Implementation and Accreditation of ISO 15189
ISO 15189: A STANDARD OF YIN AND YANG
Hannah Murfet (BSc, PCQI), Product Quality Manager, Horizon Discovery
Introduction
In a world where technologies are constantly emerging, clinical laboratories must look to take control of
their laboratory developed or adapted tests. Combining ISO 9001 quality or business requirements and ISO
17025 competence requirements, ISO 15189 address the key business relevant requirements for the clinical
laboratory. This allied nature of these two overlapping requirements makes ISO 15189 a standard of Yin
and Yang.
Adoption of ISO 15189 is increasing in clinical laboratories to gain an edge with reputation and user
confidence. Adoption is strong worldwide, with the increasing uptake even in the US which operates an
accreditation programme with CLIA (A2LA). The standard coherently integrates the essential requirements,
with specific requirements on the medical environment whilst reflecting the importance of clinical testing
to patient care.
The Yin takes the form of the quality management system requirements. These are the hidden
requirements outside the clinical laboratory, they are what make the business tick and run effectively and
should become part of business behaviour. The Yang takes the form of the laboratory competence
requirements; these are explicit, expected and can help to drive a reputation for good service. Together the
Yin and Yang provide balance and the complete set of requirements for the clinical laboratory environment
to face evolving technology and performance requirements.
Figure 1: ISO 15189 A standard of Yin and Yang
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The value of quality management systems have been demonstrated through the uptake of ISO 9001 across
all sectors; however ISO 15189 has the added benefit of industry focus. A quality management system is a
structure of organisational documents and records that establish the controls necessary for quality and
continuity of service.
Typically the quality management system takes a three tier hierarchy. At the highest level the policies
define the organisation’s strategy and focus; here you will find organisational goals, expectations and
commitments. In the case of ISO 15189, the focus includes commitment to good professional practice and
continual improvement of laboratory services (The International Organisation for Standardisation, 2012).
Procedures are defined and documented instructions on performing business/quality management or
technical activities. They provide continuity of activity and support daily operations, including the training
of staff. Records are generated through the execution of procedures; they are the recorded outputs and
provide evidence of compliance and traceability.
Figure 2: ISO 15189 Document Hierarchy
ISO 15189 contains a range of quality management system requirements; these can be split broadly into
Assurance, Responsibility and Documentation.
Figure 3: ISO 15189 Quality Management System Requirements Overview (The International Organisation
for Standardisation, 2012).
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The Yin through each of the above groups helps to ensure the clinical laboratory is focused on the needs of
its user and the patient. Implementation ensures clear accountability and unified direction across the
organisation for ethics and approach. Overall these systems facilitate improvement, traceability and
ultimately assurance of the accuracy of patient results through internal structural requirements.
The Yang’s technical requirements can be divided into two areas, the operational requirements and
examination requirements. The operational requirements cover the documentation and control of
personnel, facilities, assessment & control and laboratory information management. Together these ensure
the consistent running of the technical operations of the clinical laboratory by providing consistency of
training, environment, equipment, materials and systems; all of which can be supported by reference
materials and technical infrastructure.
Figure 4: ISO 15189 Technical Operational Requirements Overview (The International Organisation for
Standardisation, 2012).
The examination requirements include pre-examination processes and post-examination processes. Preexamination requirements serve to ensure the validity of the results of examinations. This is approached
from a number of angles including the handling of samples, as well as validation and verification
procedures. Investment in the pre-examination requirements can lead to greater clinical and user
confidence, especially with implementation of quality control materials that feedback into the operational
requirements.
Post-examination procedures tackle the handling of reports, including the methods and authorities by
which they are issued and revised. These requirements act as a gate post and should not serve as the only
process control point, as errors at this point will no doubt lead to delays. Post-examination procedures
should also include the storage, retention and disposal of clinical samples, especially as disposal regulatory
requirements can be country dependent.
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Table 1: ISO 15189 Technical Pre-Examination Requirements Overview (The International Organisation for
Standardisation, 2012).
Table 1: ISO 15189 Technical Post-Examination Requirements Overview (The International Organisation for
Standardisation, 2012).
The Technical requirements ensure and maintain laboratory confidence, both internally and externally. The
Yang is presented visually by the organisation by the results it delivers to users and interlaboratory
comparisons. The technical requirements build external reputation by reliability of results and the
consistency of their delivery.
Bringing the Yin and Yang Together
ISO 15189 is an internationally recognised standard that allows clinical laboratories to demonstrate
competence and reliability of services. By achieving accreditation to ISO 15189 clinical laboratories gain
ongoing independent validation of competence, a clear confidence message to clinical users and
accreditation schemes or licences.
By bringing the Yin and the Yang together, ISO 15189 offers a comprehensive solution to improve clinical
testing standards. There are clear benefits to the regulator, the patient and the medical laboratory. The
standard seamlessly integrates the requirements for both quality and business management with the
technical needs of the sector. Implementation of the policy, procedures and quality control materials will
no doubt serve to protect the reputation of the clinical laboratory and facilitate the continued
advancement of medical technology to standard of care without compromising on quality of service.
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Horizon Diagnostics
Horizon Diagnostics is proud to support clinical laboratories with the provision of reference materials for
research use; applications include the validation of equipment and consumables offline from patient
testing. This report has been provided for information only. The full ISO 15189 can be purchased from
standards providers to supply full details of the accreditation requirements.
Bibliography
A2LA. (n.d.). Frequently Asked Questions Related to the A2LA. Retrieved from
http://www.a2la.org/faq/medical_15189.pdf
The International Organisation for Standardisation. (2012). Medical Laboratories - Requirements for Quality
and Competence (ISO 15189:2012).
t: +44 (0)1223 655580
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e: info@horizondiscovery.com
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Horizon Discovery Ltd., Building 7100, Cambridge Research Park, Waterbeach, Cambridge, CB25 9TL, United Kingdom
UK Registration No: 05363294 UK VAT No: GB 189 1993 44