This document covers the process for sales and returns in compliance of ISO 13485.
(Version at end of page)
Signed V16 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
Distribution- The movement of goods and services from the source through a distribution channel, right up to the final customer, consumer, or user, and the movement of payment in the opposite direction, right up to the original producer or supplier.
Sale- Contract involving transfer of the possession and ownership (title) of a good or property, or the entitlement to a service, in exchange for money.
SHEQ - Safety, Health, Environment and Quality
SOP - Standard Operating Procedure
NCCA – Non-Conformance Corrective Action Record
MRP - Manufacturing Resource Planning
ISO13485 clauses 7.1, 7.2
Warehousing, Preservation, Identification and Traceability SOP
Non-Conformance, Deviations and Concessions & Corrective Action SOP
The company establishes the customer requirements related to product by determining the:
a) requirements specified by the customer, including the requirements for delivery and post-delivery are determined at the time of the purchase request;
b) requirements not stated by the customer but necessary for specified or intended use, as known are evaluated at sale confirmation;
c) applicable regulatory requirements related to the product as established, as necessary;
d) any user training needed to ensure specified performance and safe use of the medical device follow Control of Promotional & Training Material SOP;
e) any additional requirements determined by the organisation are determined.
The organisation reviews the requirements related to product, which is conducted prior to the organisation’s commitment to supply product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that:
a) product requirements are defined and documented;
b) contract or order requirements differing from those previously expressed are resolved;
c) applicable regulatory requirements are met;
d) any user training identified is available or planned to be available;
e) the organisation has the ability to meet the defined requirements.
When the customer provides no documented statement of requirement, the customer requirements are confirmed by the organisation before acceptance.
When product requirements are changed, the organisation ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements refer Change Control.
Customer requirements are established, confirmed and any changes are addressed and agreed through the sales process, which follows the standard order receipt, pick and pack, dispatch and invoice financial process using Dynamics 365.
Stock management is performed using a combination of Dynamics 365 for finished goods and Resource Requirement Planning (RRP) spreadsheet for manufacturing resource planning.
8..3.1. Products should not be returned without the necessary and relevant documentation and should not be returned in non-protective packaging.
8.3.2. Should stock be returned for whatsoever reason the stock should be isolated from other stock and placed in the designated quarantine area.
8.3.3. All returned and rejected products must be clearly labelled, sealed and stored separately in a secure manner in a clearly marked designated area.
8.3.4. Should stock be returned and deemed as non-conforming and rejected the client is credited or replaced and stock is returned to the supplier for credit and further investigation by the manufacturer refer; Warehousing, Preservation, Identification and Traceability SOP to be followed.
8.3.5. Goods returned / due to be rejected are handled in a procedurally correct manner with reasons for returns determined and any further actions followed through are recorded on Trello.
8.3.6. The final decision, after evaluation, to return the goods to stock or destroy any rejected goods and in the event of non-conformance then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed.
In the event of a new product the Regulatory processes for product registration and safety & performance processes are followed. Refer to SOP External Providers (purchasing & Supplier Management) - 8.6. Product Evaluation.
In the event of non-conformances then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed.
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.
The analytical reviews of internal audits, and any other quality related matters, are reported to management and as part of the input from Data Analysis 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.
Revision 16; 15.07.2024 - RB - Change over to SharePoint Site
Revision 15; 21/09/2022 - MR - 21.09.2022 - DK - Updated 8.3 Returns, section carried over from Maintenance SOP number 2-5.
Revision 14; 26/08/2022- MR - DK - 26/08/2022 - Correct numbering 8.2 - 8.4, Updated 8.3 - How returns should be handled and where they should be kept.
Revision 13; 19.07.2022 - MR - DK 19.07.2022 Moved 8.3. Customer Feedback to the customer feedback, complaints process SOP
Revision 12; 07.01.2022 - MR - 1. Purpose update
Revision 11; 14.10.2021 - MR - Updated 8.3 Customer feedback
Revision 10; 05.08.2021 - MR - Reviewed
Revision 9, 24.06.2021 - TNA - New format with Approval, Scope, Responsibilities and revision history added and new google site format.
Revision 8; Digitally signed on 10.12.2019 by WJW
Revision 1-7, unknown due to google site change to new google site
Name Retained in Retention period Hard copies Destroyed by
Sales Financial records per FICA 5 years Manager
Customer Feedback Reports stored on the SharePoint 5 years Manager
from surveys sent out to customers.