Document No.

: HMA/QAD/SQA/001 Effective date: 11th September, 2023

Document Title: Supplier Quality Agreement: Mandatory Review date: 10th September, 2023
Company Supply Chain Management Supersede: Nil
QUALITY AGREEMENT
SUPPLIER QUALITY AGREEMENT BETWEEN

HMA MEDICAL LIMITED

AND

[SUPPLIER NAME]

This Supplier Quality Agreement (“Quality Agreement”) is entered into by and between
___________________________________________ having a principal place of business at
____________________________________________hereafter referred to as (“Supplier”) and HMA
Medical Limited having a principal place of business plot 9 block 4, Transit Camp Road, Ilorin Kwara
State hereafter referred to as (HMA Medical). The Quality Agreement is effective as of the date of last
signature by the parties below.

1.0 Scope
1.1 Scope
The parties have entered into a separate written agreement from this Quality Agreement under
which Supplier will provide to HMA Medical the products and/or services (the “Products”)
listed in Section 1.2 below. This Quality Agreement defines the obligations of the parties to
ensure that the product satisfy HMA Medical’s quality and regulatory requirements.

1.2 Products and Services Covered by This Agreement

Fill in Part Numbers
1.3 Supplier Site(s)

Supplier manufactures the Products at or provides services at the sites listed below.

Address:
2.0 Regulations, Standard and HMA Medical Requirements
 21 CFR & 820 Quality System Regulation
 ISO 9001:2015 Quality Management Systems

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  ISO 13485:2003/2012 Quality Management Systems
3.0 Quality Requirements
3.1 Quality Representative: Supplier will designate a quality representative that will be responsible
for acting as a liaison with HMA Medical Limited through HMA Medical Limited’s designated
representative(s) as the point person for any quality issues, for obtaining any regulatory
approvals or certifications required for the Products and for maintaining and updating
Specifications in accordance with HMA Medical Limited’s written instructions. Supplier shall
provide HMA Medical Limited’s upon request, with copies of any documentation relating to
applicable regulatory approvals or certifications for the Products and/or Supplier sites.

3.2 Quality Management System: Supplier’s facilities will be certified to conform to the
requirements of ISO 9001 and/or ISO 13485 or successor standards or their equivalent at all
times in manufacturing and delivering the Products under this Agreement and will provide a
copy of the certificate to HMA Medical Limited. Supplier shall inform HMA Medical Limited
of any changes to Supplier’s quality management system or certifications. This includes
certification, re-certification or withdrawals. If a Supplier has no third-party quality system
certification, at minimum, the Supplier must meet all the quality requirements of this Section.

3.3 Periodic Meetings/On-Site Visits: HMA Medical Limited and Supplier will have periodic
meetings, which may be in the form of regularly scheduled meetings (face to face or conference
call), Supplier quality/business review or impromptu meetings as required. Supplier shall allow
HMA Medical Limited personnel access to Supplier’s facility or facilities used in the
manufacture or testing of Products for observation, review for Product issues, etc.

3.4 Specifications: HMA Medical Limited shall define the specifications for Products (the
“Specifications”) in the applicable purchase order for the Products. This may include drawings,
references to commercial specifications and identification of applicable standards.

3.5 Certificate of Conformance: Supplier agrees to sign and provide a certificate of conformance
(the “Certificate of Conformance”)/ Certificate of Analysis for each shipment of Product
confirming that all the materials processes, and/or finished product supplied under that order are
specified and conform to the Specifications as well as the applicable Product environmental
compliance standard (RoHS/REACH). Upon request Supplier will provide applicable signed

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 certificates, examples of which include but are not limited to, material certificates, special
processing and Product environmental compliance specification such as RoHS/REACH.

3.6 Buildings: Supplier’s facilities in which the Product is handled, stored, packaged, labeled or
otherwise processed shall be orderly and of suitable design, size, construction and location,
including, maintaining: (i) adequate lighting, ventilation and water supply for the activities
relating to the Product; (ii) space for performing the activities; and (iii) the ability to separate
discrete operations or processes relating to the Products in order to prevent mixing or other
contamination of Product. Supplier will notify HMA Medical Limited in writing with respect to
proposed changes to facilities, related to the Product prior to the implementation of such
changes.

3.7 Document Control: Supplier shall establish a system for creating, controlling, revising and
obsoleting documents throughout the history of the Product and Product life cycle.

3.8 Qualification and Training of Personnel : Supplier will ensure all of its personnel engaged in
the storage, handling, packaging, distribution or other processing of the Products have the
training and experience sufficient to perform their assigned functions in accordance with all
applicable laws.

3.9 Inspection at HMA Medical Limited: All Products are subject to HMA Medical Limited’s
inspection and test before final acceptance at HMA Medical Limited’s facility. If any Product
delivered under this Agreement fails to conform to the Specifications, HMA Medical Limited’s
shall notify Supplier of such failure, and Supplier shall promptly deliver conforming Products to
HMA Medical Limited. If an inspection or test is made on Supplier's premises, Supplier shall
provide HMA Medical Limited's inspectors with reasonable facilities and assistance at no
additional charge.

3.10 Production and Process Controls: Supplier shall develop, conduct, control and monitor
production processes to ensure that the Product conforms to Specifications. Supplier shall
assure that production equipment and quality measurement equipment, including mechanical,
electronic, automated, chemical or other equipment, are: (i) suitable for the intended use; (ii)
capable of producing valid results; (iii) operated by trained personnel; and, (iv) properly
calibrated to the appropriate and suitable standard. If the output of a Supplier’s process is not

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 fully verified by subsequent inspection or test, the Supplier shall validate the process. The
Supplier shall create a validation protocol (describing the planned activities) and a validation
report (documenting the outcome of the planned activities). A change or a deviation from a
validated process shall be reviewed and if appropriate revalidated. Supplier shall keep records
of the validation and revalidated activities and make them available to HMA Medical Limited
upon request. If requested by HMA Medical Limited, Supplier shall create and maintain a
process map, process failure modes and effects analysis (pFMEA), and process control plans for
all steps from receiving through shipping.

3.11 Supplier Acceptance Testing/ First Article Inspection : Supplier shall be responsible for
conducting appropriate testing and/or conformance inspection (incoming, in-process and final)
to ensure that the Product will function reliably and conforms to the Specifications. For all new
part numbers and subsequent changes supplier will perform a first article and provide a copy of
the report to HMA Medical Limited.

3.12 Nonconforming Product: Supplier shall establish and maintain procedures to identify, control
and recall Product that does not conform to or fulfill the Specifications. Such procedures shall
address the identification, documentation, evaluation, segregation and disposition of
nonconforming Product. Nonconforming Product shall not be used without the prior written
consent of HMA Medical Limited.

3.13 Corrective and Preventative Action: HMA Medical Limited may initiate a Supplier corrective
action request (“SCAR”) when HMA Medical Limited identifies product/process
nonconformity. Supplier shall investigate the cause of the nonconformity and provide to HMA
Medical Limited, a corrective action plan no later than thirty (30) calendar days of receipt of a
SCAR. Supplier shall implement the agreed corrective actions and effectiveness check within
the agreed timeframe and provide the records to HMA Medical Limited.

3.14 Storage: Supplier shall establish and maintain procedures to control storage areas and stock
rooms to prevent mix-ups, damage, deterioration, contamination or other adverse effects to
Products.

3.15 Product Records: Supplier shall retain (and if applicable shall cause its affiliates and
subcontractors to retain) detailed written records of all Supplier activities relating to the Product

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 (collectively referred to as the “Product Records”). Information included or referenced in the
records includes finished Product and package labels and labeling, label accounting information
(labels/labeling produced or issued, used, sampled, rejected/destroyed), information regarding
any environmental monitoring that takes place during manufacturing and, if required, testing,
copies of release testing, if any, performed by Supplier, process deviations and approved process
change if any.

3.16 Records Retention: Supplier shall retain (and shall require any affiliates and subcontractors to
retain) all Product Records for a period of time equivalent to one year past the design and
expected life of the Product or the medical device in which the Product is intended to be
included, which is not less than seven (7) years following Product manufacture. Supplier shall
not alter, destroy or otherwise dispose of any Product Records without HMA Medical Limited’s
prior written authorization. Supplier shall provide copies of any or all Product Records to HMA
Medical Limited within three (3) business days from the date of HMA Medical Limited’s
written request for any Product Records.

3.17 Engineering and Manufacturing Changes: Supplier shall notify HMA Medical Limited in
writing for review and approval prior to implementing (i) any changes which will affect the
form, fit or function of any of the Products, (ii) any change to Supplier's part number for a
Product, (iii) any process changes (iv) any changes that require HMA Medical Limited or a
subcontractor to perform any work on items that interoperate with the Product, including but
not limited to software updates, (v) any changes in packaging and labelling or (vi) any changes
which require HMA Medical Limited or a subcontractor to perform any retesting of the
Product or which would invalidate safety or regulatory approvals (vii) changes in the location
of manufacture of the Product. HMA Medical Limited shall have the right to accept or reject
the proposed change. Supplier shall also provide notice to HMA Medical Limited of any name
change.

3.18 No Deviations: Supplier will not deviate from the Specifications (including, without limitation,
approved procedures, drawings, methods or specifications concerning the Product) without
HMA Medical Limited prior written consent.

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3.19 Use of Affiliates and Subcontractors: From time to time HMA Medical Limited may authorize
in writing third parties by HMA Medical Limited to construct, manufacture and/or assemble
products or subassemblies for HMA Medical Limited. Supplier will not use any affiliate or
subcontractor for any supply of components or services related to the Product without notifying
HMA Medical Limited in advance in writing. HMA Medical Limited may specify change
control procedures applicable to the provision of services by such affiliate or subcontractor in
addition to or in accordance with Section 3.17 (Engineering and Manufacturing Changes).

3.20 Sub-Tier Suppliers: Supplier shall implement and maintain sub-tier supplier control. Control
measures shall be sufficient to ensure that sub-tier suppliers’ manufacture, package, label, test
and release of Products are consistent with this Quality Agreement.

3.21 Supplier Audit: Upon reasonable advanced written notice to Supplier, HMA Medical Limited
shall have the right to conduct an audit of the Supplier with respect to the Product and
Supplier’s compliance with the terms of this Agreement (a “Quality Audit”). Supplier shall
also permit HMA Medical Limited, with or without notice, to conduct additional Quality
Audits as HMA Medical Limited may reasonably require to address: (i) quality problems
relating to the Product; (ii) compliance with applicable requirements and (iii) safety issues.
Supplier shall provide HMA Medical Limited with access to Supplier’s facilities, Product
records and/or operations to conduct the Quality Audit during normal business hours. Supplier
shall not in any manner unreasonably delay, condition or otherwise interfere with HMA
Medical Limited’s right to conduct the Quality Audit.

3.22 Corrective Action Plan: In the event that a Quality Audit finds or identifies any condition(s)
that are not in compliance with this Agreement, Specifications or other quality system issue
(hereinafter an “Observation”), then Supplier shall be responsible to provide HMA Medical
Limited with a written corrective action plan within a reasonable timeframe not to exceed
thirty (30) calendar days after the receipt of the Quality Audit report. The corrective action plan
shall, at a minimum, capture the results of an investigation into the cause of the Observation, a
description detailing Supplier’s steps for addressing each Observation and implementing
proposed corrective and preventive actions and a schedule indicating when such corrective and
preventive actions would be effective.

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3.23 Design Controls: This subsection applies only to suppliers that are designing products for HMA
Medical Limited. Supplier shall establish and maintain a design control procedure to define the
stages of design and/or development processes, perform verification and validation activities
appropriate to each design and/or development stage and define the responsibilities and
authorities for design and/or development activities. Supplier shall maintain design plans that
describe or reference the design and development activities and define responsibility for
implementation. Design documentation shall be available to HMA Medical Limited upon
request.

4.0 REGULATORY COMPLIANCE

4.1 Regulatory Inquiries. Supplier shall promptly inform HMA MEDICAL LIMITED of the
existence and substance of any inquiry or investigation related to the Products initiated by any
government authority or certification agency.
Regulatory Inspections. Supplier will notify HMA Medical Limited Quality Assurance
within five (5) business days of the notification or first day (whichever is earlier) of a
regulatory inspection or audit, announced or unannounced (such as by a EU notified body,
FDA, Japanese PAL or ANVISA), where such inspection or audit applies to a Supplier facility
where the Products are manufactured) or is an inspection or audit of HMA Medical Limited’s
places of manufacture and the scope of such inspection or audit includes the third party
facilities where HMA Medical Limited’s products are manufactured. Supplier shall provide
HMA Medical Limited the opportunity to be present at such inspections or audits. Supplier
shall cooperate fully with any such inspections or audits. Supplier shall provide to HMA
Medical Limited, within five (5) days of its submission or receipt by Supplier, copies of the
inspection or audit observations and copies of responses to regulatory observations pertaining
to HMA Medical Limited product (For example: FDA 483 Form). Supplier shall immediately
correct any deficiencies identified in the regulatory inspection.

4.2 Product Complaints/Reports. Supplier shall promptly provide to HMA Medical Limited any
information received by Supplier regarding real or potential deficiencies or defects in the
Products and any information that might otherwise constitute a complaint about the Products or
would reasonably be considered material to the safety of the Products and/or the Product’s
intended use. Each party shall reasonably cooperate with the other in sharing any information
that may constitute a complaint related to the Products or services. Supplier shall at all times

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 reasonably cooperate with any requests arising from a HMA Medical Limited investigation,
inspection or inquiry regarding the Products.
4.3 Recalls. HMA Medical Limited shall have the sole authority to declare a recall of any Products if
HMA Medical Limited believes there is or may be a potential significant health hazard or non-
compliance with applicable government regulations.

5.0 GENERAL
5.1 Term of Agreement. This Quality Agreement may be terminated by either party for any reason
or for no reason upon written notice of termination to the other party.
5.2 Entire Agreement, Amendments. This Quality Agreement, including any Appendices and other
attachments, is the complete, final and exclusive statement of the terms of agreement between
the parties relating to the subject hereof and merges and supersedes all prior and
contemporaneous understandings and representations, written and oral. No amendment to this
Quality Agreement is effective between the parties unless mutually agreed, in writing and
signed by authorized representatives of both parties.

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives.

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HMA MEDICAL LIMITED. [Supplier Name.]

By: _________________________________ By: _______________________________

Name: ______________________________ Name: ____________________________

Title: _______________________________ Title: _____________________________

Date: _______________________________ Date: _____________________________

This form is a template and the sections of this Quality Agreement may be revised as required.

Supplier to provide the following as applicable.

Appendix A: Vendor DOA and warranty policy

Appendix B: Pricing, terms and condition

Appendix C: Vendor contact information include Quality Team member

Supplier Quality Agreement Revision History

Revision # Date of Revision Summary of Change

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