Quality Manual

1. Purpose 

This document provides the Quality Manual.

The purpose of the procedure is to ensure that all aspects of the Quality System and regulatory consequences of the system, infrastructure, environment, procedures and/or regulatory requirements are considered and addressed in the event of a change in compliance of ISO13485

2. Approval

(Version at end of page)

Author Signed V15 HM 27.10.2025

3. Scope

The system covers the medical device ISO13485 quality management for medical device distribution and Sale in compliance with regulatory requirements. (ISO9001)

4. References

ISO13485:2016 (in some areas ISO9001:2016 has been included)

www.sahpra.org.za regulations, guidelines and forms

http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en 

https://www.fda.gov/medicaldevices/

5. Definitions and Abbreviations

Client – this can be the customer, sponsor or agent that establishes a contract or agreement

Principal – Legal manufacturer of imported goods

Contractor – a subcontract with a party to perform activities within the project

MD – Managing Director

SOP – Standard Operating Procedure

GMP – Good Manufacturing Practice

NCCA – Non Conformance Corrective Action 

QMS - Quality Management System

6. SAHPRA REQUIREMENTS

7. Exclusions and Not Applicable

7.3 Design and Development - excluded as the company is not a manufacturer, 

7.5.3 & 4 Installation & Servicing activities  - not applicable as not part of the operations

7.5.5 Particular requirements for sterile medical device - not applicable as not the manufacturer of sterile products, 

7.5.6. Validation of processes for production and service provision - not applicable as the company is not a manufacturer, 

7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems - not applicable as not the manufacturer of sterile products,  

7.5.10 Customer property - not applicable as not part of the operations

8. Quality Management System (4) 

Understanding the Organization and its Context 

In reference to ISO9001:2015 (4.1; The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues.

The organizational context refers to the scope of an entity, such as; parent organization (organization owning one or more entities) enterprise (an entire organization) division or department (a sub-organization within the overall organization) work unit (a sub-sub-organization)

Organisation context is:

• Applications of tenders to government and private sectors

• Importer and Agent / distributor of imported goods such as medical devices

• Sales and delivery of medical devices to healthcare practitioners

• Decontamination of Loan sets 

8.1 Business Purpose and Strategy

To sell and distribute safe and performing medical devices and providing high-standard medical devices to both the private and public healthcare sector and listening to our customers to and building first-class relationships to help us provide excellent standards of service and client satisfaction.

Scope of the QMS 

The organisation;

a) determines the inputs required and the outputs expected from these processes; the process, interactions and sequences refer process flow

 b) determines the sequence and interaction of these processes – refer point a)

 c) determines and apply the criteria and methods needed to ensure that both the operation and control of these processes are effective refer QMS audits,

 d) determines the resources and ensure the availability of resources and information necessary to support the operation and these processes, and assign the responsibilities and authorities for these processes (refer Resources SOP)

 e) addresses the risks and opportunities; monitor, measure and analyse these processes, and (refer Risk SOP)

f) implement actions necessary to achieve planned results and maintain the effectiveness of processes and evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results.

 g) improves the processes and the quality management system.

Control of Changes

(4.1.4)  The company through Change Control SOP review and control changes for the Quality Management System (QMS), production or service provision and Processes, to the extent necessary to ensure continuing conformity with requirements and retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

Understanding the Needs and Expectations of Interested Parties

 In reference to ISO9001 (4.2), due to their effect or potential effect on the organization's ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; Interested parties are;

· The Regulator (SAHPRA) – Organization licence to manufacture, import and distribute, Product registration

 · Principals (the legal manufacturer of imported goods) – compliance with the declaration of conformity for intended purpose,

 · Hospital Groups, Healthcare Professionals, patients – quality and performing products and communication on products, adverse incidents and post-market surveillance,

 · SABS - Standards South Africa – Compliance to standards as applicable,

 · Department of Health, NDoH – Regulatory and Technical compliance and

 · Medical aids and their administrators e.g. Discovery, Medscheme, MSO, Metropolitan Health - regulatory and technical compliance

Conformity Assessment bodies 

8.2 Quality Management Arrangement

8.2.1 Outsourced Activities 

(ISO13485) 4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it monitors and ensures control over such processes. The organization  retains responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls are proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4 External providers / Purchasing . The controls are included written quality agreements; and sometimes purchasing information.  

