EN ISO 15189:2007
(Main)Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.
ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Medizinische Laboratorien - Besondere Anforderungen an die Qualität und Kompetenz (ISO 15189:2007)
1.1 Diese Internationale Norm legt Anforderungen an die Qualität und Kompetenz im besonderen Fall medizinischer Laboratorien fest.
1.2 Diese Internationale Norm ist für die Anwendung durch medizinische Laboratorien bei der Entwicklung von deren Qualitätsmanagementsystem und der Beurteilung ihrer eigenen Kompetenz sowie für die Anwen¬dung durch Akkreditierungsstellen bei der Bestätigung oder Anerkennung der Kompetenz von medizinischen Laboratorien bestimmt.
Laboratoires d'analyses de biologie médicale - Exigences particulières concernant la qualité et la compétence (ISO 15189:2007)
L'ISO 15189:2007 spécifie les exigences de qualité et de compétence propres aux laboratoires d'analyses de biologie médicale.
L'ISO 15189:2007 est destinée à être utilisée par les laboratoires d'analyses de biologie médicale qui élaborent leurs systèmes de management de la qualité et évaluent leur propre compétence ainsi que par les organismes d'accréditation engagés dans des activités de confirmation ou de reconnaissance de la compétence des laboratoires d'analyses de biologie médicale.
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost (ISO 15189:2007)
1.1 Ta mednarodni standard opredeljuje zahteve za kakovost in usposobljenost posameznih medicinskih laboratorijev.
1.2 Medicinski laboratoriji naj ta mednarodni standard uporabljajo pri razvijanju sistemov vodenja kakovosti in ocenjevanju lastne usposobljenosti, akreditacijski organi
za potrjevanje ali priznavanje usposobljenosti medicinskih laboratorijev.
General Information
- Status
- Withdrawn
- Publication Date
- 14-Apr-2007
- Withdrawal Date
- 31-Oct-2012
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140 - In vitro diagnostic systems
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 01-Nov-2012
- Completion Date
- 01-Nov-2012
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN ISO 15189:2007 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)". This standard covers: ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
EN ISO 15189:2007 is classified under the following ICS (International Classification for Standards) categories: 03.120.10 - Quality management and quality assurance; 11.100.01 - Laboratory medicine in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15189:2007 has the following relationships with other standards: It is inter standard links to EN ISO 15189:2003/prA1, EN ISO 15189:2003, EN ISO 15189:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15189:2007 is associated with the following European legislation: EU Directives/Regulations: 765/2008; Standardization Mandates: M/417. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 15189:2007 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2007
1DGRPHãþD
SIST EN ISO 15189:2003
SIST EN ISO 15189:2003/oprA1:2005
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost (ISO
15189:2007)
Medical laboratories - Particular requirements for quality and competence (ISO
15189:2007)
Medizinische Laboratorien - Besondere Anforderungen an die Qualität und Kompetenz
(ISO 15189:2007)
Laboratoires d'analyses de biologie médicale - Exigences particulieres concernant la
qualité et la compétence (ISO 15189:2007)
Ta slovenski standard je istoveten z: EN ISO 15189:2007
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15189
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2007
ICS 11.100.01; 03.120.10 Supersedes EN ISO 15189:2003
English Version
Medical laboratories - Particular requirements for quality and
competence (ISO 15189:2007)
Laboratoires d'analyses de biologie médicale - Exigences Medizinische Laboratorien - Besondere Anforderungen an
particulières concernant la qualité et la compétence (ISO die Qualität und Kompetenz (ISO 15189:2007)
15189:2007)
This European Standard was approved by CEN on 9 April 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2007: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 15189:2007) has been prepared by Technical Committee ISO/TC 212
"Clinical laboratory testing and in vitro diagnostic test systems" in collaboration with Technical
Committee CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by
DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by October 2007, and conflicting national
standards shall be withdrawn at the latest by October 2007.
This document supersedes EN ISO 15189:2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Endorsement notice
The text of ISO 15189:2007 has been approved by CEN as EN ISO 15189:2007 without any
modifications.
INTERNATIONAL ISO
STANDARD 15189
Second edition
2007-04-15
Medical laboratories — Particular
requirements for quality and competence
Laboratoires d'analyses de biologie médicale — Exigences particulières
concernant la qualité et la compétence
Reference number
ISO 15189:2007(E)
©
ISO 2007
ISO 15189:2007(E)
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ii © ISO 2007 – All rights reserved
ISO 15189:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Management requirement . 4
4.1 Organization and management . 4
4.2 Quality management system . 5
4.3 Document control . 6
4.4 Review of contracts. 7
4.5 Examination by referral laboratories . 8
4.6 External services and supplies . 8
4.7 Advisory services . 9
4.8 Resolution of complaints. 9
4.9 Identification and control of nonconformities .9
4.10 Corrective action. 10
4.11 Preventive action . 10
4.12 Continual improvement. 10
4.13 Quality and technical records . 11
4.14 Internal audits . 11
4.15 Management review. 12
5 Technical requirements . 13
5.1 Personnel. 13
5.2 Accommodation and environmental conditions . 15
5.3 Laboratory equipment. 16
5.4 Pre-examination procedures . 18
5.5 Examination procedures. 20
5.6 Assuring quality of examination procedures . 22
5.7 Post-examination procedures . 23
5.8 Reporting of results. 23
Annex A (Informative) Correlation with ISO 9001:2000 and ISO/IEC 17025:2005. 26
Annex B (informative) Recommendations for protection of laboratory information systems (LIS). 30
Annex C (informative) Ethics in laboratory medicine. 34
Bibliography . 37
ISO 15189:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15189 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
This second edition cancels and replaces the first edition (ISO 15189:2003) which has been technically
revised in order to align it more closely with the second edition of ISO/IEC 17025.
iv © ISO 2007 – All rights reserved
ISO 15189:2007(E)
Introduction
This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for
1)
competence and quality that are particular to medical laboratories . It is acknowledged that a country could
have its own specific regulations or requirements applicable to some or all its professional personnel and their
activities and responsibilities in this domain.
Medical laboratory services are essential to patient care and therefore have to be available to meet the needs
of all patients and the clinical personnel responsible for the care of those patients. Such services include
arrangements for requisition, patient preparation, patient identification, collection of samples, transportation,
storage, processing and examination of clinical samples, together with subsequent validation, interpretation,
reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Whenever allowed by national regulations, it is desirable that medical laboratory services include the
examination of patients in consultation cases, and that those services actively participate in the prevention of
disease in addition to diagnosis and patient management. Each laboratory ought also to provide suitable
educational and scientific opportunities for professional staff working with it.
While this International Standard is intended for use throughout the currently recognised disciplines of medical
laboratory services, those working in other services and disciplines could also find it useful and appropriate. In
addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this
International Standard as the basis for their activities. If a laboratory seeks accreditation, it should select an
accrediting body which operates to appropriate international standards and which takes into account the
particular requirements of medical laboratories.
Demonstrated conformity to this International Standard does not imply conformity of the quality management
system within which the laboratory operates to all the requirements of ISO 9001. This International Standard is
not intended to be used for the purposes of certification.
The correlation between the clauses and subclauses of this second edition of ISO 15189 and those of
ISO 9001:2000 and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard.
1) In other languages, these laboratories can be designated by the equivalent of the English term “clinical laboratories.”
INTERNATIONAL STANDARD ISO 15189:2007(E)
Medical laboratories — Particular requirements for quality and
competence
1 Scope
1.1 This International Standard specifies requirements for quality and competence particular to medical
laboratories.
1.2 This International Standard is for use by medical laboratories in developing their quality management
systems and assessing their own competence, and for use by accreditation bodies in confirming or
recognising the competence of medical laboratories.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 31 (all parts), Quantities and units
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
ISO 9001:2000, Quality management systems — Requirements
ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons — Part 1: Development and operation
of proficiency testing schemes
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accreditation
procedure by which an authoritative body gives formal recognition that a body or person is competent to carry
out specific tasks
3.2
accuracy of measurement
closeness of the agreement between the result of a measurement and a true value of the measurand
[VIM:1993, definition 3.5]
ISO 15189:2007(E)
3.3
biological reference interval
reference interval
central 95 % interval of the distribution of reference values
NOTE 1 This supersedes such incorrectly used terms as “normal range”.
