Envision Africa developed and implemented the quality management system (QMS) to document the company's best business practices and to better satisfy the requirements and expectations of its customers to improve the overall management of the company. The QMS of Envision Africa meets the requirements of the ISO 13485 standard. The manual also provides procedures and references for all activities compromising the Quality Management System to ensure compliance to the necessary requirements of the standard. The manual is used internally to guide the company's employees through various requirements of the ISO 13485 standard that must be met and maintained to ensure customer satisfaction, continuous improvement and to provide the required instructions to create an empowered work force.
Envision Africa was incorporated in 2014 – a young company with a rich history. James Wright, the founder, has 25 years’ experience and a wealth of relationships built over time – not only with customers, but also the companies that Envision Africa represents. Envision Africa has grown rapidly in capacity and capability, now boasting a highly experienced and dynamic team dedicated to delivering ophthalmic products, solutions and exemplary service.
As a surgical ophthalmic distributor, it is our vision to enable the best surgical outcomes in Cataract, Retina and Glaucoma surgery by providing the best-in-class products and service to all relevant stakeholders.
We strive to give our best and be accountable for the results through
Mutual respect and understanding
Innovation
Teamwork
Trust
Absolute dedication to service.
The strategy manual of the business and operation strategies developed by the COO of Envision Africa to the management team includes historic data, market factors and input from the departmental managers and CEO.
2.1. The quality manual is distributed to the following:
2.2. Chief Operations Officer
2.3. QA & RA Officer
2.4. Production Manager
2.5. Supply Chain Manager
2.6. Customer Service Manager
2.7. Finance Manager
2.8. Technical Service Manager
2.9. IT Support Specialist
2.10. Office Coordinator
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 regulatory requirements are addressed in the event of a change in compliance of ISO 13485. The intent of the quality management system is to provide reference to the applicable procedures for each procedure required.
(Version at end of page)
Signed V31 - MR 25.01.2023 - DK - 25.01.2023
4.1. Changes of this document are approved by the QA & RA Officer with the oversight of the COO.
4.2. Changes to the document are implemented by the Management Representative.
This document defines how Envision Africa's Quality Management System complies with the applicable quality system regulations and standards identified in number 6. References. The scope of the Quality Management System is specific to the following location:
5.1. Administrative office and manufacturing facility address:
229 Sidney Road, Nestpark AH, Bapsfontein, 1510, South Africa
5.2. Office Hours:
Monday - Thursday: 8am - 4pm,
Friday: 8am - 2pm
5.3. Africa Tel: +27 10 007 2431
5.4. Email: Info@envisionafrica.co.za OR orders@envisionafrica.co.za
5.5. Website: http://www.envisionafrica.co.za
5.6. Licensing: ISO 13485:2016 Certified and SAHPRA Manufacturing license
5.7. The type of risk class medical devices imported, manufactured, distributed, exported or services: Class A, B, C and D - Refer to SAHPRA license application
5.8. The intended population of the medical devices: Human Administration
The system covers the Medical Device ISO 13485 quality management for medical device distribution and sale in compliance with regulatory requirements. In particular this QMS is for one site.
The following documents were used as reference during the preparation of the QMS to comply with ISO13485 (in some areas ISO9001 has been included):
ISO 13485:2016- Medical Devices, Quality Management Systems
ISO 9001, - Quality Management Systems
ISO 14971 - Medical Device Application of Risk Management of Medical Devices
ISO 31000 - Risk Management Guidelines
SAHPRA Guidelines: www.sahpra.org.za regulations, guidelines and forms
EU Harmonised Standards: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
Medicines and Related Substances Control Act 101 of 1965: MEDICINES AND RELATED SUBSTANCES CONTROL ACT 101 OF 1965.Integrated Act 101 incl B44.doc
ISO 80002-2:2017 - Quality System Software Validation
ISO 11135 - Sterilisation of Health Care Products - Ethylene Oxide - requirements for the development, validation and routine control of a sterilisation process for medical devices
ISO 14644-2: Cleanrooms and Associated Controlled Environments - Part 1: Classification of air cleanliness by particle concentration
- Part 2 Specifications for monitoring and periodic testing to prove continued compliance
General
This document serves as an overview of the quality standards, processes and personnel that Envision Africa (Pty) Ltd. will harness to ensure that the quality of sales, service and manufacturing is always at an optimal level. The Quality Manual outlines the policies, procedures and requirements of the QMS., whilst complying to the set conditions of the standard.
