Mawj Alsama Medical Company

Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 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 INSPECTION AND TESTING

Authorized By Name Designation Date & Sign

Prepared By

Reviewed By

Approved By

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 Mawj Alsama Medical Company

Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

Revision History and Approval

Rev. Nature of Changes Approval Date

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 Mawj Alsama Medical Company

Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

Table of Contents
1. Purpose……………………………………………………………………………………………………………………..…………………………………….....4
2. Scope……………………………………………………………………………………………………….……………….…………………..…………………….4
3. Resposibilities…………………………………………………………………………..…………...……………................................................4
4. Definitions………………………………………………………………………………………………………….....…………….……………………….…....4
5. Procedure…………………………………………………...……………………………………….................................................................4
5.1 Competencies Resources of Inspection Program………………………………………………………............................…….........4
5.2 Inspection Program………………………………….............................................................................................................5
5.3 Random Inspection.....................….…………………………….…......................................................................................5
5.4 Annual Inspection Plan & Schedule ……………...…………………………………...................................................................5
5.5 Inspection Documentation.....................................................................................................................................6
5.6 Inspection Program Record Keeping & Updating of MD-QMS Inspection Checklist……………………………………..……6
5.7 Monitoring and Reviewing of Inspection Program………………………….…………………………….………………………………….6
5.8 Performing the MD-QMS Inspection………………………………………………………………………..………………………………….…..7
5.9 Inspection Program Reporting & Monitoring…………………………………………………………………………………….……………..7
5.10 Subcontractor Inspection and Test Plans………………………………………………………….……………………………………………8
5.11 Sector MD-QMS Inspections Categories………………………………………………………………………………………………………..8
6. Records Or Exhibits…………………………………………..……………………………………………………………..………………………..……...8

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Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

1. Purpose
The purpose of this procedure is to establish, implement and maintain a documented process for planning
and conducting the on-going workplace inspection, testing and monitoring activities in order to ensuring
the implementation of safe work practices in Mawj Alsama Medical Company.

2. Scope
This procedure is applicable to Mawj Alsama Medical Company activities in conformance to its Health &
Safety Management System based on the requirements of the guidelines of the Audit and Inspection and
Technical Guideline.

3. Responsibilities
The MD-QMS Officer is responsible for ensuring that appropriate workplace inspection, testing and
monitoring activities are carried out in Mawj Alsama Medical Company.
All supervisors and department heads are responsible for performing MD-QMS inspections of the
workplace in accordance with this procedure.

4. Definitions
Inspection – Refer to critical examination of work tasks, facilities and equipment during a physical walk –
through of an area to determine conformance to applicable requirements, standards and policies.
Non-Conformance – Is a non-fulfillment of a requirement. Specially, a nonconformance is any deviation
from work standards, parties, procedures, regulations, management system performance etc. that could
either directly or indirectly lead to injury or illness, property damage, or a combination of these.
Corrective Action - Steps that are taken to remove the causes of an existing non conformity or undesired
situation. The corrective action process is designed to prevent the recurrence of nonconformance or
undesired situation.
MR – “Management Representative”, a person appointed to manage and monitor the implementation of
the organization.

5. Procedure
5.1 Competencies Resources of Inspection Program
• Planning for MD-QMS Inspection, Testing & Monitoring
Inspection program planning and implementation processes, including:
i. Criteria
ii. Frequency and schedules
iii. Methods of collecting and verifying information
iv. Reporting inspection results
v. Non-conformance and corrective action process

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Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

vi. Inspection program record keeping

• MD-QMS Inspection Team

The MD-QMS Management Representative and/or MD-QMS Officer shall form and maintain an MD-QMS
Inspection Team who will be responsible for conducting inspection, testing and monitoring for the purpose
of establishing and maintaining safe working conditions and discovering unsafe practices in the workplace.
It shall be the responsibility of the MD-QMS Officer to train all members of the MD-QMS Inspection Team
in matters related to health & safety workplace inspection.
The MD-QMS Inspection Team shall be composed of first-line supervisors and department heads, who shall
conduct 2 different types of inspections:
i. Supervisory Inspection
MD-QMS inspections in supervisory level shall be conducted on a monthly basis by first line supervisors
and to be facilitated by the MD-QMS Officer.
ii. Management Inspection
MD-QMS inspections in management level shall be conducted on a quarterly basis by department
heads, and shall be facilitated by the MD-QMS Management Representative and/or MD-QMS Officer.