NOTE 2 It is an arbitrary but common convention to define the reference interval as the central 95 % interval. Another
size or an asymmetrical location of the reference interval could be more appropriate in particular cases. See [13] in the
Bibliography.
3.4
examination
set of operations having the object of determining the value or characteristics of a property
NOTE In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests, observations or
measurements.
3.5
laboratory capability
physical, environmental and information resources, personnel, skills and expertise available for the
examinations in question
NOTE A review of laboratory capability could include results of earlier participation in interlaboratory comparisons or
external quality assessment schemes or the running of trial examination programmes, or all these, in order to demonstrate
uncertainties of measurement, limits of detection, etc.
3.6
laboratory director
competent person(s) with responsibility for, and authority over, a laboratory
NOTE 1 For the purposes of this International Standard, the person or persons referred to are designated collectively
as "laboratory director".
NOTE 2 National, regional and local regulations may apply with regard to qualifications and training.
3.7
laboratory management
person(s) who manage the activities of a laboratory headed by a laboratory director
3.8
measurement
set of operations having the object of determining a value of a quantity
[VIM:1993, definition 2.1]
3.9
medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological,
biophysical, cytological, pathological or other examination of materials derived from the human body for the
purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of
the health of, human beings, and which may provide a consultant advisory service covering all aspects of
laboratory investigation including the interpretation of results and advice on further appropriate investigation
NOTE These examinations also include procedures for determining, measuring or otherwise describing the presence
or absence of various substances or micro-organisms. Facilities which only collect or prepare specimens, or act as a
mailing or distribution centre, are not considered to be medical or clinical laboratories, although they may be part of a
larger laboratory network or system.
2 © ISO 2007 – All rights reserved
ISO 15189:2007(E)
3.10
post-examination procedures
postanalytical phase
processes following the examination including systematic review, formatting and interpretation, authorization
for release, reporting and transmission of the results, and storage of samples of the examinations
3.11
pre-examination procedures
preanalytical phase
steps starting, in chronological order, from the clinician’s request and including the examination requisition,
preparation of the patient, collection of the primary sample, and transportation to and within the laboratory,
and ending when the analytical examination procedure begins
3.12
primary sample
specimen
set of one or more parts initially taken from a system
NOTE In some countries, the term “specimen” is used instead of primary sample (or a subsample of it), which is the
sample prepared for sending to, or as received by, the laboratory and which is intended for examination.
3.13
quantity
attribute of a phenomenon, body or substance that may be distinguished qualitatively and determined
quantitatively
[VIM:1993, definition 1.1]
3.14
quality management system
management system to direct and control an organization with regard to quality
[ISO 9000:2005, definition 3.2.3]
NOTE For the purposes of this International standard, the "quality" referred to in this definition relates to matters of
both management and technical competence.
3.15
referral laboratory
external laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure
and report
3.16
sample
one or more parts taken from a system and intended to provide information on the system, often to serve as a
basis for decision on the system or its production
EXAMPLE A volume of serum taken from a larger volume of serum.
3.17
traceability
property of the result of a measurement or the value of a standard whereby it can be related to stated
references, usually national or international standards, through an unbroken chain of comparisons all having
stated uncertainties
[VIM:1993, definition 6.10]
ISO 15189:2007(E)
3.18
trueness of measurement
closeness of agreement between the average value obtained from a large series of results of measurements
and a true value
NOTE Adapted from ISO 3534-1:1993, definition 3.12
3.19
uncertainty of measurement
parameter, associated with the result of a measurement, that characterizes the dispersion of the values that
could reasonably be attributed to the measurand
[VIM:1993, definition 3.9]
4 Management requirement
4.1 Organization and management
4.1.1 The medical laboratory or the organization of which the laboratory is a part shall be legally identifiable.
4.1.2 Medical laboratory services, including appropriate interpretation and advisory services, shall be
designed to meet the needs of patients and all clinical personnel responsible for patient care.
4.1.3 The medical laboratory (hereafter referred to as “the laboratory”) shall meet the relevant requirements
of this International Standard when carrying out work in its permanent facilities, or at sites other than the
permanent facilities for which it is responsible.
4.1.4 The responsibilities of personnel in the laboratory with an involvement or influence on the examination
of primary samples shall be defined in order to identify conflicts of interest. Financial or political considerations
(e.g. inducements) should not influence testing.
4.1.5 Laboratory management shall have responsibility for the design, implementation, maintenance and
improvement of the quality management system. This shall include the following:
a) management support of all laboratory personnel by providing them with the appropriate authority and
resources to carry out their duties;
b) arrangements to ensure that management and personnel are free from any undue internal and external
commercial, financial or other pressures and influences that may adversely affect the quality of their work;
c) policies and procedures for ensuring the protection of confidential information (see Annex C);
d) policies and procedures for avoiding involvement in any activities that would diminish confidence in its
competence, impartiality, judgement or operational integrity;
e) the organizational and management structure of the laboratory and its relationship to any other
organization with which it may be associated;
f) specified responsibilities, authority and interrelationships of all personnel;
g) adequate training of all staff and supervision appropriate to their experience and level of responsibility by
competent persons conversant with the purpose, procedures and assessment of results of the relevant
examination procedures;
h) technical management which has overall responsibility for the technical operations and the provision of
resources needed to ensure the required quality of laboratory procedures;
4 © ISO 2007 – All rights reserved
ISO 15189:2007(E)
i) appointment of a quality manager (however named) with delegated responsibility and authority to oversee
compliance with the requirements of the quality management system, who shall report directly to the level
of laboratory management at which decisions are made on laboratory policy and resources;
j) appointment of deputies for all key functions, while recognizing that in smaller laboratories individuals can
have more than one function and that it could be impractical to appoint deputies for every function.
4.1.6 Laboratory management shall ensure that appropriate communication processes are established
within the laboratory and that communication takes place regarding the effectiveness of the quality
management system.
4.2 Quality management system
4.2.1 Policies, processes, programmes, procedures and instructions shall be documented and
communicated to all relevant personnel. The management shall ensure that the documents are understood
and implemented.
4.2.2 The quality management system shall include, but not be limited to, internal quality control and
participation in organized interlaboratory comparisons such as external quality assessment schemes.
4.2.3 Policies and objectives of the quality management system shall be defined in a quality policy
statement under the authority of the laboratory director and documented in a quality manual. This policy shall
be readily available to appropriate personnel, shall be concise and shall include the following:
a) the scope of service the laboratory intends to provide;
b) the laboratory management’s statement of the laboratory’s standard of service;
c) the objectives of the quality management system;
d) a requirement that all personnel concerned with examination activities familiarize themselves with the
quality documentation and implement the policies and procedures at all times;
e) the laboratory’s commitment to good professional practice, the quality of its examinations, and
compliance with the quality management system;
f) the laboratory management’s commitment to compliance with this International Standard.
4.2.4 A quality manual shall describe the quality management system and the structure of the
documentation used in the quality management system. The quality manual shall include or make reference to
the supporting procedures including technical procedures. It shall outline the structure of the documentation in
the quality management system. The roles and responsibilities of technical management and the quality
manager, including their responsibility for ensuring compliance with this International Standard, shall be
defined in the quality manual.
All personnel shall be instructed on the use and application of the quality manual and all referenced
documents, and of the requirements for their implementation. The quality manual shall be kept up to date
under the authority and responsibility of an individual appointed to be responsible for quality by the laboratory
management [see 4.1.5 i)].
The table of contents of a quality manual for a medical laboratory might be as follows.
a) Introduction.
b) Description of the medical laboratory, its legal identity, resources and main duties.
c) Quality policy.
d) Staff education and training.
