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 ISO 13485.

2. Approval

(Version at end of page)

Signed V10 RB 17.05.2024

3. Scope

The process covers communication both internally and externally.

4. Responsibilities

Approval: Author of the document, Marelize Robertson

Changes: Author of the document, Dean Kowalski

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 organisation 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 - Authorised 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 Authority

SR/M - Sales Representative / Management

7. References

ISO 13485 Clause 5.5.3. & 7.2.3.

SOP Promotional & Training Material

SOP Regulatory Control

8. Procedure

The communication procedure provides a common, structured process that everyone within the organisation can follow. The resource requirements are reviewed in the management review. The procedure should assist with an effective feedback channel between the organisation and its customers, stakeholders, and employees by ensuring that the quality-related information that needs to be communicated is:

Valid

Accurate

Consistent

Controlled

Communicated before a change or effect takes place

Able to receive and understood

What to communicate:

Quality-related issues including the quality policy, quality management system requirements, processes, organisation performance, customer satisfaction, changes etc.   

When to communicate:

Management review meetings, scheduled meetings and meetings based upon the urgency.

Who to communicate:

External parties: Customers, suppliers, regulators, stakeholder and media.

Internal parties: Envision Africa employees and contractors.

How communication occurs (Communication channels used):

• Internal: E-mails, Trello, Meetings (Scheduled / Unscheduled), designated whatsapp groups and management review.

• External: E-mails, website, survey, formal letter, and communicate via the representative.

Who undertakes the communication:

• EXCO, Line Managers, Supervisors, Operators and Sales Representatives.

Communication (7.4.) 

8.1. Communication arrangement

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

8.2. Internal Communication

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

a) Verbal feedback meetings - held on an ad hoc basis. In order to exchange information, plan and coordinate tasks, staff meetings are held.  

• Check the boardroom availability with the Office Coordinator refer to the Boardroom Booking SOP.

• The person schedules a meeting via e-mail and informs all employees that are supposed to attend.

b) Formal management meetings - held monthly, with record kept on file (not within the scope of this site)

• During formal meetings minutes will be taken and distributed afterwards via email.

c). Internal electronic communication channel is via email, the employees have a business email address in the name@envisionafrica.co.za format. Signatures in emails are uniform. 

d).  Other internal communication tools include Trello

• All dates and deadlines regarding project activities are indicated on the Trello board in the due date field.

e).  The following letterhead template is available.

8.3. External Communication

The organisation 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 organisation, through its Authorised representative communicates with regulatory authorities in accordance with applicable regulatory requirements and Regulatory Control SOP

a). Telephone communication

• The telephone should be answered no later than the third ring 

• After the connection has been established, you should identify yourself as well as the organisation

• If a person who is called is not available at the time, you are required to write down the caller's first and last name, the organisation and the contact number 

• During the conversation, make your voice sound as pleasant as possible

• Always be professional, polite and concise

• During work time calls to friends and family should be avoided, as well as any other private calls

b).  Business letters

• For business letters make use of the letterhead

• Address the letter appropriately to the person his/her position and company

• Finish the letter with your full name, position in the organisation, signature as well as with all the contact information

• Before sending the letter always proofread

• Respond to letters as soon as possible 

9. Risk Based Approach

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

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

9.1. Trend Analysis and Continual Improvement

Not Applicable - feedback from communication is an Input to Management Review.

10. Revision History 

Revision 10; 15.07.2024 - RB - Change over to SharePoint Site

Revision 9; 25.07.2022 - MR  - DK 25.07.2022 - 8. Updated the procedure added who what how,  8.2. Updated internal electronic communications, 8.3. External communication populated, 8.1.  Communication document updated_V2

Revision 8;  14.10.2021 - MR -Updated

Revision 7; 05.08.2021 - MR - Website reviewed

Revision 6; 22.06.2021 - TNA - amending links and forms to new format / Approval / Scope / Responsibilities / Risk Based Approach / Revision History

Revision 5; Digitally signed on 29.11.2019 by WJW

Revision  1 - 4; unknown due to google site change to new google site format

11. Records

Name Retained in Retention period Hard copies Destroyed by

Boardroom booking SOP SharePoint indefinite N/A

Letterhead Template SharePoint indefinite N/A