This Document provides the process for documentation of information in compliance with ISO 13485.
(Version at end of page)
Signed V6 RB 15.07.2024
The process covers all documents and process and products as defined in the Standard of Procedure.
Approval: Author of the Document, Marelize Robertson
Changes: Author of the Document, Rachel Belcher
Surgical Platform - a piece of capital equipment with various surgical functions. Used in conjunction with consumable items.
QMS - Quality Management System
SOP -Standard Operating Procedure.
ISO 13485 clause 7.5.10. (Customer Property)
Customer property comes into the control of the company only for the purposes of servicing and repair. The company does not handle customer consumables other than for the shipping of customer orders. Thus, the scope for this SOP is limited to the surgical platforms sent to the company premises for servicing and repair.
The procedure for handling the customer-owned surgical platforms is as follows:
1. When receiving the surgical platform, the technical services manager must check the asset register to ensure that the surgical platform has an up-to-date record with serial number. This serves as the primary way in which customer equipment is identifiable.
2. Once on company premises, the platform must be stored in the technical services office, which is an area restricted to the technical services team. Should the platform need to be moved or shipped it must be packaged securely in an appropriate transit case before leaving the technical services office.
3. The platform may only be removed from a transit case in the technical services workshop.
4. Only competent technicians and the technical services manager may handle or work on the surgical platform.
Revision 6; 15.07.2024 - RB - Change over to SharePoint Site
Revision 5; 14.10.2021 - MR - Updated Responsibilities
Revision 4; 05.08.2021 - MR - Reviewed
Revision 3, 24.06.2021 - TNA - New format with Approval, Scope, Responsibilities and revision history added and new google site format.
Revision 2; Digitally signed on 28.01.2019 by WJW
Revision 1, unknown due to google site change to new google site