Internal & External Communication

1. Purpose

This document provides the process for establishing Internal & External communication and defines the provision for communication for staff, customers and regulatory authorities in compliance of ISO13485

2. Approval

(Version at end of page)

Signed V11 HJM 23.06.2025

3. Scope

The process covers communication both internally and externally 

4. Responsibilities

Approval: Author of the document, Monica Lucas

Changes: General Manager

5. Definitions

Communication - the imparting or exchanging of information by speaking, writing, or using some other medium

Internal communication -  takes place between employees within an organisation

External communication - occurs between those within the company and those in the outside world.

Conformity Assessment Body - testing and calibration laboratories, certification bodies as well as inspection bodies that provide "conformity assessment" by checking that products, materials, services, systems or people measure up to the specifications of a relevant standard ; CAB - issue certificates against standards (e.g. 9001, 13485, 18001 etc.). Could be accredited by national accreditation service (e.g. UKAS for UK, SANAS for SA). SAHPRA  "conformity assessment body" means a body corporate or other legal entity, locally or internationally, accredited by SANAS or an international body recognised by the Council as competent to carry out the assessment, verification, inspection testing or certification, as applicable, of medical devices or IVOs, before they are placed on the market by manufacturers, according to criteria determined by the Council and "conformity assessment certificate" means a certificate issued, by a Conformity Assessment Body, to demonstrate compliance with the Essential Principles of Safety and Performance for Medical Device and IVD requirements;

Notified Body - an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards.  Assessment can include inspection and examination of a product, its design and manufacture (CE certificates)  (NB - accredited by an EU Competent Authority (e.g. MHRA in the UK) to assess and issue certification against the requirements of the Medical Directives (MDD, IVDD, AIMD)) https://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies_en 

6. Abbreviations

AR - Authorized Representative

CAB - Conformity Assessment Body / NB

SOP – Standard Operating Procedure

QMS – Quality Management System

Mgt - Management

Mgt  Rep - Management Representative

NB - Notified body

SAHPRA - South African Health Products Regulatory Authority

SR/M - Sales Representative / Management

7. References

ISO13485 Clause 5.5.3 & 7.2.3

SOP Promotional & Training Material

SOP Regulatory Control

8. Procedure

The resource requirements are reviewed in the management review.

Communication (7.4) 

8.1 Communication arrangement

The organization determines the internal and external communications relevant to the quality management system, which is limited due to the size of the organization and intimate roles and functions, including:

8.2 Internal Communication

Top management provides  appropriate communication. Processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system by:

a) verbal feedback meetings e.g. staff, supplier or customer meetings,  these can be recorded through attendance register or notes through emails where actions are required or be followed up and reports or minutes where there is a need for recording of the communication in regards to meeting the standard, quality management system or regulatory requirements

and 

b) formal management meetings where notes or minutes are recorded e.g. management meetings

8.3 External Communication

The organization communicates with its customers in relation to:

1.         product information through marketing material, Promotional & Training Material SOP;

2.         enquiries, contracts or order handling, including amendments;

3.         customer feedback, including complaints through Complaints handling SOP;

4.         advisory notices.

The organization, through it's Authorised representative communicates with regulatory authorities in accordance with applicable regulatory requirements and Regulatory Control SOP

Recording of communication can be through email communication, notes through emails where actions are required or be followed up and reports or minutes where there is a need for recording of the communication in regards to meeting the standard, quality management system or regulatory requirements

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

9.1 Trend Analysis and Continual Improvement

not applicable - feedback from communication is an Input to Management review

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

 10. REVISION HISTORY

Revision 11; 23.06.2025 HJM - Pt 8.2 Added further info to a) & b). Pt 8.3 Added another paragraph referring to recording of communication

Revision 10;  14.10.2024 - ML -  Digitally signed by ML; Checked and Confirmed

Revision 9;  20.11.2023 - ML -  Digitally signed by ML; Checked and Confirmed

Revision 8;  17.10.2022 - ML -  Digitally signed by ML; Checked and Confirmed

Revision 7;  10.05.2021 - ML -  Digitally signed by ML

Revision 6;  22.04.2021 - TNA -  New format with Approval / Responsibilities / Scope / Revision History.  Changes to Risk Based Approach.  

Revision 5; Digitally signed 12.11.2018 by ML

Revision 1-4; unknown due to Google Site change to new Google site