Mawj Alsama Medical Company

Procedure for Monitoring & Reporting

Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

Mawj Alsama Medical Company

ISO 13485:2016

Medical Devices-Quality Management System

Address: AL NAHDA DISTRICT AL SAFA STREET, JEDDAH, 21493, KSA

PROCEDURE FOR MONITORING & REPORTING

Authorized By Name Designation Date & Sign

Prepared By

Reviewed By

Approved By

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 Mawj Alsama Medical Company

Procedure for Monitoring & Reporting

Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

Revision History and Approval

Rev. Nature of Changes Approval Date

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 Mawj Alsama Medical Company

Procedure for Monitoring & Reporting

Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

Table of Contents
1. Purpose………………………………………………………………………………………………………………..………..…………………….........….....4
2. Scope………………………………………………………………………………………………….……………….…………………..…………………….......4
3. Resposibilities………………………………………………………………………................................................................................4
4. Definitions…………………………………………………………………………...…………….………………………………………………….…..........4
5. Procedure…………………………………………………...…………………………………………………………..............................................4
5.1 Developing MD-QMS Monitoring Program……………………………………………...............................................................4
5.2 Implementation of MD-QMS Monitoring Program………………………………………………...............................................5
5.3 Reporting of MD-QMS Performance…………………....................................................................................................5
5.4 Occupational Health and Safety Monitoring……………...…........................................................................................5
5.5 Monitoring Parameters……………...…........................................................................................................................6
6. Records Or Exhibits………………………………………..……………………………………………………..………………………………..............7

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Procedure for Monitoring & Reporting

Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

1. Purpose
The purpose of this Procedure is to establish, implement and maintain a process for the MD-QMS
monitoring and reporting requirements of Mawj Alsama Medical Company.

2. Scope
This Procedure applies to all MD-QMS activities of Mawj Alsama Medical Company in conformance to its
MD-QMS.

3. Responsibilities
Top Management – Responsible for ensuring that the MD-QMS implementation of the Mawj Alsama
Medical Company is properly monitored and reported.
MD-QMS Representative – Responsible for developing and coordinating the MD-QMS monitoring and
reporting framework; and for reporting to the Top Management, MD-QMS Management Committee.

4. Definitions
Monitoring – Measurement of the properties of a material (such as a discharge) or sampling of a material
together with immediate or subsequent analysis or other form of measurement.
Discharge Monitoring - Monitoring of a discharge usually carried out for the purpose of acquiring
information of environmental significant.
Process Monitoring – Monitoring of process stream or materials usually carried out for the purpose of a
safe and efficient operation of a process operation. Process monitoring may be continuous or intermittent
(result of process monitoring may sometimes be useful in calculating or estimating information on
discharges).
Monitoring Program -A planned set of discharge monitoring activities.
Organization – Company, corporation, firm, enterprise, authority or institution, or part or combination
thereof, whether incorporated or not, public or private, that has its own functions and administration.
OH&S – Refers to Occupational Health & Safety
MD-QMS – Refers to Integrated Management System.

5. Procedure
5.1 Developing MD-QMS Monitoring Program
The MD-QMS Representative shall develop the monitoring of MD-QMS and of this manual, as implemented
by Mawj Alsama Medical Company this shall include the monitoring of:

• Monitoring of the MAMC’s MD-QMS Targets and Objectives;

• Monitoring the effectiveness of MD-QMS programs and control measures;
• Proactive and reactive measures of performance to monitor conformance with MD-QMS programs and
control measures;
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Procedure for Monitoring & Reporting

Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

• Requirements outlined in Competent Authorities permits/ licenses/ no objection certificates, or

Equivalent.
• Requirements outlined in approved MD-QMS Plans and studies.
• Description of methodologies and instruments used to monitor, including, calibration requirements and
records.
An MD-QMS monitoring and reporting plan shall be developing, which outlines the Targets & Objectives
and Key Performance Indicators to be monitored and reported. A List of Targets & Objectives with shall be
prepared and maintained by the MD-QMS Representative.
The MD-QMS Representative shall use the Key Performance Indicators stated in Targets & Objectives
Procedure from KPI set to measure the performance of MD-QMS.
MD-QMS Representative shall conduct proactive and reactive measures of performance to monitor
conformance with MD-QMS programs and controls.
MD-QMS Representative shall conduct proactive and reactive measures of performance to monitor
approved MD-QMS plan, studied and implementation.

