HEALTH EDUCATION & LEARNING PROTOCOLS

Quality Management Systems and Internal Audit in Medical Labs as per

ISO 15189:2012

EXERCISE - I
Identification of clauses

The 30 brief scenarios represent situations, which are found during the assessment of
a laboratory. Everybody should attempt to relate each one of the listed scenarios to the
clauses in ISO 15189 which apply to the situations.

Sr. Scenario Clause

No.
01. The Quality Manual of the supreme hospital laboratory does not
describe the roles and responsibilities of the Laboratory Director
and Quality Manager. Also the Quality Manual does not give
references to Management and Technical clauses
02. Samples of MDX Hospital trustees and relatives of the
management are processed urgently so as to please them. They
are treated as urgent and reported immediately.
03. Laboratory’s document control system allows hand made
changes in documents. Quality manager is making the changes
in documents by hand without giving date & his initials as there
is no procedure & authority established for such changes.
04. The laboratory has system of feedback collection. However
feedback so collected are not analyzed to monitor lab
performance, so record of actions taken are also missing.
05. The lab director informed the assessor that there is a daily
discussions with the staff therefore it is not necessary to discuss
it again in the Management Review.
06. The lab obtains second opinion from referral lab but does not
evaluate referral lab and also does not have procedure for
selecting the referral lab.
07. Last accreditation audit had 10 Major Non Conformities, for
which lab had taken satisfactory corrective action, however
records in support of their review w.r.t corrective actions and
preventive actions were not kept.
08. The Lead Assessor observed that the feedbacks from the users
were not received and evaluated.
09. The multi-central laboratory of West Valley Hospital daily
receives the complaints. The Lab Director Dr. Vishal informed
that all the complaints are resolved verbally to the statisfaction
of selected customer. Dr. Vishal also informed, since the
complaints are resolved verbally on random basis as no time was
available to cover all complaints no records were maintained.

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10. NCs identified in pre-examination process of the Angel hospital
laboratory are closed immediately without any delay. Analysis
of reasons of non conformance was not done.
11. The lab is part of hospital. The organization structure in Quality
Manual describes only lab director, department heads and other
functionaries of the laboratory. Parent organization is not
depicted in organization structure.
12. The documents have been Xeroxed to uncontrolled distribution.
There is no available distribution list. Technicians in
Microbiology section are using different versions of SOP for
testing HbsAg test.
13. The laboratory management has neither defined and nor
documented the responsibilities, authorities and interrelations of
the personnel in the lab
14. Quality Manual is in safe custody of Quality Manager. It is not
accessible to lab technicians.
15. The Quality Manual of the Star hospital laboratory has not
described the roles and responsibilities of the Laboratory
Director Dr. Qasimand Quality Manager Mr. Shresta. Mr.
Shresta does not give references to Management and Technical.
16. The sigma Laboratory conducted its internal audit for
examination and post-examination processes, seven months back
and five non-conformities were raised by auditor. The NCs were
still not closed.
17. Management review of the laboratory is done to ensure
adequacy & effectiveness of quality management system at
annual interval, but previous review has not discussed about last
NABL assessment and results of lab’s PT participation.
18. During the assessment it was observed that the manufacture
recommends the change of cuvettes of the instrument after every
four months but for the last six months these were not changed.
Also there many QC failures.
19. The laboratory has developed and defined Quality Indicators for
examination procedures but no Quality Indicators defined for
Pre- and Post- Examination procedures.
20. For improvement in the lab services, regular inputs are taken
from the Doctors/ Technicians. Such suggestions are verbally
discussed with senior management.
21. No reference to the supporting procedures including technical
procedures has been given in the quality manual.

22. Lead assessor observed that the quality manual of the laboratory
lacks in:
 staff education and training,
 document control and,
validation of examination procedures

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23. The laboratory has a documented procedure of retaining records
of all its testing activities for a minimum of 5 years. The records
were being stored in accordance with the procedure. However, at
the time of assessment the laboratory could not retrieve the
same.
24. A laboratory was accredited in the year 2003. In the surveillance
of 2005 it was observed that thereafter various documents of the
laboratory have not been reviewed and revised.

25. Technical assessor of hematology observed that one copy each

of currently authorized version and obsolete standard operating
procedures in haematology were available at the testing site.
26. Quality manual of the laboratory does not have edition and
authority for issue.
27. A patient reported at the reception counter of the laboratory for
getting himself tested for prostatic specific antigen. The
phlebotomist collected the blood and the same was sent to
immunology laboratory. There it was observed that neither the
laboratory is aware of the testing method nor it has the testing kit
for this test.
28. The laboratory is frequently seeking second opinions from
referral laboratories on histopathology and cytopathology slides
but documented procedure for evaluating and selecting referral
laboratories is lacking
29. The laboratory is procuring equipment and consumable supplies
that affect the quality of test from standard suppliers. However,
these are put to use without verifying as complying with
standard specifications.
30. The laboratory has not evaluated suppliers of critical reagents,
supplies and service that affect the quality of examinations.