The organisation:
a) determines the inputs required and the outputs expected from these processes; the process, interactions and sequences refer process flow/ operational procedures,
b) determines the sequence and interaction of these processes,
c) applies 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
e) addresses the risks and opportunities by monitorisation, measurement and analysis of these processes refer Risk SOP,
f) implement actions necessary to achieve planned results and maintain the effectiveness of processes,
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results,
h) improves the processes and the quality management system.
It is noted that only clause 7.3 Design and Development may be excluded. Exclusions none.
7.2.1. Clause 7.5.9.2. - Implantable - non-applicable, the product does not form part of Envision Africa's product portfolio.
All other clauses as per ISO 13485 Clause 1, is applicable
The following clauses are applicable to the quality management system, the process is outsourced to a subcontractor and therefore the process is managed through the supplier quality management procedure (External Providers SOP):
Enter applicable clauses (Third Party Service Providers)
ISO 11135 - Sterilisation of Health Care Products: Steri Solutions
EO Residue - Chemtech
ISO 11737 - Bioburden Testing: Aspirata / Assurecloud / Steris
Pyrogen Testing: MicroChem
Cleanroom Maintenance - Shamus Rennie
BMS Monitoring and Maintenance - SatchTech
Calibration of Devices: Fairbridge, National Medical Supplies, Richter Scale
Peel Strength Testing: Boss Packaging
Cleanroom Access Control: Masc Solutions
EU Authorised Representative is undertaken by TNMC - Andre ten Napel.
The references for the QMS are defined above in section 6 of this manual.
Organisation - Organisation refers to Envision Africa
Client – This can be the customer, sponsor or agent that establishes a contract or agreement
Contractor – Third party individual or group that is a given mandate by the organisation to fulfill a particular role
Customer Supplied Product - Any type of service or material supplied to be utilized in the manufacture, modification or repair of customer-owned property
Principal – Legal manufacturer of imported goods
MD – Managing Director
SOP – Standard Operating Procedure
GMP – Good Manufacturing Practice
GDP - Good Distribution Practice
Medical Device File - For each medical device type or family the organisation shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of ISO 13485 and compliance with applicable regulatory requirements
Medical Device Family - Group of medical devices manufactured by or the same organisation and having the same basic design and performance characteristics related to safety, intended use and function
NCCA – Non Conformance Corrective Action
QMS - Quality Management System
Quality Records - Documentation wherein records of activities must be maintained, will be specified in the procedure or work instruction level document, as applicable.
Sterile Medical Device - A medical device intended to meet the requirements for sterility.
EA - Envision Africa (Pty) Ltd
Envision Africa shall maintain the effectiveness of the Quality Management System by monitoring and measuring processes and reviewing the data analysis during the management reviews. All the procedures required by the standard ISO 13485 are identified in this manual and a cross reference is provided.
Envision Africa undertakes the following roles within South Africa and Nigeria:
Agent / distributor of imported goods such as medical devices
Sales and delivery of medical devices to healthcare practitioners
Installation and repairs
Servicing of equipment by outsources subcontractors
Management representative & authorised representative : Production QA and RA Manager.
Envision Africa undertakes the following roles within Europe:
Distribute CE marked devices to distributor for distribution in EU
The role of the EU authorised representative is undertaken by TNMC - Andre ten Napel.
