PROCEDURES MANUAL

Title Document Code Revision Code

Calibration of Medical Equipment PM-UHS-005 0

Department Effectivity Date Page

Health Services January 25, 2021 1 of 5

Prepared by: Reviewed by: Approved by:

JOANALYN K. LOZANO, RN JERIEMAY C. POLIDARIO

BEA NADINE B. DELA TORRE
SCHOOL NURSE QUALITY MANAGEMENT
DOCUMENT CONTROL STAFF
REPRESENTATIVE

1.0 Objectives: ​To assess and ensure that all medical equipment that needs calibration are
calibrated and well accounted.

To maintain the equipment effectiveness and decrease the risk of causing

harm to a patient.

2.0 Scope: This procedure defines the action and responsibilities of School Nurses in
ensuring all medical equipment that requires calibration are submitted to accredited
laboratories with certified professionals such as the Department of Science and
Technology (DOST).
3.0 Definition of terms:
Medical equipment ​- ​is any device intended to be used for medical purposes. ​Medical
equipment/devices benefit patients by helping health care providers diagnose and treat patients and
helping patients overcome sickness or disease, improving their quality of life.

Calibration - is the comparison of measurement values delivered by a device under test with those
of a calibration standard of known accuracy.

FO-UDZ-011, REVISION 0, SEPTEMBER 23, 2019

Printed copies of this document are ​CONTROLLED ​unless otherwise stamped by UZ’s Document Controller
 PROCEDURES MANUAL
Title Document Code Revision Code

Calibration of Medical PM-UHS-005 0

Equipment

Department Effectivity Date Page

Health Services January 25, 2021 2 of 5

Accredited Laboratory - refers to a laboratory that has been evaluated and has complied with
the requirements of the International Standardization Organization (ISO) 17025 Standard
"General Requirements for the Competence of Testing and Calibration Laboratories," and
accredited by the national accrediting body.

Department of Science and Technology (DOST)- The authorized agency responsible for the
calibration of medical equipment that requires measurement of Health Services.

Sphygmomanometer ​- ​a device that measures blood pressure. It is composed of an inflatable

rubber cuff, which is wrapped around the arm. A measuring device indicates the cuff's pressure.
A bulb inflates the cuff and a valve releases pressure. A stethoscope is used to listen to arterial
blood flow sounds.

Manual sphygmomanometers- consist of aneroid (dial) and mercury (column) devices.

Operating these aneroid and mercury devices is nearly the same, except that aneroid devices
require periodic calibration.

Weighing Scale -​ ​a device used to measure weight and mass

Oxygen Regulator ​- ​Oxygen Flow control regulators and conserving devices are pressure
reducing devices designed to regulate or lower oxygen pressure from a cylinder to levels
that can be safely used by the patient.

4.0 Reference: FDA CODE OF FEDERAL REGULATIONS TITLE 21 AND 820

QUALITY SYSTEM REGULATION (QSR)
ISO 13485

FO-UDZ-011, REVISION 0, SEPTEMBER 23, 2019

Printed copies of this document are ​CONTROLLED ​unless otherwise stamped by UZ’s Document Controller
 PROCEDURES MANUAL
Title Document Code Revision Code

Calibration of Medical PM-UHS-005 0

Equipment

Department Effectivity Date Page

January 25, 2021
Health Services 3 of 5

5.0 Records: Calibration Plan

Schedule Calibration
Certificate
Job Order from DOST
Instrument Equipment History Card (IEHC)

6.0 Flowchart:

FO-UDZ-011, REVISION 0, SEPTEMBER 23, 2019

Printed copies of this document are ​CONTROLLED ​unless otherwise stamped by UZ’s Document Controller
 PROCEDURES MANUAL
Title Document Code Revision Code

Calibration of Medical PM-UHS-005 0

Equipment

Department Effectivity Date Page

January 25, 2021
Health Services 4 of 5

Notes:

1. Calibration of medical equipment needs to be performed on a routine basis by accredited

laboratories and trained and certified professionals.
2. The frequency of calibration is influenced by the following factors:
- usage of medical equipment
- behavior of the equipment - frequent out of tolerance result
- equipment manufacturer recommended calibration interval
- Unscheduled calibration due to accidental dropping, or mishandling that leads to
non-conforming results
3. The School Nurse makes the calibration plan and schedule according to manufacturer's
guidelines.

4. Create a master list of all medical equipment and instruments needing calibration,
including details of equipment ID, make (brand), location, etc.
5. Define frequency or the intervals of calibration – quarterly, bi-annually, annually
6. The list of medical equipment to be calibrated by the identified and certified laboratory such
as DOST-IX are as follows:
● Sphygmomanometer
● Weighing Scale
● Oxygen Regulator

7. Two (2) months before expiration date of calibration, the list and equipment to be calibrated
must be submitted and delivered to the accredited laboratory such as DOST-IX for job order and
calibration respectively.

Take note, that upon request, it is the discretion of the DOST-IX to schedule a calibration of medical
equipment.

FO-UDZ-011, REVISION 0, SEPTEMBER 23, 2019

Printed copies of this document are ​CONTROLLED ​unless otherwise stamped by UZ’s Document Controller
 PROCEDURES MANUAL
Title Document Code Revision Code

Calibration of Medical PM-UHS-005 0

Equipments

Department Effectivity Date Page

Health Services January 25, 2021 5 of 5

8. The School Nurse processes the request for calibration fee to the Finance Department and
will pay the amount to the accredited laboratory such as the DOST IX.

9. The calibration certificate is stored in the Health Services Unit as reference.

10. All calibrated medical equipment shall be properly documented and updated in the
Instrument Equipment History Card (IEHC).

11. Affix calibration status labels which identify date and due date of calibration, providing a control
to ensure that only calibrated equipment is used.

12. ​If errors are noticed, adjustments and repairs need to be made, followed by
re-calibration to verify the accuracy of ​calibrated equipment​.

13. If an accredited laboratory will assess and recommend for replacement or repair of
equipment, Health Services will process requests for job order or replacement of
equipment.

FO-UDZ-011, REVISION 0, SEPTEMBER 23, 2019

Printed copies of this document are ​CONTROLLED ​unless otherwise stamped by UZ’s Document Controller