This document provides the process for Sales, Customer related processes and Returns
This document covers the process for sales and returns in compliance of ISO13485
(Version at end of page)
Signed V20 ML 15.10.2024
The process covers all documents and process and products as defined in the SOP
This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, (“POPI”), the Company POPI Policy, PAIA Manual. And processing of personal information envisaged under this Policy must be done in accordance with the aforementioned
Approval: Author of the document, Monica Lucas
Changes: National Sales Manager/ General Manager
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
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 organization are determined.
The organization reviews the requirements related to product, which is conducted prior to the organization’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 organization has the ability to meet the defined requirements.
When the customer provides no documented statement of requirement, the customer requirements are confirmed by the organization before acceptance.
When product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements refer Change Control.
Sales process follows the standard order receipt, pick and pack, dispatch and invoice financial process
8.3.1 OPERATIONS - CUSTOMER FEEDBACK
Sales activities are limited and monitored on hand
Sales, returns and credits provides feedback on the customer, including customer feedback. Please refer to documents attached below
As one of the measurements of the effectiveness of the quality management system, customer information is gathered and monitored to determine whether the organization has met customer requirements.
The feedback process includes provisions to gather data from sales as well as post-production activities.
The information gathered in the feedback process serves as potential input into risk management for monitoring and maintaining the product requirements as well as the service realization or improvement processes.
If applicable regulatory requirements require the organization to gain specific experience from post-production activities, the review of this experience forms part of the feedback process.
Feedback is therefore reviewed by management, this can then be included as input in the management review.
8.3.2 Sales
Orders, delivery notes and invoices follow financial practices through Sage ERP
Should stock be returned and deemed as non-conforming and rejected the client is credited and stock is returned to the supplier for credit refer; Warehousing, Preservation, Identification and Traceability SOP to be followed : Stock Return Policy
In the event of a new product the Regulatory processes for product registration and safety & performance processes are followed
26. Record of implantable medical device and custom made medical device
(1) A permanent record in respect of a Class D implantable medical device and a high-risk custom made medical device must be kept on the premises by the healthcare institution or healthcare professional where the medical devices are sold to the patient, and must contain the following information:
(a) The name and the product code of the medical device;
(b) the date on which the order for the implantable or custom made medical device was raised;
(c) the model number, batch number, and serial number, if applicable; the name, address and identity number of the patient; where applicable, the name of the user and, in the case of an implantable medical device, the person responsible for the implantation of the medical device;
(d) the name and address of the health establishment ;
(e) the name of the manufacturer of the implantable or custom made medical device; and
(f) information relating to the design, manufacturing and performance of the medical device including expected performance.
(2) The order record must be retained at the business address of the seller for a period of at least five years beyond the expected life of the medical device.
(3) The manufacturer, distributor or wholesaler of Class D or implantable custom made medical devices must keep a record of Class D or implantable custom made medical devices in the form of invoices that must reflect-
(a) the date of transaction of every sale;
(b) the proprietary name of the medical device;
(c) the name and address of every purchaser;
(d) the quantities sold; and
(e) the batch number or serial number.
(4) A record referred to in sub-regulation (3) must be kept for a period of fifty years from the date of sale.
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 PREVENTIVE 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 20; 15.10.2024 - ML - Goods Return updated. Digitally signed by ML
Revision 19; 20.11.2023 - ML - Goods Return updated. Digitally signed by ML
Revision 18; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 17; 04.10.2021 - ML - Formatting. Digitally signed by ML
Revision 16; 02.08.2021 - ML - POPI information included. Digitally signed by ML
Revision 15; 10.05.2021 - ML - Digitally signed by ML
Revision 14, 07.05.2021 - TNA - Updating Responsibilities names
Revision 13, 30.04.2021 - TNA - Updating the SOP to the new format. Approval / Scope / Responsibilities / Risk Based Approach / Records and Revision History. Amending links and forms
Revision 12, Digitally signed on 28.01.2020 by ML
Revision 1-11, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
Sales SAGE ERP indefinite n/a
Implant invoices fifty (50) years indefinite n/a
from date of sale (invoices SAGE ERP)