Envision Africa applies a risk-based approach by defining risks that may have a negative impact on the effectiveness of the QMS. Risk controls shall be implemented and will be described in the risk management section of each SOP.
Envision Africa shall determine the methods of controlling each process. Quality objectives are identified in the outputs of the management review meeting. Roles and procedures for each process are defined to ensure that each process has the necessary resources. For critical processes such as adverse event reporting, recalls, advisory notices and management reviews back-up are identified where possible. The records from each process are defined in the records section of each procedure and the records retention policy for each record is defined in the procedure.
Envision Africa shall maintain the effectiveness of the Quality Management System processes. If process changes are made, any revised procedures shall be evaluated for the impact on the quality system. Changes shall be evaluated for the impact on the quality of devices produced, and changes shall be evaluated for compliance with ISO 13485, with customer requirements.
Envision Africa shall monitor and control outsourced processes that may affect the quality of the product. Roles and responsibilities of Envision Africa and providers of outsourced processes shall be documented in a supplier quality agreement.
Envision Africa shall validate any quality system software in accordance with the procedure. The applicable standard for quality system software is ISO 80002-2:2017. records of the quality system software must be maintained.
Control of Changes
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) authorising the change, and any necessary actions arising from the review.
Quality Management Arrangement
8.1.1. Outsourced Activities
(ISO 13485) When the organisation chooses to outsource any process that affects product conformity to requirements, it monitors and ensures control over such processes. The organisation retains responsibility of conformity to this International Standard, the 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 External providers / Purchasing. The controls are included written quality agreements; and sometimes purchasing information.
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 Envision Africa (Pty) Ltd
Contract Acceptor - the external provider's name
OUTSOURCED activities are detailed in the following table.
8.2.1. General
Understanding the Needs and Expectations of Interested Parties
ISO 9001 (4.2): Due to their effect or potential effect on the organisation's ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; interested parties are:
· The Regulator (SAHPRA) – Organisation license 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,
· Standards South Africa – Compliance to standards as applicable,
· Department of Health – Regulatory and Technical Compliance and
· Medical Aids and their Administrators e.g. Discovery, Medscheme, MSO, Metropolitan Health - regulatory and technical compliance.
8.2.2. Quality Manual
Refer to this document.
8.2.3. Medical Devices/ Technical Files
After a supplier/ manufacturer has been approved and the product is evaluated and approved as per - External Provider (Purchasing & Supplier Management) SOP. A medical device file is created for the supplier / manufacturer if one does not exist. In case of an existing file If the file, the new product shall be added to the medical device file in the following manner:
For each medical device type or medical device family, a file is developed and maintained either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements.
For PRINCIPAL Suppliers the responsibility of the Medical Device is with the Manufacturer where access is enabled through a contract agreement or declaration of supply. Accessible from the Principals, and from Envision Africa (who will maintain medical device files for goods which they manufacture).
The content of the file(s) includes fulfillment to Essential Principles of Safety and Performance of the device to the Intended use and also, but is not limited to:
a) general description of the medical device, intended use/purpose, and labeling, including any instructions for use;
b) specifications for product;
c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;
d) procedures for measuring and monitoring;
e) as appropriate, requirements for installation;
f) as appropriate, procedures for servicing.
8.2.4. Document & Record Control
Refer to SOP - Control of Documents & Control of Records
Refer to SOP Includes requirements for Protection of Personal Information (POPI)
8.2.5. SAHPRA Requirements
The Top Management demonstrates leadership and commitment with respect to the quality management system by:
a) Training new employees on the quality policy, ensuring they understand the relevance and impact of defects in their work.
b) Training employees on the quality objectives ensuring they understand the objectives are important to customer and regulatory requirements,
c) Conducting management review meetings twice a year and more frequently when there are any major changes in the quality management system.