(refer PIC GMP chapter 7) There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the roles and responsibilities of each party. The Pharmaceutical Quality System of the Contract Giver must clearly state the way that the Authorised Person certifying each batch of product for release exercises his/her full responsibility.  Some agreements are in the form of contracts e.g. Pest Control or the template QA Agreement applied

Note that the contract must specify, although not actually record the title 'Contract Giver' and 'Contract Acceptor' the;

• Contract Giver - as Implantcast SA (Pty) Ltd

• Contract Acceptor - the external providers name

OUTSOURCED activities are detailed in the table below

8.3. DOCUMENTATION

In reference to ISO 9001:2015 4.2 requires a “Documented quality management system”, and not a “system of documents”.  Documented information can be used for Communication of Information to communicate a message, Evidence of conformity to provide evidence of what was planned has actually been done, or knowledge sharing and to disseminate and preserve the organization’s experiences.

The quality management system documentation “to maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned” shall include; refer Documentation &  regulatory control SOP

INTERNATIONAL, NATIONAL OR REGIONAL REGULATIONS

    1) EU CE Medical device Directive .MDD 93-42-EEC eng.doc & MEDICAL DEVICE REGULATION (EU) 2017/745

    2) SA Health Act .Health Act.pdf & MEDICINES AND RELATED SUBSTANCES CONTROL  ACT 101 OF 1965 .Integrated Act 101 incl B44.doc

    3) Registration applications and required GMP per Country &  regulations and documents provided by relevant Ministries of Health

   4) Local Regulatory requirements www.sahpra.org.za 

For ISO9001:2015; the system includes : Documented information is to be maintained by the organization for the purposes of establishing a QMS (high level transversal documents).  These include: − The scope of the quality management system (clause 4.3) − Documented information necessary to support the operation of processes (clause 4.4) − The quality policy (clause 5.) − The quality objectives (clause 6.2) − This documented information is subject to the requirements of clause 7.5 of ISO9001.

Quality Manual 

(4.2.2); refer this document

MEDICAL DEVICE / TECHNICAL FILES 

(4.2.3) - Accessible from the Principals

Document & Record Control

follows the DOCUMENTATION SOP and the Director approves the Quality Manual and further documents have designated Authors and Approval as per the SOP.

Includes requirements for Protection of Personal Information (POPI)

And cybersecurity 

8.4. Management Responsibilities 

8.4.1 Management Commitment (5)

The company demonstrates leadership and commitment with respect to the quality management system by:

a) taking accountability for the effectiveness of the quality management system with regular management reviews, review of the quality objectives and support of internal audits;

b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization

c) ensuring the integration of the quality management system requirements into the organization's business processes (Quality system arrangement) ; refer below:

d) promoting the use of the process approach and risk-based thinking (refer Quality Risk Assessment);

e) ensuring that the resources needed for the quality management system are available (refer resource management);

f) communicating the importance of effective quality management and of conforming to the quality management system requirements  (refer 5.5.3 Internal communication however this small business has intimate involvement of and between management and staff); 

g) ensuring that the quality management system achieves its intended results (internal auditing, analysis of data through quality objective monitoring and management review) and ensuring the product safety and quality of its products refer clause 7;

h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

8.4.2 Customer Focus

(5.2.5); Management demonstrates leadership and commitment with respect to customer focus by ensuring that: refer Customer SOP

a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

c) the focus on enhancing customer satisfaction is maintained as management ensures that customer requirements are determined and are met 

8.4.3 QUALITY POLICY

(5.3); The Quality Policy provides;

    a) information appropriate to the purpose and context of the organization and supports its strategic direction;

    b) a framework for setting quality objectives;

    c) includes a commitment to satisfy applicable requirements;

    d) includes a commitment to continual improvement of the quality management system;

and is signed and printed for display, accessible to staff and available to relevant interested parties

8.4.4 Quality Management System Planning

(5.4.1) Quality Objectives are established at relevant functions, levels and processes needed for the quality management system and are consistent with the quality policy, measurable, take into account applicable requirements, relevant to conformity of products and services and to enhancement of customer satisfaction, monitored, communicated, and updated as appropriate. (refer Google Drive).