ISO 15189:2007(E)
e) Quality assurance.
f) Document control.
g) Records, maintenance and archiving.
h) Accommodation and environment.
i) Instruments, reagents and/or relevant consumables management.
j) Validation of examination procedures.
k) Safety.
l) Environmental aspects [e.g., transportation, consumables and waste disposal, in addition to, and different
from, h) and i)].
m) Research and development (If appropriate).
n) List of examination procedures.
o) Request protocols, primary sample, collection and handling of laboratory samples.
p) Validation of results.
q) Quality control (including interlaboratory comparisons).
r) Laboratory information system (see Annex B).
s) Reporting of results.
t) Remedial actions and handling of complaints.
u) Communications and other interactions with patients, health professionals, referral laboratories and
suppliers.
v) Internal audits.
w) Ethics (see Annex C).
4.2.5 Laboratory management shall establish and implement a programme that regularly monitors and
demonstrates proper calibration and function of instruments, reagents and analytical systems. It shall also
have a documented and recorded programme of preventive maintenance and calibration (see 5.3.2), which, at
a minimum, follows manufacturer’s recommendations.
4.3 Document control
4.3.1 The laboratory shall define, document and maintain procedures to control all documents and
information (from internal and external sources) that form its quality documentation. A copy of each of these
controlled documents shall be archived for later reference and the laboratory director shall define the retention
period. These controlled documents may be maintained on any appropriate medium – including, or not, paper.
National, regional and local regulations concerning document retention could apply.
NOTE In this context, “document” is any information or instructions, including policy statements, text books,
procedures, specifications, calibration tables, biological reference intervals and their origins, charts, posters, notices,
memoranda, software, drawings, plans, and documents of external origin such as regulations, standards or examination
procedures.
6 © ISO 2007 – All rights reserved
ISO 15189:2007(E)
4.3.2 Procedures shall be adopted to ensure that:
a) all documents issued to laboratory personnel as part of the quality management system are reviewed and
approved by authorized personnel prior to issue;
b) a list, also referred to as a document control log, identifying the current valid revisions and their
distribution is maintained;
c) only currently authorized versions of appropriate documents are available for active use at relevant
locations;
d) documents are periodically reviewed, revised when necessary, and approved by authorized personnel;
e) invalid or obsolete documents are promptly removed from all points of use, or otherwise assured against
inadvertent use;
f) retained or archived superseded documents are appropriately identified to prevent their inadvertent use;
g) if the laboratory’s documentation control system allows for the amendment of documents by hand
pending the re-issue of documents, the procedures and authorities for such amendments are defined,
while amendments are clearly marked, initialled and dated, and a revised document is formally re-issued
as soon as practicable;
h) procedures are established to describe how changes to documents maintained in computerized systems
are to be made and controlled.
4.3.3 All documents relevant to the quality management system shall be uniquely identified, to include:
a) title;
b) edition or current revision date, or revision number, or all these;
c) number of pages (where applicable);
d) authority for issue;
e) source identification.
4.4 Review of contracts
4.4.1 Where a laboratory enters into a contract to provide medical laboratory services, it shall establish and
maintain procedures for review of contracts. The policies and procedures for these reviews leading to a
change in the arrangements for examinations or contracts shall ensure that:
a) requirements, including the methods to be used, are adequately defined, documented and understood
(see 5.5);
b) the laboratory has the capability and resources to meet the requirements;
c) appropriate procedures selected are able to meet the contract requirements and clinical needs (see 5.5).
In reference to b), the review of capability should establish that the laboratory possesses the necessary
physical, personnel and information resources, and that the laboratory’s personnel have the skills and
expertise necessary, for the performance of the examinations in question. The review may also encompass
results of earlier participation in external quality assurance schemes using samples of known value in order to
determine uncertainties of measurement, limits of detection, confidence limits, etc.
4.4.2 Records of reviews, including any significant changes and pertinent discussions, shall be maintained
(see 4.13.3).
ISO 15189:2007(E)
4.4.3 The review shall also cover any work referred by the laboratory (see 4.5).
4.4.4 Customers (e.g. clinicians, health care bodies, health insurance companies, pharmaceutical
companies) shall be informed of any deviation from the contract.
4.4.5 If a contract needs to be amended after work has commenced, the same contract review process
shall be repeated and any amendments shall be communicated to all affected parties.
4.5 Examination by referral laboratories
4.5.1 The laboratory shall have an effective documented procedure for evaluating and selecting referral
laboratories as well as consultants who are to provide second opinions for histopathology, cytology and
related disciplines. Laboratory management, with the advice of users of laboratory services where appropriate,
shall be responsible for selecting and monitoring the quality of referral laboratories and consultants and shall
ensure that the referral laboratory or referral consultant is competent to perform the requested examinations.
4.5.2 Arrangements with referral laboratories shall be reviewed periodically to ensure that:
a) requirements, including the pre-examination and post-examination procedures, are adequately defined,
documented, and understood;
b) the referral laboratory is able to meet the requirements and that there are no conflicts of interest;
c) selection of examination procedures is appropriate for the intended use;
d) respective responsibilities for the interpretation of examination results are clearly defined.
Records of such reviews shall be maintained in accordance with national, regional or local requirements.
4.5.3 The laboratory shall maintain a register of all referral laboratories that it uses. A register shall be kept
of all samples that have been referred to another laboratory. The name and address of the laboratory
responsible for the examination result shall be provided to the user of laboratory services. A duplicate of the
laboratory report shall be retained in both the patient record and in the permanent file of the laboratory.
4.5.4 The referring laboratory and not the referral laboratory shall be responsible for ensuring that referral
laboratory examination results and findings are provided to the person making the request. If the referring
laboratory prepares the report, it shall include all essential elements of the results reported by the referral
laboratory, without alterations that could affect clinical interpretation.
National, regional and local regulations may apply.
However, this does not require that the referring laboratory report include every word and have the exact
format of the referral laboratory report, unless national/local laws or regulations require it. The referring
laboratory director may elect to provide additional interpretative remarks to those, if any, of the referral
laboratory, in the context of the patient and the local medical environment. The author of such added remarks
should be clearly identified.
4.6 External services and supplies
4.6.1 Laboratory management shall define and document its policies and procedures for the selection and
use of purchased external services, equipment and consumable supplies that affect the quality of its service.
Purchased items shall consistently meet the laboratory’s quality requirements. National, regional or local
regulations may require records of purchased items. There shall be procedures and criteria for inspection,
acceptance/rejection and storage of consumable materials.
4.6.2 Purchased equipment and consumable supplies that affect the quality of the service shall not be used
until they have been verified as complying with standard specifications or requirements defined for the
procedures concerned. This may be accomplished by examining quality control samples and verifying that
8 © ISO 2007 – All rights reserved
ISO 15189:2007(E)
results are acceptable. Documentation of the supplier’s conformity with its quality management system may
also be used for verification.
4.6.3 There shall be an inventory control system for supplies. Appropriate quality records of external
services, supplies and purchased products shall be established and maintained for a period of time, as
defined in the quality management system. This system shall include the recording of lot numbers of all
relevant reagents, control materials and calibrators, the date of receipt in the laboratory and the date the
material is placed in service. All of these quality records shall be available for laboratory management review.
4.6.4 The laboratory shall evaluate suppliers of critical reagents, supplies and services that affect the quality
of examinations and shall maintain records of these evaluations and list those approved.
4.7 Advisory services
Appropriate laboratory professional staff shall provide advice on choice of examinations and use of the
services, including repeat frequency and required type of sample. Where appropriate, interpretation of the
results of examinations shall be provided.
There should be regular documented meetings of professional staff with the clinical staff regarding the use of
the laboratory services and for the purpose of consultation on scientific matters. The professional staff should
participate in clinical rounds, enabling advice on effectiveness in general as well as in individual cases.
4.8 Resolution of complaints
The laboratory shall have a policy and procedures for the resolution of complaints or other feedback received
from clinicians, patients or other parties. Records of complaints and of investigations and corrective actions
taken by the laboratory shall be maintained, as required [see 4.13.3 i)].
NOTE Laboratories are encouraged to obtain both positive and negative feedback from the users of their services,
preferably in a systematic way (e.g. surveys).
