INTERNAL AUDIT PLAN

Date: 17/03/2020
Auditor: Dr. Charandeep Singh Sahni
Auditee: Bhor Diagnostic Centre

Audit Plan:

Sr. No Area Audited Auditee

1. Managerial Requirements Dr. Charandeep Singh Sahni
2. Technical Requirements Dr. Charandeep Singh Sahni
3. Sample Collection Facility Dr. Charandeep Singh Sahni

Prepared By: ………………….

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 INTERNAL AUDIT REPORT
BHOR DIAGNOSTIC CENTRE

The internal audit of Bhor Diagnostic Centre was done on 17/03/2020 by Dr. Charandeep Singh
Sahni as per ISO 15189:2012

The team audited as per NABL checklist and following sections were audited:

 Management Requirement (Organization and management, Quality Management

system, Document control, Review of contract, Examination by referral laboratories,
external services and supplies, advisory services, resolution of complaint, identification
and control of non conformities, corrective action, preventive action, continual
improvement, quality and technical records, internal audits and management review,
technical requirements, laboratory equipment, pre- examination procedure,
examination procedures and post examination procedures, reporting and review of
results)
 Hematology & Clinical Pathology
 Waste disposal and housekeeping
 Biochemistry
 Sample collection
 Purchase section
 Personnel files
 Outside sample collection center

This was the second audit. The Lab has adequate space for its activities and is well maintained.
All major and minor equipments in the department are serviced properly as per schedule and
are maintained.

The doctors and technicians are well qualified and have adequate strength to meet the
activities. All sections of Lab are doing IQA and all sections are participating in EQAS to assess
the accuracy and their performance. Sample collection centre was also audited and needs more
attention.

During the audit the team identified the 10 NC’s.

The Lab Director agreed to take corrective action in 30 days. The team feels that the training and
updating of knowledge of technicians may be done regularly.

Dr. Charandeep Singh Sahni

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Date – 17/03/2020

Bhor Diagnostic Centre

NC Summary Sheet

S.No. Nature of NC Clause No. Action Proposed and

Timed Required
1. Mou of referral lab has to QMS 4.5 Proposed to do the
be renewed. same- 30 days
2. Staff training has been QMS 5.1 Proposed to do the
missed since 1 month same- 30 days
3. Bio medical waste was QMS 5.2 Proposed to do the
not properly disposed off same- 30 days
4. Temperature Charts of Hematology 5.4 Proposed to do the
refrigerator were not up to same- 30 days
date
5. Obsolete document was QMS 4.3 Proposed to do the
seen in main lab area. same- 30 days
6. Back ground error of Hematology 5.3 Proposed to do the
hematology analyser not same- 30 days
done regularly
7. CAPA for IQC outliers Biochemistry 5.6 Proposed to do the
not addressed properly. same- 30 days
8. Helper does not know, Collection 5.1 Training will be given
how to prepare centre to staff- 30 days
hypochlorite
9. Gloves were not worn by Collection 5.2 Training will be given
phlebotomist while centre to staff - 30
sample collection days

10. Sample transportation kit Collection 5.4 Proposed to do the

does not show biohazard Centre same- 30 days
label

Kindly submit the necessary corrective action within 30 days.

Dr. Charandeep Singh Sahni

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