PROMOTIONAL AND TRAINING MATERIAL APPROVAL
1. Purpose
This document provides the process for the approval and dissemination of promotional and training material in compliance with ISO13485.
2. Approval
Version at end of page)
Signed V4 AA 19.08.2021
3. Scope
The process covers all quality management system, processes, activities, products and regulatory requirements
4. Responsibilities
Approval: Author of the document, Alexi Arhondonis
Changes: Author of the document, Alexi Arhondonis
5. Definitions
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 organization
6. Abbreviations
IFU - instructions for use
NCCA - non-conformance corrective action
7. References
ISO13485
8. Procedure
8.1 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 management 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.
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.
9. Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]
9.1 Trend Analysis and Continual Improvement
The analytical reviews of internal audits, and any other quality related matters, are reported through Data Analysis to management and as part of the input to management review.
The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
10. Revision History
Revision 4, 19.08.2021 - AA Updating responsibilities
Revision 3, 03.05.2021 - AA Approved
Revision 2, 23.04.2021 - TNA - New Approval / Scope / Responsibilities, Risk based approach , Revision history and Records added and new google site format. amending forms and links
Revision 1-, unknown due to google site change to new google site
11. Records
Name Retained by/ in Retention period Hard copies Destroyed by
Promotional and training material approval form Google Drive indefinite n/a
New promotional and training material form Google Drive indefinite n/a