5.2 Implementation of MD-QMS Monitoring Program

The MD-QMS Representative shall regularly monitor the implementation of the MD-QMS of Mawj Alsama
Medical Company this shall be carried out through formal audits, inspections and management reviews. All
audits and inspections shall be carried out in accordance with Doc #: MAMC-MD-QMS-PR-11 Internal and
Doc #: MAMC-MD-QMS-PR-15 Inspection & Testing Procedure.
The MD-QMS Representative shall ensure that adequate resources are provided for the effective
implementation of audits, inspections and reviews. In addition, he shall ensure that resources are
committed to collating, evaluating, analysing and reporting MD-QMS performance.

5.3 Reporting of MD-QMS Performance

• The MD-QMS Representative shall develop an MD-QMS performance report format. The “MD-QMS
Performance Report” shall contain performance data covering the minimum reporting requirements as
outlined in the ‘Objectives, Targets & Programs’ (OTP).
• Quarterly OH&S Performance Reports shall be submitted to the MD-QMS Manager.
• MD-QMS Representative will ensure the timely reporting of MD-QMS
• MD-QMS Representative shall be responsible for the reporting of MD-QMS
• MD-QMS Representative shall also ensure that reporting requirements.

5.4 Occupational Health and Safety Monitoring

The MD-QMS Representative in cooperation with Operation Manager shall identify the following
monitoring of occupational health and safety;

• Occupational noise, air and lighting

• Ergonomic and workplace design factor
• Waste management
• Wellness programs
• Hazardous substances
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Procedure for Monitoring & Reporting

Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

• Health surveillance
• Occupational illnesses
• MD-QMS hazards, near- misses and incidents
MD-QMS Representative will establish and maintain a self-monitoring plan, OH&S audit plan which contain
the following:
• Occupational Parameters (working environment, solid waste, waste water, noise pollution, etc.)
• Activity/Process
• Frequency
• Person in charge
• Reference documents
This Monitoring plan will be updated in case of new process, activity or parameter.

5.5 Monitoring Parameters

The occupational performance and impacts of the project shall be monitored and evaluated based on the
following parameters.

• Potable Water
i. Monitoring of water intended for human consumption in the office and workplace will be conducted
on a quarterly basis. Testing is carried out in accordance with the legal requirements. Testing
includes chemical assay and bacteriological tests.
ii. Testing is carried out by accredited laboratories. The test reports are maintained by the MD-QMS
Departments and the results are communicated to all involved parties.
iii. The MD-QMS Representative is responsible to raise any necessary corrective actions in relation to
the test results.
• Noise Levels
i. Noise levels are monitored and measured at various points around the workplace by the engineer.

• Data Analysis
i. MR follows up with each process owner as per the Targets and Objectives Program for the relevant
data for analysing the same.
ii. Upon receipt of data from the process owners, MR analyse the data by using suitable statistical tool.
iii. The results of analysis are submitted to the Manager for his review and copy is sent to the relevant
process owner.
iv. Upon receipt of analysis, it is responsibility of the process owner to submit in writing to the MR, his
actions to improve the process effectiveness.
v. Analysis and recommendations for the improvement of effectiveness of the processes is discussed in
the Management Review Meeting.
vi. MD-QMS data will be collected from daily inspection, monthly audit and incident reports. MD-QMS
Representative will prepare an internal monthly report based on the data analysis and submit to the
Management for review and recommendations for improvements.

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Doc No.: MAMC-MD-QMS-PR-13 Date: 06/02/2022

vii. MD-QMS data will also be analysed based on KPI set by the - MD-QMS Performance and Incident

Resp. for
Monitoring/ Mode of Data
S No. Frequency Measurement Implementing
Inspections Collection
and Reporting
Health & Safety
Monthly Statistics
No: of Incidents/
1 Records Monthly Report, Analysis and Safety Officer
Accidents
compliance Ratio
No: of hazardous
Total no: of injuries/
2 substances related Records Monthly Safety Officer
accidents per year.
injuries/ accidents
Noise Monitoring
3 Noise Records Monthly Safety Officer
Report
4 OH&S Inspections Records Fortnightly Inspection Records Safety Officer
Inspections Record
5 Fire Extinguishers Records Quarterly and External Party Safety Officer
Maintenance Contract
Inspections Record
Fire Hydrant
6 Records Monthly and External Party Safety Officer
inspection
Maintenance Contract
Garbage collection 3rd Party Inspection Safety Officer/
7 Records Annually
vehicles certificates Main. Incharge
Warnings,
Compliance Ratio vs
violation, penalties
8 Records Quarterly No of non- Safety Officer
and enforcement
conformances
notices
Health Surveillance
records, Medical
Fitness Records upon Safety Officer/
9 No of illness Records Annually
joining, Health Admin or HR
Practitioner/ Hospital
Visit records if any
Reporting.

6. Records or Exhibits
Monthly MD-QMS Report MAMC-MD-QMS-PR-13-F-01
Work Injury Stats MAMC-MD-QMS-PR-13-F-02

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