QSP:2

MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND

HOSPITAL, DAHOD, GUJARAT

QUALITY SYSTEM PROCEDURE FOR

DOCUMENT CONTROL

ISO 15189: 2012 MANAGEMENT

CLAUSE NO. 4.3

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 1 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

AMENDMENT SHEET
SI Page Clause Date of Amendment Reasons Signature Signature
No No Amendment Of QM Of Lab
Director

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 2 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Purpose: - To assure that quality system documents used by Molecular Laboratory at Zydus
Medical College and Hospital, Microbiology department employees are properly developed,
approved, current, located where needed, and archived properly. Quality system documents
include the following: manuals, procedures, work Instructions (WIs), policies, biological
reference intervals, and their origins, and documents of external origin such as regulations,
standards, etc.

Introduction: - Document control, also known as document management, is a system that is

implemented to organize all of the important documents within a laboratory and manage
them throughout their life cycles, i.e., from creation to retirement. Document control is an
important aspect of quality management. It ensures consistency by applying a standardized
system.
Documents are considered as being information (e.g., specifications or procedures) and its
supporting medium (e.g., paper or electronic). Over time these documents evolve as new
information supersedes old and that change must be managed. Documents are active and
dynamic. Records, on the other hand, are more static since they are historical in nature. They
are the documents that state the results of activities undertaken in accordance with the
product realization, measurement, analysis, and improvement processes (e.g. calibration logs
and non-conformance or corrective action reports). They also provide evidence that the
activity was performed in the manner specified (e.g., inspection records).

A document control system ensures the following aspects:

 All documents, including those maintained in a computerized system, issued as part of

the quality management system are reviewed and approved by authorized personnel
prior to issue.
 Documents are available to staff who need them.
 All documents are legible.
 All documents are written in the approved format
 Only current versions of documents are available at points of use.
 The documents that are in use are approved and reviewed at the required frequency.
 All personnel have read the policies and procedures that are relevant to their jobs
including revisions, if and when they occur.
 Discontinued policies/procedures are removed from active files and maintained in a
separate file for the required retention times.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 3 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

All policies and procedures that are currently in use and all documents that were previously
used and are still retained by the laboratory should be managed using a document control
system.

Scope: This procedure applies to the control of documents including electronic and external,
which calls for quality requirements or prescribes activities affecting quality such as methods,
regulations, directives, procedures, and instructions, pertaining to the Molecular Laboratory,
Zydus Medical College and Hospital, Dahod laboratory’s Quality Management System
(QMS).

Responsibility:
Quality Manual:
Author: Dr. NiteshKumar Jaiswal (Quality Manager)
Amendment/Annual Review-Dr. Rekha Kishori (Technical Expert/ Section Head –
Assistant Professor)
Approve: Dr. Deepak Deshkar (Laboratory Director)
Issue: 2.0
Quality System Procedures:
Author: Dr. NiteshKumar Jaiswal (Quality Manager)
Amendment/Annual Review- Dr. Rekha Kishori (Technical Expert/ Section Head –
Assistant Professor)
Approve: Dr. Deepak Deshkar (Laboratory Director)
Issue: 2.0

Specimen Collection and Handling Manual:

Author: Ms. Shital Sangani (Section Head)
Suggest Amendment/Annual Review: Dr. Pankti Pargi (Microbiologist)
Approve: Dr. Deepak Deshkar (Laboratory Director)
Issue: 2.0

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 4 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Laboratory Safety Manual:

Author: Dr. Dipak Patanvadia (Lab Safety Officer)
Suggest Amendment: Ms. Hetal Rav (Head of Operations)
Annual Review: Dr. NiteshKumar Jaiswal (Quality Manager)
Approve: Dr. Deepak Deshkar (Laboratory Director)
Issue: 2.0

Standard Operating Procedures:

Author: Ms. Shital Sangani (Section Head)
Suggest Amendment/Annual Review: Dr. Rekha Kishori (Technical Expert)
Approve: Dr. Deepak Deshkar (Laboratory Director)
Issue: 2.0

Quality Records: - Respective technical staff / Section Head /Operation Head/Manager-

Quality

It is the responsibility of the concerned Section Head/ HOD to read and implement this SOP.
It is the responsibility of the Quality Manager (QM) to implement and maintain a document
control system, coordinate reviews and revisions of quality system documents, maintain an
electronic document log sheet to ensure active and revised documents are provided to staff,
and archive superseded or obsolete documents

Procedure: Policies and procedures under document control follow a defined cycle. The
general flow of document control is as follows:

 Procedure is written by competent staff, including input from testing personnel if

possible.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 5 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

 Procedure is reviewed for accuracy by competent staff.

