DOCUMENTATION

1. Purpose

This document provides the process for documentation of information and covers control of Documents and Records in compliance of ISO13485

2. Approval

(Version at end of page)

Signed V23 ML 14.10.2024

3. Scope

The process covers all documents and records and contents as per the Procedure table of contents

4. Responsibilities

Approval: Author of the document, Monica Lucas

Changes: General Manager

5. Definitions

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 )

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

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

7. References

ISO13485 clauses 4.2

PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT

CHANGE CONTROL

8. Procedure

8.1 FORMAT

Procedures are presented on the GoogleSite 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
Format varies for FORMS, SHEETS, Work Instructions, which maybe video's, flow diagrams and TECHNICAL DOCUMENTATION for products
Format for POLICY includes POLICY, Responsibilities and Revision History
Format for the Quality Manual is defined by the contents table in the document Quality Manual
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

The Documentation requirements (4.2) 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 organization 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)

Click on the heading to go to the 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 google site with headers identifying the relevant procedures

8.4 Approval

as defined in Responsibilities and where the revision is stated under point 2. Approval where the Approver overtypes Signed Initials followed by date DD.MM.YYYY of the change persons initials and date but retains the Version i.e. Approved the changed Version - and adds Digitally signed by Initials
The Homepage footer is then overtyped with the persons initials and date and time of PUBLISH and then click PUBLISH to update the Site

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 GM of the document referred in the Responsibilities Heading.
A change maybe done if the person has EDIT "shared" rights, where a change 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 Version in Edit mode under Pages - click the 3 dots and select properties then advanced and increase the Version.
The REVISION HISTORY heading is completed; 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 CEO,GM, or Director, is responsible for the withdrawal, re-issuing and disposal of documents after an update has taken place. No documents are obsoleted in the Google DRIVE / Site.

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

8.7 Distribution

There is no formal Distribution for procedures as access and visibility is through email address access control provision by the General Manager.

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 Documents

Documents such as ISO standards, contracts, drawings are logged on a Google Drive under Documentation TECHNICAL FILE to ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and enable distribution control
TECHNICAL FILE folders provides for medical device type or medical device family, as applicable, where the organization establishes and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements e.g. Certificates, Brochures
SAHPRA Licenses follow SAHPRA guidelines that are tabled on the SAHPRA website and located under REGULATORY

8.9 POPI

To comply with the Protection of Personal Information the POLICY is to be followed and a FORM can be completed as a RECORD

8.10 STANDARDS, LAWS AND DIRECTIVES

The Management Representative/ Director maintains access to all applicable Standards, laws and directives through the SAHPRA website www.sahpra.gov.za, accessibility on the internet, in a folder in ISO in Google drive or the Records in the Google site.

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

Refer SOP Regulatory Control

8.11 LABELS AND IFU APPROVAL

Not applicable

8.12 MEDICAL DEVICE FILE

The Medical Device File (4.2.3), 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 is held by the registered manufacturer and access is available as required.

The content of the file(s) shall include 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.

8.13 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.

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 SETTINGS tab and CLICK Download Drive - saves into "downloads folder" and save it in a company folder "Google Drive Backup)

8.14 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 by/ in Retention period Hard copies Destroyed by

file name of the document DRIVE or if physically the location 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.

Google Drive is a source of RECORDS and as an electronic media fulfills the above

8.14.1 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 it is electronically recorded in the Google Site ERP

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 google 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 organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less.

8.14.2 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

8.14.3 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.

Google 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 PREVENTIVE ACTION RISK ASSESSMENT refer Document

10. REVISION HISTORY

Revision 23; 10.09.2024 - ML - Numbering updated, removal of Repairs for Instruments, MD file info updated. - 14.10.2024 Digitally Signed & Approved ML

Revision 22; 7.06.2024 - PM - Points moved down from 8.6 (Obsolete) and Repairs for Instruments added

Revision 21; 15.04.2024 - SCR - point 8.4 for Publishing of Site and 8.5 Changes for Version to be updated in Pages properties and 8.8 External Documents revised to meet ISO13485 requirements. Digitally signed by

Revision 20; 20.11.23 - ML - Checked and approved. Digitally signed by ML

Revision 19; 25.10.23 - SCR - Removal of PALIN re labelling

Revision 18; 1.11.2022 - ML - Updated External Documents. Digitally signed by ML

Revision 17; 17.10.2022 - ML - Updated Responsibilities. Digitally signed by ML

Revision 16; 07.10.2021 - ML - Formatting. Digitally signed by ML

Revision 15; 10.05.2021 - ML - Digitally signed by ML

Revision 14, 21.04.2021 New format with Responsibilities, Risk based approach and Records added and new googlesite format. Also definition of the Approval, Change, revision and records aligned to the new GoogleSite process. Updating links and forms. amendment to items 5 / 6 / 8.1 / 8.2 / 8.4 / 8.8 / 8.9 / 8.12 /8.13 / 8.14.2.

Revision 13, Digitally signed on 12.11.2018 by ML

Revision 1-12, unknown due to googlesite change to new googlesite

11. RECORDS

Name Retained by/ in Retention period Hard copies Destroyed by

None n/a n/a n/a

Page updated

Google Sites

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