheduling, leave planning, sickness substitution
Education, training and development of staff
Continuing education programme for all staff
Post-graduate education of professional staff
Availability of handbooks and literature
Supervising point of care testing staff
Training of point of care testing staff
Testing and certifying of point of care testing staff
Registration of point of care testing staff
Continuing education for point of care testing staff
Staff appraisal system
Records of appraisal and objectives for staff

Not addressed

Not addressed

5.1.2/5.1.10
5.1.3/5.1.13
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed

5.2.2
5.2.2
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed

Not addressed

Not addressed

5
5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
5.1.6
5.1.7
5.1.8
5.1.9
5.2
5.2.1
5.2.2
5.3
5.3.1
5.3.2
5.3.3
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.5
5.5.1
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
5.6
5.6.1
5.7
5.7.1
5.7.2

Premises and environment

Laboratory space
Adequate bench space
Adequate space for each specialisation
Adequate space for personnel to perform functions
Equipment space
Circulation space
Space for sample reception and handling
Separate space for high risk work
Access regulation
Good house keeping of areas
Office space
Office space for professional staff and administration
Computer space
Facilities for personnel
Staff relaxation
Locker space
Sanitary accommodation
Facilities for patients
Reception area
Waiting space
Phlebotomy rooms
Room for collection of special samples
Room for dynamic function tests
Sanitary facilities for urine collection
Safety facilities
Emergency exits
Fire protection
Protection against high risk materials
Safety boxes for high risk materials
Protection against hazards of biological material
Safety of point of care testing environment
Provisions for working environment
Provisions for environmental control
Storage facilities
Refrigerators and freezers
Storage for supplies and specimens

5.2.2
5.2.1/5.2.6
5.2.2
5.2.4
5.2.2
5.2.3
5.2.6
5.2.7
5.2.10/5.2.11

5.3
5.3
5.3
5.3
(5.3)
(5.3)
5.3.3
5.3.4
5.3.5

Not addressed
B.2.1

Not addressed
Not addressed

Not addressed
Not addressed
Not addressed

Not addressed
Not addressed
Not addressed

5.2.3
Not addressed
5.2.3
Not addressed
Not addressed
5.2.3

Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
Not addressed

Not addressed
Not addressed
5.2.2/5.2.5/5.3.7
5.2.9
5.2.2
5.3.6/5.3.7

Not addressed
Not addressed
(5.3.3)
Not addressed
Not addressed
Not addressed

5.2.4/5.2.5

5.3.1/5.3.2

5.2.9
5.2.9

Not addressed
Not addressed

6
6.1
6.1.1
6.1.2
6.1.3
6.1.4
6.2
6.2.1
6.2.2

Equipment, materials and reagents

Administration of equipment
List of equipment
Equipment out of order
Selection of point of care testing equipment
Inventory of point of care testing equipment
Purchasing of equipment
Specification of requirements
Validation of performance of equipment

4.5.3/5.3.4
5.3.6
Not addressed
5.3.4

(5.5.1)/5.5.5
Not addressed
Not addressed
Not addressed

4.5.1/5.3.1
4.5.2/5.3.2

5.5.2
5.5.2

Jansen et al.: EC4 essential criteria as guideline to ISO 15189

Tab. 1

Continue.

EC4 essential criteria

ISO/FDIS 15189

ISO/FDIS 17025

Section

Description

Paragraph

Paragraph

6.2.3
6.2.4
6.2.5
6.2.6
6.3
6.3.1
6.3.2
6.4
6.4.1
6.4.2
6.4.3
6.4.4
6.4.5
6.5
6.5.1
6.5.2
6.5.3
6.5.4
6.5.5
6.5.6
6.6
6.6.1
6.6.2
6.6.3
6.6.4
6.6.5
6.6.6
6.6.7
6.6.8
6.6.9
6.7
6.7.1
6.7.2