 The Head of the department/lab director or appropriate laboratory authority approves
the procedure.
 Testing personnel read the procedure and understand it. In case of any doubt seek
clarification from the Quality Manager/Laboratory Director.
 Procedure goes into use in the laboratory.
 Procedure is reviewed annually by the respective HOD/Quality Manager/ Laboratory
Director to ensure continued relevance. This is accomplished by having a master list
or inventory of documents (document control log) that shows which documents are
currently in use, their revision number, and the date of revision.
 The master list also identifies obsolete documents, which are removed from all places
of use and stamped in red as “Obsolete” with the date.
 A copy of the obsolete document is archived for two years but precautions are taken
to avoid inadvertent use.
 Amendments and corrections in any of the controlled documents are done through the
proper channel and the amended or corrected copy is issued as the next version. The
amendments or corrections are included in the revision history of the document.

All the laboratory documents are controlled (as per the Table below). Only one hard
copy (Controlled Copy) of QUALITY documents is printed and is available in the
Quality department. Only one hard copy (Controlled Copy) of Standard Operating
Procedures is printed and is available with respective sections. Master copy
(Electronic) of QUALITY documents (Quality Manual, Quality System Procedures,
etc) & SOPs is available with the Quality Assurance department

Name of Document Person Responsible

the Control Preparation Approval Amendment Annual Issue
Document Review

Quality Quality Any Quality Quality Any Laboratory

Manual Manual has a Managerial/Lab Manager Manager Managerial/La Director
Title, Prepared staff b staff
and issued by
& date,
Approved by
& date,
Effective date,
Issue number,

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 6 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

copy number,
page number
to the total
number of
pages,
reviewed on
the date, and
appropriate
signatures.

Quality Quality Any Quality Quality Any Laboratory

System System Managerial/Lab Manager Manager Managerial/La Director
Procedures Procedures staff b staff
have a Title,
document
number,
Prepared and
issued by &
Specimen date,
Specimen Any Quality Quality Any Laboratory
Collection Collection and Managerial/Lab Manager Manager Managerial/La Director
and Handling staff b staff
Handling Manual have a
Manual Title, Prepared
and issued by
& date,
Approved by
Laboratory & date,
Laboratory Any Quality Quality Any Laboratory
Safety Safety Manual Managerial/Lab Manager Manager Managerial/La Director
Manual has a Title, staff b staff
Prepared and
issued by &
date,
Approved by
& date,
Effective date,
Version
number, copy
number, page

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 7 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

number to
total number
of pages,
reviewed on
date and
appropriate
signatures.

Standard Standard Any Quality Quality Any Laboratory

Operating Operating Managerial/Lab Manager Manager Managerial/La Director
Procedures Procedures staff b staff
have details
such as a
Title,
document
number,
Prepared and
issued by &
date,
Approved by
& date,
Effective date,
Version
number, page
number to
total number
of pages,
reviewed on
date and
appropriate
signatures.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 8 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Record Format ID. Any Quality Quality Any Laboratory

logs Managerial/Lab Manager Manager Managerial/La Director
staff b staff
(are
annexed to
respective
QSP or
SOP)

Document Numbering: The numbering format is alphanumeric, for example in the

document title “DEPT/ EQUIPMENT/ SOP- NO/ DEPT is an abbreviation for the
department, EQUIPMENT is the name of the instrument and SOP-NO is Standard Operating
Procedure no.
Or in the document title QSP-NO. VER; QSP is the Quality System Procedure number
version. Versions are numbered sequentially. QUALITY Assurance department assigns and
maintains document numbers in the document control log.

Header & Footer of document: The header contains the name and logo of the laboratory and
the document name/title. The Footer of the document contains the laboratory name and
location, type of document (SOP, QSP, etc.), version number, and the page number.

Document request protocol:

Department identifies the need for the document (SOP, log sheet /format, etc) and notifies the
QUALITY Assurance department. In case there is a requirement for a new procedure/format
or change of procedure/format then the change control form is filled and submitted to the
QUALITY Assurance department. Section Head/authorized person writes or revises
(existing) procedure/format by referring to package insert of the kit, literature, relevant
guidelines, etc.

In case a new procedure or revision (in the old procedure) is required by the department the
concerned department Section Head Laboratory Quality Manager/ laboratory Director writes
or revises (existing ) procedure by referring product broacher of the kit.
The completed document is then forwarded to the QUALITY Assurance department for
formatting.

After the document is ready; it is submitted to the assigned approver.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 9 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

The approver reads and evaluates the document. Concerns and changes are noted and
discussed with the author. After changes and identification, if any, of additional training and
resources or impact on customers, the following actions are taken.

If the document is approved, then the name and date are entered and the document is issued.
The concerned staff is trained (self-reading) on the document and it is implemented.

If the document is not approved; the reason is identified and the QUALITY Assurance
department is notified which in turn notifies the author. If any conflicts are there then these
are resolved between both the author and the approver.

Approver reads and reviews the document. Changes and concerns are noted and discussed
with the authors. The approver determines the final action. After resolution, the document is
forwarded to the QUALITY department for formatting and the above-mentioned procedure is
followed.

Document Formatting and issue.

Once the document is ready; it is formatted by the Quality Assurance department, all
signatures are obtained and it is issued with a “CONTROL COPY” stamp on the top right
side of each page. Document issue details are maintained by the QUALITY Assurance
department.

Document Monitoring (Document Control Log)

As mentioned earlier, a document control log is a listing (spreadsheet, database, or paper

copy log) of all the policies, procedures, forms, and quality management records that are
currently being used in the laboratory. This is one comprehensive list, & is divided into
separate laboratory sections.
The log lists all current policies and procedures and the locations of copies and derivative
documents. It includes the effective date of each document, the document number, and the
version. It also includes the schedule for document review, the identity of the reviewer, and
the current status.

Approval of new documents and revisions

All new documents and the documents that have undergone a substantial revision are
approved by the Head of the respective department or appropriate laboratory authority. The

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 10 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

approval of new documents and revisions to current documents is done before the procedures
are used by laboratory personnel.

Substantial revisions vs. minor revisions

The substantial revision designation is applied to any revision that impacts the performance
of the procedure, for example, changes in procedural steps, quality control, reaction times and
temperatures, and sample size.
Documents with substantial revisions are released with version changes and are approved by
the head of the department or appropriate laboratory authority and reviewed by testing
personnel.
The minor revision designation is applied for the correction of typos and spelling mistakes,
the addition of a new logo, or other purely display issues.
Minor revisions are included as amendments to the document without changing the version.

Document retention and archival

When a document is discontinued from use in the laboratory, it is removed from places where
concerned personnel can access it and stamped as an “Obsolete” document in red. Obsolete
documents are handed over to QUALITY Assurance personnel (a log of handing over
obsolete documents is maintained). Documents are retained and archived according to the
procedure. Refer to QSP: Control of Records”.

External Documents:
Documents from external sources are controlled using listings to track the use of versions as
part of
the quality system. The date and version are to appear on these lists. Lists are maintained for
the
reference documents (CLSI documents, NABL documents, etc.)

External electronic documents available and maintained online (few NABL documents) are
checked and controlled by periodically [annually] checking the appropriate website.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 11 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Lab Records

Manual entries
All the manual entries are done using a black/blue ball-point pen. Care is taken to minimize
errors while writing. In case of an error, erroneous data is struck out (making sure that it is
still visible clearly) and the correct value or figure is entered. This is authenticated by the date
and initials of the person involved in making changes and the reason for making changes
(e.g., wrong entry, calculation error, interpretation error, etc)

Equipment logs
All analytical equipment should essentially have the following two log sheets:
 Maintenance & calibration log
 QC failure log

Minor equipment that would not adversely affect the sample analysis (e.g. Vortex, shaker,
dry bath, sonicator, etc.) need not have any of the above log sheets.

General instructions:
 After completion of the log sheets, they should be handed over to QUALITY for
archival and new log sheets should be taken from QUALITY personnel before the
completion of the log sheets which are in use.
 Every log sheet should contain the Equipment Record number.
 Every log sheet should be given through QUALITY and authenticated for the utility.
 Log sheet should be withdrawn immediately by QUALITY if the equipment or the log
sheet itself is no more used.
 Every log sheet should have the user-specified or equipment-customized format which
should be approved by QUALITY.

Archival of log sheets: After completion of the log sheet or in case of removal of the
equipment from service, these log sheets should be archived.

Maintenance and calibration log: There should be equipment dedicated file to record all the
details of the maintenance and calibrations done each time. The maintenance includes that
has to be performed as per the respective equipment SOP along with the preventive
maintenance if any.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 12 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

QC failure log: Whenever a QC is an outlier, it should be logged in this log sheet with
necessary elements like the corrective action taken, user signature, and date. Replace with a
new log sheet, on completion.

Equipment Files
All analytical equipment should essentially have the following documents but not limited to:
 Control & calibrator insert
 IQ /OQ /PQ records
 L.J. printouts
 Control reconstitution records
 Daily maintenance records
 Calibration printout records
 Control printout records
 Service report & breakdown records
 Preventive maintenance records
 Installation/calibration on certificate service report
 Operation/user manual
 Validation records

Soft copy documentation

This includes equipment-generated data (source data) e.g., QC data, Calibration data, graphs,
etc. Patient testing-related records data is stored on the hard disk of the equipment and back-
up is taken on a compact disk by the equipment operating personnel. Patient-related data in
Laboratory Information System is secured through user-level access (password protected). A
comprehensive backup of LIMS data is taken as per the schedule.
Unity real-time, internal QC software (for generation of LJ plots, worldwide peer group, and
method group analysis) backup is taken automatically every day. Quality System Documents
are on the QUALITY document Drive.
Instructions for retention/archival and retrieval of laboratory data
 Accurate data archiving, with an audit trail, is required to help ensure that all
laboratory data is accurately captured and can be verified as original data, or an
accurate reproduction upon need. The right data must be captured and stored, and it
also must be retrievable.
 In-house archival: Should be done in at least three months. The traceability of the same
should be well documented.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 13 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

 Outsourcing of the archived data: Should be done for a period of two years except for
the molecular diagnostic gel pictures, histopathology, and cytopathology test reports
which should be retained for ten years.

Data destruction
The archived data should be destroyed after retaining it for the required time period, using a
shredder (hard copy) or by deletion (soft copy).

Do’s and Don’ts with laboratory documents

 Do not carry the laboratory documents outside the laboratory without the written
consent of the HOD.
 Do not destroy any of the documents.
 Do not tear off pages from log sheets.
 Do not mutilate any of the laboratory documents.
 If any of the laboratory documents is mutilated accidentally or found mutilated,
inform QUALITY for replacement of the same.
 Corrections on computer-generated print-outs should not be attempted.

Definitions
Activity: A defined set of work. The output of one activity or set of activities becomes the
input to another activity or set of activities.

Controlled copy - A controlled copy is a formal copy of the latest, correct issue of a
document; an identified issue of a document to an individual or location of the record. The
controlled copy is officially tracked, updated, and destroyed to assure that it is current.

Document - Any recorded information or object which can be treated as a unit. Records are
considered a subset of documents that have specific attributes.

Electronic documents - Documents that are communicated and maintained by means of

electronic equipment.

Form: A document that is used to record information related to an activity.

Master Copy - The original records or archival materials that are preserved and used to make
access copies.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 14 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Minor revision: A revision that does not affect the nature of a policy or the way in which a
procedure is conducted. The revision would not affect patient results or patient outcomes. For
example, a spelling or grammatical correction would be a minor revision.

Policy: A defined course of action that is intended to guide current and future decisions.
Policies are established by individuals within the organization and are endorsed by the
management.

Procedure: The specific instructions that must be followed to complete activities within a
process.

Process: Interrelated activities that result in final output.

Record: Data that is generated when policies, procedures, or processes are followed.

Substantial: Having significant worth or consequence.

Substantial revision: A change that affects the nature of a policy or the way in which a
procedure is conducted that could impact patient test results or patient outcome.

Uncontrolled copy - An informal copy of a document for which no attempt is made to

update it after distribution; the document is marked “Uncontrolled” and the user determines
if the document is active prior to use.

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 15 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
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MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Annexure1

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 16 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 17 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager:
 QSP:2
MOLECULAR LABORATORY, ZYDUS MEDICAL COLLEGE, AND
HOSPITAL, DAHOD, GUJARAT

References
Ref. Title
No.

1 ISO 15189:2012 Standard

2 NABL-specific criteria (NABL -112)

Molecular Laboratory, Zydus Medical College and Hospital Dahod, Gujarat 38915
Doc. No.: QSP 02 Document Control
Issue No.: 02 Issue Date: 11- Amendment No.: Nil Amendment Date: - Page 18 of 18
Oct-2022
Copy: Prepared By: Reviewed By: Quality Issued By: Laboratory Director:
Section Head: Manager: