Hma Medcal Limited

HMA MEDICAL LTD Page 1 of 86
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

ESTABLISHMENT DOCUMENT
Title: Quality Manual
Department: Quality Assurance Issued Date: 4th September, 2023
Mandatory Review Date: 10th September, 2025 Effective Date: 11th September, 2023
DOC. No.: HMA/QAD/QMS001-01 Supersede: HMA/QAD/QMS001-00
HMA MEDCAL LIMITED
INTEGRATED QUALITY MANUAL

For The Implementation
Of
QUALITY MANAGEMENT SYSTEM

And
PRODUCT REALIZATION
IN LINE WITH ISO 9001:2015 & 13485:2016
A. APPROVAL PAGE
FUNCTION NAMES POSITION SIGNATURE DATE
Compiled By
Review By
Approved By
Authorized By
B. QUALITY POLICY STATEMENT

C. HMA MEDICAL LIMITED is committed to the continual production of quality pharmaceutical and
medical consumables, through global best practices with quality systems that are designed to satisfy our
customers and meet all applicable regulatory expectations. In our production and service delivery, we have
committed to constantly seek out and apply continual improvement to our Quality Management System
D. QUALITY OBJECTIVE
E. MISSION STATEMENT
“To contribute to the improvement of quality of life in Africa and beyond through provision of superior
quality and affordable medical consumables by using local content, talent, modern technology and adherence
to best global standards’’.
F. VISION STATEMENT
“To contribute to the improvement of quality of life in Africa and beyond through provision of superior
quality and affordable medical consumables by using local content, talent, modern technology and adherence
to best global standards’’.
1.0 COMPANY PROFILE

HMA MEDICAL LIMITED is an indigenous, fast-growing, emerging leader in the design, manufacture and
sales of Pharmaceuticals and Medical Devices. Committed to improving access to healthcare and supporting
the people we serve throughout the continuum of care. From prevention to treatment, by transforming
scientific and technological innovations into healthcare solutions in the production of pharmaceuticals and
medical devices. Approximately 1000 people at HMA Medical Limited are dedicated to making a difference
in patients’ daily lives, wherever they live, and enabling them to enjoy a healthier life through a network of
sales and marketing agents and representatives complementing its support activities nationwide and beyond.
HMA has a philosophy to pursue niche markets in which products of the utmost quality, highest reliability
and most innovative functions are required. The Company is a maker and supplier of the brands DELEJECT,
and DELE FLUIDS to pharmacies, hospitals, government organisations within and beyond the border of the
country Nigeria.
The company was incorporated by the Corporate Affairs Commission (CAC) on the 4 th of May, 2017 and
licensed by the Pharmacy Council of Nigeria (PCN)- renewable every year while the products are registered
and being regulated by National Food and Drugs Administration and Control (NAFDAC) and Standard
Organisation of Nigeria (SON).
The medical device arm located at Plot 9B, Block 4, Hajj Transit Camp Road, Lubcon Avenue, Adewole
Industrial Estate, Ilorin, Kwara State, Nigeria having been commissioned in November, 2017, has been
manufacturing disposable syringes and needles of varying pack sizes under the trade mark name ‘Deleject’
Disposable Syringes and needles brand while the intravenous fluids manufacturing arm located at KM 3,
Afon Road, Ogbondoroko, Kwara State-Nigeria; was commissioned in March, 2023 has many products to
its credit under the brand name DELE FLUIDS. These two manufacturing sites of HMA Medical Limited
have in less than a decade of their existence been moving with a virile vision to become an emerging leader in
Nigeria and beyond in the production of a wide range of pharmaceutical products (intravenous fluids) and
medical devices (disposable hypodermic Syringe and Needles, sampling bottles) of various pack sizes
through continuous improvement that is driven by consumer value maximization, innovation, team work and
strong ethical practices. With our commitment to excellence not only limited to our customers but to our
supply chain and our employees.
1.1 HMA Medical Organization and Activities

The HMA Medical Limited manufacturing outfit is organized into two Business Units
The name of the registered office is:
Plot 9B, Block 4, Hajj Transit Camp Road, Lubcon Avenue, Adewole Industrial Estate,
Ilorin, Kwara State, Nigeria where the medical device site is located.
The Pharmaceutical arm manufacturing intravenous fluids located at
KM 3, Afon Road, Ogbondoroko, Kwara State-Nigeria.
With the Official phone Numbers:
+2347025793264, +2347025733347, +2348031918697
Email: ged@delepharma.com hmamedicallimited@gmail.com; md.shittu@gmail.com
1.2 Our Business Strategy
The HMA Medical Limited business strategy is built upon five key priorities:
 Consistent Focus on Growth: Portfolio prioritization to strengthen profile
 Leadership with Innovation: providing our customers with superior and contrast medical devices,
pharmaceuticals and related solutions adapted to their needs.
 Accelerated Efficiency: Through prompt and Decisive actions to expand margins
 Achieving customers’ unalloyed loyalty by practicing a policy of strong and efficient
Communication through best and effective technology, manufacturing and assembly processes by
working closely with customers to deliver to their exact satisfaction and beyond.
 Good understanding of the importance of prompt order response, quality manufacturing and on
time delivery.
1.3 Our Products

HMA Medical Limited manufactures a diverse profile class of products categorized as:
 Medical devices, including syringes and needle of different pack sizes, sterile sampling Bottles under
the brand name DELEJECT
The medical device business unit manufactures the following products (as at 2024/03/21):
 Deleject 5ML disposable Hypodermic Needle and syringe
 Deleject 21G X 11/2’’disposable hypodermic Needle
 Pharmaceuticals (intravenous fluid) under the brand name DELE FLUIDS

The pharmaceutical business unit manufactures the following products (as at21/03/2024):
 0.9% w/v Normal Saline 500ml
 0.9% w/v Normal Saline 1000ml
 5.0%w/v Dextrose in Water 500ml
 5.0% w/v Dextrose in Water 1000ml
 50% Dextrose in Water 100ml
 Delegyl Metro solution
While those been listed below are being presented for registration:
 4.3%w/v Dextrose saline
 Mannitol 10%w/v
 Mannitol 20% w/v

Ringer’s lactose
1.4 Our core values are:

 Quality
 Integrity
 Team work
 Customer centricity
 Courage
 Innovation
 Continuous improvement
F. ORGANOGRAM OF THE COMPANY

1.7 Quality Manual:
HMA Medical Limited has developed and implemented a Quality Management System in order to document best
business practices, better satisfy the requirements and expectations of its customers and for the improvement of the
overall management of the company.
This is done using a Quality Manual that aligns with both the requirements of ISO 9001:2015 for general quality
management and ISO 18345:2016 (specifically for medical devices) for the implementation of a Quality
Management System to demonstrate that it is continuously maintained generally for effectiveness and process
improvements.
The Quality Management System of HMA Medical Limited meets both the requirement of the ISO 9001:2015 and
ISO 18345:2016 international Standards and addresses the design, development, production of the company’s
products by incorporating the process approach for the achievement of consistent and predictable results or outputs
more effectively and efficiently when activities and activities are understood and managed as interrelated processes.
Using this process approach allows for the management of the quality system and its processes through the
application of “Plan-Do-Check-Act” methodology and with focus on “Risk Based Thinking” resulting in the
prevention of undesirable outcomes.
The purpose of this manual is to define and describe the Quality Management System, to define authorities, inter
relationships and responsibilities of the personnel involved in the operation of the system, and provide general
documented procedures for all activities comprising the Quality Management System in HMA Medical Limited
which ensures the compliance to the necessary requirements of the standards.
This manual is for use internally to guide the company’s employees through the various requirements of the ISO
standards that must and maintained in order ensure customer satisfaction, continuous improvement and provide the
necessary instructions that create an empowered workforce. Another purpose of this manual is that it is used
externally to present the Quality Management System to our customers and other external organisation or
interested parties to assure them of what specific controls are being implemented to assure quality.
The exclusions to the requirements of ISO 9001:2015, and ISO 18345 applies as outlined in section on exclusions.
This Quality Manual applies to the activities and operations of HMA Medical Limited in the following two
locations: The medical device arm located at Plot 9B, Block 4, Hajj Transit Camp Road, Lubcon Avenue,
Adewole Industrial Estate, Ilorin, Kwara State, Nigeria. and the pharmaceutical arm manufacturing intravenous
fluids located at KM 3, Afon Road, Ogbondoroko, Kwara State-Nigeria
1.8 Scope
This Quality Manual applies to all sites including all activities related to research, development, manufacturing and
distribution of all products of HMA Medical Limited.
HMA Medical Limited developed and implemented a Quality Management System to demonstrate that is
continuously maintained for effectiveness and process improvements in accordance with the requirements of ISO
9001:2015 and ISO 13485:2016.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization in,
regardless of its type or size, or the products it manufactures and therefore covers both sites of the organization,
HMA Medical Limited; while the ISO 13485:2016 is specific in application to medical devices by virtue of its
emphasis on design and development as a key process in product realization as a requirement.
This Quality Manual specifies requirements that HMA Medical Limited uses to address customer satisfaction, to
meet customer and applicable regulatory and statutory requirements and to meet ISO 9001:2015 and ISO
13485:2016 requirements, which is supported by additional procedures where necessary.
Conformity to the ISO Quality Management Systems used may only be claimed if the requirements determined as
not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products
and the enhancement of customer satisfaction.
In the event that any of the requirement is not applicable at HMA Medical Limited, justification for any instance
where a requirement cannot be applied is documented.
1.9 Purpose
To define the HMA Medical Limited Quality Management System; a system which integrates the operation and
development of a quality system with strategic business planning which is required to demonstrate HMA Medical
Limited’s ability to consistently provide products that meets the patients, customers’ and applicable regulatory
requirements and to enhance our patients & customers’ satisfaction through the effective application of the quality
system, including processes for continual improvement of the system and the assurance of conformity to our
patients & customers and applicable regulatory requirements. This manual is supported by a document and data
system which further defines operations and processes, which are all in alignment with corporate objectives and
compliant to ISO 9001:2016 for general quality management for both sites and ISO 18345:2016 (specifically for
medical devices) for the implementation of a Quality Management System to demonstrate that it is continuously
maintained generally for effectiveness and process improvements.
1.10 Application
HMA Medical Limited has developed and implemented the Quality Management System (QMS) described
in this manual to help our organization operate with increased effectiveness, consistency and to achieve
customer satisfaction. Our QMS utilizes the process approach and quality management principles contained in
the international standards ISO 9001:2015 and ISO 13485:2016 to create a customer focus while consistently
meeting customer and regulatory requirements. Our QMS encompasses all operations at our facilities that have
influence on quality, safety and efficiency of products marketed by the company., covering also aspects such
as storage, distribution and the provision of associated services throughout the life cycle of a component of our
products the medical device such as from initial conception to production and post production. The organisation
is licensed for the manufacture of range of pharmaceuticals intravenous fluid employing ISO 9001:2015 and
medical devices which include syringes and needles employing the ISO 13485:2016 international standard
requirement services with the goal and objective of providing a strong commitment to continual improvement
and giving customers confidence in its ability to bring safe and effective products to the market.
1.11 Exclusions/Exceptions
HMA Medical Limited has determined that the following requirements are not applicable to the operations at the
sites specified and are documented as exclusions/exceptions as per the individual site concerned:
 Exclusion: ISO 13485 (2016) 7.5.9.2 ‘’Particular requirements for implantable medical devices’’
Justification: HMA Medical Limited presently does not engage in the manufacturing of non-sterile products and
implantable medical devices.
 Exclusion: ISO 13485 (2016) Section 7.5.10 Customer Property
Justification: HMA Medical Limited does not receive from customers any tangible or intellectual property that is
intended for incorporation into, or in any way associated with the medical device.
 Exclusion : ISO 13485 (2016) Section 7.5.3 ‘’Installation Activities’’
Justification: HMA Medical Limited does not install product.
 Exclusion : ISO 13485 (2016) Section 7.5.4

Justification: HMA Medical Limited does not service product
 Exclusion : ISO 13485 (2016) Section 7.5.6.
Justification: HMA Medical Limited can verify its product’s conformity through inspection,
monitoring, testing or measuring methods to confirm that the product meets customer requirements of
safety and effectiveness prior to delivery but does not provide servicing of product
Justification: HMA Medical Limited does not install product.
 Exclusion : ISO 13485 (2016) Section 7.5.4

Justification: HMA Medical Limited does not service product
 Exclusion : ISO 13485 (2016) Section 7.5.6.
Justification: HMA Medical Limited can verify its product’s conformity through inspection,
monitoring, testing or measuring methods to confirm that the product meets customer requirements of
safety and effectiveness prior to delivery but does not provide servicing of products.
Certainly! Integrating ISO 9001:2015 (Quality Management System) and ISO 13485:2016 (Medical Devices - Quality
Management Systems) can lead to a robust and efficient system. Let’s explore the key points of integration:
1. High-Level Structure (HLS):
o Both standards now follow the ISO Annex SL, which provides a common high-level structure with 10
clauses.
o This structure standardizes terminology and aligns with the Plan-Do-Check-Act (PDCA) principle.
o Organizations implementing an integrated system (e.g., QMS, EMS, ISMS) can benefit from this common
structure.
2. Identical Core Text and Numbering Schemes:
o The major clause numbers and titles are consistent between ISO 9001:2015 and ISO 13485:2016.
o Key areas include leadership, planning, support, operation, performance evaluation, and improvement.
o For instance:
 Clause 4: Context of the Organization (understanding the organization and its context).
 Clause 5: Leadership and Commitment (leadership, policy, organizational roles).
 Clause 6: Planning (addressing risks, objectives, and planning).
 Clause 7: Support (resources, competence, awareness, communication, documented information).
 Clause 8: Operation (operational planning and control).
 Clause 9: Performance Evaluation.
 Clause 10: Improvement.
3. Increased Emphasis Areas:
o Feedback, validation, verification, and design risk transfer management.
o Regulatory requirements and improved linkage of clauses.
o Outsourced processes and supplier control.
4. Risk-Based Thinking:
o Both standards emphasize risk management.
o Organizations must consider risks and opportunities in their processes.
5. Context of the Organization:
o Understanding the organization’s context is crucial.
o Consider external and internal factors that impact quality and medical devices.
6. Outsourcing and Purchasing:
o ISO 9001:2015 combines outsourcing and purchasing.
o Ensure effective control over suppliers and outsourced processes.
7. Quality Manual:
o Unlike previous versions, a separate quality manual is no longer mandatory.
Remember that successful integration requires careful planning, alignment of processes, and effective communication across
the organization. If you’d like more detailed guidance or specific examples, consider consulting experts or exploring
resources from authoritative bodies123.
Learn more
1 bsigroup.com2 medical-device-regulation.eu3 13485store.com4 bsigroup.com5

cdn2.hubspot.net+1 more
Show learn more suggestions
Let’s chat
 Can you provide an example of a combined process?

 How do I implement risk-based thinking in my organization?
 What are the benefits of integrating these standards?
Certainly! While pharmaceutical and medical device manufacturing have distinct characteristics, there are
some shared processes and considerations. Let’s explore them:
1. Quality Management System (QMS):
o Both industries benefit from a robust QMS.
o Shared processes include document control, change management, risk assessment, and
corrective/preventive actions.
o Harmonizing QMS elements ensures consistency and compliance1.
2. Supplier Management:
o Both pharmaceuticals and medical devices rely on suppliers.
o Shared processes involve supplier qualification, audits, and performance monitoring.
o Ensuring quality materials and components is critical for both sectors.
3. Design Controls:
o Both industries follow design control processes.
o Shared aspects include requirements gathering, design verification, validation, and risk management.
o Aligning design controls ensures safe and effective products.
4. Risk Management:
o Risk assessment is crucial for both pharmaceuticals and medical devices.
o Shared processes involve identifying hazards, assessing risks, and implementing mitigations.
o Balancing risk-benefit profiles is essential.
5. Validation and Verification:
o Shared processes include product validation and verification.
o Pharmaceutical validation (e.g., process validation) aligns with medical device verification (e.g.,
testing).
o Ensuring product quality and safety is a common goal.
6. Regulatory Submissions:
o Both sectors submit regulatory applications.
o Shared processes include compiling data, preparing dossiers, and interacting with health authorities.
o Compliance with regulations is paramount.
7. Clinical Trials and Studies:
o While more common in pharmaceuticals, medical devices also undergo clinical evaluations.
o Shared processes involve study design, data collection, and reporting.
o Demonstrating safety and efficacy is essential.
8. Change Control:
o Managing changes (e.g., process changes, material substitutions) is universal.
o Shared processes include impact assessments, approvals, and implementation.
o Ensuring product consistency during changes is critical.
9. Audits and Inspections:
o Both sectors face regulatory audits.
o Shared processes include preparing for inspections, addressing findings, and maintaining compliance.
o Transparency and adherence to standards matter.
10. Post-Market Surveillance:
o Monitoring product performance after launch is essential.
o Shared processes involve adverse event reporting, complaint handling, and trend analysis.
o Ensuring ongoing safety and effectiveness is a joint effort.
Remember that while the industries differ, collaboration, knowledge sharing, and adherence to quality
standards benefit both pharmaceutical and medical device manufacturing123.
Learn more
1 medtecheurope.org2prescouter.com3rsc.org4 mckinsey.com5mdpi.com
8of30
 How do companies manage shared processes across global manufacturing sites?

 What challenges arise when integrating these processes in a multinational organization?
 Are there any case studies on successful alignment of pharmaceutical and medical device manufacturing
practices?
 Design Controls:
o ISO 13485 emphasizes design controls for medical devices, ensuring that they are safe and
effective. However, pharmaceutical products typically follow a different development process, and
design controls are not a standard part of pharmaceutical manufacturing 1.
o These controls involve activities such as design planning, risk management, design verification, and
validation. For pharmaceuticals, the focus is more on formulation, clinical trials, and regulatory
submissions.
 Traceability of Measurement:
o ISO 13485 requires maintaining traceability of measurement according to the needs of relevant
regulatory bodies2.
o For pharmaceutical products, traceability of measurement is not typically a critical aspect. Instead,
pharmaceutical companies focus on quality control during manufacturing and testing.
 Product and Service Provision Requirements:
o ISO 13485 includes requirements related to product and service provision, including aspects like raw
materials, communication with customers, and other operational elements.
o Some of these requirements may not directly align with pharmaceutical production processes, where
the focus is on drug formulation, clinical trials, and distribution.
 Regulatory Compliance:
o ISO 13485 emphasizes compliance with regulatory requirements specific to medical devices. These
requirements vary by country and region.
o While pharmaceutical products also have regulatory requirements, they differ significantly from those
for medical devices. Pharmaceutical regulations focus on safety, efficacy, and clinical trials.
 Quality Management System (QMS):
o ISO 13485 outlines QMS requirements tailored to medical devices. These include documentation, risk
management, corrective actions, and management review.
o Pharmaceutical companies may have their own QMS, but it operates differently due to the distinct
nature of drug development and manufacturing.
In the context of ISO 13485, which pertains to Quality Management Systems (QMS) for medical devices,
there are specific requirements that may not be directly applicable to pharmaceutical products. Let’s explore
these:
1. Design Controls:
o ISO 13485 emphasizes design controls for medical devices, ensuring that they are safe and
effective. However, pharmaceutical products typically follow a different development process, and
design controls are not a standard part of pharmaceutical manufacturing1.
o These controls involve activities such as design planning, risk management, design verification, and
validation. For pharmaceuticals, the focus is more on formulation, clinical trials, and regulatory
submissions.
2. Traceability of Measurement:
o ISO 13485 requires maintaining traceability of measurement according to the needs of relevant
regulatory bodies2.
o For pharmaceutical products, traceability of measurement is not typically a critical aspect. Instead,
pharmaceutical companies focus on quality control during manufacturing and testing.
3. Product and Service Provision Requirements:
o ISO 13485 includes requirements related to product and service provision, including aspects like raw
materials, communication with customers, and other operational elements.
o Some of these requirements may not directly align with pharmaceutical production processes, where
the focus is on drug formulation, clinical trials, and distribution.
4. Regulatory Compliance:
o ISO 13485 emphasizes compliance with regulatory requirements specific to medical devices. These
requirements vary by country and region.
o While pharmaceutical products also have regulatory requirements, they differ significantly from those
for medical devices. Pharmaceutical regulations focus on safety, efficacy, and clinical trials.
o ISO 13485 outlines QMS requirements tailored to medical devices. These include documentation, risk
management, corrective actions, and management review.
o Pharmaceutical companies may have their own QMS, but it operates differently due to the distinct
nature of drug development and manufacturing.
Remember that while ISO 13485 certification is not legally required, adhering to its principles can enhance
product safety and quality in both medical devices and pharmaceuticals3. However, pharmaceutical
companies often follow other quality standards specific to their industry.
Learn more
1mpo-mag.com2advisera.com3propharmagroup.com4iso.org
1of30
You
How can pharmaceutical companies adapt ISO 13485 principles?

Adapting medical device manufacturing processes to the ISO 9001:2015 standard within a single quality manual involves
several key steps. Let’s break it down:
1. Quality Manual Structure:
o Begin by creating a comprehensive quality manual that encompasses all relevant aspects of your medical
device manufacturing processes.
o The quality manual should outline the organization’s quality management system (QMS) and serve as a
reference for employees, auditors, and stakeholders.
2. ISO 9001:2015 Requirements:
o Familiarize yourself with the ISO 9001:2015 standard. Understand its principles, requirements, and
structure.
o Key areas include context of the organization, leadership commitment, risk-based thinking, process
approach, and continual improvement.
3. Mapping ISO 9001:2015 Clauses:
o Identify the relevant clauses of ISO 9001:2015 that apply to medical device manufacturing.
o Map these clauses to specific sections or chapters within your quality manual.
4. Incorporate ISO 9001:2015 Elements:
o Address each ISO 9001:2015 requirement within the quality manual.
o Examples of elements to include:
 Quality Policy: Clearly state the organization’s commitment to quality.
 Context of the Organization: Describe the internal and external factors affecting your processes.
 Risk Management: Detail how risks are assessed and managed.
 Leadership and Commitment: Explain the roles and responsibilities of management.
 Process Approach: Describe how processes are defined, controlled, and monitored.
 Document Control: Specify procedures for document creation, approval, and revision.
 Training and Competence: Outline training requirements for employees.
 Product Realization: Cover design, production, and post-production activities.
 Monitoring and Measurement: Describe how performance is monitored and measured.
 Corrective and Preventive Actions: Explain procedures for addressing nonconformities.
 Internal Audits: Detail the audit process.
 Management Review: Discuss periodic reviews by top management.
5. Single Quality Manual:
o Consolidate all ISO 9001:2015-related content into a single quality manual.
o Ensure clear cross-references between sections to maintain coherence.
o Use a logical structure that aligns with the ISO 9001:2015 framework.
6. Document Control and Versioning:
o Implement robust document control procedures.
o Clearly indicate the version of the quality manual and track revisions.
o Ensure that all employees have access to the most up-to-date version.
7. Training and Awareness:
o Train employees on the quality manual’s content and ISO 9001:2015 requirements.
o Foster awareness of the QMS throughout the organization.
Remember that ISO 9001:2015 emphasizes a process-based approach, risk management, and continual
improvement. Regularly review and update your quality manual to reflect changes in processes, regulations, and
organizational context12345.
Learn more
1flukebiomedical.com2qualitiso.com3fda.gov4cdn.who.int5meddeviceonline.com
Let’s chat
 What are the benefits of ISO 9001:2015 certification?

 How can I ensure effective implementation across all departments?
 Can you provide an example of a risk-based approach in medical device
1.1 Terms and Definitions

Terms and Definitions for the purposes of this document, the terms and definitions given in ISO
9000 and ISO 13485:2016 apply.
1.2 Normative References:
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies. ISO 9001:2015, Quality
management systems — Fundamentals and vocabulary.
 ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory
purposes”.
 ISO 9001:2015, Quality Management systems- Fundamentals and vocabulary
 ISO 14001(Environmental)
 OHSAS 18001(Occupational)
 ISO/TR 14969:2004: A Technical Report intended to provide a guidance on the application of ISO
13485:2016.
 21 CFR Part 820: Quality System Regulation
 GHTF/SG3/N15R8: Implementation of risk management principles and activities within a Quality
Management System
 GHTF/SG3/N17:2008: Quality Management System – Medical Devices – Guidance on the Control of

Products and Services Obtained from Suppliers
 ISO 9001:2008 Quality Management Systems – Requirements Medical Device Quality Agreement
Template Page 6 of 17 Prepared by Ombu Enterprises, LLC www.OmbuEnterprises.com
 ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory
purposes
 ISO 14971:2007 Medical devices – Application of risk management to medical devices
4.0 Quality Management System
4.1 General requirements
4.1.1 HMA Medical Limited shall establish, document, implement a quality management system and
maintain its effectiveness in accordance with the requirements of the International Standard ISO
13485:2016 and applicable regulatory requirements.
4.1.2 To design and implement the QMS HMA Medical Limited shall:
a) identify the processes needed for the quality management system and the application of these processes
throughout the organisation.
b) determine the sequence and interaction of these processes and documenting them on the Process Flow
Diagram.
c) apply a risk-based approach to the control of the appropriate processes needed for the quality
management system;
4.1.3 For each management system process, HMA Medical Limited shall:
a) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective; and document them in quality plans, work instructions and the Measuring, Monitoring and
Analysis table
b) ensure continuing availability of resources and information necessary to achieve planned results and
continual improvement of these processes.
c) implement actions necessary to achieve planned results and maintain the effectiveness of these
processes;
d)establish systems to monitor, measure as appropriate, and analyses these processes;

e) establish and maintain records needed to demonstrate conformance to this International Standard and
compliance with applicable regulatory requirements (see 4.2.5).
4.1.4 HMA Medical Limited shall manage these quality management system processes in accordance
with the requirements of this International Standard and applicable regulatory requirements. Changes to
Quality Management System processes shall be controlled through management Planning and Review
and these controls shall include:
a) An evaluation of the proposed impact upon the Quality Management System;
b) An evaluation of the proposed changes impact upon the medical devices produced under this Quality
Management System;
c) Review and approval proposed changes in accordance with the requirements of this International
Standard and applicable regulatory requirements.
4.1.5 When HMA Medical Limited chooses to outsource any process that affects product conformity to
requirements, it shall monitor and ensure control over such processes. HMA Medical Limited shall retain
responsibility of conformity to this International Standard and to customer and applicable regulatory
requirements for outsourced processes. The controls shall be:
a) Proportionate to the risks involved and the ability of the external party to provide the outsourced
process, meet the requirements in accordance with 7.4.
b) The controls shall include the receipt of a signed Supplier Quality Agreement.
4.1.6 HMA Medical Limited shall document procedures for the validation of the computer software
used in the application of Quality Management System. Such software applications shall be validated
prior to initial use and, as appropriate, after changes to such software or its application. The specific
approach and activities associated with software validation and revalidation shall be proportionate to the
risk associated with the use of the software. Records of such activities shall be maintained (see 4.2.5).
4.2 Documentation requirements
4.2.1 General
HMA Medical Limited shall establish a comprehensive QMS for the purpose of assuring achievement of its
Quality Policy and Objectives. The quality management system documentation shall include:
a) documented statements of a Quality Policy and Quality Objectives,
b) a Quality Manual,
c) documented procedures required by ISO 13485,
d) documents, including records, determined by HMA Medical Limited to be necessary to ensure the
effective planning, operation, and control of its processes
e) other documentation specified by applicable regulatory requirements
QUALITY MANAGEMENT
Quality Policy SYSTEM DOCUMENTATION
and Objectives
Quality Manual
BMS Procedure
Procedures or Work Instructions
Reference Documentation and Quality Records

Management of HMA Medical Limited shall ensure that employees have access and awareness of procedures
related to their job responsibilities by providing access to controlled document via computer or binder of
controlled paper copies of procedures and required forms.
4.2.2 Quality manual
HMA Medical Limited shall establish and maintain a quality manual that includes
a) definition of the scope of the quality management system, including details of and justification for any
exclusion and/or non-application (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system. The structure of
the documentation used in the quality management system is described in Context of HMA Medical Limited.
The application, sequence and interaction of the processes that make up our quality management system is as
shown in the flow diagram on fig 2
Continual Improvement of the quality management system
Management
responsibility
Customers
Customers Resource Measurement,

Management analysis &improvement Satisfaction
Requirements input Product

Realization Product output
Key: information flow
Value-adding activities
Figure 1- Model of a process-based quality management system
4.2.3 Medical device file
For each medical device type or medical device family, HMA Medical Limited shall establish and maintain
one or more files named Device Master Record file either containing or referencing documents generated to
demonstrate conformity to the requirement of this International Standard and compliance with applicable
regulatory requirements. The content of the file(s) shall include, but is not limited to:
a) general description of the medical device, intended use/purpose, and labelling, including any instructions
for use;
b) specifications for the product including appropriate customer specifications;
c) specifications or procedures for manufacturing processes, methods and equipment used, handling
specifications and environmental conditions requirements when required;
d) procedures for measuring and monitoring.
e) packaging, storage, labelling and distribution specifications;
f) Acceptance criteria for the products provided by the customer;
4.2.4 Control of documents
HMA Medical Limited has established and maintained documented procedures for creation, review and
approval, change control, and distribution all documents and records required by the QMS. Documents
required by the quality management system shall be controlled. Records are a special type of document and
shall be controlled according to the requirements given in 4.2.4. The documented procedures are established
to define the controls needed:
a) to review and approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to clearly identify the changes and the current revision status of documents,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) ensure that documents of external origin, determined by HMA Medical Limited to be necessary for the
planning and operation of the quality management system, are identified and their distribution controlled
g) prevent deterioration or loss of documents;
h) prevent the unintended use of obsolete documents and apply suitable identification to them. HMA Medical
Limited shall ensure that changes to documents are reviewed and approved either by the original approving
function or another designated function which has access to pertinent background information upon which to
base its decisions. HMA Medical Limited shall define the period for which at least one copy of obsolete
controlled documents shall be retained. This period shall ensure that documents to which medical devices
have been manufactured and tested are available for at least the lifetime of the medical device as defined by
HMA Medical Limited, but not less than the retention period of any resulting record (see 4.2.5), or as
specified by relevant regulatory requirements.
4.2.5 Control of records HMA Medical Limited shall maintain Records to provide evidence of conformity to
requirements and of the effective operation of the quality management system. HMA
Medical Limited shall document procedures to define the controls needed for the identification, storage,
security and integrity, retrieval, retention time and disposition of records. HMA Medical Limited shall define
and implement methods for protecting confidential health information contained in records in accordance
with the applicable regulatory requirements. Changes to a record shall remain identifiable. HMA Medical
Limited shall retain the records for at least the lifetime of the medical device as defined by the organisation,
or as specified by applicable regulatory requirements, but not less than five years from the medical device
release by HMA Medical Limited. When completed forms shall be retained as records, identified with a title,
form number, revision date and/or number when applicable, or pictured within a procedure or work
instruction,
5 Management responsibility
5.1 Management commitment Top management of HMA medical Limited shall provide evidence of its
commitment to the development, implementation and maintaining the effectiveness of the quality
management system per ISO 13485 by:
a) communicating to all members of HMA Medical Limited the importance of meeting customer, statutory
and regulatory requirements,
b) establishing the quality policy and objectives,
c) ensuring that quality policy and objectives are established,
d) conducting periodic management reviews,
e) ensuring the availability of necessary resources.
5.2 Customer focus
Top management of HMA Medical Limited shall ensure that current and future customer requirements and
applicable regulatory requirements are determined and met with the goal of increasing customer satisfaction.
Customer requirements shall be determined, and satisfaction measured through our product realization and
measurement, analysis and improvement of processes and procedures.
Top management shall ensure that the product conformity and on-time delivery are measured and that
appropriate actions are taken if planned results are not or will not be, achieved. Since quality metrics are
subject to changes over time, reference to specific measurements can be found in management reviews
records for each division of the organization.
Top management shall ensure that customer requirements are understood and met, by requiring compliance
with documented customer communication procedures. Customer requirements are determined, converted
into internal requirements, and communicated to the appropriate people in our organization.
5.3 Quality policy
The Quality policy is a high-level document containing statements about the general direction of the
organisation and its commitment to quality and customer satisfaction.
HMA Medical Limited accepts responsibility for the complete satisfaction of its customers. We exercise this
responsibility through adequate training of our employees, adherence to proven procedures, and total commitment to
meeting and exceeding customer requirements.
The Top management of HMA Medical Limited shall ensure that the quality policy
a) is appropriate to the purpose of HMA Medical Limited in meeting or exceeding customer requirements
and expectations by complying with requirements and to maintain the effectiveness of the Quality
Management System
b) provides a framework for establishing and reviewing quality objectives,
c) is periodically reviewed by the top management to ensure its continuing suitability.
d) is communicated and understood throughout HMA Medical Limited
e) Contain or reference product acceptance criteria
f) Specify the characteristics of the product that are essential for its safe and proper use
5.4 Planning
Executive management shall ensure that quality objectives are established and that the QMS is planned to
ensure that the quality objectives are met.
5.4.1 Quality Objectives
Top management shall ensure that measurable quality objectives and supporting documents, including those
needed to meet applicable regulatory requirements and requirements for product and processes, improving
quality and performance, and maintaining and enhancing customer satisfaction are established at relevant
functions and departments (HR, Production, purchase, quality control etc.) within HMA Medical Limited.
The quality objectives shall be timed, measurable, quantitative and consistent with the quality policy so that it
can be determined whether objectives are met and if not, what should be done.
5.4.2 Quality management system planning
Top management shall ensure the planning of the Quality Management System in order:
a) to meet the requirements given in clause 4.1of the standard, as well as the quality objectives,
b) for the integrity of the quality management system to be maintained when changes occur to the process or
product, identifying possibilities for improvement, audits etc., the changes in the quality management system
shall be evaluated and planned accordingly during management review and implemented.
c) to accomplish quality objectives through planning of resources, deadlines, responsibilities, and appropriate
evidence. Planning is therefore a continuous process since objectives are changeable.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are
defined, documented and communicated within HMA Medical Limited. Top management shall establish the
interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the
independence and authority necessary to perform these tasks. This is achieved via any or combination of the
Quality Systems Manual, Procedures, Work Instructions, Job Descriptions, Organizational Chart, and other
means suitable for HMA Medical Limited.
5.5.2 Management representative The Top management shall appoint the Quality Control/Assurance
Manager for each of the division of HMA Medical Limited as management representative for their site. The
site management representative shall be responsible for maintaining total compliance with the corporate QMS
as well as the monitoring and control of product quality. The site management representative reports to the
Group Executive Director and the Group Managing Director and shall, irrespective of other responsibilities,
have responsibility and authority that includes
a) ensuring that processes and requirements needed for the quality management system are well defined,
documented, implemented and maintained at the site,
b) organizational freedom and unrestricted access to top management to resolve matters pertaining to quality,
c) reporting to top management on the performance of the quality management system and any need for
review and as a basis for improvement of the QMS, and
d) ensuring the promotion of awareness of applicable regulatory requirements and quality management
system requirements throughout HMA Medical Limited.
e) Management representative shall also act as a liaison with external parties on matters related to the QMS
5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within HMA Medical
Limited and that communication takes place regarding the effectiveness of the quality management system.
Communication to be discharged includes information regarding:
a) Quality policies
b) Quality objectives and requirement,
c) Effectiveness of the QMS
5.6 Management review
5.6.1 General HMA Medical Limited shall document procedures for management review. Top management
shall review HMA Medical Limited’s quality management system at documented planned intervals to ensure
its continuing:
a) applicability-are activities performed according to procedures?
b) suitability- Does serve its purpose and satisfy the needs of the organisation?
c) adequacy- does the QMS conform to the standard’s requirements?
d) effectiveness- does it achieve the planned results?
The review shall include assessing opportunities for improvement and the need for changes to the quality
management system, including the quality policy and quality objectives. Records from management reviews
shall be maintained.
The Quality Control/Assurance Manager shall schedule and maintains records of management review meeting
for their respective division.
5.6.2 Review input
The input to management review shall include, but not limited to, information arising from
a) Customer feedback;
b) complaint handling;
c) reporting regulatory activities;

d) reports of audits;
(e) monitoring and measurement of processes;
f) monitoring and measurement of product;
g) status of preventive action and corrective actions;
i) follow-up actions from previous management reviews;
j) changes that could affect the quality management system;
k) recommendations for improvement;
l) applicable new or revised regulatory requirements.
5.6.3 Review output
The output from the management review shall include any decisions and actions related but not limited to :
a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management
system and its processes;
b) improvement of product related to customer requirements,
c) changes needed to respond to applicable new or revised regulatory requirements;
d) resource needs.
6 Resource management
6.1 Provision of resources
HMA Medical Limited shall determine and provide the resources needed to
a) implement the quality management system and to maintain its effectiveness

b) meet applicable regulatory and customer requirements.
6.2 Human resources
Personnel performing work affecting product quality shall be competent based on appropriate education,
training, skills and experience. HMA Medical Limited shall document the process(es) for establishing
competence, providing needed training, and ensuring awareness of personnel. HMA Medical Limited shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to achieve or maintain the necessary competence
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives,
e) maintain appropriate records of education, training, skills and experience (see 4.2.5)
6.3 Infrastructure
HMA Medical Limited shall document the requirements for the infrastructure needed to achieve conformity
to product requirements, prevent product mix-up and ensure orderly handling of product. Infrastructure
includes, as appropriate
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication or information systems). HMA Medical Limited
shall document requirements for the maintenance activities, including the interval of performing the
maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As
appropriate, the requirements shall apply to equipment used in production, the control of the work
environment and monitoring and measurement. Records of such maintenance shall be maintained (see 4.2.5).
6.4 Work environment and contamination control
6.4.1 Work environment
HMA Medical Limited shall document the requirements for the work environment needed to achieve
conformity to product requirements. If the conditions for the work environment can have an adverse effect on
product quality, HMA Medical Limited shall document the requirements for the work environment and the
procedures to monitor and control the work environment. HMA Medical Limited shall:
a) document requirements for health, cleanliness and clothing of personnel if contact between such personnel
and the product or work environment could affect medical device safety or performance;
b) ensure that all personnel who are required to work temporarily under special environmental conditions
within the work environment are competent or supervised by a competent person.
c) ensure compliance with legislation, guidelines, and requirements on working environmental conditions
(humidity, light, temperature, noise, vibration); health and safety of the staff working environment.
6.4.2 Contamination control: For sterile medical devices
HMA Medical Limited by virtue of the sterile nature of its products shall document procedures and
requirements for control of contamination with microorganisms/particulate matter and maintain required
cleanliness throughout all the stages of processing of the medical device product.
HMA Medical Limited shall plan and document arrangements for the control of contaminated or potentially
contaminated product in order to prevent contamination of the work environment, personnel, or product.
The overall responsibility for this procedure belongs to the Chairman/Chief Executive Officer with the
guidance and direction of the Management Representative and Management Policy Committee
7 Product realization
7.1 Planning of product realization
HMA Medical Limited shall plan and develop the processes and documents needed for product realization.
Planning of product realization shall be consistent with the requirements of the other processes of the quality
management system. HMA Medical Limited shall document one or more processes for risk management in
product realization. Records of risk management activities shall be maintained (see 4.2.5). In planning
product realization, HMA Medical Limited shall determine the following, as appropriate in meeting the
specific requirements for products:
a) preparation of quality plans and objectives and requirements for the product;
b) the need to establish processes and documents (see 4.2.4) and to provide resources specific to the product,
including infrastructure and work environment;
c) required verification, validation, monitoring, measurement, inspection and test, handling, storage,
distribution and traceability activities specific to the product together with the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements
(see 4.2.5). The output of this planning shall be documented in a form (quality records) suitable for HMA
Medical Limited’s method of operations.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
HMA Medical Limited shall determine

a) requirements specified by the customer, including the requirements for delivery and post-delivery
activities;
b) requirements not stated by the customer but necessary for specified or intended use, as known;
c) applicable regulatory requirements related to the product;
d) any user training needed to ensure specified performance and safe use of the medical device;
e) any additional requirements determined by HMA Medical Limited.
7.2.2 Review of requirements related to the product
HMA Medical Limited shall review the requirements related to the product. This review shall be conducted
prior to HMA Medical Limited's commitment to supply a product to the customer (e.g. submission of tenders,
acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined and documented;
b) contract or order requirements differing from those previously expressed are resolved;
c) applicable regulatory requirements are met;
d) any user training identified in accordance with 7.2.1 is available or planned to be available;
e) HMA Medical Limited has the ability to meet the defined requirements. Records of the results of the
review and actions arising from the review shall be maintained (see 4.2.5). When the customer provides no
documented statement of requirement, the customer requirements shall be confirmed by HMA Medical
Limited before acceptance. When product requirements are changed, HMA Medical Limited shall ensure that
relevant documents are amended and that relevant personnel are made aware of the changed requirements.
7.2.3 Communication
HMA Medical Limited shall plan and document arrangements for communicating with customers in relation
to:
a) product information,
b) enquiries, contracts or order handling, including amendments,
c) customer feedback, including complaints
d) advisory notices (see 8.5.1).
HMA Medical Limited shall communicate with regulatory authorities in accordance with applicable
regulatory requirements.
7.3 Design and development Note that these elements of the standard are excluded from HMA Medical
Limited’s scope.
7.4 Purchasing
7.4.1 Purchasing process
HMA Medical Limited shall establish documented procedures to ensure that purchased product for use in the
production of our products conforms to specified requirements. HMA Medical Limited shall establish criteria
for selection, evaluation and re-evaluation of suppliers. The criteria shall be:
a) based on the supplier’s ability to provide product that meets HMA Medical Limited’s requirements; b)
based on the performance of the supplier;
c) based on the effect of the purchased product on the quality of the medical device;
d) proportionate to the risk associated with the medical device. HMA Medical Limited shall plan the
monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased
product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation
process. Non-fulfilment of purchasing requirements shall be addressed with the supplier proportionate to the
risk associated with the purchased product and compliance with applicable regulatory requirements. Records
of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and
any necessary actions arising from these activities shall be maintained (see 4.2.5).
7.4.2 Purchasing information
Purchasing documents contain the information necessary to describe the product to be purchased.
HMA Medical Limited shall ensure the adequacy of specified purchasing requirements prior to their
communication to the supplier.
Where appropriate, purchasing information includes:
a) product specifications;
b) requirements for product acceptance, procedures, processes and equipment;
c) requirements for qualification of supplier personnel;
d) quality management system requirements.
e) change notification and verification
f) a written agreement that the supplier notify HMA Medical Limited of changes in the purchased product
prior to implementation of any changes that affect the ability of the purchased product to meet specified
purchase requirements.
g) To the extent required for traceability given in 7.5.9, HMA Medical Limited shall maintain relevant
purchasing information in the form of documents (see 4.2.4) and records (see 4.2.5).
7.4.3 Verification of purchased product

HMA Medical Limited shall establish and implement documented procedures that shall assure the inspection
or other activities necessary for ensuring that purchased product meets specified purchasing mandatory or
other requirements. The extent of verification activities shall be based on the supplier evaluation results and
proportionate to the risks associated with the purchased product. When HMA Medical Limited becomes
aware of any changes to the purchased product, HMA Medical Limited shall determine whether these changes
affect the product realization process or the medical device. When HMA Medical Limited or its customer
intends to perform verification at the supplier’s premises, HMA Medical Limited shall state the intended
verification activities and method of product release in the purchasing information. Records of the verification
shall be maintained (see 4.2.5).
7.5 Production and service provision
7.5.1 Control of production and service provision
HMA Medical Limited shall develop processes and procedures to ensure all aspects of Production activities
are planned, carried out, monitored, controlled and validated, and properly identified and protected
throughout the manufacturing and delivery to ensure that product conforms to specification. As appropriate,
production controls shall include but are not limited to:
a) documentation of procedures and methods for the control of production (see 4.2.4);
b) equipment suitable for the production of the product or performance is used, including qualification of
infrastructure;
c) implementation of monitoring and measurement of process parameters and product characteristics; d)

availability and use of monitoring and measuring equipment;
e) implementation of defined operations for labelling and packaging;
f) implementation of product release, delivery and post-delivery activities.

g) work instructions describing the performance of the process are available as necessary to ensure safety,
quality, and compliance with regulatory requirements,
h) accountability is maintained of all products during manufacturing,
i) product characteristics information is provided that describe the characteristics of the product
j) Criteria for workmanship are provided in the clearest practical way
k) in-process verification points are identified when adequate verification of conformance is needed to
prevent escape of non-conformant to later stage of production
l) process controls and control plans are established where key characteristics have been identified
m) utilities such as water, compressed air, electricity and chemical products, are monitored and controlled
where they affect product quality,
HMA Medical Limited shall establish and maintain a record (see 4.2.5) for each medical device or batch of
medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount
manufactured and amount approved for distribution. The record shall be verified and approved. 7.5.2
Cleanliness of product.
HMA Medical Limited shall document requirements needed for cleanliness of the product either before or
after sterilization or its use.
7.5.3 Installation activities
Note that this element of the standard is excluded from HMA Medical Limited’s scope.
7.5.4 Servicing activities
Note that this element of the standard is excluded from HMA Medical Limited’s scope.
7.5.5 Particular requirements for sterile medical devices

HMA Medical Limited shall keep the record of the sterilization process parameters for each sterilization
batch. These records shall be traceable to each manufacturing batch of medical devices.
7.5.6 Validation of processes for production and service provision
HMA Medical Limited shall validate any processes for production where the resulting output cannot be or is
not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent
only after the product is delivered or in use. Validation shall demonstrate the ability of these processes to
achieve planned results consistently. HMA Medical Limited shall document procedures for validation of
processes, including:
a) defined criteria for review and approval of the processes;
b) equipment qualification and qualification of personnel;
c) use of specific methods, procedures and acceptance criteria;
d) as appropriate, statistical techniques with rationale for sample sizes;
e) requirements for records (see 4.2.5);
f) revalidation, including criteria for revalidation;
g) approval of changes to the processes. HMA Medical Limited shall document procedures for the validation
of the application of computer software used in production and service provision. Such software applications
shall be validated prior to initial use and, as appropriate, after changes to such software or its application. The
specific approach and activities associated with software validation and revalidation shall be proportionate to
the risk associated with the use of the software, including the effect on the ability of the product to conform to
specifications. Records of the results and conclusion of validation and necessary actions from the validation
shall be maintained (see 4.2.4 and 4.2.5).
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
HMA Medical Limited shall document procedures for the validation of the sterilization process and sterile
barrier systems, when applicable. HMA Medical Limited’s products shall be evaluated if re-validation for
sterilization processes prior to implementation and following product changes is required. All records of the
processes, results, and conclusion shall be maintained per 4.2.4 and 4.2.5
7.5.8 Identification
HMA Medical Limited shall document procedures for product identification and identify product by suitable
means throughout product realization. HMA Medical Limited shall identify product status with respect to
monitoring and measurement requirements throughout product realization. Identification of product status
shall be maintained throughout production, storage of product to ensure that only product that has passed the
required inspections and tests or released under an authorized concession is dispatched. If required by
applicable regulatory requirements, HMA Medical Limited shall document a system to assign unique device
identification to the medical device. HMA Medical Limited shall document procedures to ensure that medical
devices returned to HMA Medical Limited for non-conformance reasons are identified and distinguished from
conforming product.
7.5.9 Traceability
7.5.9.1 General
HMA Medical Limited shall document procedures for traceability. These procedures shall define the extent of
traceability in accordance with applicable regulatory requirements and the records to be maintained (see
4.2.5).
7.5.9.2 Particular requirements for implantable medical devices
Note that this element of the standard is not applicable to HMA Medical Limited products.
7.5.9.3 Customer property
Note that this element of the standard is not applicable to HMA Medical Limited products.
7.5.9.4 Preservation of product
HMA Medical Limited shall document procedures for preserving the conformity of product to requirements
during processing, storage, handling, and distribution. Preservation shall apply to the constituent parts of a
medical device. HMA Medical Limited shall protect product from alteration, contamination or damage when
exposed to expected conditions and hazards during processing, storage, handling, and distribution by:
a) providing suitable packaging and shipping containers;
b) documenting requirements for special conditions needed if packaging alone cannot provide preservation.
If special conditions are required, they shall be controlled and recorded (see 4.2.5).
7.6 Control of monitoring and measuring devices
HMA Medical Limited shall determine the monitoring and measurement to be undertaken and the monitoring
and measuring devices needed to provide evidence of conformity of product to determined requirements.
HMA Medical Limited shall establish documented procedures to ensure that monitoring and measurement
can be carried out and are carried out in a manner that is consistent with the monitoring and measurement
requirements. As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to
international or national measurement standards; where no such standards exist, the basis used for calibration
or verification shall be recorded;
b) be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded c) have

identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage. HMA Medical
Limited shall perform calibration or verification in accordance with documented procedures. In addition,
HMA Medical Limited shall assess and record the validity of the previous measuring results when the
equipment is found not to conform to requirements. HMA Medical Limited shall take appropriate action in
regard to the equipment and any product affected. Records of the results of calibration and verification shall
be maintained (see 4.2.5). HMA Medical Limited shall document procedures for the validation of the
application of computer software used for the monitoring and measurement of requirements. Such software
applications shall be validated prior to initial use and, as appropriate, after changes to such software or its
application. The specific approach and activities associated with software validation and revalidation shall be
proportionate to the risk associated with the use of the software, including the effect on the ability of the
product to conform to specifications. Records of the results and conclusion of validation and necessary
actions from the validation shall be maintained (see 4.2.4 and 4.2.5).
8 Measurement, analysis and improvement
8.1 General
HMA Medical Limited shall plan and implement the monitoring, measurement, analysis and improvement
processes needed
a) to demonstrate conformity of the product with customer’s requirements
b) to ensure conformity of the quality management system, and
c) to maintain the effectiveness of the quality management This shall include determination of applicable
methods, including statistical techniques, and the extent of their use.
8.2 Monitoring and measurement
8.2.1 Feedback
As one of the measurements of the performance of the quality management system, HMA Medical Limited
shall gather and monitor information relating to whether HMA Medical Limited has met customer
requirements. The methods for obtaining and using this information shall be documented. The methods for
obtaining and using this information shall be determined. HMA Medical Limited shall document procedures
for the feedback process. This feedback process shall include provisions to gather data from production as
well as post-production activities. The information gathered in the feedback process shall serve as potential
input into risk management for monitoring and maintaining the product requirements as well as the product
realization or improvement processes. If applicable regulatory requirements require HMA Medical Limited to
gain specific experience from post- production activities, the review of this experience shall form part of the
feedback process
8.2.2 Complaint handling
HMA Medical Limited shall document procedures for timely complaint handling in accordance with
applicable regulatory requirements. These procedures shall include at a minimum requirements and
responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the appropriate regulatory authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective actions. If any complaint is not investigated,
justification shall be documented. Any correction or corrective action resulting from the complaint handling
process shall be documented. If an investigation determines activities outside HMA Medical Limited
contributed to the complaint, relevant information shall be exchanged between HMA Medical Limited and the
external party involved. Complaint handling records shall be maintained (see 4.2.5).
8.2.3 Reporting to regulatory authorities

If applicable regulatory requirements require notification of complaints that meet specified reporting criteria
of adverse events or issuance of advisory notices, HMA Medical Limited shall document procedures for
providing notification to the appropriate regulatory authorities. Records of reporting to regulatory authorities
shall be maintained (see 4.2.5).
8.2.4 Internal audit
HMA Medical Limited shall conduct internal audits at planned intervals to determine whether the quality
management system:
a) conforms to planned and documented arrangements, requirements of this International Standard, quality
management system requirements established by HMA Medical Limited, and applicable regulatory
requirements;
b) is effectively implemented and maintained. HMA Medical Limited shall document a procedure to describe
the responsibilities and requirements for planning and conducting audits and recording and reporting audit
results. An audit program shall be planned, taking into consideration the status and importance of the
processes and area to be audited, as well as the results of previous audits. The audit criteria, scope, interval
and methods shall be defined and recorded (see 4.2.5). The selection of auditors and conduct of audits shall
ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. Records of
the audits and their results, including identification of the processes and areas audited and the conclusions,
shall be maintained (see 4.2.5). The management responsible for the area being audited shall ensure that any
necessary corrections and corrective actions are taken without undue delay to eliminate detected
nonconformities and their causes. Follow-up activities shall include the verification of the
8.2.5 Monitoring and measurement of processes
HMA Medical Limited shall apply suitable methods for monitoring and, as appropriate, measurement of the
quality management system processes. These methods shall demonstrate the ability of the processes to
achieve planned results. When planned results are not achieved, correction and corrective action shall be
taken, as appropriate.
8.2.6 Monitoring and measurement of product
HMA Medical Limited shall monitor and measure the characteristics of the product to verify that product
requirements have been met. This shall be carried out at applicable stages of the product realization process in
accordance with the planned and documented arrangements and documented procedures. Evidence of
conformity to the acceptance criteria shall be maintained. The identity of the person authorizing release of
product shall be recorded (see 4.2.5). As appropriate, records shall identify the test equipment used to perform
measurement activities. Product release shall not proceed until the planned and documented arrangements
have been satisfactorily completed.
8.3 Control of nonconforming product
8.3.1 General
HMA Medical Limited shall ensure that product which does not conform to product requirements is identified
and controlled to prevent its unintended use or delivery. HMA Medical Limited shall document a procedure
to define the controls and related responsibilities and authorities for the identification, documentation,
segregation, evaluation and disposition of nonconforming product. The evaluation of nonconformity shall
include a determination of the need for an investigation and notification of any external party responsible for
the nonconformity. Records of the nature of the nonconformities and any subsequent action taken, including
the evaluation, any investigation and the rationale for decisions shall be maintained (see 4.2.5)
8.3.2 Actions in response to nonconforming product detected before delivery
HMA Medical Limited shall deal with nonconforming product by one or more of the following ways: a)
taking action to eliminate the detected nonconformity;
b) taking action to preclude its original intended use or application;

c) authorizing its use, release or acceptance under concession. HMA Medical Limited shall ensure that
nonconforming product is accepted by concession only if the justification is provided, approval is obtained
and applicable regulatory requirements are met. Records of the acceptance by concession and the identity of
the person authorizing the concession shall be maintained (see 4.2.5).
8.3.3 Actions in response to nonconforming product detected after delivery
When nonconforming product is detected after delivery or use has started, HMA Medical Limited shall take
action appropriate to the effects, or potential effects, of the nonconformity. Records of actions taken shall be
maintained (see 4.2.5). HMA Medical Limited shall document procedures for issuing advisory notices in
accordance with applicable regulatory requirements. These procedures shall be capable of being put into
effect at any time. Records of actions relating to the issuance of advisory notices shall be maintained (see
4.2.5).
8.3.4 Rework
HMA Medical Limited shall not perform rework but reprocess in accordance with documented procedures
that takes into account the potential adverse effect of the reprocess on the product quality parameters. These
procedures shall undergo the same review and approval as the original procedure. After the completion of
rework, product shall be verified to ensure that it meets applicable acceptance criteria and regulatory
requirements. Records of rework shall be maintained (see 4.2.5).
8.4 Analysis of data
HMA Medical Limited shall document procedures to determine, collect and analyse appropriate data to
demonstrate the suitability, adequacy and effectiveness of the quality management system. The procedures
shall include determination of appropriate methods, including statistical techniques and the extent of their use.
The analysis of data shall include data generated as a result of monitoring and measurement and from other
relevant sources and include, at a minimum, input from:
a) feedback;
b) conformity to product requirements;
c) characteristics and trends of processes and product, including opportunities for improvement;
d) suppliers;
e) audits;
If the analysis of data shows that the quality management system is not suitable, adequate or effective, HMA
Medical Limited shall use this analysis as input for improvement as required in 8.5. Records of the results of
analyses shall be maintained (see 4.2.5).
8.5 Improvement
8.5.1 General
HMA Medical Limited shall identify and implement any changes necessary to ensure and maintain the
continued suitability, adequacy and effectiveness of the quality management system as well as medical device
safety and performance through the use of the quality policy, quality objectives, audit results, post- market
surveillance, analysis of data, corrective actions, preventive actions and management review.
8.5.2 Corrective action
HMA Medical Limited shall take action to eliminate the cause of nonconformities in order to prevent
recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be
proportionate to the effects of the nonconformities encountered. HMA Medical Limited shall document a
procedure to define requirements for:
a) reviewing nonconformities (including complaints);
b) determining the causes of nonconformities;

c) evaluating the need for action to ensure that nonconformities do not recur;
d) planning and documenting action needed and implementing such action, including, as appropriate,
updating documentation;
e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory
requirements or the safety and performance of the medical device;
f) reviewing the effectiveness of corrective action taken. Records of the results of any investigation and of
action taken shall be maintained (see 4.2.5).
8.5.3 Preventive action
HMA Medical Limited shall determine action to eliminate the causes of potential nonconformities in order to
prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.
HMA Medical Limited shall document a procedure to describe requirements for: a) determining potential
nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) planning and documenting action needed and implementing such action, including, as appropriate,
updating documentation;
d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or
the safety and performance of the medical device;
e) reviewing the effectiveness of the preventive action taken, as appropriate. Records of the results of any
investigations and of action taken shall be maintained (see 4.2.5)
This Quality Manual specifies requirements that Millennium uses to address customer satisfaction, to meet customer and
applicable regulatory and statutory requirements and to meet ISO 9001:2015 requirements, and is supported by additional
procedures where necessary.
1.2 SCOPE The Quality Manual applies to all Guerbet sites including all activities related to research, development,
manufacturing and distribution of all Guerbet products & services.
This Quality Manual specifies requirements that Millennium uses to address customer satisfaction, to meet customer and
applicable regulatory and statutory requirements and to meet ISO 9001:2015 requirements, and is supported by additional
procedures where necessary. The quality management principles stated in ISO 9000, and ISO 9004, have been taken into
consideration during the development of this Quality Policy Manual. This Quality Manual specifies the general requirements for
Millennium competence towards a management system for quality, administrative and technical operations. 1 Scope This
Quality Manual specifies requirements for a quality management system where Millennium: a) Needs to demonstrate its ability
to consistently provide product and services that meet customer and applicable statutory and regulatory requirements, and b)
Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of
the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the
requirements of this ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or
size, or the products and services it provides;
2 Normative References The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
ISO 9001:2015, Quality management systems — Fundamentals and vocabulary
2 Terms and Definitions For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
Adapting medical device manufacturing processes to the ISO 9001:2015 standard within a single quality manual involves
several key steps. Let’s break it down:
1. Quality Manual Structure:
o Begin by creating a comprehensive quality manual that encompasses all relevant aspects of your medical
device manufacturing processes.
o The quality manual should outline the organization’s quality management system (QMS) and serve as a
reference for employees, auditors, and stakeholders.
2. ISO 9001:2015 Requirements:
o Familiarize yourself with the ISO 9001:2015 standard. Understand its principles, requirements, and
structure.
o Key areas include context of the organization, leadership commitment, risk-based thinking, process
approach, and continual improvement.
3. Mapping ISO 9001:2015 Clauses:
o Identify the relevant clauses of ISO 9001:2015 that apply to medical device manufacturing.
o Map these clauses to specific sections or chapters within your quality manual.
4. Incorporate ISO 9001:2015 Elements:
o Address each ISO 9001:2015 requirement within the quality manual.
o Examples of elements to include:
 Quality Policy: Clearly state the organization’s commitment to quality.
 Context of the Organization: Describe the internal and external factors affecting your processes.
 Risk Management: Detail how risks are assessed and managed.
 Leadership and Commitment: Explain the roles and responsibilities of management.
 Process Approach: Describe how processes are defined, controlled, and monitored.
 Document Control: Specify procedures for document creation, approval, and revision.
 Training and Competence: Outline training requirements for employees.
 Product Realization: Cover design, production, and post-production activities.
 Monitoring and Measurement: Describe how performance is monitored and measured.
 Corrective and Preventive Actions: Explain procedures for addressing nonconformities.
 Internal Audits: Detail the audit process.
 Management Review: Discuss periodic reviews by top management.
5. Single Quality Manual:
o Consolidate all ISO 9001:2015-related content into a single quality manual.
o Ensure clear cross-references between sections to maintain coherence.
o Use a logical structure that aligns with the ISO 9001:2015 framework.
6. Document Control and Versioning:
o Clearly indicate the version of the quality manual and track revisions.
o Ensure that all employees have access to the most up-to-date version.
7. Training and Awareness:
o Train employees on the quality manual’s content and ISO 9001:2015 requirements.
o Foster awareness of the QMS throughout the organization.
Remember that ISO 9001:2015 emphasizes a process-based approach, risk management, and continual
improvement. Regularly review and update your quality manual to reflect changes in processes, regulations, and
organizational context12345.
Learn more
1flukebiomedical.com2qualitiso.com3fda.gov4cdn.who.int5meddeviceonline.com
Let’s chat
 What are the benefits of ISO 9001:2015 certification?

 How can I ensure effective implementation across all departments?
 Can you provide an example of a risk-based approach in medical device
HOW THE ISO 9001:2015 REVISION AFFECTS MEDICAL DEVICE COMPANIES

The 2015 revision of the ISO 9001 quality standard contains fundamental changes to the structure
and contents of the standard and offers a preview of some revisions to ISO 13485 expected in the
coming year.
November 4, 2015
4 Min Read
The 2015 revision of the ISO 9001 quality standard contains fundamental changes to the structure
and contents of the standard and offers a preview of some revisions to ISO 13485 expected in the
coming year.
Walt Murray
(click to enlarge)
ISO recently published quality management system (QMS) standard ISO 9001:2015. As a result,
regulated companies with or that are seeking ISO 9001 certification now have three years to meet
the QMS requirements in the 2015 edition of the standard.
Hear Walt Murray discuss the keys to rock-solid risk assessment in a conference session at MD&M
Minneapolis on September 21, 2016.
The 2015 version follows a new, higher-level structure developed by ISO to ensure that
management system standards are aligned with a set of common requirements. All ISO
management system standards are now required to adopt the structure, with the purpose of
making it easier for organizations to address the requirements of more than one ISO management
system standard within a single, integrated system.
 Additional key changes in ISO 9001:2015 include the following:

 Greater emphasis on risk-based thinking as a basis for the management system.
 Fewer prescriptive requirements.
 Increased emphasis on organizational context.
 Major focus on achieving value for the organization and its customers.
 More flexibility regarding documentation.
 Enhanced leadership involvement in the management system.
One of the key changes in the 2015 revision is an explicit requirement for risk-based thinking to
support and improve the understanding and application of the process approach. In fact, risk is
covered in nearly every section of ISO 9001:2015, and there are considerable changes to the
application of risk.
Risk-based thinking makes preventive action part of strategic and operational planning, so
reference to preventive action has been replaced with "actions to address risks and opportunities"
in ISO 9001:2015. The standard now requires that organizations and top management identify--
from a risk-management perspective--and address any internal and external factors that may
affect their QMS's ability to deliver intended results to customer requirements.
ISO 9001:2015 Helps Forecast Forthcoming ISO 13485 Changes
The updated standard directly affects all kinds of manufacturing organizations, including medical
device manufacturers. The changes also have implications for other standards, including ISO
13485, which outlines QMS requirements for medical devices.
For medical device manufacturers, the publication of ISO 9001:2015 offers something of a
preview of forthcoming revisions to ISO 13485, as corresponding changes are expected to follow.
ISO 13485 is often harmonized with ISO 9001. Whereas ISO 9001 can be used by any company
within any industry sector, ISO 13845 is tailored specifically to medical device companies.
Currently, ISO is in the process of finalizing draft international standard (DIS) ISO 13485:201X,
which is expected to shift to a similar orientation as 9001:2015. Medical device companies will
then have three years to transition to the new ISO 13485.
As such, ISO 9001:2015 can help medical device manufacturers anticipate some changes that will
eventually be reflected in the ISO 13485 standard. For instance, the final ISO 9001:2015 standard
and the DIS of 13485 have increased representation of risk.
Like the final ISO 9001:2015, the DIS of ISO 13845 places significant emphasis on risk
management and stating that a risk-based approach is needed when developing processes.
Preventative maintenance is not enough. Anything the medical device company does that affects
the QMS must be viewed from a risk perspective. It requires device manufacturers, as well as
their subtier suppliers and contractors, to apply risk management and risk analysis from product
development through product realization.
Like ISO 9001:2015, when processes are outsourced, the DIS of ISO 13485 wants organizations
to look at controls from a risk perspective. If a supplier fails to meet specifications, how will that
affect the organization's quality system?
Risk is further emphasized in a number of other areas of the DIS of ISO 13485, including human
resources. If an employee is incompetent, what are the risks to quality?
For medical device manufacturers providing life-enhancing products, there are risks in all
systems, processes, and functions. That is why in the medical device industry, where safety to the
patient and consumer is paramount, risk management is a critical part of all processes.
With both ISO 9001:2015 and DIS ISO 13845 emphasizing a more risk-based view of the entire
quality system, medical device manufacturers should be working now on incorporating the
concepts of risk management and risk-based thinking to ensure that risk is considered from the
beginning and throughout the quality system.
Walt Murray is director of quality and compliance consulting services at MasterControl. Reach
him at [email protected]. To learn more, check out MasterControl's three-part webinar
series on preparing for ISO 9001:2015 changes or hear Murray speak about process validation
planning at the MD&M West Conference.
Certainly! A Quality Manual is a crucial document that outlines an organization’s approach to quality management. It
provides insights into how the company meets the requirements of ISO standards and ensures the consistent delivery of
products and services.
Here are a couple of options for obtaining a sample Quality Manual that aligns with both ISO 13485:2016 (specifically for
medical devices) and ISO 9001:2015 (for general quality management):
1. Qualitio’s Quality Manual Template:
o Qualitio offers a free template for a Quality Manual that conforms to the requirements of Regulation (EU)
2017/745 (Medical Device Regulation) and EN ISO 13485:2016 + A11:2021.
o The template can be customized according to your organization’s activities and products.
o It covers essential sections such as general information, organization details, regulatory roles, and more.
o You can find the template here1.
2. Advisera’s ISO 13485 Quality Manual:
o Advisera provides a Quality Manual specifically optimized for small and medium-sized organizations.
o It demonstrates the organization’s capability to consistently provide products and services that meet
customer requirements.
o While it focuses on ISO 13485, it can be adapted to include ISO 9001 elements as well.
o You can explore this template here2.
Remember that these templates serve as starting points, and you should tailor them to your organization’s unique context,
processes, and products. 📄✨

Learn more
1 qualitiso.com2 advisera.com3 complianceonline.com4 prodres.com
Let’s chat
 What is the difference between ISO 13485 and ISO 9001?

 How do I implement a Quality Manual in my organization?
 Are there any other templates available for free?
Adapting both a pharmaceutical manufacturing site and a medical device manufacturing site of the same
company under the ISO 9001:2015 Quality Management System requires a strategic approach. Let’s
explore some steps to achieve this:
1. Integrated Quality Management System (QMS):
o Establish an integrated QMS that encompasses both pharmaceutical and medical device manufacturing.
o Ensure alignment with ISO 9001:2015 requirements, emphasizing quality, risk management, and
continuous improvement.
2. Risk Assessment and Gap Analysis:
o Conduct a thorough risk assessment and gap analysis for both sites.
o Identify gaps between existing processes and ISO 9001:2015 requirements.
o Prioritize areas for improvement based on risk and criticality.
3. Standardization and Harmonization:
o Standardize quality processes across both sites.
o Harmonize documentation, procedures, and work instructions.
o Ensure consistency in quality practices, audits, and inspections.
4. Training and Competency:
o Train employees on ISO 9001:2015 principles and requirements.
o Enhance their understanding of quality management.
o Ensure competency in quality-related roles.
5. Document Control and Records Management:
o Maintain accurate records for both pharmaceutical and medical device manufacturing.
o Ensure version control and accessibility.
o Evaluate suppliers jointly for both sites.
o Assess their compliance with ISO 9001:2015.
o Monitor supplier performance and address any deviations.
7. Process Validation and Verification:
o Validate critical processes and equipment.
o Verify product quality through testing, inspection, and validation.
o Align validation protocols across both manufacturing sites.
8. Audits and Corrective Actions:
o Conduct internal audits regularly.
o Address non-conformities promptly.
o Implement corrective and preventive actions (CAPAs) consistently.
9. Continuous Improvement:
o Foster a culture of continuous improvement.
o Use data-driven approaches (e.g., Six Sigma, Lean) to enhance processes.
o Monitor key performance indicators (KPIs) for both sites.
10. Management Review:
o Regularly review the QMS performance.

o Involve top management from both pharmaceutical and medical device divisions.
o Make informed decisions based on data and feedback.
Remember that successful adaptation requires collaboration, clear communication, and commitment from all
stakeholders. By aligning both sites under a unified ISO 9001:2015 QMS, your company can achieve
consistent quality and regulatory compliance1
How can we adapt a pharmaceutical manufacturing site and medical device manufacturing site of the same company
under ISO 9001: 2015 Quality Management System??
Copilot
o Establish an integrated QMS that encompasses both pharmaceutical and medical device
manufacturing.

consistent quality and regulatory compliance1.
Learn more
1mckinsey.com2freyrsolutions.com3americanpharmaceuticalreview.com4tulip.co
You
How do we handle conflicting requirements between pharmaceutical and medical device regulations?
Copilot
Handling conflicting requirements between pharmaceutical and medical device regulations can be complex,
but it’s crucial for maintaining compliance and ensuring patient safety. Let’s explore some strategies to
address these conflicts:
1. Understand the Differences:
o Pharmaceuticals and medical devices have distinct regulatory frameworks. Pharmaceuticals are
typically regulated under drug-specific guidelines, while medical devices fall under separate directives
or regulations1.
o Learn the nuances of each set of regulations to identify potential conflicts.
2. Risk Assessment:
o Conduct a comprehensive risk assessment to identify areas where requirements may clash.
o Prioritize addressing high-risk conflicts that could impact patient safety or product quality.
3. Cross-Functional Collaboration:
o Establish a cross-functional team comprising experts from both pharmaceutical and medical device
domains.
o Foster open communication to discuss conflicts and find common ground.
4. Harmonization Efforts:
o Seek opportunities for harmonization between the two sets of regulations.
o Identify areas where alignment is feasible without compromising safety or efficacy.
5. Gap Analysis:
o Perform a gap analysis to compare existing processes against both pharmaceutical and medical device
requirements.
o Address gaps by developing integrated procedures or modifying existing ones.
6. Documentation and Training:
o Create clear and concise documentation that outlines how conflicting requirements are resolved.
o Train employees on handling these conflicts during their day-to-day work.
7. Risk-Based Decision-Making:
o When conflicts arise, use a risk-based approach to make decisions.
o Consider factors such as patient impact, regulatory consequences, and business implications.
8. Regulatory Intelligence:
o Stay informed about regulatory updates for both pharmaceuticals and medical devices.
o Monitor changes and adapt your processes accordingly.
o Integrate pharmaceutical and medical device requirements into a unified QMS.
o Ensure that the QMS addresses both sets of regulations effectively.
o Conduct regular internal audits to assess compliance with conflicting requirements.
o Prepare for external inspections by regulatory authorities.
Remember that transparency, communication, and adherence to patient safety are paramount. Seek legal
advice when necessary and collaborate with regulatory experts to navigate these challenges 21.
Learn more
1 rcpjournals.org2 arnoldporter.com3 lifesciences.enago.com4 ema.europa.eu5 ema.europa.eu6
cambridge.org7 compliancecosmos.org8 hbr.org9 journalofethics.ama-assn.org10

doi.org+6 more
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 Can you provide examples of specific conflicting requirements?

 How do we prioritize conflicts when resources are limited?
Copilot
manufacturing.

Learn more
You
Copilot
or regulations1.
2. Risk Assessment:
domains.

5. Gap Analysis:
requirements.
Learn more

doi.org+6 more
You
Can you provide examples of specific conflicting requirements?
Copilot
Certainly! Let’s delve into some specific examples of conflicting requirements between pharmaceutical and
medical device regulations:
1. Drug-Eluting Stents:
o These are medical devices used in cardiology to treat coronary artery disease.
o The pharmaceutical component involves the drug coating on the stent, which affects drug release
kinetics.
o The medical device component includes stent design, material, and mechanical properties1.
2. Bone Cement Containing an Antibiotic:

o Bone cement is used in orthopedic surgeries, especially joint replacements.
o The pharmaceutical aspect relates to the antibiotic’s efficacy and safety.
o The medical device aspect involves cement properties, such as viscosity and setting time1.
3. Catheters Coated with Heparin or Antibiotics:

o Catheters are both medical devices and drug delivery systems.
o The pharmaceutical component focuses on the drug coating (heparin or antibiotics).
o The medical device component considers catheter design, biocompatibility, and insertion technique 1.
4. Condoms Coated with Spermicides:

o Condoms are medical devices used for contraception.
o The pharmaceutical aspect involves spermicidal agents.
o The medical device aspect includes material quality, size, and effectiveness1.
5. Pre-Filled Syringes and Pre-Filled Pens:

o These are used for drug administration (e.g., insulin).
o The pharmaceutical component relates to drug stability, compatibility, and dosing accuracy.
o The medical device component includes syringe design, needle quality, and ease of use2.
6. Tablet Delivery Systems with Controllers for Pain Management:

o These combine drug delivery and medical device technology.

o The pharmaceutical aspect involves drug formulation and release.
o The medical device aspect includes the controller, sensors, and patient interface2.
Remember that addressing these conflicts requires collaboration, risk assessment, and adherence to both sets
of regulations. Balancing safety, efficacy, and compliance is essential for successful product development and
patient well-being12.
Learn more
1 ema.europa.eu2 ema.europa.eu3 rcpjournals.org4 md.sunflare.com5 ema.europa.eu6 arn
oldporter.com7 policymed.com8 mpo-mag.com9 media.gettyimages.com10

media.gettyimages.com+6 more
3of30
Copilot
manufacturing.

Learn more
You
Copilot
or regulations1.
2. Risk Assessment:
domains.
5. Gap Analysis:
requirements.
Learn more

doi.org+6 more
You
Copilot
kinetics.







Learn more

You
How do companies typically resolve these conflicts during product development?
Copilot
During product development, companies employ several strategies to resolve conflicts arising from the
intersection of pharmaceutical and medical device regulations. Let’s explore some common approaches:
o Companies assess risks associated with conflicting requirements.
o Prioritize actions based on risk severity and potential impact on patient safety.
o Decisions are guided by a balance between regulatory compliance and patient well-being.
o Establish cross-functional teams comprising experts from regulatory affairs, quality assurance, R&D,
and clinical affairs.
o Foster open communication to address conflicts effectively.
o Seek consensus on solutions that align with both sets of regulations.
3. Harmonization and Alignment:

o Identify areas where harmonization is feasible.
o Develop integrated processes that satisfy both pharmaceutical and medical device requirements.
o Align documentation, testing protocols, and validation procedures.
4. Customized Solutions:
o Tailor solutions for specific products.
o For combination products (e.g., drug-eluting stents), design unique approaches that meet both
aspects.
o Consider individual context and risk profiles.
o Stay informed about evolving regulations.
o Monitor updates from health authorities (FDA, EMA, etc.).
o Adapt strategies accordingly to maintain compliance.
6. Documentation and Traceability:
o Maintain clear records of decisions made during conflict resolution.
o Document rationale, risk assessments, and mitigations.
o Ensure traceability for audits and inspections.
7. Legal and Regulatory Expertise:
o Consult legal counsel and regulatory experts.
o Seek their guidance on interpreting conflicting requirements.
o Understand implications and explore viable options.
8. Clinical Studies and Post-Market Surveillance:
o Conduct robust clinical studies.
o Monitor real-world performance post-launch.
o Address any emerging conflicts promptly.
o Integrate both sets of requirements into a unified QMS.
o Ensure that quality processes cover all aspects.
o Regularly review and update the QMS.
10. Transparency with Regulators:
o Engage in open dialogue with regulatory agencies.
o Seek pre-submission meetings or guidance.
o Demonstrate efforts to comply while managing conflicts.
Remember that patient safety, product efficacy, and regulatory compliance are paramount. Companies
must navigate these challenges with diligence and a commitment to delivering safe and effective healthcare
products .
4of30
Copilot
manufacturing.

Learn more
You
Copilot
or regulations1.
2. Risk Assessment:
domains.

5. Gap Analysis:
requirements.
Learn more

doi.org+6 more
You
Copilot
kinetics.






Learn more

You
How do companies typically resolve these conflicts during product development?
Copilot
During product development, companies employ several strategies to resolve conflicts arising from the
intersection of pharmaceutical and medical device regulations. Let’s explore some common approaches:
o Companies assess risks associated with conflicting requirements.
o Prioritize actions based on risk severity and potential impact on patient safety.
o Decisions are guided by a balance between regulatory compliance and patient well-being.
o Establish cross-functional teams comprising experts from regulatory affairs, quality assurance, R&D,
and clinical affairs.
o Foster open communication to address conflicts effectively.
o Seek consensus on solutions that align with both sets of regulations.
3. Harmonization and Alignment:
o Identify areas where harmonization is feasible.
o Develop integrated processes that satisfy both pharmaceutical and medical device requirements.
o Align documentation, testing protocols, and validation procedures.
4. Customized Solutions:
o Tailor solutions for specific products.
o For combination products (e.g., drug-eluting stents), design unique approaches that meet both
aspects.
o Consider individual context and risk profiles.
o Stay informed about evolving regulations.

o Monitor updates from health authorities (FDA, EMA, etc.).
o Adapt strategies accordingly to maintain compliance.
6. Documentation and Traceability:
o Maintain clear records of decisions made during conflict resolution.
o Document rationale, risk assessments, and mitigations.
o Ensure traceability for audits and inspections.
7. Legal and Regulatory Expertise:
o Consult legal counsel and regulatory experts.
o Seek their guidance on interpreting conflicting requirements.
o Understand implications and explore viable options.
8. Clinical Studies and Post-Market Surveillance:
o Conduct robust clinical studies.
o Monitor real-world performance post-launch.
o Address any emerging conflicts promptly.
o Integrate both sets of requirements into a unified QMS.
o Ensure that quality processes cover all aspects.
o Regularly review and update the QMS.
10. Transparency with Regulators:
o Engage in open dialogue with regulatory agencies.
o Seek pre-submission meetings or guidance.
o Demonstrate efforts to comply while managing conflicts.
Remember that patient safety, product efficacy, and regulatory compliance are paramount. Companies
must navigate these challenges with diligence and a commitment to delivering safe and effective healthcare
products .
You
Can you provide examples of companies successfully resolving such conflicts?
Copilot
Certainly! Here are examples of companies that have successfully navigated conflicting requirements
between pharmaceutical and medical device regulations:
1. Johnson & Johnson (J&J):
o J&J, a multinational healthcare company, has effectively resolved conflicts in their combination
products.
o Their drug-eluting stents (medical devices) incorporate pharmaceutical components (drug coatings).
o By harmonizing processes, conducting rigorous testing, and collaborating with regulatory agencies,
J&J ensures compliance while maintaining patient safety.
2. Novartis:
o Novartis, a pharmaceutical giant, faced challenges with combination products like inhalers.
o Their solution involved close collaboration between pharmaceutical and device teams.
o They aligned documentation, conducted joint risk assessments, and implemented a robust QMS.
3. Medtronic:
o Medtronic, a leader in medical devices, resolved conflicts related to insulin pumps.
o Their integrated approach considered both drug delivery (pharmaceutical) and device functionality.
o By addressing design, usability, and regulatory requirements, Medtronic achieved successful product
launches.
4. Abbott Laboratories:
o Abbott, known for diagnostic devices and pharmaceuticals, tackled conflicts in point-of-care testing.
o Their glucose monitoring systems combine device technology with reagents (pharmaceuticals).
o They customized validation protocols, trained staff, and maintained transparency with regulators.
5. Roche Diagnostics:
o Roche faced challenges with diagnostic kits that include reagents (pharmaceuticals) and instruments
(medical devices).
o Their strategy involved risk-based decisions, cross-functional teams, and robust post-market
surveillance.
o Roche’s commitment to quality and compliance ensures reliable diagnostic results.
Remember that these examples highlight successful approaches, but each company’s context and products
vary. Adaptability, collaboration, and patient-centric focus are key to resolving conflicts effectively.
You
How did these companies manage conflicting requirements during regulatory submissions?
Copilot
Certainly! Let’s explore how these companies managed conflicting requirements during regulatory
submissions:
1. Johnson & Johnson (J&J):
o Approach: J&J established a cross-functional team comprising regulatory experts, quality assurance
professionals, and R&D specialists.
o Strategy:
 Conducted thorough risk assessments to identify potential conflicts.
 Developed customized solutions for drug-eluting stents (combining pharmaceutical and
medical device aspects).
 Documented decisions, risk mitigations, and harmonized processes.
 Engaged in transparent communication with regulatory agencies during submissions.

2. Novartis:
o Approach: Novartis recognized the need for alignment between pharmaceutical and device
requirements.
o Strategy:
 Collaborated closely between pharmaceutical and device teams.
 Addressed gaps through joint risk assessments.
 Integrated documentation and harmonized procedures.
 Demonstrated compliance while ensuring patient safety.
3. Medtronic:
o Approach: Medtronic focused on insulin pumps, a combination product.
o Strategy:
 Balanced drug delivery (pharmaceutical) and device functionality.
 Customized validation protocols to meet both sets of requirements.
 Trained staff on handling conflicts.
 Prepared comprehensive regulatory submissions.
4. Abbott Laboratories:
o Approach: Abbott faced challenges with point-of-care testing.
o Strategy:
 Developed glucose monitoring systems (device combined with reagents).
 Addressed design, usability, and regulatory aspects.
 Maintained clear documentation and traceability.
 Collaborated with regulators proactively.
5. Roche Diagnostics:
o Approach: Roche dealt with diagnostic kits involving reagents and instruments.
o Strategy:
 Utilized risk-based decision-making.
 Formed cross-functional teams.
 Ensured robust post-market surveillance.
 Prioritized patient safety and compliance.
In summary, these companies navigated conflicting requirements by emphasizing collaboration, risk

assessment, and adherence to both pharmaceutical and medical device regulations. Their success lies in a
patient-centric approach and effective communication with regulatory bodies .
6of30

SIMPLIFYING FINISHED PRODUCT MANUFACTURER

SITE TRANSFER VARIATIONS
Sunday, October 1, 2023
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Valeria Grigoriev- Senior Regulatory Affairs Specialist, Arriello.
The COVID-19 pandemic highlighted the scale of the risk of breaks in medicines supply, causing regulators to issue new
manufacturer/MAH recommendations. One change in the EU is the transition to the more streamlined ICH Q12 PACMP protocol,
designed to support greater agility and innovation in medicines supply by making it easier to manage production site changes.
Arriello’s Valeria Grigoriev looks more closely at the benefits of the new protocol, and what’s involved in using the new framework
for post-approval change management linked to finished product manufacturing sites.
High-profile events ranging from Brexit in the UK, the global COVID-19 pandemic, blockages in the Suez Canal, and the war in
Ukraine, to the turbulent worldwide economy currently, have driven home the importance of shoring up medicinal supplies, as
breaks in supply have resulted in visible shortages of critical products ranging from vaccines to antibiotics to hormone replacement
therapies (HRT).
The latest statistics from the Pharmaceutical Group of the European Union (PGEU), which tracks drug shortages year on year,
found that all 29 responding countries had experienced medicine shortages in 2022, which for more than three-quarters had
worsened from the previous year. As just one example, Spain identified 140% more shortages in 2022 compared to 2021.
Cardiovascular, respiratory system, and nervous system medications, and anti-infectives for systemic use are the most common
drug classes in short supply.

Four countries reported the death of patients due to medicine shortages, and 18 proposed sourcing the same medicine from
alternative authorized sources as a legal solution for covering gaps in supply. This required the regulatory submission of finished
product manufacturing site transfer variations.
Recognizing the need to secure pharma supply chains, and as part of wider drives to streamline the path of drugs to market,
regulators are working toward new approaches to bringing new manufacturing sites online more swiftly, without cutting corners
and potentially introducing quality or safety concerns.
Specific new measures under the International Council for Harmonization (of Technical Requirements for Pharmaceuticals for
Human Use) guideline Q12 include the Post-Approval Change Management Protocol (PACMP). This aims to simplify the process
of registering site changes under certain criteria, through an emphasis on gaining accelerated upfront feedback from the Regulator
before detailed submissions are compiled. Already, to date, this has been seen to reduce the approval cycle by up to six months.
So, what’s involved under this protocol, and in using the new framework for post-approval change management linked to finished
product manufacturing sites?
Current Challenges with Traditional CMC Variations Management Protocols

The established approach to site-related changes can become mired in complexity, especially if there is a cluster of interrelated
changes that, ideally, would be handled simultaneously with the Regulator – e.g., changes that go beyond the addition of a new
manufacturing site. This take on CMC variations management sets out various pathways for the different types of change-related
submissions, each with its own set of expectations and expected timelines.
That the likelihood of and timeframes for approvals are difficult to predict can prevent MAHs from moving as nimbly as they might
like with finished product manufacturing site transfer. This, in turn, can present a risk to sustainable product supply – and indeed
the rollout of important and innovative new therapies and treatments. Because the outcome of the approvals process isn’t ultimately
known until the end, which could be many months down the line, there is a temptation for MAHs to be overly thorough in their
submissions, to maximize their chances of a good outcome.
ICH Q12 PACMP: Streamlining Site Transfer Approvals

The ICH Q12 guideline provides a globally harmonized framework to facilitate the management of post-approval CMC changes in
a more transparent, predictable, and efficient manner across the product lifecycle. It introduces regulatory mechanisms such as
established conditions (ECs), product lifecycle management (PLCM), and the post-approval change management protocol
(PACMP) to simplify and speed up post-approval change implementation and to encourage continuous product improvement.
The main aim is to provide greater opportunities for an increased science- and risk-based approach for assessing changes, with a
view to greater flexibility in managing post-approval changes. This, in turn, is designed to promote manufacturing innovation and
ongoing incremental improvements, while allowing regulatory authorities to better understand companies’ pharmaceutical quality
systems (PQSs).
Specifically, PACMP allows MAHs to first have their variation strategy approved, and then the agreed supportive data evaluated. In
practice, this can cut approval timescales by around six months, because Applicants can confidently collate the information needed,
knowing that their site change submission strategy is on the right track.
The Evolution of PACMP

As a concept, the PACMP is more than a decade old, used for post-approval filings in the US and EU, having been first introduced
as a means for MAHs to keep a running record describing all changes planned during the lifecycle of the medicinal product. Under
ICH Q12, the harmonized international protocol presents a comprehensive plan for assessing the effect of a proposed change, or
multiple (related and consequential) CMC-only post-approval changes, on the quality of a product – e.g., its identity, strength,
purity, potency, performance, and/ or stability.

The protocol describes specific quality change(s) that the Applicant would like to implement during the lifecycle of a product and
how the impact can be verified. Based on product process understanding, and a risk assessment of the potential impact of the
change on the quality of the product, a PACMP would include studies, specific tests, and the acceptance criteria that demonstrate
the lack of negative impact of the proposed CMC changes on the factors mentioned above.
The main parameters of PACMP are as follows:
 CMC changes only: PACMP-based submissions are not supported where non-CMC data including non-clinical, clinical,
and/or immunogenicity data would be required to support the change.
 Type of products: PACMPs can be applied to all product types, i.e., small and large molecules, including vaccines.
 A clear, two-step approach to the regulator’s assessment of any changes:
» Early step 1: evaluation of the strategy for the change(s).
» Step 2: separate evaluation of the data produced, based on the agreed strategy.
Geographical Applicability
Although relatively new in its current format, the PACMP tool presented in the ICH Q12 guideline is aligned with FDA
Comparability Protocols, as used in the US since 2003. The European Medicines Agency (EMA) was the first global Health
Authority to employ ICH Q12 in January 2020, with implementation guidance authorized in March 2020. Yet, as the Regulatory
framework invariably supersedes scientific and technical regulations, full integration in the EU legislative system is restricted at this
point.
Post Brexit, the UK has not provided any specific advice on the implementation of Q12 guidance. Swissmedic applies the ICH Q12
guideline, with restrictions concerning ECs and the PLCM document to all applications submitted from 1 April 2020 onwards.
Japan’s PACMP pilot program started in April 2018, while China and Taiwan are in the process of implementing the ICH Q12
guideline. Singapore, South Korea, and Brazil have not yet implemented the guidelines. Canada’s ICH Q12 Pilot Program - the ICH
Q12 Established Conditions and Post Approval Change Management Protocol Pilot Program - started in December 2021.
Traditional Variations Process or PACMP?

Ultimately, if toxicological and/or clinical data are not required as a result of the site changes being proposed, PACMP could well
be the way to go.
The best advice for MAHs looking to streamline their own processes, improve efficiency, mitigate supply risk, and shorten the time
to market via new facilities, is to embrace this simplified new process sooner rather than later.
Author Biography
Valeria Grigoriev is a Senior Regulatory Affairs Specialist at Regulatory Affairs service provider Arriello. Her experience spans
Research and Development and Project Management for different types of submissions, from initial Due Diligence to Approval,
across Europe, for regulatory activities including new MAA and Variations (National, DCP, and MRP).
Arriello is at the forefront of ICH Q12/PACMP-based finished product manufacturer site transfer variations management. Over the
two years to March 2023, the company catered for up to 50 finished product manufacturing site transfer variations, both national
and MRP applications, with submissions successfully performed across the EU and Eastern Europe.
valeria.grigoriev@arriello.com, https://arriello.com/
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HMA MEDICAL LTD Page 1 of 86

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

HMA MEDCAL LIMITED

INTEGRATED QUALITY MANUAL

QUALITY MANAGEMENT SYSTEM

IN LINE WITH ISO 9001:2015 & 13485:2016

FUNCTION NAMES POSITION SIGNATURE DATE

B. QUALITY POLICY STATEMENT

1.0 COMPANY PROFILE

1.1 HMA Medical Organization and Activities

1.3 Our Products

 Deleject 5ML disposable Hypodermic Needle and syringe

 Deleject 2ML disposable Hypodermic Needle and syringe

 Deleject 21G X 11/2’’disposable hypodermic Needle

 Deleject 23G X 11/4’’disposable hypodermic Needle

 Deleject 22G X 11/4’’disposable hypodermic Needle

 Deleject 18G X 11/2’’disposable hypodermic Needle

 Deleject 10ML disposable Hypodermic Needle and syringe

 Pharmaceuticals (intravenous fluid) under the brand name DELE FLUIDS

 4.3%w/v Dextrose saline

 Mannitol 20% w/v

1.4 Our core values are:

F. ORGANOGRAM OF THE COMPANY

1.7 Quality Manual:

Justification: HMA Medical Limited does not install product.

 Exclusion : ISO 13485 (2016) Section 7.5.4

Justification: HMA Medical Limited does not install product.

 Exclusion : ISO 13485 (2016) Section 7.5.4

1 bsigroup.com2 medical-device-regulation.eu3 13485store.com4 bsigroup.com5

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 Can you provide an example of a combined process?

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 How do companies manage shared processes across global manufacturing sites?

How can pharmaceutical companies adapt ISO 13485 principles?

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 What are the benefits of ISO 9001:2015 certification?

1.1 Terms and Definitions

1.2 Normative References:

 GHTF/SG3/N17:2008: Quality Management System – Medical Devices – Guidance on the Control of

4.0 Quality Management System

4.1 General requirements

d)establish systems to monitor, measure as appropriate, and analyses these processes;

a) An evaluation of the proposed impact upon the Quality Management System;

4.2 Documentation requirements

a) documented statements of a Quality Policy and Quality Objectives,

c) documented procedures required by ISO 13485,

e) other documentation specified by applicable regulatory requirements

Quality Policy SYSTEM DOCUMENTATION

Procedures or Work Instructions

Reference Documentation and Quality Records

4.2.2 Quality manual

Continual Improvement of the quality management system

Customers Resource Measurement,

Requirements input Product

Realization Product output

Key: information flow

Figure 1- Model of a process-based quality management system

4.2.3 Medical device file

b) specifications for the product including appropriate customer specifications;

d) procedures for measuring and monitoring.

e) packaging, storage, labelling and distribution specifications;

f) Acceptance criteria for the products provided by the customer;

4.2.4 Control of documents