The Plan details in the heading; refer management review minutes for measurement and action plans

8.4.5 QUALITY OBJECTIVES

Management ensure that the planning of the quality management system is carried, through the implementation of the clauses listed, out in order to meet the requirements of medical device product safety and quality as well as the quality objectives, and the integrity of the quality management system is maintained when changes to the quality system are planned and implemented refer Change Control; 

a) the purpose of the changes and their potential consequences;

b) the integrity of the quality management system;

c) the availability of resources;

d) the allocation or reallocation of responsibilities and authorities.

Quality Management System Planning

Responsibility, Authority and Communication

(5.5) Roles & Responsibilities : refer Organogram refer Staff Contacts

Responsibilities and authorities are defined, assigned, understood and communicated through Job descriptions and the interrelation of all personnel who manage, perform and quality is indicated on the organizational structure, which ensures the independence and authority necessary to perform the tasks to ensure that the quality management system conforms to the requirements of the Standard, that the processes are delivering their intended outputs, reporting on the performance of the quality management system and on opportunities for improvement, the promotion of customer focus throughout the organization and that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented

Specific persons are nominated as responsible for activities related to monitoring experience from the post-production stage and reporting adverse events refer Post Market Surveillance SOP

8.4.6 Management Representative

(5.5.2) The implementation and maintenance of the Quality System is delegated to:

NAME: HENRY MANYIKE

TITLE: MANAGING DIRECTOR

Who is a member of management, irrespective of other responsibilities, has responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained, reporting to the company management on the performance of the quality management system, ensures the promotion of awareness of regulatory and customer requirements the organization, including liaison with external parties relating to the quality management system and any need for improvement, and ensuring the promotion of awareness of the quality management system and any need for improvement.  (A letter of appointment is available and submitted to SAHPRA) 

8.4.7 Internal Communication

(5.5.3) Appropriate communication processes in the form of e-mails notices and management meetings are used to communicate any quality and system matters regarding the effectiveness of the quality system, updates and changes to the system and any other topics incidental to the products quality and safety requirements

8.4.8 Management Review

(5.6) Management reviews the organization's quality management system to ensure it’s adequacy and effectiveness – refer Management Review

This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

9. Resource Management

Provision of Resources

The resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system reviews;

a) the capabilities of, and constraints on, existing internal resources;

b) what needs to be obtained from external providers.

c)  and the QMS Effectiveness and Regulatory and customer requirements 

Human Resources

The organization determines and provides a system administrator necessary for the effective implementation of its quality management system and for the operation and control of its processes refer Organogram

9.1 Competence, Awareness and Training

(6.2) Personnel performing work affecting product quality shall be competent on the basis of appropriate training, skills and experience refer SOP Competence, Awareness and Training

 The company;

a) determines the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

b) ensures that these persons are competent on the basis of appropriate education, training, or experience;

c) where applicable, takes actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;

d) retains appropriate documented information as evidence of competence.

 Company ensures that persons doing work under the organization's control hold induction to make them aware of:

a) the Quality policy; 

b) relevant quality objectives; 

c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance; and 

d) the implications of not conforming with the quality management system requirements.

9.2 Infrastructure & Work Environment

(6.3) The infrastructure & environment is provided to achieve product requirements. 

Infrastructure includes,

a) an office and warehousing building, which does not require controlled storage temperature conditions, a component cleaning work space and associated utilities,

b) process equipment (not applicable except for sales computer interface controlled through Document & Record Control)

c) supporting services (such as transport, which is contracted out or communication through e-mails and management meetings)

d) maintenance activities form part of subcontract manufacturing and sterilization agreements or part of product or Service Realisation (7) 

(e) information and communication technology with internet, website and electronic storage of the documentation (within google sites, google drive and on the company server folders as indicated), and

(f) the environment necessary for the operation of its processes and to achieve conformity of products and services through separation of the component cleaning, product packaging, storage and administration areas.

6.4.1 Work environment

The organization has documented 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, the document provides the requirements for the work environment and the procedures to monitor and control the work environment.

in addition the following is included where relevant;

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;  including Pandemic and Occupational Health Hazards;

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.

