This document provides the process for Technical Services to enable for Product / Service Realisation.
This document covers the procedure for the practices that must be followed for compliance of ISO13485
(Version history at end of page)
Signed V8 RB 15.07.2024
The process covers all documents and process and products as defined in the SOP
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Dean Kowalski
Departmental responsibility: Technical Service Manager
Product/ Service realisation - Enabling the service process or workflow to be realised through quality assurance, quality control and following a documented and recorded quality management system
SHEQ - Safety, Health, Environment and Quality
NCR – Non-Conformance Record
SOP – Standard Operating Procedure
ISO 13485 Clause 7.5.
SOP Non-Conformance, Deviations and Concessions & Corrective Action
The technical service documentation is stored on the technical cloud drive. The following procedures are listed in technical and could be made available upon request:
SOP 0120_Installation
SOP 0121_Training Envision Staff
SOP 0122_Training Hospital Staff
SOP 0123_Application
SOP 0124_Demo Preparation
SOP 0125_Information and Queries
SOP 0126_Devices Asset Management
SOP 0127_Equipment Asset Management
SOP 0128_Information and Queries
SOP 0129_Annual Service
SOP 0131_Pre-delivery inspection
SOP 0132_Routine service
SOP 0133_Service planning
SOP 0134_Repairs
SOP 0135_Responding to technical calls
Listed: 2022.07.22
In the event of non-compliance follow SOP NON-CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
An analytical review is reported monthly to management and this forms part of the input through Data Analysis to management review
The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Revision 8; 15.07.2024 - RB - Change over to SharePoint Site
Revision 7; 22.07.2022 - MR - DK 22.07.2022 - Listed SOPs under procedure, 4- Responsibilities added the Technical Manager, 11 - Updated the records
Revision 6; 17.09.2021 - MR - Responsibilities updated, Records added
Revision 5, 17.09.2021 - TNA - New format with Approval, Scope, Responsibilities and Risk Base Approach and revision history added and new google site format.
Revision 4; Digitally signed on08.01.2018 by WJW
Revision 1-3, unknown due to google site change to new google site
Name Retained in Retention period Hard copies Destroyed by
Technical Service Documentation SharePoint indefinite n/a