DOCUMENTATION

1. Purpose

This document provides the process for documentation of information and covers control of Documents and Records in compliance of ISO 13485. This procedure ensures documents within Envision Africa's quality management system are appropriately reviewed, approved and released and that documentation are accessible to those who need to use them. 

2. Approval

(Version at end of page)

Signed V17 rb 17.05.2024

3. Scope

This procedure covers all documents that form part of Envision Africa's quality management system

4. Responsibilities

Approval: Author of the document, Marelize Robertson

Changes: Author of the document, Dean Kowalski

5. Definitions

Attachments: Documents used to clarify or show examples of information described in the procedures and work instructions.

External documents: Defined as Legal Regulations, Medical Device and In-Vitro Diagnostics Council Directives (MDD/ AIMD/ MDR/ MDIVDR), Government Gazettes, EN Standards, ISO Standards, DIN-standards, BS-Standards and documents where the configuration is controlled by an external authority. (Electronic documentation maybe on websites e.g. GMDN)

Forms: Documents used to make a record of completing all or part of the process described in procedures and work instructions.

PRINCIPAL Suppliers i.e. the supplier from which a distributor purchases goods for import and is considered to be the manufacturer or an affiliate company to the manufacturer as labelled on the product.

Document: Any manual or electronic record of a text or graphics image that represents a drawing, parts list, Bill of Material, purchasing specification, process specification, assembly procedure, test or inspection procedure, business procedure, etc., relating to products processed or administrated under the control of the company's document control process.

Work Instructions: Step by step directions on how a task should be done.

Procedure: A document that outlines specific work processes, ensuring requirements are being met in accordance with the ISO 13485 standard.

Promotional Material: Any written or graphic artifact that has been created and distributed for the purposes of increasing awareness about a product or service with the aim of increasing sales of that product or service.

Training Material: Any written or graphic artifact intended to impart knowledge or skill with regard to a particular subject matter.

External Circulation: The dissemination of any promotional and training material to parties outside of the organisation i.e. any person not employed by the organisation.

Records: Completed forms or information that is generated as the end result of the process described in a document and retained as indicated in the control of quality records procedures. 

Related Documents: Documents that may need to be altered should an existing/current document be revised or changed.

References: External documents or sources used in preparing documentation and completing work. 

Template: Electronic documents used to create quality system documentation.

6. Abbreviations

GMDN- Global Medical Device Nomenclature

IMDRF - International Medical Device Regulatory Forum

SAHPRA - South African Health Products Regulatory Authority

SOP -Standard Operating Procedure.

QMS - Quality Management System

IFU - instructions for use

NCCA - non-conformance corrective action

7. References & Documentation

Reference

ISO 13485 clauses 4.2.

Documentation

Medical Device File QMS Site

Procedure for Preventative, Corrective Action and Handling of Non-Conforming Product QMS Site

Change Control QMS Site

Quality Policy QMS Site

Quality Manual QMS Site

Regulatory Control SOP QMS Site

Quality Objectives SharePoint

SAHPRA External Site (Reference)

GMDN External Site (Reference)

IMDRF External Site (Reference)

8. Procedure

8.1. Format

1. Procedures are presented on the SharePoint dashboard and the FORMAT for procedures are as per this SOP refer Content table only at Heading level as subheading may vary depending on content e.g. under heading Procedures.

2. Format varies for FORMS, SHEETS, Work Instructions, which maybe video's, flow diagrams and TECHNICAL DOCUMENTATION for products.

3. Format for QUALITY POLICY includes POLICY, Responsibilities and Revision History.

4. Format for the Quality Manual is defined by the contents table in the Quality Manual document.

5. The Format, if applicable, for Medical Device File maybe be that of the Principal Supplier or if manufactured locally then the IMDRF format is recommended.

8.2. Requirements (4.2.1.)

The Documentation requirements for the quality management system documentation includes:

a) documented statements of a quality policy and quality objectives;

b) a Quality Manual;

c) documented procedures and records required by this International Standard;

d) documents, including records, determined by the organisation to be necessary to ensure the effective planning, operation, and control of its processes;

e) other documentation specified by applicable regulatory requirements.

8.3. Quality Manual (4.2.2.)

Refer to Section 7. Reference & Documents " Quality Manual" which includes:

a) the scope of the quality management system, including details of and justification for any exclusion or non-application;

b) the documented procedures for the quality management system, or reference to them;

c) a description of the interaction between the processes of the quality management system.

and outlines the structure of the documentation used in the quality management system in the form of the SharePoint Site with headers identifying the relevant procedures.