6.4.2 Contamination control

The organization has documented , as applicable, the arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product.

not applicable re sterile medical devices, the document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes.

10. Service & Service Realization

Planning of Product Realization

• Lifetime of the medical device refer Medical Device Technical File. 

i) When planning for the quality management system ISO13485 7.1 consideration to any issues and requirements to determine the risks and opportunities that need to be addressed are to;

a) give assurance that the quality management system can achieve its intended result(s), 

b) enhance desirable effects, 

c) prevent, or reduce, undesired effects, 

d) achieve improvement 

ii) Risk Management - Risk Management Safety Evaluation Product Biological Packaging is covered by the Principal & Quality Risk Management is covered within the SOP

iii)  Lifetime of the medical device is defined by the principal 

However, considering the direction of maintaining the regulatory compliance for product safety and performance therefore Actions are taken to address risks and opportunities are proportionate to the potential impact on the conformity of products and services

10.1 Customer-Related Processes

Principals products and controls / requirements are covered within Contract Agreements and follow External Providers  / Purchasing SOP

Customer related processes ISO13485 7.2  are covered in SOP Customer Focus and Customer related processes

Determination of Requirements related to the Product

In determining the requirements for the products and services to be offered to customers, the company ensures that:

a) the requirements for the products and services are defined in the technical files and related documentation, which includes:

    1) any applicable statutory and regulatory requirements;

    2) those considered necessary by the organization;

b) the organization can meet the claims for the products and services it offers; which is affirmed in the Declaration of Conformity.

The Declaration of Conformity (DoC) is the written statement and a single declaration drawn up by the manufacturer to demonstrate the fulfillment of the requirements relating to a product. The declaration shall be in respect of compliance to required conformity with essential principals of safety and performance of the product.

Review of Requirements related to the Product

The company ensures that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed: refer Change Control

Customer Communication

The effective arrangements for communicating;

a) product information are through package inserts and product detail aids which are reviewed and approved by the MD to ensure substantive evidence is in compliance with data or information in the Technical dossier, Product Family Description, Risk Management Safety Evaluation Product Biological Packaging documents 

b) enquiries, contracts or order handling, including amendments are recorded by e-mails, formal letters or contract change records

c) customer feedback, which is provided by the sales representative reports, including customer complaints and advisory notes (refer Control of Non Conformance)  SOP008.doc

d) establishing specific requirements for contingency actions, when relevant.

10.2 Design and Development

(7.3) not applicable

10.3 Purchasing

(7.4)  The Purchasing/ External Providers SOP ; protocols or contracts / agreements determine and apply criteria for the evaluation, selection, monitoring and records of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. 

Control of Externally provided Processes, Products and Services

The company ensures that the externally provided processes, products and services conform to requirements through contractual agreements defining roles and responsibilities or work instructions (e.g. Rework protocol) where the controls to be applied are determined when:

a) products and services from external providers are intended for incorporation into any products and services;

b) products and services are provided directly to the customer(s) by external providers on behalf of the company;

c) a process or part of a process, is provided by an external provider as a result of a decision by the company.

10.3 Control of Production and Service Provision

(7.5)  General Requirements

The organization ensures production and service provision under controlled conditions, as applicable through:

a) the availability of information that describes the characteristics of the product, refer Product Family Description

b) the availability of documented procedures, documented requirements, work instructions, materials and reference measurement procedures as necessary,

c) the use of suitable infrastructure and environment for the operation of processes,

d) the availability and use of monitoring and measuring devices,

e) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met and 

f) the appointment of competent persons, including any required qualification, the validation, and periodic re-validation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement,

g) the implementation of release, delivery and post-delivery activities and the implementation of actions to prevent human error,

h) the implementation of defined operations for labeling and packaging - provided by the principal,

i) records of each batch of medical devices, that are verified and approved, which provides traceability to the extent specified, provided by the subcontract manufacturer or sterilizer agreements for compliance to ISO13485 

(7.5.2) Cleanliness of Product and Contamination Control

The organization provides for the requirements for cleanliness of product - refer Cleanliness & Hygiene SOP 

a) product is cleaned by the organization prior to sterilization and/or its use (only for Orthopaedic products) refer Warehousing and Dispatch & Product Decontamination SOP, or

b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization an (only for Orthopaedic products) refer Warehousing and Dispatch & Product Decontamination SOP

c) product is supplied to be used non-sterile and its cleanliness is of significance in use – not applicable, or

d) process agents are to be removed from product during manufacture – not applicable.

7.5.3 & 4 Installation & Servicing Activities 

- not applicable

7.5.5 Particular requirements for sterile medical devices

-Provided through subcontract agreement and auditing 

7.5.6 Validation of processes for production and service provision

Provided through subcontract agreement and auditing for Packaging seal integrity and sterilization ISO11135-1 

7.5.7 Validation of processes for sterilization and sterile barrier systems 

Provided through subcontract agreement and auditing to meet ISO11135-1:2007 

7.5.8 & 9 Identification and Traceability

Refer Identification and Traceability SOP

Particular requirements for active implantable medical devices and implantable medical devices – not applicable as this is covered by the legal manufacturer.

Status identification - Identification and Traceability SOP

7.5.10 Customer Property

 - not applicable

7.5.11 Preservation of Product

The organization has established documented procedure  SOP Warehousing, Preservation, Identification & Traceability  for conformity of product during internal processing and delivery to the intended destination, which includes the identification, handling, packaging, storage, protection and the limited shelf-life or required special storage conditions, which are applicable for products and components.   Product Family Description  

10.4 Control of Monitoring and Measuring Devices

No monitoring and measurement is undertaken and there are no measuring devices and therefore no calibration, verification of devices or method validation at the company.

For Product Decontamination, a standard clock is used to indicate the time period for the cleaning process where exact timing is not critical.

Post-delivery Activities

The company determines the extent of post-delivery activities that are required, considering:

a) statutory and regulatory requirements;

b) the potential undesired consequences associated with its products and services;

c) the nature, use and intended lifetime of its products and services;

d) customer requirements;

e) customer feedback.

Release of Products and Services

The Company through Purchasing / External Providers, verify that the product and service requirements have been met, planned arrangements, at appropriate stages.

 The release of products and services to the customer do not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.

 Documented information is retained on the release of products and services which includes;

a) evidence of conformity with the acceptance criteria;

b) traceability to the person(s) authorizing the release.

11 Measurement, Analysis and Improvement  (8)

11.1 General (8.1)

The organization develops specifications of the products and conducts auditing for the monitoring, measurement, analysis and processes needed at the subcontract manufacturing and/or sterilisation facilities;

a) to demonstrate conformity of the product,

b) to ensure conformity of the quality management system, and

c) to maintain the effectiveness of the quality management system.

 Resources are provided to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements; which for imports is through Certificate of Conformance or Analysis (CoC, CoA). refer Analysis of Data SOP

Certificate of compliance; A document certified by a competent authority that the supplied good or service meets the required specifications. Also called certificate of conformance, certificate of conformity.

Certificate of Analysis; A document issued by a regulatory or quality assurance entity verifying the adherence to product specifications and standards of production of certain products such as food products and drugs. The certificate usually includes the actual test results performed on the product batch.

 The company provides resources and equipment, where required but to-date is not applicable, that :

a) are suitable for the specific type of monitoring and measurement activities being undertaken;

b) are maintained to ensure their continuing fitness for their purpose.

11.2 SYSTEM

1. The organization shall retain appropriate documented information, CoC / CoA as applicable, as evidence of fitness for purpose of the monitoring and measurement resources.

2.  Measurement traceability as a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment is through the CoC/ CoA

3.  The corrective action process is followed if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and appropriate action as necessary is taken

4. The knowledge necessary for the operation of its processes and to achieve conformity of products and services follows procedures Warehousing and Dispatch  SOP or  Batch and Packing Instruction SOP and this knowledge is maintained and be made available to the extent necessary through records as defined in the procedure. 

5. When addressing changing needs and trends, the current knowledge is considered and determined how to acquire or access any necessary additional knowledge and required updates refer Change Control SOP

11.3 KNOWLEDGE

can be based on:

a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);

b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

11.4 Monitoring and Measurement  (8.2)

8.2.1 Feedback

The measurements of the performance of the quality management system and the monitoring of information relating to whether the organization has met customer requirements is covered through customer complaint review and sales representative reporting; refer Non Conformance and Corrective Action  SOP  and Post Market Surveillance refer PharmacoVigilance and Post Market Surveillance SOP where applicable.

 Customers' perceptions of the degree to which their needs and expectations have been fulfilled is monitored through the sales staff meetings with customers, with feedback to management

8.2.2. Complaint Handling

8.2.3 Reporting to the Regulatory Authorities

8.2.4. Internal Audit (Self Inspection)

Self Inspection or Internal Auditing, as well as auditing by external sources or suppliers / external providers follows SOP QMS Auditing 

8.2.5 Monitoring and Measurement of Processes 

Provided through subcontract agreement and auditing and Warehousing and Dispatch SOP

Provided through work instructions, post market surveillance or Analysis of Data.

8.2.6  Monitoring and Measurement of Product

8.2.6.1 General Requirements

Provided through subcontract agreement and auditing and Warehousing and Dispatch SOP

Product release and service delivery does not proceed until the planned arrangements are satisfactorily completed. (see 7)

8.2.6.2 Particular requirement for active implantable medical devices and implantable medical devices – not applicable

8.3 Control of Nonconforming Product

Non Conformance and Corrective Action SOP which includes when a nonconformity occurs, including any arising from Complaints, or control of non conforming product, where the organisation ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

The 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 including the determination of the need for an investigation and notification of any external party responsible for nonconformity. The SOP also covers:

8.3.2 Actions in response to nonconforming product detected before delivery

8.3.3 Actions in response to nonconforming product detected after delivery

8.3.4 Rework

8.4 Analysis of Data

The organization shall collect and analyse appropriate data  - Analysis of Data SOP - to demonstrate the suitability and effectiveness of the quality management system and facilitate improvement of the effectiveness of the quality management system.

1. Self Inspection (Internal Audit) SOP

2. Control of Non Conformance SOP

3. PharmacoVigilance and Post Market Surveillance SOP

4. Management Review SOP, including customers complaints, monthly management reports, which include customer feedback from sales representatives

5. Internal and subcontractor supplier audits as required or relevant, generally ISO13485 certification by sub-contractors provide confidence of supply and compliance to quality and product safety

6. CCPs (Critical Control Point) maybe monitored through data analysis on a monthly basis 

11.5 Improvement (8.5)

The organization identifies and implements any changes necessary to ensure and maintain the suitability and effectiveness of the quality management system through the use of the quality objectives, audit results, analysis of data, corrective and preventive actions and management review

 The documented procedures for the issue and implementation is Change Control SOP . For customer complaints refer Non Conformance and Corrective Action  SOP

11.5.2 Corrective Action  (8.5.2)

Non Conformance and Corrective Action  SOP

11.5.3 Preventive Action  (8.5.3)

Prevention is built into the system through Quality Risk Management

12. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document

Each process procedure covers a risk assessment to provide for appropriate control measures

13. REVISION HISTORY

Revision 15, 27.10.2025 - HM - 8 updated addresses for branch warehouses & 8.3 further documents have designated authors and approvers 

Revision 14, 07.03.2024 - HM - 8.3 further to NT no longer at IC the Director approved the Quality Manual and further documents have designated authors and approvers

Revision 13, 11.04.2023 - NT - IA correction point 6 re SAHPRA requirements and scope, point  7 Exclusions correction

Revision 12, 16.05.2022 - NT - approval by HM

Revision 11, 03.02.2022 - NT - updating version

Revision 10, 07.01.2022 - TNA - amendment 10.1 (7.2) with links

Revision 9, 10.11.2021 - NT - signed off from TNA

Revision 8, 10.06.2021- TNA- addition to items 8.3 and 9 (6.4.1)

Revision 7, 10.05.2021- TNA- addition of item 8.2.1 and correcting of numbering

Revision 6, 03.02.2021- TNA - New format with Responsibilities, Risk based approach, Approval and Records added and new google site format.  Updating numbering and amending links and forms

Revision 5, Digitally signed on 11.06.2020 by TNA

Revision 1-4, unknown due to Google site change to new Google site

14. RECORDS

Name Retained by/ in Retention period Hard copies Destroyed by

not applicable - relevant to each process procedure; any relevant document