Al Azhar Hospital

Riyadh, Kingdom of Saudi Arabia

TOTAL QUALITY MANAGEMENT DEPARTMENT
MOH HOSPITAL COMMISSIONING STANDARDS
INTERNAL AUDITING TOOL & CORRECTIVE ACTION PLAN
CHAPTER: MEDICAL EQUIPMENT DATE OF AUDIT:
RESPONSIBLE TARGET
SCORE STANDARD REQUIREMENT FINDINGS &ACTION PLAN PERSON/ DEPT
STATUS
DATE
All medical equipment related are ready and
Ensure equipment & furniture are available & ready for operation BMD/
1 Cx.ME1 available except one anesthesia machine in asap open
as per MOH equipment standards MAINTENANCE
Operating Theatre
2 Cx.ME2 Ensure Availability of User manual and operation manual for Users BMD CLOSED
2 Cx.ME3 Availability of the equipment's list at the biomedical department BMD CLOSED
Cx.ME4 Available Approval certificates for all items N/A
For computerized equipment's ensure a software copy and license
Cx.ME5 IT
key is available for users
2 Cx.ME6 Ensure manufacture Performance test result certificate is available BMD CLOSED
2 Cx.ME7 Ensure QA results & certificate are available BMD CLOSED
2 Cx.ME8 Ensure technical training for the users and certificates are available BMD CLOSED
Complete elements of the contract as follow: Operation,
Cx.ME9 maintenance, Safety, security, Housekeeping & Warehouse maintenance
employee as per the contract terms
Ensure Completed Testing and commissioning checklist
2 Cx.ME10 BMD CLOSED
(Certificate)
2 Cx.ME11 Ensure Availability of 3-month consumables inventory BMD CLOSED
2 Cx.ME12 Ensure installation as per approved build drawing BMD CLOSED
no assurance of electrical safety testing results,
calibration of available ESA has been long due.
Ensure the Availability of the following requirements (Asset
ACTION PLAN: PURCHASE NEW ANALYZER URGEN
1 Cx.ME13 identification, warranty information, Performance test pass, BMD OPEN
(re calibration of the available analyzer is not T
Electrical safety pass, Next PPM due date Labels) for all items possible because of unavailability/obsolete
calibration tool)
Ensure the delivery agreement include all required documents
2 Cx.ME14 including the manufacture recommendations in both languages BMD CLOSED
(Arabic and English)
Ensuring the medical device technical support information from
vendor is submitted (address, person in- charge, telephone and
2 Cx.ME15 BMD CLOSED
mobile number, fax number, email, medical device registration
number and any relevant information)
TOTAL QUALITY MANAGEMENT DEPARTMENT PAGE 1 OF 5 AL AZHAR HOSPITAL
 Al Azhar Hospital
Riyadh, Kingdom of Saudi Arabia
TOTAL QUALITY MANAGEMENT DEPARTMENT
MOH HOSPITAL COMMISSIONING STANDARDS
INTERNAL AUDITING TOOL & CORRECTIVE ACTION PLAN
CHAPTER: MEDICAL EQUIPMENT DATE OF AUDIT:
RESPONSIBLE TARGET
SCORE STANDARD REQUIREMENT FINDINGS &ACTION PLAN PERSON/ DEPT
STATUS
DATE
Ensure that the medical device is exactly as ordered and
2 Cx.ME16 BMD CLOSED
corresponds with delivery note
Verifying of quantity, specification, consumable item and
2 Cx.ME17 BMD CLOSED
accessories delivered as stated in the purchase agreement
Ensure the equipment has successfully undergone performance
2 Cx.ME18 BMD CLOSED
and safety tests with documented results
Ensure the Availability of technical training certificate (installment,
2 Cx.ME19 troubleshot, service, repair, and maintain equipment and BMD CLOSED
instruments) to the technical personnel provided
Ensure visual inspection documents of the device or equipment for
2 Cx.ME20 physical damage Incompleteness, misassemble, void, wear and/ or BMD CLOSED
abuse
2 Cx.ME21 Availability of product recall process BMD CLOSED
Documented verification of Calibration test report and calibration
2 Cx.ME22 BMD CLOSED
certificate of the medical device
2 Cx.ME23 Ensure installation as per approved a-build drawing BMD CLOSED
2 Cx.ME24 Updated risk assessment as needed BMD CLOSED
Ensure documented approval of Radiation & Magnetic shielding,
2 Cx.ME25 BMD CLOSED
Vault room concrete wall & sLab by accredited Engineer
Ensure Building utilities & services T&C Conducted (HVAC, Chilled HVAC/
1 Cx.ME26
water, heat exchanger, domestic MAINTENANCE
1 water, drainage, medical gases, IT/LAN & Electrical Power) MAINTENANCE
Ensure RF, AC/DC interference & Vibration test conducted & pass
0 Cx.ME27 all requirements for MRI, PET-CT & other sensitive Medical N/A
equipment
1 Cx.ME28 Ensure the finished floor complete with all provisions for medical MAINTENANCE
equipment installation such as base plates, fixing bolts, shielding,
electrical trunking for power and controls, compressed air gases