5.2 Inspection Program

The Inspection program should cover all the activities that the Mawj Alsama Medical Company undertakes
and should be developed on a risk-based approach.
When developing an inspection program, the FIES should review the output of their MD-QMS to determine
which areas of their business require more frequent inspection than others.
It is good practice to ensure that all areas of the business are inspected as minimum twice (2) per year.
However, for more medium to high-risk activities/ process the FIES should consider monthly inspections.
The inspection program should be communicated to all relevant stakeholders within the FIES so they are
aware of the requirements.

5.3 Random Inspection

Although the program should detail what the planned inspection requirements are, the FIES should also
consider undertaking random inspections when the need arises.
Random inspections should be used to compliment the planned inspections and also to verify their results.
Further the frequency of random inspections should be based upon the outputs of the MD-QMS and where
poor compliance is seen, it may be that the MD-QMS Manager decides to undertake more frequent
random inspections.

5.4 Annual Inspection Plan & Schedule

MD-QMS Officer shall prepare “Annual Inspection Plan” of MD-QMS inspections every start of the year and
shall be approved and signed by the MD-QMS Management Representative.
The approved Annual Inspection Plan shall be posted in MD-QMS related bulletin board and shall serve

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Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

as a monitoring sheet for the actual performance of inspection.

MD-QMS Officer shall be responsible to monitor the actual performance of inspection and shall update the
“Annual Inspection Plan” on a regular basis.
The MD-QMS Officer shall prepare the “Detailed inspection Plan” which will include the following
information:

• Objectives of the inspection;

• inspection Scope;
• Assigned inspector;
• Date & Time of inspection;
• Itinerary.
Internal inspection shall be based on the activities related to MD-QMS, which include the work instructions,
compliances to health & safety legal requirements, and other requirements from interested parties (e.g.,
Competent Authority, Sector Regulatory Authority, etc.).
The inspection plan shall be based on the MD-QMS Monitoring Program as provided in
Doc #: MAMC-MD-QMS-PR-13 Monitoring and Reporting procedure which includes but not limited to:

• Fire Fighting Equipment Inspection (Fire Extinguisher, Fire Pump, Fire Alarms etc.)
• Machinery safety inspection
• Fork Lift Inspection
• Personnel Protective Inspection
• General Amenities Inspection
• Ladders Inspection
• Hygiene Inspection
• First Aid Equipment Inspection

5.5 Inspection Documentation

The MD-QMS Manager/ MD-QMS Officer shall develop checklist that can be used to standardize the
inspections being undertaken. Inspection’s checklist should be developed as basic checklist that can verify
work practices and equipment is being maintained in line with the FIES.
Depending on the size and complexity of the entity, it may be decided to develop several checklists to cover
the undertakings. These can be split by function or even by hazard.
It shall be the responsibility of the MD-QMS Officer to update an inspection checklist using the “Workplace
Inspection Checklist”.

5.6 Inspection Program Record Keeping & Updating of MD-QMS Inspection Checklist
Inspection results should record leaving the area to discuss findings and recommendations. Report even
minor items which the supervisor can immediately correct. Record this in the report as corrected. This
keeps the report up-to-date and serves as a reminder to check the condition during the next inspection. All
Inspection records must be kept at least for 5 years at least.

