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 V10 AA  19.08.2021 

3. Scope

The process covers communication both internally and externally 

4. Responsibilities

Approval: Author of the document, Alexi Arhondonis

Changes: Author of the document, Alexi Arhondonis

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 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: