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Quality System Procedure (QSP) : 1.0 Objective: 2.0 Scope

This quality system procedure outlines the labeling system for instruments and equipment at a laboratory to ensure easy identification. Major instruments are labeled with a department abbreviation and sequential number. Supportive equipment is also labeled with the department and sequential number. Records of all instruments and equipment are maintained along with calibration details to ensure equipment is properly calibrated. The labeling system allows for clear identification of all instruments and equipment in the laboratory.

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Dhruvi Patadia
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363 views

Quality System Procedure (QSP) : 1.0 Objective: 2.0 Scope

This quality system procedure outlines the labeling system for instruments and equipment at a laboratory to ensure easy identification. Major instruments are labeled with a department abbreviation and sequential number. Supportive equipment is also labeled with the department and sequential number. Records of all instruments and equipment are maintained along with calibration details to ensure equipment is properly calibrated. The labeling system allows for clear identification of all instruments and equipment in the laboratory.

Uploaded by

Dhruvi Patadia
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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QUALITY SYSTEM PROCEDURE (QSP)

1.0 Objective: To ensure the standard labeling of instruments & equipments for
their easy identification.

2.0 Scope: This QSP is applicable to all the main instruments and / or
equipments with supportive instruments or equipments like
Pipettes, Centrifugesand Refrigerators etc.

3.0 Responsibility: QM, Asst. QM, LD, Senior Scientist/s

4.0 Reference: ISO 15189:2012 Clause no. 5.3.1.2, 5.3.1.7

5.0 Procedure:

5.1 All laboratoryinstruments and equipments are categorized in two different


categories

(A) Main Instruments / Equipments


(B) Supportive Instruments / Equipments

These categories are derived on the basis of


 Their specific use in specific departments and
 Supportive use in all departments i.e. Instruments which are
required to perform the tests & samples storage (Centrifuges,
Pipettes, Refrigerators etc.)

5.2 Labeling of Main Instruments or Equipments (Category A)

5.2.1 First three digits (Capital Alphabets& Bold) represents departmentlike

MOL Means Molecular Testing

and last two digits (Numeric and Bold) represents sequential increasing
numbers starting from 01. These numbers will increase up to 99 for
particular department and then after will be converted to three digits
after 99 i.e. 100, 101 etc.

5.2.2 Total five digits together will be divided by hyphen (-) in bold letters
without living the space in between.

5.2.3 Together numbers will look like as shown below as e.g.

MOL-01

Doc. No.: QSP 01 LABELLING OF INSTRUMENTS & EQUIPMENTS


Issue No.: 01 Issue Date:01-10-2020 Amendment No.: Amendment Date: Page No.: 1 of 3

Prepared By (QM / Asst. QM) Review & Approved By (Lab Owner) Issued By (QM / Asst. QM)
QUALITY SYSTEM PROCEDURE (QSP)

5.2.4 Records of such instruments/equipments are maintained as per format


shown in QSM as List of Major Test Equipments

5.2.5 Label on instrument format is as shown below as e.g. :

Instrument Name : Bio Safety Cabinet


Identity No. : MOL-01
Department : Molecular testing
Service Frequency : Once / Year
Last Service/Cal Done On : Date to write
Next Service/Cal Due On : Date / Refer Cal Calendar
Make : xyz
5.3 Labeling of Phone no. : xxxxxxxxxx
Supportive
Instruments or Equipments (Category B)
5.3.5

5.3.1 First three digits (Capital Alphabets& Bold) represents


department like.

MIL Means Manglam In Vitro Lab

5.3.2 Total five digits together will be divided by hyphen (-) in bold letters
without living the space in between.

FRG-01 For Refrigerator-01


CEN-01 For Centrifuge-01
PIP-03 For Pipette-03

5.3.4 If same types of instruments or equipments aremore in numbers, their


company serial no. is mentioned along with description &lab
identification to differentiate from one another in the records.

5.3.6 Records of such supportive instruments&equipments are maintained as


per format shown in QSM as List of Supportive Equipments.

5.3.7 Label format for supportive instrument or equipment is as shown below


as e.g. Label on Centrifuge may look like as mentioned below

Doc. No.: QSP 01 LABELLING OF INSTRUMENTS & EQUIPMENTS


Issue No.: 01 Issue Date:01-10-2020 Amendment No.: Amendment Date: Page No.: 2 of 3

Prepared By (QM / Asst. QM) Review & Approved By (Lab Owner) Issued By (QM / Asst. QM)
QUALITY SYSTEM PROCEDURE (QSP)
Lab ID No.: CEN-01
Calibration Done on:

Calibration Due Date:

Agency: In-House
AMPLIGENE, AHMEDABAD

5.4 For Category (A) &(B), calibration records are maintained with their next
calibration due date of instruments&Equipments in Calibration Plan available
with QM & also on the label / sticker for easy reminder on daily basis.

6.0 Records:

Sr. Description Form No. Agency Retention


No. Period
1 List of Major&Supportive Format as shown LD, Senior 1 Year
Equipments in QSM Scientist/s
2 Calibration Plan Excel Sheet QM/LD 1 Year

Doc. No.: QSP 01 LABELLING OF INSTRUMENTS & EQUIPMENTS


Issue No.: 01 Issue Date:01-10-2020 Amendment No.: Amendment Date: Page No.: 3 of 3

Prepared By (QM / Asst. QM) Review & Approved By (Lab Owner) Issued By (QM / Asst. QM)

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