Assessment of supplies
Responsibility for criteria for selection
Criteria for selection of equipment
Evaluation of capital expenditure
Calibration
Calibration of basic equipment
Calibration of major equipment
Instructions for use and maintenance
Use and operation of instruments
Periodic maintenance
Logbooks for major equipment
Ordering and operation of equipment outside laboratory
Maintenance of point of care testing equipment
Computer facilities
Documentation of hardware and software
Reliability and back-up
System validation
Facilities for storage
Access protection from non-authorised persons
Access definition
Administration of materials and reagents
Selection of reagents and materials
Purchasing and ordering
Establishing of criteria for reagents and materials
Assessment of suppliers
Condition upon delivery and storing
Inventory control
Identification of reagents and materials
Cost per work station and test
Recording point of care testing reagents and materials
Safety and environment
Danger indication on reagents and materials
Collection of waste

4.5.2
4.5.1
Not addressed
Not addressed

4.6.5
Not addressed
Not addressed
Not addressed

4.2.5/5.3.2/5.3.8
4.2.5/5.3.2/5.3.8/5.6.3

5.5.9
5.5.9

5.3.4/5.3.5
4.2.5/5.3.6
5.3.4.i/5.3.4.j
Not addressed
5.3.4/5.3.5

5.5.3
5.5.7
(5.5.8)
5.5.6 NOTE/5.5.10
5.5.6 NOTE/5.5.10

5.3.10.a/B.3.1
5.3.10.b/B.6.5/B.7.2
5.3.10/B.7.4/B.7.6
B.6.4
B.4.1
B.4.2/B.5.8

5.4.8.2a
5.4.8.2c
5.4.8.2a
Not addressed
5.4.8.2b
5.4.8.2b

4.5.1/5.3.1
Not addressed
4.5.1
4.5.2
4.5.1
4.5.3
4.5.3
Not addressed
Not addressed

4.6.1
4.6.1
4.6.2
4.6.5
4.6.1/4.6.4
Not addressed
4.6.3
Not addressed
Not addressed

Not addressed
Not addressed

Not addressed
Not addressed

7
7.1
7.1.1
7.2
7.2.1
7.2.2
7.2.3
7.2.4
7.2.5
7.2.6
7.2.7
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.4
7.4.1
7.4.2
7.4.3
7.4.4
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.6

Pre-analytical phase
User information
User information system
Consultation and efficacy
Consultation concerning efficacy and repeat frequency
Meetings of professional staff with clinical staff
Participation of professional staff in clinical rounds
Medical audit of consultation function
Documentation on active participation of staff
Consultation on new developments
Consultation on changing services and reference values
Repertoire
List of Stat and 24 hours repertoire
List of repertoire including specimen requirements
Roll of laboratory in point of care testing repertoire
Medical audit of repertoires
Request procedures
Procedures for urgent and routine requests
Design of request form
Efficacy of request form
Indication on request form of requirements for patient
Information and preparation of patients
Information for patients regarding preparatory measures
Information for patients regarding collection of samples
Information for patients regarding opening hours
Criteria for waiting time
Sample collection

5.4.2/5.4.3

Not addressed

4.8.1/5.1.4.a/5.4.3.a
4.8.1/5.1.4.b
4.8.1 Note
5.1.4.e
4.8.1
Not addressed
5.5.7

Not addressed
Not addressed
Not addressed
Not addressed
Not addressed
5.4.2
4.4

Not addressed
5.5.6
Not addressed
5.5.1/5.5.2

Not addressed
Not addressed
Not addressed
Not addressed

5.4.10
5.4.1
Not addressed
Not addressed

5.4.1
Not addressed
Not addressed
Not addressed

5.4.3.a
Not addressed
Not addressed
Not addressed

Not addressed
Not addressed
Not addressed
Not addressed

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Tab. 1

Continue.

EC4 essential criteria

ISO/FDIS 15189

ISO/FDIS 17025

Section

Description

Paragraph

Paragraph

7.6.1
7.6.2
7.6.3
7.7
7.7.1
7.7.2
7.7.3
7.7.4
7.8
7.8.1
7.8.2
7.8.3
7.9
7.9.1
7.9.2
7.9.3

Procedure for specimen collection

Procedure for identification of samples
Information per test of collection requirements
Sample transport and handling
Procedures for transport and handling of samples
Minimising risk of sample interchange
Procedures for transport to referral laboratories
Defining responsibilities regarding referred samples
Experimental testing
Informed consent for experimental testing
Protocols for experimental testing
Expliciting conditions differing from routine
Confidentiality and safety
Guaranteeing biological safety of patient and personnel
Guaranteeing confidentiality of patients
Documentation of accidents

5.4.2/5.4.3
5.4.3.c/5.4.5
5.3.2.b/5.4.3.c/5.4.9

(5.4.1)/5.7.1/5.7.3
5.7.3
5.7.3

5.4.2/5.4.6/5.4.13/5.7.2
Not addressed
4.4.2
4.4.2

5.8.1
5.8.2
Not addressed
4.5

5.4.3.a
Not addressed
5.8.3 Note 2

Not addressed
Not addressed
Not addressed

5.2.2/C.3.2
Not addressed
Not addressed

Not addressed
Not addressed
Not addressed

8
8.1
8.1.1
8.1.2
8.1.3
8.1.4
8.2
8.2.1
8.2.2
8.2.3
8.3
8.3.1
8.3.2
8.3.3
8.3.4
8.3.5
8.4
8.4.1
8.4.2
8.4.3
8.4.4
8.4.5
8.4.6
8.4.7
8.4.8
8.5
8.5.1
8.5.2
8.5.3
8.6
8.6.1
8.6.2
8.6.3
8.6.4
8.6.5
8.6.6
8.6.7
8.6.8
8.7
8.7.1
8.7.2

Analytical phase
Validation
Validation of performance of new methods
Validation items
Limitations of applicability of materials
Manufacturer validation of basic equipment functions
Calibration and traceability of methods
Calibration frequency
Calibration materials
Origin of co-efficients and factors
Working procedures
Written working procedures
Working procedures at the bench
Different types of working procedures
Content of working procedures
Point of care testing working procedures
Quality control and assessment
System of internal quality control
Criteria for judgement of analytical processes
Criteria based on biological variance
Checking of internal quality control results
External quality assessment schemes
Evaluation of internal and external quality results
Quality assessment of point of care testing
Review of point of care quality assessment data
Authorisation
Verifying of measurements by competent staff
Authorisation by senior staff
Final authorisation by professional staff
Archiving
Archiving of outdated procedures
Archiving of requests
Archiving of worklists
Archiving of results
Ensuring patient confidentiality in archives
Archiving internal quality control results
Archiving external quality assessments results
Archive destruction and ensuring confidentiality
Disposal of samples
Considering patient material as infectious
Disposal of samples and contaminated materials

5.5.2/5.6.6
5.5.3
Not addressed
Not addressed

5.4.5
5.4.5
Not addressed
Not addressed

5.3.8
5.6.3
5.3.12/5.6.3

5.6.2.1/5.4.7.1
Not addressed
5.6.2.2.2

5.5.3
4.3.2.c/5.5.3
Not addressed
5.5.3
5.6.6

5.4.1
5.4.1
Not addressed
Not addressed
Not addressed

4.2.2/5.6.1
5.6.1/5.6.2/5.6.3
Not addressed
5.6.2
5.6.4
5.6.4/5.6.5
5.6.5/5.6.6
5.6.5/5.6.6

5.9
Not addressed
Not addressed
Not addressed
5.6.2.2.2/5.9
Not addressed
Not addressed
Not addressed

5.7.1
5.7.1
Not addressed

5.10.2i
5.10.2i
Not addressed

4.10.3
4.10.3
4.10.3
5.8.4
C.6.1
4.10.3
4.10.3
Not addressed

4.3
4.12
4.12.2
4.12.2
Not addressed
4.12
4.12
Not addressed

Not addressed
5.4.3.c/5.7.3

Not addressed
Not addressed

Jansen et al.: EC4 essential criteria as guideline to ISO 15189

Tab. 1

Continue.