4.9 Identification and control of nonconformities
4.9.1 Laboratory management shall have a policy and procedure to be implemented when it detects that
any aspect of its examinations does not conform with its own procedures or the agreed upon requirements of
its quality management system or the requesting clinician. These shall ensure that:
a) personnel responsible for problem resolution are designated;
b) the actions to be taken are defined;
c) the medical significance of the nonconforming examinations is considered and, where appropriate, the
requesting clinician informed;
d) examinations are halted and reports withheld as necessary;
e) corrective action is taken immediately;
f) the results of nonconforming examinations already released are recalled or appropriately identified, if
necessary;
g) the responsibility for authorization of the resumption of examinations is defined;
h) each episode of nonconformity is documented and recorded, with these records being reviewed at regular
specified intervals by laboratory management to detect trends and initiate preventive action.
NOTE Nonconforming examinations or activities occur in many different areas and can be identified in many different
ways, including clinician complaints, quality control indications, instrument calibrations, checking of consumable materials,
staff comments, reporting and certificate checking, laboratory management reviews, and internal and external audits.
ISO 15189:2007(E)
4.9.2 If it is determined that nonconforming examinations could recur or that there is doubt about the
laboratory’s compliance with its own policies or procedures as given in the quality manual, procedures to
identify, document and eliminate the root cause(s) shall be promptly implemented (see 4.10).
4.9.3 The laboratory shall define and implement procedures for the release of results in the case of
nonconformities, including the review of such results. These events shall be recorded.
4.10 Corrective action
4.10.1 Procedures for corrective action shall include an investigative process to determine the underlying
cause or causes of the problem. These shall, where appropriate, lead to preventive actions. Corrective action
shall be appropriate to the magnitude of the problem and commensurate with possible risks.
4.10.2 Laboratory management shall document and implement any changes required to its operational
procedures resulting from corrective action investigations.
4.10.3 Laboratory management shall monitor the results of any corrective action taken, in order to ensure
that they have been effective in overcoming the identified problems.
4.10.4 When the identification of non-conformity or the corrective action investigation casts doubt on
compliance with policies and procedures or the quality management system, laboratory management shall
ensure that appropriate areas of activity are audited in accordance with 4.14. The results of corrective action
shall be submitted for laboratory management review.
4.11 Preventive action
4.11.1 Needed improvements and potential sources of nonconformities, either technical or concerning the
quality management system, shall be identified. If preventive action is required, action plans shall be
developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities
and to take advantage of the opportunities for improvement.
4.11.2 Procedures for preventive action shall include the initiation of such actions and application of controls
to ensure that they are effective.
NOTE 1 Apart from the review of the operational procedures, preventive action might involve analysis of data, including
trend- and risk-analyses and external quality assurance.
NOTE 2 Preventive action is a pro-active process for identifying opportunities for improvement rather than a reaction to
the identification of problems or complaints.
4.12 Continual improvement
4.12.1 All operational procedures shall be systematically reviewed by laboratory management at regular
intervals, as defined in the quality management system, in order to identify any potential sources of
nonconformance or other opportunities for improvement in the quality management system or technical
practices. Action plans for improvement shall be developed, documented and implemented, as appropriate.
4.12.2 After action has been taken resulting from the review, laboratory management shall evaluate the
effectiveness of the action through a focused review or audit of the area concerned.
4.12.3 The results of action following the review shall be submitted to laboratory management for review and
implementation of any needed changes to the quality management system.
4.12.4 Laboratory management shall implement quality indicators for systematically monitoring and
evaluating the laboratory’s contribution to patient care. When this programme identifies opportunities for
improvement, laboratory management shall
...
SLOVENSKI SIST EN ISO 15189
STANDARD
september 2007
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
Medical laboratories – Particular requirements for quality and competence
(ISO 15189:2007)
Laboratoires d'analyses de biologie médicale – Exigences particulières
concernant la qualité et la compétence (ISO 15189:2007)
Medizinische Laboratorien – Besondere Anforderungen an die Qualität und
Kompetenz (ISO 15189:2007)
Referenčna oznaka
ICS 11.100.01; 03.120.10 SIST EN ISO 15189:2007 (sl,en)
Nadaljevanje na straneh II in III ter od 1 do 69
© 2011-04. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 15189 : 2007
NACIONALNI UVOD
Standard SIST EN ISO 15189 (sl, en), Medicinski laboratoriji – Posebne zahteve za kakovost in
usposobljenost (ISO 15189:2007), 2007, ima status slovenskega standarda in je istoveten
evropskemu standardu EN ISO 15189 (en, de, fr), Medical laboratories – Particular requirements for
quality and competence (ISO 15189:2007), 2007.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15189:2007 je pripravil tehnični odbor ISO/TC 212 Preskušanje kliničnih
laboratorijev ter diagnostični sistemi in vitro v sodelovanju s tehničnim odborom Evropskega komiteja
za standardizacijo CEN/TC 140 Diagnostični medicinski sistemi in vitro. Slovenski standard SIST EN
ISO 15189:2007 je prevod evropskega standarda EN ISO 15189:2007. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard.
Slovenski prevod SIST EN ISO 15189:2007 je pripravila delovna skupina, ki so jo sestavljali
predstavniki SIST/TC VAZ Varovanje zdravja, SIST/TC VZK Vodenje in zagotavljanje kakovosti ter
SIST/TC UGA Ugotavljanje skladnosti.
Odločitev za izdajo tega standarda je dne 28. avgusta 2007 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omenjeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST ISO 31 (vsi deli) Veličine in enote
SIST EN ISO 9000:2005 Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)
SIST EN ISO 9001:2000 Sistemi vodenja kakovosti – Zahteve (ISO 9001:2000)
SIST EN ISO/IEC 17025:2005 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15189:2007
PREDHODNA IZDAJA
SIST EN ISO 15189:2003 Medicinski laboratoriji – Posebne zahteve za kakovost in
usposobljenost (ISO 15189:2003)
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard” oziroma “mednarodni
standard”, v SIST EN ISO 15189:2007 to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.
II
SIST EN ISO 15189 : 2007
– Ta nacionalni dokument je istoveten EN ISO 15189:2007 in je objavljen z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija
This national document is identical with EN 13108-20:2006 and is published with the permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
III
SIST EN ISO 15189 : 2007
IV
EVROPSKI STANDARD EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM april 2007
ICS 11.100.01; 03.120.10 Nadomešča EN ISO 15189:2003
Slovenska izdaja
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
Medical laboratories – Particular Laboratoires d'analyses de biologie Medizinische Laboratorien –
requirements for quality and médicale – Exigences particulières Besondere Anforderungen an die
competence (ISO 15189:2007) concernant la qualité et la Qualität und Kompetenz
compétence (ISO 15189:2007) (ISO 15189:2007)
Ta evropski standard je CEN sprejel 9. aprila 2007.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem
centru ali katerem koli članu CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN, veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske. Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de normalisation
Europäisches Komitee für Normung
Upravni center: Rue de Stassart, 36 B-1050 Brussels
© 2007 CEN. Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka: EN ISO 15189:2007: E
SIST EN ISO 15189 : 2007
VSEBINA Stran Contents Page
Predgovor.4 Foreword.4
Uvod.5 Introduction.5
1 Področje uporabe . 7 1 Scope.7
2 Zveza s standardi . 7 2 Normative references .7
3 Izrazi in definicije.7 3 Terms and definitions .7
4 Zahteva za vodenje . 11 4 Management requirement .11
4.1 Organizacija in vodenje.11 4.1 Organization and management.11
4.2 Sistem vodenja kakovosti.12 4.2 Quality management system.12
4.3 Obvladovanje dokumentov. 14 4.3 Document control .14
4.4 Pregled pogodb.16 4.4 Review of contracts.16
4.5 Preiskava, ki jo opravijo prejemni 4.5 Examination by referral
laboratoriji. 17 laboratories .17
4.6 Zunanje storitve in nabava 4.6 External services and supplies.18
materialnih sredstev. 18
4.7 Svetovanje. 19 4.7 Advisory services .19
4.8 Reševanje pritožb. 19 4.8 Resolution of complaints .19
4.9 Prepoznavanje in obvladovanje 4.9 Identification and control of
neskladnosti . 19 nonconformities.19
4.10 Korektivni ukrepi. 20 4.10 Corrective action .20
4.11 Preventivni ukrepi.21 4.11 Preventive action.21
4.12 Nenehno izboljševanje . 21 4.12 Continual improvement .21
4.13 Zapisi o kakovosti in tehnični zapisi . 22 4.13 Quality and technical records.22
4.14 Notranje presoje.23 4.14 Internal audits.23
4.15 Vodstveni pregled. 24 4.15 Management review.24
5 Tehnične zahteve . 25 5 Technical requirements.25
5.1 Osebje . 25 5.1 Personnel .25
5.2 Prostori in pogoji okolja.28 5.2 Accommodation and environmental
conditions.28
5.3 Laboratorijska oprema.30 5.3 Laboratory equipment .30
5.4 Predpreiskovalni postopki. 33 5.4 Pre-examination procedures.33
5.5 Preiskovalni postopki. 37 5.5 Examination procedures .37
5.6 Zagotavljanje kakovosti preiskovalnih 5.6 Assuring quality of examination
postopkov. 39 procedures.39
5.7 Popreiskovalni postopki. 41 5.7 Post-examination procedures .41
5.8 Poročanje o rezultatih. 41 5.8 Reporting of results .41
Dodatek A (informativni): Primerjava z Annex A (informative): Correlation with
ISO 9001:2000 in ISO/IEC 17025:2005. 46 ISO 9001:2000 and ISO/IEC 17025:2005.47
Dodatek B (informativni): Priporočila za Annex B (informative): Recommendations for
varovanje laboratorijskih informacijskih protection of laboratory information systems
sistemov (LIS) . 54 (LIS).55
Dodatek C (informativni): Etika v Annex C (informative): Ethics in laboratory
laboratorijski medicini. 59 medicine.59
Literatura.64 Bibliography.64
SIST EN ISO 15189 : 2007
Foreword
Predgovor
Ta dokument (EN ISO 15189:2007) je pripravil This document (EN ISO 15189:2007) has
tehnični odbor ISO/TC 212 Preskušanje been prepared by Technical Committee
kliničnih laboratorijev ter diagnostični sistemi in ISO/TC 212 "Clinical laboratory testing and in
vitro v sodelovanju s tehničnim odborom vitro diagnostic test systems" in collaboration
CEN/TC 140 Diagnostični medicinski with Technical Committee CEN/TC 140 "In
pripomočki in vitro, katerega sekretariat vodi vitro diagnostic medical devices", the
DIN. secretariat of which is held by DIN.
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda bodisi z objavo status of a national standard, either by
istovetnega besedila ali z razglasitvijo najpozneje publication of an identical text or by
oktobra 2007, nasprotujoče nacionalne standarde endorsement, at the latest by October 2007,
pa je treba razveljaviti najpozneje oktobra 2007. and conflicting national standards shall be
withdrawn at the latest by October 2007.
Ta dokument nadomešča EN ISO 15189:2003. This document supersedes EN ISO 15189:
2003.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standardizacijo organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Cyprus, Czech
Finske, Francije, Grčije, Irske, Islandije, Italije, Republic, Denmark, Estonia, Finland, France,
Latvije, Litve, Luksemburga, Madžarske, Malte, Germany, Greece, Hungary, Iceland, Ireland,
Nemčije, Nizozemske, Norveške, Poljske, Italy, Latvia, Lithuania, Luxembourg, Malta,
Portugalske, Romunije, Slovaške, Slovenije, Netherlands, Norway, Poland, Portugal,
Španije, Švedske, Švice in Združenega Romania, Slovakia, Slovenia, Spain,
kraljestva. Sweden, Switzerland and United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo standarda ISO 15189:2007 je CEN The text of ISO 15189:2007 has been
odobril kot evropski standard EN ISO approved by CEN as EN ISO 15189:2007
15189:2007 brez sprememb. without any modifications.
SIST EN ISO 15189 : 2007
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).
ponavadi pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is
član, ki želi delovati na določenem področju, za normally carried out through ISO technical
katero je bil ustanovljen tehnični odbor, ima committees. Each member body interested in a
pravico biti zastopan v tem odboru. Pri delu subject for which a technical committee has
sodelujejo tudi mednarodne vladne in nevladne been established has the right to be represented
organizacije, povezane z ISO. V vseh zadevah, on that committee. International organizations,
ki so povezane s standardizacijo na področju governmental and non-governmental, in liaison
elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO
Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.
Mednarodni standardi so pripravljeni skladno s International Standards are drafted in
pravili, podanimi v 2. delu Direktiv ISO/IEC. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Glavna naloga tehničnih odborov je priprava The main task of technical committees is to
mednarodnih standardov. Osnutki mednarodnih prepare International Standards. Draft
standardov, ki jih sprejmejo tehnični odbori, se International Standards adopted by the technical
pošljejo vsem članom v glasovanje. Za objavo committees are circulated to the member bodies
mednarodnega standarda je treba pridobiti for voting. Publication as an International
soglasje najmanj 75 odstotkov članov, ki se Standard requires approval by at least 75 % of
udeležijo glasovanja. the member bodies casting a vote.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. ISO ne prevzema odgovornosti za subject of patent rights. ISO shall not be held
identifikacijo katerihkoli ali vseh takih patentnih responsible for identifying any or all such patent
pravic. rights.
ISO 15189 je pripravil tehnični odbor ISO/TC ISO 15189 was prepared by Technical
212 Preskušanje kliničnih laboratorijev ter Committee ISO/TC 212, Clinical laboratory
diagnostični sistemi in vitro. testing and in vitro diagnostic test systems.
Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the
izdajo (ISO 15189:2003), ki je bila strokovno first edition (ISO 15189:2003) which has been
revidirana z namenom natančnejše uskladitve z technically revised in order to align it more
drugo izdajo ISO/IEC 17025. closely with the second edition of ISO/IEC
17025.
SIST EN ISO 15189 : 2007
Uvod Introduction
Ta mednarodni standard, ki temelji na This International Standard, based upon ISO/IEC
standardih ISO/IEC 17025 in ISO 9001, podaja 17025 and ISO 9001, provides requirements for
zahteve za usposobljenost in kakovost, competence and quality that are particular to
1) 1)
namenjene posebej za medicinske laboratorije . medical laboratories. It is acknowledged that a
Dopušča se, da ima država lastne specifične country could have its own specific regulations or
predpise ali zahteve, ki veljajo za določeno ali requirements applicable to some or all its
vse njeno strokovno osebje ter njihove professional personnel and their activities and
aktivnosti in odgovornosti na tem področju. responsibilities in this domain.
Storitve medicinskih laboratorijev so bistvenega Medical laboratory services are essential to
pomena za oskrbo pacientov in morajo biti zato patient care and therefore have to be available to
na voljo za izpolnjevanje potreb vseh pacientov meet the needs of all patients and the clinical
in kliničnega osebja, odgovornega za oskrbo personnel responsible for the care of those
teh pacientov. Take storitve vključujejo načine patients. Such services include arrangements for
urejanja naročil, priprave pacienta, identifikacije requisition, patient preparation, patient identifi-
pacienta, odvzema vzorcev, transporta, cation, collection of samples, transportation,
shranjevanja, obdelave in preiskave kliničnih storage, processing and examination of clinical
vzorcev, skupaj s poznejšimi validacijo, samples, together with subsequent validation,
interpretacijo, poročanjem in svetovanjem, ob interpretation, reporting and advice, in addition to
upoštevanju varnosti in etike pri delu v the considerations of safety and ethics in
medicinskih laboratorijih. medical laboratory work.
Kadar nacionalni predpisi to dopuščajo, je Whenever allowed by national regulations, it is
zaželeno, da v primerih konzultacije storitve desirable that medical laboratory services include
medicinskih laboratorijev zajemajo tudi pregled the examination of patients in consultation cases,
pacientov ter da te storitve poleg diagnoze in and that those services actively participate in the
oskrbe pacientov aktivno sodelujejo pri prevention of disease in addition to diagnosis and
preprečevanju bolezni. Vsak laboratorij bi moral patient management. Each laboratory ought also
strokovnemu osebju, ki zanj dela, zagotavljati to provide suitable educational and scientific
tudi ustrezne možnosti izobraževanja in opportunities for professional staff working with it.
znanstvenega dela.
