Comparative characteristics of Standards ISO

15189:2012 and EN ISO/IEC 17025:2005 – detalization

and peculiarities of accreditation process.

Ioannis Sitaras
ESYD Laboratories Accreditation Division Director
ISO 15189 and ISO/IEC 17025
• ISO 15189 is a standard dedicated for medical laboratories
• Description of requirements and terminology fit for purpose for the medical
sector
• Focusing on sectors/functions of the medical laboratory
• Additional requirements (regarding ethics, contingency plan, risk assessment,
referral laboratories, organization structure,LIS)
• 3 editions 2003,2007 and 2012: technical and metrological requirements
were gradually approached current status of testing laboratories
ISO 15189 and ISO/IEC 17025
• The structure and the context of ISO/IEC 17025 are
transferred/aligned and interpreted according to the needs of the
medical laboratories in the ISO 15189
• Table A.2 of ISO 15189:2012 shows the correlation and the cross
reference for each set of requirements
• Does it mean that we can use the same Lead Assessors/accreditation
managers/decision making procedures?
• Does it mean that ISO/IEC 17025 assessors could participate into ISO 15189
assessments
• Is the implementation of ISO 15189 by a Laboratory already accredited by
ISO/IEC 17025 a simple procedure?
ISO 15189 and ISO/IEC 17025
Management System Requirements
• Both standards have the same requirement for legal entity
• Need for structure and organization in case of Laboratories being part of
larger organizations
• In ISO/IEC 17025: arrangements for impartiality, confidentiality, freedom
from other pressures while in ISO 15189 a clause for “ethical” conduct goes
further: declaration of conflicts of competing interest, if exist
• In ISO/IEC 17025 the laboratory has technical and managerial personnel
while ISO 15198 mainly focus and emphasize the role of Laboratory
Director
• Both standards require a quality manager, in ISO 15189 duties are further
specified
ISO 15189 and ISO/IEC 17025
Management System Requirements
• In ISO 15189 additional requirements for quality policy
• No significant differences for document control
• In ISO 15189:2012 edition the concept of “Service Agreements” is much more
aligned with the general requirements of ISO/IEC 17025 for
Contracts/tenders/Requests
• Still the concept of “Referral” Laboratory is different than this of the
subcontractor-an expertise is sought not only a “testing/or calibration” service
• No significant differences for the general requirements for Services/Suppliers. In
ISO 15189 it is recognized that a medical lab will probably have its suppliers
selected by other parts of the organization, while this is not so clear in the
ISO/IEC 17025. Additional requirements exist regarding notifications to suppliers
and authorities in case of incidents
ISO 15189 and ISO/IEC 17025
Management System Requirements
• Advisory Service is totally different than the general concept of
ISO/IEC 17025 “service to the customer” and the way this
requirement is interpreted in testing and calibration laboratories
• The concept of non-conforming work, corrective actions, internal
audits and management reviews is almost the same. ISO 15189
further analyses these processes regarding the medical laboratories.
The term of potential non-conformity is introduced regarding
preventive actions. Additional requirements exist for staff
suggestions, handling of results of external assessments and risk
assessment.
ISO 15189 and ISO/IEC 17025
• Τechnical Requirements
Personnel
In ISO 15189 requirements for personnel are very detailed presented
and there are all the necessary elements for the evaluation of
competence, training and evaluation of the effectiveness of training.
In addition to ΙSO/IEC 17025 training is required for health & safety and
ethics, records for immunization status (where relevant), accidents and
occupational hazards.
ISO 15189 and ISO/IEC 17025
• Τechnical Requirements
Facilities
In addition to ΙSO/IEC 17025 requirements facilities are expanded for
staff and storage facilities, are very detailed regarding the purpose of
the laboratory and the concept of “quiet and uninterrupted work” is
introduced.
In addition to ΙSO/IEC 17025 health staff is included in the
requirements
ISO 15189 and ISO/IEC 17025
• Τechnical Requirements
Equipment and Traceability-Reagents and consumables
Requirements of ISO/IEC 17025 have been transferred to ISO 15189
while the concept of traceability is referred to the equipment clause of
the standard.
In addition there are requirements for adverse incident reporting.
Requirements for reagents and consumables, otherwise dealt by 4.6 of
ISO/IEC 17025 are in detail presented in 5.3.2 of ISO 15189
ISO 15189 and ISO/IEC 17025
• Τechnical Requirements
Pre-examination Processes-Examination Process
Pre-examination Process is presented in far more detailed way than
sampling in ISO/IEC 17025.
In the new edition of ISO 15189:2012 an excellent presentation of what
the standard requires regarding verification and validation is given,
while in the ISO/IEC 17025:2005 a lot of “grey” areas still exist
Requirements for uncertainty have been aligned
Reference for biological intervals exist in ISO 15189-in ISO/IEC 17025
this cannot be easily handled
ISO 15189 and ISO/IEC 17025
• Τechnical Requirements
Ensuring the quality examination results
The reference in the external and internal quality control is very
comprehensive in ISO 15189 but in general, requirements are the same
with testing laboratories.

There are additional requirements for PTs and how laboratories take
part to external control programs
ISO 15189 and ISO/IEC 17025
• Τechnical Requirements
Reports
Apart from the requirements for reports which are dedicated for
medical labs, in ISO 15189 there are detailed requirements for the
release of results and the use of LIS for automated selection and
reporting of results
LIS
This an additional to ISO/IEC 17025 requirement
ISO 15189 and ISO/IEC 17025- Accreditation
Bodies
ABs need to assure access to expertise regarding the assessors’ pool,
technical competence and the decision management process
They need to have effective and continuous communication with the
medical profession and relative scientific unions in the country they
operate
They need to take into account the health sector in their interested
parties (State, medical profession, public)-it depends on how they deal
their interested parties regarding decision management process
ISO 15189 and ISO/IEC 17025
Access to expertise and selection of assessors

Technical Assessors from the medical profession and relative sciences

have to be selected according to their competence in specific
examinations and trained according to ISO 15189

Lead Assessors from ISO/IEC 17025 cannot be used without training for
ISO 15189
ISO 15189 and ISO/IEC 17025
Accreditation Procedure-Documents
• Accreditation Procedure for medical laboratories does not have to be
different than the other laboratories
• Traceability, Calibration of Equipment have to be the same as in
testing laboratories
• Requirements for participation in PTs have to be reviewed in order to
be fit for purpose for the medical laboratories
• Multi-site accreditation procedure might be needed
• Flexible scope accreditation policy is also needed