EC4 essential criteria

ISO/FDIS 15189

ISO/FDIS 17025

Section

Description

Paragraph

Paragraph

9
9.1
9.1.1
9.1.2
9.1.3
9.1.4
9.1.5
9.2
9.2.1
9.2.2
9.2.3
9.2.4
9.3
9.3.1
9.3.2
9.3.3
9.3.4
9.3.5
9.4
9.4.1
9.4.2
9.5
9.5.1
9.5.2
9.5.3
9.5.4
9.5.5
9.6
9.6.1
9.6.2
9.6.3
9.6.4
9.6.5
9.7
9.7.1

Post-analytical phase
Reporting procedures
Procedures for reporting
Contents of reports
Authorisation before reporting
Reporting of Stat and alarming results
Reporting by telephone
Correction procedures
Responsibility for correction of reported results
Reporting corrected results to requestor
Indication of corrected results
Investigation of underlying cause of wrong result
Turn-around time
Familiarity of physicians with reporting times
Audit of turn-around times of stat and routine tests
Audit of turn-around times of referred tests
Turn-around times in medical audit
Efficacy of turn-around times
Reference values
Availability of reference values
Checking of reference values
Interpretation and consultation
Availability of consultation concerning interpretation
Consultation regarding use of laboratory and results
Consultation in individual cases
Participation in medical and clinical audit
Interpretation remarks on reports
Archiving
Archiving of results
Ensuring patient confidentiality in archives
Back-up procedures for electronic archives
Archive damage protection
Point of care testing result archiving
Confidentiality
Procedure to ensure confidentiality

5.8.1/5.8.2/B.5.4
5.8.3
5.8.3/5.8.9
5.8.6
5.8.6/5.8.10

5.10.1
5.10.2/5.10.5
Not addressed
Not addressed
Not addressed

5.9.1/5.1.8
4.6.1/5.9.2
5.9.1
4.7.1

5.10.9
5.10.9
5.10.9
Not addressed

5.8.7
5.8.7
Not addressed
5.8.7
5.8.7

Not addressed
Not addressed
Not addressed
Not addressed
Not addressed

5.8.3
5.5.5

Not addressed
Not addressed

4.8.1/5.1.4.a/B.6.3
4.8.1
4.8.1/5.1.4.g
Not addressed
5.8.3.j/5.8.3.k

Not addressed
Not addressed
Not addressed
Not addressed
5.10.5

B.6.1/B.6.2/B.7.2
B.7.1
B.6.5
B.6.4/B.7.1
Not addressed

4.12.2
Not addressed
Not addressed
Not addressed
Not addressed

B.6.1/B.7.1

Not addressed

10
10.1
10.1.1
10.1.2

Evaluation of the quality system

Internal audit
System of planned internal audits
Results of internal audits

4.13

10.1.3
10.1.4

Documentation of actions
Procedure for corrective actions

10.1.5
10.1.6
10.1.7
10.1.8
10.2
10.2.1
10.2.2
10.2.3
10.2.4
10.2.5
10.3
10.3.1
10.3.2
10.3.3
10.3.4

Checking of all procedures

Checklist of items and aims of handbook
Costs of quality system
Review of efficacy of point of care testing
Internal and external complaints
Reporting internal complaints and ideas
Registration of internal complaints and ideas
Registration of external complaints and ideas
Actions to complaints and ideas
Urgency of actions to (near) accidents
External audit
Professional staff in medical audit
Inspection and accreditation according to the Criteria
Functioning of professional staff as auditor
Clinical audit check on effectiveness and efficiency

4.1.5/4.9.1/4.11.1/4.12.1
4.9.1/4.9.3/4.11.3/4.
12.2/4.12.4
4.7.2/4.11.2
4.7.1/4.7.2/4.7.3/4.7.4/
4.9.2
4.9.1/4.12.2
4.12.2
Not addressed
Not addressed

4.13
4.13
4.10
Not addressed
Not addressed
Not addressed
Not addressed

Not addressed
Not addressed
4.8.2
4.1.5/4.8.2/4.12.2.f
4.6.1

Not addressed
Not addressed
4.8
4.8
Not addressed

4.1.5/4.12.3
4.1.3
Not addressed
4.12.3

Not addressed
Not addressed
Not addressed
Not addressed

1063

1064

Jansen et al.: EC4 essential criteria as guideline to ISO 15189

medicine. It is lacking almost completely in the ISO

documents with respect to responsibility, education,
equipment, as well as operation and archiving.
Only limited attention is paid in the ISO 15189 document to the requirements for space, for personnel as
well as for patients. It is not addressed in ISO 17025.
Although requirements for computer facilities are
extensively summarised in ISO 15189, these are put in
an annex and are considered not obligatory. These are
considered essential by EC4.
The pre-analytical phase is extremely important for
the interpretation and outcome of medical laboratory
data. Aspects regarding this phase are practically not
addressed at all in the ISO 17025 document in contrast
to the ISO 15189 document. However, in the latter document there are no requirements with respect to information for patients, experimental testing or confidentiality. There is, however, in the ISO 15189 document,
an annex included on ethics in laboratory medicine. Although not mandatory, issues are addressed here such
as the informed consent of the patient, collection of information and access to medical records. The Essential
Criteria 7.1 require the availability of a User Handbook.
Such a handbook is somewhat more elaborate than the
primary sample collection manual which is mentioned
in ISO 15189 5.4. The handbook should include lists of
repertoire (STAT and routine), terms and abbreviations
used by the laboratory, sample collection information,
information on special requests, functional tests etc.,
and on responsible staff.
With regard to the analytical phase there is no mention in ISO 17025 to requirements for internal quality
control or external quality assessment. No reference is
made in ISO 15189 to rejection criteria in relation to biological variation.
The post-analytical phase includes reporting procedures. Requirements for STAT results and critical results are not addressed in ISO 17025, nor are requirements for turn around times.
Participation in medical audit is considered necessary by EC4 to evaluate the performance of the laboratory in relation to patient care and the needs of physicians. It is not addressed in the ISO 17025 document
and only partially in ISO 15189.
Internal ideas and complaints form input for contin uous improvement and motivation of staff. There
should be a low threshold for reporting such remarks
from the laboratory personnel, and a recording and
evaluation system should be in place. It is addressed to
some extent in ISO 15189, but not in ISO 17025.

Conclusion
The new ISO 15189 document is an important document for the accreditation of medical laboratories. It
suits the situation in our laboratories much better than
the documents EN 45001, ISO guide 25 and also the
new ISO 17025, particularly in the pre- and post-analytical aspects. It is important that the public understands
and accepts the level of accreditation according to the
ISO 15189 standard. The ISO 9000 series are very well
known. Therefore it is important that ISO 15189 fully
covers the requirements of the ISO 9000:2000 standard.
The development of standards for accreditation is a
dynamic process. They are regularly revised according
to the state of the art. Issues raised by the extensive introduction of Point-of-Care-Testing led EC4 to publish
its Additional Essential Criteria. In the ISO documents
POCT is hardly addressed, but it is to be expected that
in future versions this issue will also be addressed in
ISO documents. This also pertains to budget management issues and particularly total quality management
and continuous improvement, which are main issues
in the EFQM model. All these aspects are incorporated
in the EC4 Essential Criteria. The Criteria therefore
prove practical as a guide for implementation of quality
systems, which are to be accredited according to the
ISO 15189 standard.

References
1. Jansen RTP, Blaton V, Burnett D, Huisman W, Queralt JM,
Zrah S, et al. Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 1997;
35:12132.
2. Jansen RTP, Blaton V, Burnett D, Huisman W, Queralt JM,
Zrah S, et al. Additional essential criteria for quality systems of medical laboratories. Clin Chem Lab Med 1998;
36:24952.
3. International Organisation for Standardization (ISO). Quality Management for the Medical Laboratory. (ISO/FDIS
15189). ISO: Geneva.
4. International Organisation for Standardization (ISO). General Requirements for the Competence of Testing and Calibrating Laboratories. (ISO/FDIS 17025). ISO: Geneva.
5. European Foundation for Quality Management, The European Quality Award 1997:132. Avenue des Pliades 15,
1200 Brussels, Belgium.
Received 6 July 2000; accepted 11 July 2000
Corresponding author: Dr. R.T.P. Jansen, St. Anna Hospital,
Department of Clinical Chemistry, P.O. Box 90, NL-5660 AB
Geldrop, The Netherlands