CONFIDENTIAL

FQI Examination Paper

(Time given: 90 minutes)

For

ISO 15189:2012 Four days Auditors certificate course

Please write your name in BLOCK / CAPITALS, Date and signature in the space below:

NAME:

Organization:

Date:

Signature:

Section Valuer 1 Valuer 2 Maximum Minimum

1 15 6
2 25 10
3 30 12
4 30 12
Total 100 70

Result

Note: There are FOUR sections. All questions are compulsory.

Maximum marks: 100. The time allowed is 90 minutes.

Minimum required for pass: 70.
A minimum of 40% in each section is mandatory.

Your answers must be within the space provided. Additional sheets are not permitted. However, the
reverse side may be used if required.

The Standard always means ISO 15189:2012. During the Examination access to ISO 15189:2012 is allowed.
Reference to any other document/internet is prohibited. The word ‘Clause’ refers to a paragraph or
section of the standard, which is identified by a set of numbers such as 5.5.6 of ISO 15189.

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 SECTION 1: Max marks: 15 (15 x 1)

1.0 Place a circle around the letters (a, b, c or d) to indicate which you judge to be the best answer.
Each question carries 1 mark.

1.1 The Internal audit of a laboratory is the responsibility of:

a) Laboratory Director
b) Laboratory owner
c) Quality Manager
d) All of the above

1.2 Identification of non-conformities is the duty of:

a) Lab director only

b) Quality manager only
c) Pathologist only
d) All staff

1.3 Pick the odd one out:

a) Calibration functions and conversion factors

b) Records of quality improvement activities
c) Request for examinations
d) Quality policy statement

1.4 Laboratory seeking accreditation should have conducted the activities in the following sequence:

a) Management review, internal audit, training all personnel and QMS establishment
b) QMS establishment, management review, training all personnel and internal audit
c) Internal audit, management review, training all personnel and QMS establishment
d) QMS establishment, training all personnel, internal audit and management review

1.5 Which of the following is considered as a post-examination activity?

a) Completion of request form

b) Storage of examined samples no longer required
c) Inventory management of reagents
d) Inclusion of time limits for requesting additional examinations on the same primary sample

1.6 The interval between management reviews should not be greater than:

a) 12 months
b) 21 months
c) 18 months
d) 24 months

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 1.7 Pick the odd one out:

a) Management review
b) Accreditation assessments
c) Periodic review of requests, and suitability of procedures and sample requirements
d) Internal audit

1.8 According to ISO 15189, ‘measurement uncertainty’ may be calculated using values of:

a) Internal quality control samples

b) External quality assessment programme samples
c) Control materials that are tested daily in interlaboratory programme
d) Calibrator values

1.9 Identify the clause which begins with NOTES

a) 4.3
b) 5.7.2
c) 5.3
d) 4.9

1.10 In which of the following documents instructions for pre-examination activities are likely to be found?

a) Quality Manual
b) Patient Report
c) Primary sample collection manual
d) ISO 15189: 2012

Indicate the clause (including sub-clause) of ISO 15189:2012, which is applicable to following statements: -
(Each carries 1 mark).

1.11 Laboratory maintained equipment and reagents records were not readily available for the
lifespan of the microbiology equipment as specified in the laboratory’s Control of Records
procedure in that section
Clause No. ________________

1.12 Authorized personnel shall systematically review the results of examinations, evaluate them
in conformity with the clinical information available regarding the patient and authorize the
release of the results. Clause No. ___________

1.13 Laboratory facilities at which patient sample collection procedures are performed shall
enable the sample collection to be undertaken in a manner that does not invalidate
the results.
Clause No. _______________

1.14 Laboratory did not have a documented procedure for the calibration of equipment that
directly or indirectly affects examination results.
Clause No. ______________

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 1.15 Not even one copy of an obsolete controlled document was retained by the laboratory for a
specified time period in accordance with applicable specified requirements in the molecular
genetics laboratory
Clause No. ____________

Section 2: Maximum marks: 25 (5 x 5)

2.0 Five questions, which require a brief written answer in the space provided.
Each question is worth 5 marks.

2.1 What is purpose of Internal audit and assessment

Internal audit Assessment

i)

ii)

iii)

iv)

v)

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2.2 Explain the terms with examples:

a) Vertical audit

b) Witness audit

c) Horizontal audit

d) System tracer audit

e) Regulatory requirement

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2.3 Explain with the help of a flow chart, the typical audit planning in the pathology section

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2.4 Explain, what is the basis to identity the non-conformities and how to categorize them as
“Major” and “Minor” during the internal audit?

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2.5 List the formats used during the internal audit.

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 Section 3: Maximum marks: 30 (10 x 3)

These Questions require a detailed answer & will normally fill the space provided.

3.1. Draw and explain the structure of documentation in the quality management system.

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 3.2 As an auditor, while auditing the examination processes in a laboratory provide a checklist that
can be used.

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3.3 You are leading an audit team for auditing of XYZ medical testing laboratory. You have two technical
auditors in your team. In all there were 12 NCs (3 Major& 9 Minor).

1. Prepare the final audit report

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 2. Prepare an agenda of closing meeting of audit

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 Section 4: Maximum marks: 30 (6 x 5)

1. The following incidents occurred during the audit of XYZ laboratory. Please report the non-
conformances

2. NCR formats to be prepared by you

3. You may use fictitious auditee name and assessor’s name.

Incident Number – 1

During an audit of a laboratory, located at other location in a hospital, the technical auditor asked the
technician about the methodology for collecting and processing the samples. The technician told to the
auditor that samples are collected as per the collection manual given by the main central laboratory.
Further it was noticed by the auditor, the secondary samples are also prepared by that section. It was
observed by the auditor that there was no evidence of calibration of centrifuge, water bath and
thermometer used for preparation of secondary samples were not calibrated.

Incident Number- 2

In a hospital based large laboratory, the in-patient samples were also being examined by the
laboratory. While auditing the Clinical biochemistry section for release of reports, it was observed by
the auditor the technicians were directly informing the results of patients to the ward boy without
verification/authorization from the consultant who is the authorized signatory of Clinical biochemistry.

Incident Number- 3

During the annual audit, of a hospital based laboratory, the auditor observed that the Central authority
of the hospital were purchasing the reagents, kits and other consumables. The laboratory was using the
kits and other consumables, which are critical for quality results, on the basis of acceptance report of
the hospital store in-charge only. However as per the laboratory's procedures these are to be verified
by the concerned laboratory consultants.

Incident Number- 4

As per the laboratory's Document control procedure , the amendment in any document including SOP
are to be reviewed by respective consultants of relevant sections, approved by Head of the laboratory
and issued by the Quality Manager. While assessing the Haematology division, it was observed that SOP
for manual method after amendments is being used without approval and issuance, however it was
observed that the consultant had reviewed and it was found to be fit for use.

Incident Number- 5

The auditor observed that the laboratory was referring the histopathology tests for second opinion to
an accredited laboratory. The Dy. Technical Manager is responsible to maintain the records /register of
the examinations sent to the referral laboratory. He explained to auditor that laboratory maintains the
reports of referral laboratory in original and issuing the reports on their own laboratory's format.
However, it was observed that the original Histopathology report of a patient from referral laboratory
was not available.

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 Incident Number- 6

The laboratory has identified an increase in no of tests by 20% per month and to achieve this target,
laboratory has defined a policy to pay the financial incentives to technicians who perform the tests to
achieve this quality indicator.

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