Medtem ko je ta mednarodni standard While this International Standard is intended for
namenjen uporabi v vseh trenutno priznanih use throughout the currently recognised
strokah medicinskih laboratorijskih storitev, pa disciplines of medical laboratory services, those
je lahko uporaben in ustrezen tudi za working in other services and disciplines could
laboratorije, ki izvajajo storitve v drugih strokah. also find it useful and appropriate. In addition,
Poleg tega bodo lahko ta mednarodni standard bodies engaged in the recognition of the
kot podlago za svoje dejavnosti uporabljali tudi competence of medical laboratories will be able
organi, ki se ukvarjajo s priznavanjem to use this International Standard as the basis for
usposobljenosti medicinskih laboratorijev. Če their activities. If a laboratory seeks accredi-
želi laboratorij pridobiti akreditacijo, naj izbere tation, it should select an accrediting body which
akreditacijski organ, ki deluje po ustreznih operates to appropriate international standards
mednarodnih standardih in ki upošteva and which takes into account the particular
posebne zahteve medicinskih laboratorijev. requirements of medical laboratories.
Izkazana skladnost s tem mednarodnim Demonstrated conformity to this International
standardom pa ne pomeni skladnosti sistema Standard does not imply conformity of the quality
vodenja kakovosti, v okviru katerega laboratorij management system within which the laboratory
deluje, z vsemi zahtevami ISO 9001. Ta operates to all the requirements of ISO 9001. This
mednarodni standard ni namenjen uporabi za International Standard is not intended to be used
namene certificiranja. for the purposes of certification.
1) 1)
V drugih jezikih so ti laboratoriji lahko poimenovani z In other languages, these laboratories can be designated
drugim izrazom, ki je enakovreden angleškemu izrazu by the equivalent of the English term "clinical
"clinical laboratories". laboratories".
SIST EN ISO 15189 : 2007
Primerjava med točkami in podtočkami te druge The correlation between the clauses and
izdaje ISO 15189 ter točkami in podtočkami ISO subclauses of this second edition of ISO 15189
9001:2000 in ISO/IEC 17025:2005 je podrobneje and those of ISO 9001:2000 and of ISO/IEC
opisana v dodatku A k temu mednarodnemu
17025:2005 is detailed in Annex A of this
standardu. International Standard.
SIST EN ISO 15189 : 2007
Medicinski laboratoriji – Medical laboratories –
Posebne zahteve za kakovost in Particular requirements for quality
usposobljenost and competence
1 Področje uporabe 1 Scope
1.1 Ta mednarodni standard opredeljuje 1.1 This International Standard specifies
zahteve za kakovost in usposobljenost requirements for quality and competence
posameznih medicinskih laboratorijev. particular to medical laboratories.
1.2 Medicinski laboratoriji naj ta mednarodni 1.2 This International Standard is for use by
standard uporabljajo pri razvijanju svojih medical laboratories in developing their quality
sistemov vodenja kakovosti in ocenjevanju management systems and assessing their own
lastne usposobljenosti, akreditacijski organi pa competence, and for use by accreditation
za potrjevanje ali priznavanje usposobljenosti bodies in confirming or recognising the
medicinskih laboratorijev. competence of medical laboratories.
2 Zveza s standardi 2 Normative references
Za uporabo tega standarda so nujno potrebni The following referenced documents are
spodaj navedeni dokumenti. Pri datiranih indispensable for the application of this
dokumentih velja samo navedena izdaja. Pri document. For dated references, only the
nedatiranih dokumentih velja najnovejša izdaja edition cited applies. For undated references,
dokumenta (vključno z morebitnimi spremembami). the latest edition of the referenced document
(including any amendments) applies.
ISO 31 (vsi deli), Veličine in enote ISO 31 (all parts), Quantities and units
ISO 9000:2005, Sistemi vodenja kakovosti – ISO 9000:2005, Quality management systems –
Osnove in slovar Fundamentals and vocabulary
ISO 9001:2000, Sistemi vodenja kakovosti – ISO 9001:2000, Quality management systems –
Zahteve Requirements
Vodilo ISO/IEC 43-1, Preskušanje strokovne ISO/IEC Guide 43-1: Proficiency testing by
usposobljenosti z medlaboratorijskimi primerjavami interlaboratory comparisons – Part 1:
– 1. del: Razvoj in delovanje shem strokovne Development and operation of proficiency testing
usposobljenosti schemes
ISO/IEC 17025:2005, Splošne zahteve za ISO/IEC 17025:2005: General requirements for
usposobljenost preskuševalnih in kalibracijskih the competence of testing and calibration
laboratorijev laboratories
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo naslednji izrazi For the purposes of this document, the
in definicije: following terms and definitions apply.
3.1 3.1
akreditacija accreditation
postopek, s katerim pooblaščeni organ procedure by which an authoritative body gives
formalno priznava, da je neki organ ali oseba formal recognition that a body or person is
usposobljena za izvajanje specifičnih nalog competent to carry out specific tasks
3.2 3.2
merilna točnost accuracy of measurement
ujemanje merilnega rezultata s pravo vrednostjo closeness of the agreement between the result
merjene veličine [VIM:1993, definicija 3.5] of a measurement and a true value of the
measurand [VIM:1993, definition 3.5]
SIST EN ISO 15189 : 2007
3.3 3.3
biološki referenčni interval biological reference interval
referenčni interval reference interval
osrednji 95-odstotni interval porazdelitve central 95 % interval of the distribution of
referenčnih vrednosti reference values
OPOMBA 1: To nadomešča take nepravilno uporabljene NOTE 1: This supersedes such incorrectly used
izraze, kot je npr. "normalno območje". terms as “normal range”.
OPOMBA 2: Označevanje referenčnega intervala kot NOTE 2: It is an arbitrary but common convention to
osrednji 95-odstotni interval je poljubno, a define the reference interval as the central
splošno dogovorjeno. V posameznih 95 % interval. Another size or an
primerih bi bila mogoče ustreznejša asymmetrical location of the reference
drugačna velikost ali nesimetrična lokacija interval could be more appropriate in
referenčnega intervala. Glej [13] v literaturi. particular cases. See [13] in the
Bibliography.
3.4 3.4
preiskava examination
niz postopkov, katerih cilj je določiti vrednost ali set of operations having the object of determining
značilnosti posamezne lastnosti the value or characteristics of a property
OPOMBA: V nekaterih strokah (npr. v mikrobiologiji) je NOTE: In some disciplines (e.g. microbiology) an
preiskava celota večjega števila preskusov, examination is the total activity of a number
opazovanj ali meritev. of tests, observations or measurements.
3.5 3.5
zmogljivost laboratorija laboratory capability
fizični, okoljski in informacijski viri, osebje, physical, environmental and information
veščine in strokovnost, ki so na voljo za resources, personnel, skills and expertise
zadevne preiskave available for the examinations in question
OPOMBA Pregled zmogljivosti laboratorija lahko NOTE: A review of laboratory capability could
vključuje rezultate predhodnega sodelovanja include results of earlier participation in
v medlaboratorijskih primerjavah ali shemah interlaboratory comparisons or external
za zunanjo oceno kakovosti ali vodenje quality assessment schemes or the running
programov poskusnih preiskav, ali pa vse te of trial examination programmes, or all
aktivnosti, da bi se dognale merilne these, in order to demonstrate uncertainties
negotovosti, meje detekcije itd. of measurement, limits of detection, etc.
3.6 3.6
vodja laboratorija laboratory director
usposobljena(-e) oseba(-e) z odgovornostjo in competent person(s) with responsibility for, and
pooblastili za laboratorij authority over, a laboratory
OPOMBA 1: V tem mednarodnem standardu se NOTE 1: For the purposes of this International
ustrezna oseba ali osebe označujejo s Standard, the person or persons referred to
skupnim imenom "vodja laboratorija". are designated collectively as "laboratory
director".
OPOMBA 2: Glede kvalifikacij in usposobljenosti se NOTE 2: National, regional and local regulations may
lahko uporabljajo nacionalni, regionalni ali apply with regard to qualifications and
lokalni predpisi. training.
3.7 3.7
vodstvo laboratorija laboratory management
oseba(-e), ki vodi(-jo) dejavnosti laboratorija, na person(s) who manage the activities of a
čelu z vodjo laboratorija laboratory headed by a laboratory director
3.8 3.8
meritev, merjenje measurement
niz operacij, da se ugotovi vrednost veličine set of operations having the object of
determining a value of a quantity
[VIM:1993, definicija 2.1] [VIM:1993, definition 2.1]
SIST EN ISO 15189 : 2007
3.9 3.9
medicinski laboratorij medical laboratory
klinični laboratorij clinical laboratory
laboratorij za izvajanje bioloških, mikrobioloških, laboratory for the biological, microbiological,
imunoloških, kemijskih, imunohematoloških, immunological, chemical, immunohaematological,
hematoloških, biofizikalnih, citoloških, patoloških haematological, biophysical, cytological, patho-
ali drugih preiskav materialov, pridobljenih iz logical or other examination of materials derived
človeškega telesa, z namenom pridobiti podatke from the human body for the purpose of providing
za postavitev diagnoze, preprečevanje bolezni in information for the diagnosis, prevention and
zdravljenje človeških bitij ali za ocenjevanje treatment of disease in, or assessment of the
njihovega zdravja in ki lahko zagotavlja tudi health of, human beings, and which may provide
svetovalne storitve, ki zajemajo vse vidike a consultant advisory service covering all aspects
laboratorijskih preiskav, vključno z interpretacijo of laboratory investigation including the
rezultatov in svetovanjem glede ustreznih interpretation of results and advice on further
nadaljnjih preiskav appropriate investigation
OPOMBA: Te preiskave zajemajo tudi postopke za NOTE: These examinations also include
določanje, merjenje ali drugačno opisovanje procedures for determining, measuring or
prisotnosti ali odsotnosti različnih substanc otherwise describing the presence or
ali mikroorganizmov. Prostori in oprema, ki absence of various substances or micro-
so namenjeni samo odvzemu in pripravi organisms. Facilities which only collect or
vzorcev ali kot zbirni ali distribucijski centri, prepare specimens, or act as a mailing or
se ne štejejo za medicinske ali klinične distribution centre, are not considered to be
laboratorije, čeprav so lahko sestavni del medical or clinical laboratories, although
večje mreže ali sistema laboratorijev. they may be part of a larger laboratory
network or system.
3.10 3.10
popreiskovalni postopki post-examination procedures
poanalitska faza postanalytical phase
procesi, ki sledijo preiskavi, vključno s processes following the examination including
sistematičnim pregledom, oblikovanjem in systematic review, formatting and interpretation,
interpretacijo, odobritvijo izvida, poročanjem in authorization for release, reporting and
prenosom rezultatov ter shranjevanjem vzorcev transmission of the results, and storage of
preiskav samples of the examinations
3.11 3.11
predpreiskovalni postopki pre-examination procedures
predanalitska faza preanalytical phase
postopki, ki se, po kronološkem vrstnem redu, steps starting, in chronological order, from the
začnejo z naročilom zdravnika ter vključujejo clinician’s request and including the
naročilo preiskave, pripravo pacienta, odvzem examination requisition, preparation of the
primarnega vzorca ter transport do laboratorija patient, collection of the primary sample, and
in v njem, končajo pa, ko se začne analitski transportation to and within the laboratory, and
preiskovalni postopek ending when the analytical examination
procedure begins
3.12 3.12
primarni vzorec primary sample
vzorec specimen
niz enega ali več delov, prvotno odvzetih iz set of one or more parts initially taken from a
sistema system
OPOMBA: V nekaterih državah se namesto izraza NOTE In some countries, the term “specimen” is
primarni vzorec (ali njegov podvzorec) used instead of primary sample (or a subsample of it),
uporablja izraz "vzorec", pomeni pa vzorec, which is the sample prepared for sending to, or as received
ki je pripravljen za pošiljanje v laboratorij ali by, the laboratory and which is intended for examination.
ga laboratorij prejme in je namenjen za
preiskavo.
SIST EN ISO 15189 : 2007
3.13 3.13
veličina quantity
lastnost pojava, telesa ali snovi, ki se lahko attribute of a phenomenon, body or substance
razlikuje kakovostno in ugotavlja količinsko that may be distinguished qualitatively and
determined quantitatively
[VIM:1993, definicija 1.1] [VIM:1993, definition 1.1]
3.14 3.14
sistem vodenja kakovosti quality management system
sistem vodenja za usmerjanje in obvladovanje management system to direct and control an
organizacije glede kakovosti organization with regard to quality
[ISO 9000:2005, definicija 3.2.3] [ISO 9000:2005, definition 3.2.3]
OPOMBA: V tem mednarodnem standardu se NOTE: For the purposes of this International
"kakovost", na katero se sklicuje ta standard, the "quality" referred to in this
definicija, nanaša tako na vodstveno kot na definition relates to matters of both
strokovno usposobljenost. management and technical competence.
3.15 3.15
prejemni laboratorij referral laboratory
zunanji laboratorij, ki se mu vzorec predloži v external laboratory to which a sample is
dodatne ali potrditvene preiskovalne postopke submitted for a supplementary or confirmatory
in poročanje examination procedure and report
3.16 3.16
vzorec sample
eden ali več delov, ki se odvzamejo iz sistema one or more parts taken from a system and
za pridobitev informacije o sistemu in pogosto intended to provide information on the system,
služijo kot podlaga za odločanje o sistemu ali often to serve as a basis for decision on the
njegovi proizvodnji system or its production
PRIMER: Količina seruma, odvzeta iz večje EXAMPLE A volume of serum taken from a
količine seruma. larger volume of serum.
3.17 3.17
sledljivost traceability
lastnost meritvenega rezultata ali vrednosti property of the result of a measurement or the
etalona, ki omogoča navezavo na navedene value of a standard whereby it can be related to
reference, ponavadi nacionalne ali mednarodne stated references, usually national or
etalone, skozi neprekinjeno verigo primerjav, ki international standards, through an unbroken
imajo opredeljeno negotovost chain of comparisons all having stated
uncertainties
[VIM:1993, definicija 6.10] [VIM:1993, definition 6.10]
3.18 3.18
pravilnost meritve trueness of measurement
ujemanje med povprečno vrednostjo, dobljeno closeness of agreement between the average
iz velike serije rezultatov meritev, in pravo value obtained from a large series of results of
vrednostjo measurements and a true value
OPOMBA: Prilagojeno iz ISO 3534-1:1993, definicija NOTE: Adapted from ISO 3534-1:1993, definition
3.12. 3.12
3.19 3.19
merilna negotovost uncertainty of measurement
parameter, ki je povezan z merilnim rezultatom parameter, associated with the result of a
in označuje raztros vrednosti, ki jih je mogoče measurement, that characterizes the dispersion
SIST EN ISO 15189 : 2007
upravičeno pripisati merjeni veličini of the values that could reasonably be
attributed to the measurand
[VIM:1993, definicija 3.9] [VIM:1993, definition 3.9]
4 Zahteva za vodenje 4 Management requirement
4.1 Organizacija in vodenje 4.1 Organization and management
4.1.1 Medicinski laboratorij ali organizacija, 4.1.1 The medical laboratory or the organization
katere sestavni del je laboratorij, mora biti of which the laboratory is a part shall be legally
pravno prepoznavna. identifiable.
4.1.2 Storitve medicinskega laboratorija, vključno 4.1.2 Medical laboratory services, including
z ustreznimi interpretacijskimi in svetovalnimi appropriate interpretation and advisory
storitvami, morajo biti namenjene izpolnjevanju services, shall be designed to meet the needs
potreb pacientov in celotnega medicinskega of patients and all clinical personnel responsible
osebja, odgovornega za oskrbo pacientov. for patient care.
4.1.3 Medicinski laboratorij (v nadaljevanju: 4.1.3 The medical laboratory (hereafter
laboratorij) mora pri izvajanju dela na svojih referred to as “the laboratory”) shall meet the
stalnih lokacijah ali na lokacijah, ki niso stalne, relevant requirements of this International
a je zanje odgovoren, izpolnjevati ustrezne Standard when carrying out work in its
zahteve tega mednarodnega standarda. permanent facilities, or at sites other than the
permanent facilities for which it is responsible.
4.1.4 Opredeljene morajo biti odgovornosti 4.1.4 The responsibilities of personnel in the
laboratorijskega osebja, ki je vključeno v laboratory with an involvement or influence on
preiskavo primarnih vzorcev ali ki nanjo vpliva, the examination of primary samples shall be
da bi se ugotovilo nasprotje interesov. Na defined in order to identify conflicts of interest.
preskušanje ne smejo vplivati finančni ali Financial or political considerations (e.g.
politični vidiki (npr. spodbude). inducements) should not influence testing.
4.1.5 Vodstvo laboratorija mora biti odgovorno 4.1.5 Laboratory management shall have
za snovanje, izvajanje, vzdrževanje in responsibility for the design, implementation,
izboljševanje sistema vodenja kakovosti. To maintenance and improvement of the quality
mora vključevati: management system. This shall include the
following:
a) podporo vodstva celotnemu laboratorijskemu a) management support of all laboratory
osebju z dajanjem ustreznih pooblastil in personnel by providing them with the
zagotavljanjem virov za opravljanje dolžnosti, appropriate authority and resources to
carry out their duties;
b) tako ureditev, ki zagotavlja, da vodstvo in b) arrangements to ensure that management
osebje nista pod nikakršnimi notranjimi in and personnel are free from any undue
zunanjimi poslovnimi, finančnimi ali drugimi internal and external commercial, financial
pritiski in vplivi, ki bi lahko škodljivo vplivali or other pressures and influences that may
na kakovost njihovega dela, adversely affect the quality of their work;
c) politiko in postopke za varovanje zaupnih c) policies and procedures for ensuring the
informacij (glej dodatek C), protection of confidential information (see
Annex C);
d) politiko in postopke, ki preprečujejo d) policies and procedures for avoiding
vpletenost v katerekoli dejavnosti, ki bi involvement in any activities that would
lahko zmanjšale zaupanje v njegovo diminish confidence in its competence,
usposobljenost, nepristranskost, presojo impartiality, judgement or operational
ali neoporečnost delovanja, integrity;
SIST EN ISO 15189 : 2007
e) organizacijsko in vodstveno strukturo e) the organizational and management
laboratorija ter njegov odnos do vsake structure of the laboratory and its
druge organizacije, s katero bi lahko bil relationship to any other organization with
povezan, which it may be associated;
f) določene odgovornosti, pooblastila in f) specified responsibilities, authority and
medsebojna razmerja za vse osebje, interrelationships of all personnel;
g) ustrezno usposabljanje vsega osebja in g) adequate training of all staff and
nadzor, ki ustreza njegovim izkušnjam in supervision appropriate to their experience
ravni odgovornosti, in ga izvajajo and level of responsibility by competent
usposobljene osebe, seznanjene z persons conversant with the purpose,
namenom, postopki in ocenjevanjem procedures and assessment of results of
rezultatov ustreznih preiskovalnih the relevant examination procedures;
postopkov,
h) strokovno vodstvo, ki je v celoti odgovorno h) technical management which has overall
za strokovno delovanje in zagotovitev responsibility for the technical operations
virov, potrebnih za doseganje zahtevane and the provision of resources needed to
kakovosti laboratorijskih postopkov, ensure the required quality of laboratory
procedures;
i) imenovanje vodje kakovosti (naziv je lahko i) appointment of a quality manager
poljuben) s podeljenima odgovornostjo in (however named) with delegated
pooblastilom za nadzor skladnosti z responsibility and authority to oversee
zahtevami sistema vodenja kakovosti, ki compliance with the requirements of the
mora biti neposredno odgovoren tisti ravni quality management system, who shall
vodstva laboratorija, na kateri se report directly to the level of laboratory
sprejemajo odločitve o politiki in virih management at which decisions are made
laboratorija, on laboratory policy and resources;
j) imenovanje namestnikov za vse ključne j) appointment of deputies for all key functions,
funkcije ob upoštevanju, da imajo lahko v while recognizing that in smaller laboratories
manjših laboratorijih posamezniki več funkcij individuals can have more than one function
in da bi bilo imenovati namestnike za vsako and that it could be impractical to appoint
funkcijo nepraktično. deputies for every function.
4.1.6 Vodstvo laboratorija mora zagotoviti 4.1.6 Laboratory management shall ensure that
vzpostavitev ustreznih komunikacijskih appropriate communication processes are
procesov v laboratoriju ter komunikacijo glede established within the laboratory and that
uspešnosti sistema vodenja. communication takes place regarding the
effectiveness of the quality management system.
4.2 Sistem vodenja kakovosti 4.2 Quality management system
4.2.1 Politika, procesi, programi, postopki in 4.2.1 Policies, processes, programmes,
navodila morajo biti dokumentirani in posredovani procedures and instructions shall be documented
vsemu ustreznemu osebju. Vodstvo mora and communicated to all relevant personnel. The
zagotoviti, da so dokumenti razumljivi in da se management shall ensure that the documents are
uporabljajo. understood and implemented.
4.2.2 Sistem vodenja kakovosti mora med drugim 4.2.2 The quality management system shall
vključevati notranjo kontrolo kakovosti ter include, but not be limited to, internal quality
sodelovanje v organiziranih medlaboratorijskih control and participation in organized
primerjavah, kot so npr. sheme za zunanjo oceno interlaboratory comparisons such as external
kakovosti. quality assessment schemes.
4.2.3 Politika in cilji sistema vodenja kakovosti 4.2.3 Policies and objectives of the quality
morajo biti opredeljeni v izjavi o politiki kakovosti, management system shall be defined in a
za katero je pooblaščen vodja laboratorija in je quality policy statement under the authority of
SIST EN ISO 15189 : 2007
dokumentirana v poslovniku kakovosti. Ta politika the laboratory director and documented in a
mora biti vedno na voljo ustreznemu osebju, biti quality manual. This policy shall be readily
mora kratka in jedrnata ter mora vključevati available to appropriate personnel, shall be
naslednje elemente: concise and shall include the following:
a) obseg storitev, ki jih namerava izvajati a) the scope of service the laboratory intends
laboratorij, to provide;
b) izjavo vodstva laboratorija o ravni b) the laboratory management’s statement of
kakovosti storitev laboratorija, the laboratory’s standard of service;
c) cilje sistema vodenja kakovosti, c) the objectives of the quality management
system;
d) zahtevo, da se mora osebje, vključeno v d) a requirement that all personnel concerned
preiskovalne aktivnosti v laboratoriju, with examination activities familiarize
podrobno seznaniti z dokumentacijo themselves with the quality documentation
sistema kakovosti ter ob vsakem času and implement the policies and procedures
izvajati njegovo politiko in postopke, at all times;
e) zavezanost laboratorija dobri strokovni e) the laboratory’s commitment to good
praksi, kakovosti njegovih preiskav in professional practice, the quality of its
skladnosti s sistemom vodenja kakovosti, examinations, and compliance with the
quality management system;
f) zavezanost vodstva laboratorija skladnosti f) the laboratory management’s commitment
s tem mednarodnim standardom. to compliance with this International
Standard.
4.2.4 Poslovnik kakovosti mora opisati sistem 4.2.4 A quality manual shall describe the quality
vodenja kakovosti in zgradbo dokumentacije, ki management system and the structure of the
se v sistemu vodenja kakovosti uporablja. documentation used in the quality management
Poslovnik kakovosti mora vsebovati podporne system. The quality manual shall include or
postopke, tudi tehnične, ali se nanje sklicevati. make reference to the supporting procedures
Vsebovati mora tudi pregled dokumentacije including technical procedures. It shall outline
sistema vodenja kakovosti. V poslovniku the structure of the documentation in the quality
kakovosti morajo biti določeni vloga in management system. The roles and
odgovornosti tehničnega vodstva in vodje responsibilities of technical management and the
kakovosti ter njihova odgovornost za quality manager, including their responsibility for
zagotavljanje skladnosti s tem mednarodnim ensuring compliance with this International
standardom. Standard, shall be defined in the quality manual.
Vse osebje mo
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