8.4. Approval 

Approval is as per the Responsibilities listed above point 4. Heading Responsibilities, where in point 2. Heading Approval, the revision is stated and then Signed Initials followed by date DD.MM.YYYY is completed, and the site is published.

When a change as per point 8.5 is done the scriber will insert the new revision with the date and their initials however the approval will retain the version and the approver will only change the date and add their initials over the scriber.

8.5. Changes 

Change to documents are recorded in the revision history and only allowed by the author of the document or process owner, administrator or CEO of the document referred in the Responsibilities Heading. 

A change maybe done if the person has EDIT "shared" rights, where a changed is done and Signed Initials / EDITED followed by date DD.MM.YYYY is completed and published, the Approval responsibility is notified by email to conclude Approval

The REVISION HISTORY heading is competed; ONLY the past 5 changes are to be recorded as Revisions on the Site post certification and during QMS implementation all the changes to be recorded on a document revision report and saved in a OBSOLETE document folder to illustrate the development of the process document. Example of the REVISION HISTORY format is in the heading section below.

8.6. Obsolete

The Management Representative is responsible for the withdrawal, re-issuing and disposal of documents after an update has taken place. No documents are obsoleted as this is electronically managed in Googles Sites Tab Revision History and Share Point. 

In the event of Invalid and/or obsolete hard copy documents, they are removed, from all points of issue or use. At least one copy of previous revisions of paper documents are archived, clearly indicating " OBSOLETE ", scanned and placed in the document history Tab in the Google drive site.  

Documents used to manufacture or test medical devices will be maintained for at least the lifetime of the device.

8.7. Distribution 

There is no formal Distribution for procedures as access and visibly is through email address access control provision by the Director.

A copy of all Medical Device Files, if applicable, are retained for at least 5 years after the product’s life cycle. A copy must be available to the Authorised Representative; generally through the supplier agreement. 

8.8. External Document 

Documents such as ISO standards, contracts, drawings are available on the External Document Register. Note that the SAHPRA Licenses follow SAHPRA guidelines that are tabled on the SAHPRA website.

8.9. Promotional and Training Material Approval 

8.9.1.  Approval

All promotional and training material must be approved by a member of management and the management representative, who has knowledge about the subject matter, prior to external circulation. The approval process for material that is generated both internally and externally is as follows:

The member of management with knowledge of the subject matter involved in the promotional/training material must submit a New promotional and training material form. It is assumed that the member of mgt. who submits the application already approves the material.

The management representative will then review the application and approve or decline using the Promotional and training material approval form according to the following criteria:

1. The material has a document number. 

2. Any claims made by the material in terms of the product or service's safety and/or performance are in line with the original manufacturer/ service provider and do not claim additional safety or performance characteristics. 

3. The material does not provide any advice, knowledge or skill that contradicts the IFU of the original manufacturer.

4. Any advice, knowledge or skill imparted by the material is in accordance with the original manufacturer/service providers IFU and/or other instructional material.

Updates or new additions of material in circulation must be put through the change control procedure. Approved material is recorded here.

Any updates to promotional or training material that arise due to incorrect or misleading information in the material already in circulation could mean that the material in circulation is unsafe or inaccurate and thus non-conforming.

8.10. POPI

To comply with the Protection of Personal Information, Envision Africa implemented a policy that is followed. Refer to Envision Africa SOPs and Policies.  

8.11. Standards, Laws and Directives

The Management Representative/ Director maintains access to all applicable Standards, laws and directives through the SAHPRA website and "Regulatory Guideline Folder" refer to 11. Records. 

Where updating has taken place, the new standards/ laws are brought to the attention of all employees concerned by the management representative as necessary to the function and role of the employee.

Refer SOP Regulatory Control  

8.12. Labels and IFU Approval 

Labeling is provided as per the requirements as per the Medical Device File below. The Labeling and Literature may be translated into the official language, where required. A technical translator with competence in the product and language shall verify and authorise it. 

The labeling and literature should be controlled by means of document control where relevant. All new or altered labels shall be submitted to the Team Identified by Marketing for Approval, who signs and dates the document, which is filed in the Technical File prior to release of a print order and before printing will commence. A Copy of the Approved document is submitted for printing, where required.

For the Production Labels refer to "Production Label Templates" under 11. Records.

8.13. Medical Device File 

Refer to the Quality Manual.