TOTAL QUALITY MANAGEMENT DEPARTMENT PAGE 2 OF 5 AL AZHAR HOSPITAL

 Al Azhar Hospital
Riyadh, Kingdom of Saudi Arabia
TOTAL QUALITY MANAGEMENT DEPARTMENT
MOH HOSPITAL COMMISSIONING STANDARDS
INTERNAL AUDITING TOOL & CORRECTIVE ACTION PLAN
CHAPTER: MEDICAL EQUIPMENT DATE OF AUDIT:
RESPONSIBLE TARGET
SCORE STANDARD REQUIREMENT FINDINGS &ACTION PLAN PERSON/ DEPT
STATUS
DATE
and other building services requirement for the equipment
operation as required by the equipment vendor
Ensure documented Air quality, Room and above celling
cleanliness for the whole floor served by AHU passed infection HVAC/
1 Cx.ME29
control department requirements and property maintained up to MAINTENANCE
preliminary handover
Documented Environmental Department clearness of pest control
0 Cx.ME30 HOUSKEEPING/IC
measures
0 Cx.ME31 Ensure Purge vent for MRI installed and tested N/A
Ensure documented Room temperature and humidity functioning. HVAC/
Cx.ME32
T&C completed and passed MAINTENANCE
Ensure stable Electrical power and grounding system compliance
ELECTRICAL/
1 Cx.ME33 to equipment manufacturer requirement installed and completed
MAINTENANCE
for all equipment components and other metallic components
Ensure Power supply contains proper local disconnect with over
1 Cx.ME34 BMD CLOSED
current protection and lock out/tag- out provisions
Ensure Suitable steel support for mounting equipment available
2 Cx.ME35 BMD CLOSED
from walls or ceiling
Ensure all architectural finishing work such as fixed cabinet, ELECTRICAL/
1 Cx.ME36
panting, sinks, and floor finishing completed as per contract MAINTENANCE
Ensure IT/Network requirements for connection to facility
0 Cx.ME37 network, Patient Information System, workstations, PACS, and IT
filming cameras available and fully commissioned
Ensure Fire Detection, Alarm System, Sprinklers or other approved
firefighting system installed and commissioned by the Building
0 Cx.ME38 Contractor and (passive and active fire protection) Clearances, SAFETY
workspace, and egress meets local and international regulatory
requirements for Fire/ Life Safety and evacuation
Ensure emphasize on Do(s) and Don’t(s) include decontamination
2 Cx.ME39 BMD CLOSED
& Sterilization procedures as per the approved manual
TOTAL QUALITY MANAGEMENT DEPARTMENT PAGE 3 OF 5 AL AZHAR HOSPITAL
 Al Azhar Hospital
Riyadh, Kingdom of Saudi Arabia
TOTAL QUALITY MANAGEMENT DEPARTMENT
MOH HOSPITAL COMMISSIONING STANDARDS
INTERNAL AUDITING TOOL & CORRECTIVE ACTION PLAN
CHAPTER: MEDICAL EQUIPMENT DATE OF AUDIT:
RESPONSIBLE TARGET
SCORE STANDARD REQUIREMENT FINDINGS &ACTION PLAN PERSON/ DEPT
STATUS
DATE
Ensure Availability of all warranties & periodic certificates for all
2 Cx.ME40 BMD CLOSED
items
Ensure documented proof of installation, testing and
2 Cx.ME41 BMD CLOSED
commissioning by the specialist
2 Cx.ME42 Ensure quantities, specification & condition as per the contract BMD CLOSED

2 Cx.ME43 Ensure Operation catalogue, Service & Spare part are available BMD CLOSED

1 Cx.ME44 Ensure built drawing are available & approved by project manager N/A

2 Cx.ME45 To follow with CBAHI standards BMD CLOSED

TOTAL ACTUAL SCORE

TOTAL MAXIMUM SCORE

(SCORABLE STANDARDS)

PERCENTAGE (%)

TOTAL QUALITY MANAGEMENT DEPARTMENT PAGE 4 OF 5 AL AZHAR HOSPITAL