d) Taking accountability for the effectiveness of the quality management system with regular management reviews by reviewing the quality objectives and with the support of internal audits. The quality policy and the quality objectives shall be compatible with the context and strategic direction of the company.
e) Review the resources available during each management review and when there are significant changes e.g. turn-over of key-personnel and regulatory requirements.
f) Ensuring the integration of the quality management system requirements into the organisation's business processes (Quality System Management).
g) Promoting the use of the process approach and risk-based thinking (refer Quality Risk Assessment).
h) Ensuring that the resources needed for the Quality Management System are available.
i) Communicating the importance of effective quality management and of conforming to the quality management system requirements.
j) 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.
k) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system.
l) Promoting improvement.
m) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
Management demonstrates leadership and commitment with respect to customer focus by ensuring that customer and regulatory requirements are determined and met. Customer requirements are verified during the customer ordering process, customer feedback process SOP, Non-conformance SOP. The regulatory requirements are reviewed in preparation for the management review meeting. The processes identified will assist with identifying opportunities that will enable Envision Africa to enhance customer satisfaction.
Envision Africa's policy is based on a process approach to quality management. Management processes that are used to maintain and improve the effectiveness of the Quality Management System, core processes that are essential to product realisation and support processes that are necessary for both management and core processes.
Top Management ensures that the quality policy includes a commitment to comply with the requirements and to maintain the effectiveness of the QMS. Top Management shall review the quality policy for continued suitability during each management review meeting, this will ensure that the policy is applicable to the purpose and scope of the organisation.
Refer to Quality Policy SOP this procedure provides a framework to assist with establishing and reviewing the quality objectives. After the policy has been reviewed and changed the COO will sign and Top Management will ensure that all employees are made aware of the quality policy upon hiring.
Quality Objectives and Quality Management System Planning.
Quality Objectives shall be established by top management at the management review meeting. They will identify the need for review and communicate the status of the objectives to all the managers. The QA and RA Officer will assist with monitoring the quality objectives. Planning should ensure that the quality objectives are being met and that the effectiveness of the QMS is maintained. Quality Management System planning shall occur when there are changes in regulatory requirements, customer requirements or the quality management system. The quality objectives should be consistent with the quality policy, be 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. QMS planning shall ensure that quality objectives are being met and the effectiveness of the QMS is maintained.
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.
9.5.1. Responsibility and Authority
The company organogram should indicate the employee title (job functions) / responsibility, and reporting structure. In the absence of any employee in any job function the responsibilities need to be delegated to an alternate. Refer Organogram refer Staff Contacts
Other responsibilities of managers include:
a) Processes needed or related to the quality management system are documented.
b) Should report to Top Management any need for improvement to ensure that the processes are delivering their intended inputs.
c) Employees understand their roles and responsibilities as they are well defined, understood and communicated through job descriptions, which ensures independence and authority necessary to perform certain tasks to ensure that the quality management system conforms to the requirements of the standard.
d) The QA and RA Officer should report on the performance of the quality management system and on opportunities for improvement. 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.
e) Top Management determines the methods of internal communication especially for quality objectives and the quality policy.
9.5.2. Management Representative
The implementation and maintenance of the Quality System is delegated to:
NAME: Rachel Belcher
TITLE: QA & RA Officer
Who is a member who, 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 organisation, 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. With the oversight of William Wright, the Chief Operating Officer as the Authorised Representative.
9.5.3. Internal Communication
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.
Management reviews the organisation's quality management system to ensure its 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.
Top Management at Envision Africa shall determine and provide the resources needed to:
10.1.1. Establish, implement, maintain and continually improvement the quality management system effectiveness.
10.1.2. Meet regulatory and customer requirements.
Resources include, but are not limited to equipment, personnel and training. This implementation was achieved due to management commitment and with sufficient resources.
10.2.1. Employees performing work that affects product quality shall be competent on the basis of appropriate education, training, skills and experience. The requirements can be set out in job descriptions and the requirements for training are set out in the Competence, awareness and training SOP. Employee records and qualifications are maintained by the Finance Manager, training or other action is taken to provide the employee with the necessary competence for the position.
10.2.1. Competence, Awareness and Training
Refer to Competence, Awareness and Training SOP
Training is an important function and a continuous process. Training is a must for each and every person in order to develop the required skills, general awareness and continuous increase in the overall efficiency. The performance of each individual reflects directly or indirectly on the quality of the product manufactured or service provided. (6.2) Personnel performing work affecting product quality shall be competent on the basis of appropriate training, skills and experience
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 organisation'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.
Envision Africa has determined the process for control of facilities, equipment and maintenance. This procedure indicates that any new equipment shall have calibration and validation requirements identified. Where validation is required the process validation procedure SOP is applicable. Systems must be implemented to ensure that the infrastructure needed to achieve conformity to product requirements is provided and maintained. This is monitored through monitoring and measuring of calibration processes, maintenance activities, monitoring of nonconforming product, product realisation for new modified products. Where the quality of products may be affected, maintenance activities are documented and recorded.
Infrastructure includes:
An office and warehousing building, which requires controlled storage temperature conditions,
A component cleaning workspace and associated utilities,
Process equipment,
Supporting services,
Maintenance activities form part of subcontract agreement but are minimal,
Information and communication technology with internet, website electronic storage of the documentation (within SharePoint and the company server folders as indicated),
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.
10.4.1. Work Environment
Refer to Cleanliness SOP, Gowning SOP, Cleanroom Policy.
The procedure for monitoring of controlled environments to achieve conformity of product requirements. Products that are manufactured in the cleanroom, the assembly process shall specify the work environment required for cleanliness of the product. The monitoring ensures that the work environment meet these conditions such as the cleanroom ISO 13485 controlled environment for the manufacturing of eye packs. Records of monitoring the work environment are required for products with cleanliness requirements.
10.4.2. Contamination Control
Refer - Cleanliness (Facility) SOP
The procedure, facilities, equipment, and maintenance. Any products that require contamination control and work instructions for cleaning of controlled environments will be referenced in that procedure. Controlled environments must be cleaned according to this procedure. Records of cleaning is required for products with cleanliness requirements. Personnel permanent or temporarily must comply with gowning procedures SOP and the Cleanroom policy.
The organisation 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.
Envision Africa shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes and the organisation 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. Envision Africa shall 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.
When planning for the quality management system, considers any issues and requirements to determine the risks and opportunities that need to be addressed 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
Are established and documented by the organisation in the form of risk analyses.
11.1.1. Risk Management - Risk Management Safety Evaluation Product Biological Packaging is covered by the Principal & Quality Risk Management is covered within the SOP.
11.1.2. Lifetime of the medical device is defined by the legal manufacturer and thus the organisation for products produced by the organisation and by the principals for products that they produce.
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.
Principal's products and controls / requirements are covered within Contract Agreements and follow External Providers / Purchasing SOP.
Customer related processes are covered in SOP Customer Focus and Customer related processes.
11.2.1. 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 organisation;
b) the organisation 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.
11.2.2. 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.
11.2.3. Customer Communication
The effective arrangements for communicating:
a) Product information is through package inserts and product detail aids which are provided by the principal to ensure substantive evidence is in compliance with data or information in the Technical File.
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).
d) Establishing specific requirements for contingency actions, when relevant.
11.3.1. General
11.3.2. Design and development planning
11.3.3. Design and development inputs
11.3.4. Design and development outputs
11.3.5. Design and development review
11.3.6. Design and development verification
11.3.7. Design and development validation
11.3.8. Design and development transfer
11.3.9. Control of design and development changes
11.3.10. Design and development files
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.
11.5.1. General Requirements
The organisation ensures production and service provision under controlled conditions, as applicable through:
a) the availability of information that describes the characteristics of the product,
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 - provided by the principal,
11.5.2. Cleanliness of Product and Contamination Control
The organisation provides for the requirements for cleanliness of product - refer Cleanliness & Hygiene SOP.
11.5.3. & 11.5.4. Installation & Servicing Activities
Refer to SOP Control of monitoring and measuring equipment
Records of installation is carried out, where appropriate Envision Africa establishes documentation requirements which contains an acceptance criteria for installation and verifying the installation of the medical device.
Envision Africa has established documented procedures for performing servicing activities and to verify that they meet the specified requirements.
11.5.5. Particular requirements for sterile medical devices
Records are maintained of the process parameters for the sterilisation process which is used for each sterilisation batch. Sterilisation records are traceable to each product and batch of medical devices. The devices cannot be released into the marked without the CoC from the Steriliser that is ISO 11135 Certified.
11.5.6. Validation of processes for production and service provision
Processes where the resulting output cannot be verified by subsequent monitoring or measurement will be validated. The validation will ensure that the processes achieve the planned results.
11.5.7. Validation of processes for sterilisation and sterile barrier systems
- refer Validation SOP
Sterilisation processes are being validated prior to initial use and after product or process changes records are being maintained.
11.5.8. & 11.5.9. Identification and Traceability
Refer Identification and Traceability SOP
Products can be identified through product realisation, and follows documented procedures for such product identification. The identification of the product is maintained throughout production, storage, installation and servicing of the product to ensure that only product has passed the required inspections and tests will be dispatched or installed.
Envision Africa exercises care with customer property while it is under its control or being serviced or tested. A documented procedure outlines the control over customer property during servicing, handling, storage, packaging and delivered back to the intended destination. The device is protected as only competent employees are allowed to work on the devices. If any customer property is lost, damaged or otherwise found to be unsuitable for use, Envision Africa shall report this to the customer and maintain records.
11.5.11. Preservation of Product
-Refer to SOP Warehousing, Preservation, Identification & Traceability
The organisation 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.
Refer to SOP Control of monitoring and measuring equipment.
Refer to SOP Monitoring and Measurement of products and processes.
Certain devices that require monitoring and measurement is provided through accredited outsourced contractors to assist with calibration, verification and validation of devices.
11.6.1. 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;
11.6.2. 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) authorising the release.
The organisation develops specifications of the products and conducts auditing for the monitoring, measurement, analysis and processes needed.
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 to Analysis of Data SOP.
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.
The QMS is based on a process approach to quality management and Envision Africa applies continuous process improvement methodology, i.e. the "Plan-Do-Check-Act Cycle" to ensure its ongoing effectiveness.
The document system is tiered as shown here. Refer to the Document SOP.
12.3.1. Feedback
The measurements of the performance of the quality management system and the monitoring of information relating to whether the organisation has met customer requirements is covered through customer complaint review and sales representative reporting; refer Non-Conformance and Corrective Action 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.
12.3.2. Complaint Handling
12.3.3 Reporting to the Regulatory Authorities
12.3.4. Internal Audit (Self Inspection)
Self-Inspection or Internal Auditing, as well as auditing by external sources or suppliers / external providers follows SOP QMS Auditing.
12.3.5. & 12.3.6. Monitoring and Measurement of Processes and Products
Provided through work Instructions, Post Market Surveillance or Analysis of Data.
Product release and service delivery does not proceed until the planned arrangements satisfactorily completed as part of incoming inspection of Principals products.
12.4.1. General
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 non-conformity. The SOP also covers:
12.4.2. Actions in response to nonconforming product detected before delivery
12.4.3. Actions in response to nonconforming product detected after delivery
12.4.4. Rework is performed in accordance with documented procedures that takes into account the potential adverse effect of the rework on the product.
The organisation 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.
12.6.1. General
The organisation 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 are the Change Control SOP. For customer complaints refer Non-Conformance and Corrective Action SOP.
12.6.2. Corrective Action
Non-Conformance and Corrective Action SOP
12.6.3. Preventive Action
-Refer to SOP Preventative Action
Prevention is built into the system through Quality Risk Management and the preventative action process ensures that action is taken to eliminate the cause of potential non-conformities, with action appropriate to the effects of the potential non-conformities. Potential non-conformities identified from production, internal audits, management review and other sources are evaluated to establish the associated level of risk and the priority given to the investigation and action. CAPA files and Trello cards includes records of investigations, action taken, and monitoring of the effectiveness of implementation and action taken.
The organisation shall retain appropriate documented information, CoC / CoA as applicable, as evidence of fitness for purpose of the monitoring and measurement resources.
Measurement traceability as a requirement, or is considered by the organisation to be an essential part of providing confidence in the validity of measurement results, measuring equipment is through the CoC/ CoA
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.
The knowledge necessary for the operation of its processes and to achieve conformity of products and services follows procedures Warehousing and Dispatch SOP and this knowledge is maintained and is made available to the extent necessary through records as defined in the procedures.
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.
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).
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
Risk Management
HAZARD: Failure to identify all applicable regulations - RISK CONTROL MEASURE: Internal auditing of procedures and process shall be performed by auditors that are competent in the applicable regulations.
HAZARD: Failure to identify all applicable quality system requirements - RISK CONTROL MEASURE: Systematic review and approval of procedures and procedure changes is identified in the document control procedure.
HAZARD: Failure to maintain the effectiveness of the processes and products - RISK CONTROL
MEASURE: Monitoring and measurement of processes, the requirements for monitoring product are defined in the appropriate procedures for manufacturing and service. Manufacturing and design processes are also risk-based to proactively reduce the risk of nonconforming product and product complaints.
Revision 16; 15.07.2024 - RB - Change over to SharePoint Site
Revision 31; 25.01.2023- MR - 25.01.2023 - DK - Under 4.2. Medical device File SOP moved to Quality Manual, 3. Terms & Definitions: Medical Device File definitions added, 4.2.3. Medical Device / Technical files Updated
Revision 30; 23.01.2023 - MR - 23.01.2023 - DK - 1.1. Implantables moved to 1.2 "non-applicable and not exclusion". 1.3 Added Chemtech
Revision 29; 21.10.2022 - MR - DK 21.10.2022 - Updated References point 2. ISO 9001 , 5. Scope updated include Design and development, 7.5.10. Customer property linked, 3. Procedure updated, 5. Scope Updated to be applicable to Envision Africa, 4. Approval Updated added responsibility, Rearranged according to the Standard, Added documents under 11. Records
Revision 28; 15.09.2022 - MR - DK 15.09.2022 - Uploaded new template Business risk and Quality Objectives
Revision 27; 06.07.2022 - MR - Added introduction, Added 2 - QMS distribution, Updated 5 Scope, Updated 6 references, updated 8.4.5. Quality Objectives - DK 06.07.2022
Revision 26; 07.01.2022 - TNA - amendment 10.1 (7.2) with links - MR 07.01.2022
Revision 25; 17.12.2021 - MR - Linked Business strategy manual
Revision 24; 14.09.2021 - MR - Updated 8.4.6 information
Revision 23; 07.09.2021 - TNA - added Medicines sentence under References
Revision 22; 07.09.2021 - MR - Details updated
Revision 21; 10.08.2021 - MR - Reviewed
Revision 20; 22.06.2021 - TNA - updating links and forms
Revision 19; Digitally signed on 25.05.2021 by WJW
Revision 1- 18; unknown due to google site change to new googles site
Name Retained in Retention period Hard copies Destroyed by
Business Strategy SharePoint indefinite N/A
Quality Objectives SharePoint indefinite N/A
Medical Device Files SharePoint indefinite N/A
Operational Procedures QMS Site indefinite N/A