5.7 Monitoring and Reviewing of Inspection Program

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Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

The implementation of the inspection program should be monitored to ensure it is meeting the
objectives and also to identify any areas for improvement. When undertaking the review FIES should
consider:
• Feedback for auditee's, inspectors and other relevant stakeholders;
• Adherence to the inspection schedule program; and
• Outputs from the inspections.
The review process should feed into the overall management review program as defined in management
review procedure.
The MD-QMS Manager in consultation with Managing Partner shall monitor and review the progress of the
recommendations and follow-up shall be carried out to ensure corrective actions have been implemented
and are effective.

5.8 Performing the MD-QMS Inspection

The MD-QMS Inspection Team, headed by the MD-QMS Manager, shall conduct workplace inspection using
Doc #: MAMC-MD-QMS-PR-15-F-01 “Workplace Inspection Checklist”.
Areas to inspect shall be as follows:
Process - Walk through the inspection area and examine the work processes taking place. Does the
workplace layout limit awkward body positioning? Is the need for repetitive motion and forceful exertion
limited?
People - Observe workers performing their jobs. Pay particular attention to worker interaction with
materials, equipment and co-workers. Are safe work procedures being followed? Are tools, equipment and
PPE being used appropriately? Are workers aware of the hazards of their jobs? Are people using safe
working postures?
Equipment - Inspect the condition of the equipment. Look for signs of wear (rust, cracks, and leaks).
Ensure that guards and safety devices are in place and that the equipment has been regularly maintained.
Consider ergonomic issues arising out of the design and use of the equipment.
Materials - Consider the hazards of the materials such as toxicity, flammability, etc. Are materials labelled
and stored properly? Are MSDS available and up-to-date? Have workers been trained is safe use and
emergency procedures?

5.9 Inspection Program Reporting & Monitoring

The MD-QMS Inspection Team shall prepare the “MD-QMS Inspection Summary Report”.
The inspection report shall include the completed checklist, a description and location of all identified
hazards, and recommendations for eliminating or controlling the hazards.
The implementation of the inspection program should be monitored to ensure it is meeting the objectives
and also to identify any areas for improvement. When undertaken the review the entity
should consider:
• Feedback for Auditee’s, inspection and other relevant stakeholders;

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Procedure for Inspection & Testing

Doc No.: MAMC-MD-QMS-PR-15 Date: 06/02/2022

• Adherence to the inspection schedule program; and

• Outputs from the inspection
The report shall be communicated to all appropriate people who have the authority to implement
the recommendation. This may include the plant Manager, MD-QMS Management Representative, and
relevant Department Heads. Once the appropriate people are involved, the report should name the
persons responsible for corrective actions, and the expected completion dates.
The MD-QMS Committee shall monitor and review the progress of the recommendations and follow-up
shall be carried out to ensure corrective actions have been implemented and are effective.

5.10 Subcontractor Inspection and Test Plans

Where elements of the work are to be performed by Suppliers / Subcontractors in the FIES, the following
steps shall apply.
• The MD-QMS Committee shall ensure that the appropriate Quality requirements are specified in the
procurement documents.
• The MD-QMS Management Representative shall ensure that supplier / subcontractor ITP’s including any
necessary Hold or Witness Points.

5.11 Sector MD-QMS Inspections Categories

MD-QMS Planned Inspections - are inspections to be conducted on regular basis and intervals; planned
inspections are inspections scheduled in advance to take place at a certain time and date. These
inspections are generally done in accordance with the hazards associated with the FIES’s operations and its
potential for serious MD-QMS incidents and threats.
MD-QMS Random Inspections - FIES shall conduct random/ surprise MD-QMS Inspections of operations to
ensure the effectiveness and efficiency of MD-QMS. FIES shall not be informed of the Schedule of Random
Inspections prior to inspections.

6. Records or Exhibits
Inspection Check List MAMC-MD-QMS-PR-15-F-01
Certificate, License Tracking Register MAMC-MD-QMS-PR-15-F-02
MD-QMS Equipment Inspection MAMC-MD-QMS-PR-15-F-03

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