8.14. Computer Data Control 

PASSWORD ACCESS CONTROL

A two-level password system shall be used. (A User Identification "user name" and a "password"). The Director, through the user parameter set-up, shall grant specific authorities for each and every user profile.

The users shall keep passwords confidential. Duplicate user identifications shall not be allowed. Misuse of any password is considered a serious offence and will be treated accordingly. Virus protection software shall be installed and maintained.

refer Cybersecurity Policy.

BACKUP CONTROL

It needs to be mentioned that all documentation is backed-up in the web through Google Documents.

GOOGLE DRIVE can also be backed up by following the COG tab, SETTINGS tab and CLICK Download Drive - saves into "downloads folder" and save it in a company folder "Google Drive Backup)

8.15. Records Strategy 

Records are maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

RECORDS are defined in each SOP, as relevant and as an output requirement to Risk based approach and the RECORDS heading is completed

Name Retained in Retention period Hard copies Destroyed by

file name of the document DRIVE as defined below Responsibilities name

All data and records are indelible, legible and identifiable to the product or process involved and stored and maintained in such a way that they are readily retrievable in facilities that provide a suitable environment to minimise deterioration or damage and to prevent loss.

SharePoint is a source of RECORDS and as an electronic media fulfills the above.

8.16.1. Method of Determining Retention Time

The following inputs shall be considered where decisions are made with regards to retention times: National laws, Statutory Requirements, such as the Medical Device Directive, the Life of the Product.

Where documentation is stored may be detailed in the relevant SOP and what the minimum retention period is or its is electronically recorded in the SharePoint Site.

The controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records are defined in the SOP or this format; but managed through SharePoint Site.

The method for protecting confidential health information contained in records in accordance with the applicable regulatory requirements is provided through password control.

If applicable, the organisation 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.

8.16.2. Storage of Records

• 1. All quality records must be stored in a manner which allows for Identification, Preservation, Accessibility and Retrieval; which is covered by Google through password control and Revision History.

  2. Good housekeeping must be maintained in all filing areas and FOLDERS.

  3. Documents maybe stored in the warehouse in boxes but they must be sealed for protection and labelled to facilitate destruction on retention time expiry.

  4. Electronic records are protected as per BACKUP CONTROL.

8.16.3 Record Destruction 

After expiry of the stated retention periods, the quality records must be removed from storage areas and destroyed by the Quality Manager or delegate. Records must be destroyed by means of shredding or incineration, to ensure the security of information.

SharePoint documentation remains on the icloud indefinitely, unless deleted as per Change Control above.

9. Risk Based Approach

In the event of non-compliance follow SOP Non-Conformance Corrective Action.

Risk Based Approach Report

The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.

10. Revision History 

Revision 17; 15.07.2024 - RB - Change over to SharePoint Site

Revision 16; 06.02.2023 - MR - 06.02.2023 - DK - External Document updated and linked, 

Revision 15; 26.01.2023 - MR - 26.01.2023 - DK - 8.12. Medical device file reference; 8.9. Added Promotional and Training Material; 11. Records added x2, 5. Definitions added i.e. training; 6. Abbreviations added; 8.9. POPIA referenced documentation location

Revision 14; 21.12.2022 - MR- 7. Change to Reference and Documents; 8.12. Medical Devices updated and referenced;  11. Records Added - None available;  1. Update Purpose;  8.11. Update Labels; 8.10. Update; 

Revision 13; 25.05.2022 - MR - Definitions added

Revision 12; 07.01.2022  - MR  - Definitions added, 8.6 Updated

Revision 11;   09.10.2021  MR  review

Revision 10;  14.10.2021 - MR -  Updated 4. Responsibilities, 8.4 Approval & Definition added

Revision 9; 10.08.2021 - MR - Reviewed

Revision 8, 22.06.2021 - TNA - amending links and forms to new format with Responsibilities / Scope / Approval / Revision History / Risk Based Approach changes.

Revision 7, Digitally signed on 02.12.2019 by WJW

Revision 1-6, unknown due to google site change to new google site

11. Records 

Name Retained in Retention period Hard copies Destroyed by

New Promotional and Training Material Form Google Forms Indefinite N/A

Promotional and Training Material Approval Form Google Forms Indefinite N/A

Promotional and Training Material Register Google Drive Indefinite N/A

Production Label Templates SharePoint Indefinite N/A

Regulatory Guidelines SharePoint Indefinite N/A

External Document Register SharePoint Indefinite N/A

POPIA Policy Share Point - (Finance Files) Indefinite N/A