This document provides the process for the practices that must be followed for handling, reporting and recording customer complaints
This document covers the process for customer complaints in compliance of ISO13485
(Version at end of page)
Signed V17 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
Customer Complaint - A consumer complaint or customer complaint is "an expression of dissatisfaction on a consumer's behalf to a responsible party" (Landon, 1980). It can also be described in a positive sense as a report from a consumer providing documentation about a problem with a product or service
CA - Corrective Action
NCCA – Non Conformance Corrective Action
SOP – Standard Operating Procedure
ISO13485 Clause 7.2, 8.1, 8.2.2, 8.3, 8.5.2, 8.5.3
SOP Non Conformance Corrective Action
This procedure provides the process for managing Customers, Customer feedback and Customer complaints.
The company establishes the customer requirements related to product refer SALES.
Top management ensure that customer requirements and applicable regulatory requirements are determined and met refer Quality Manual
As one of the measurements of the effectiveness of the quality management system, the organization needs to gather and monitor information relating to whether the organization has met customer requirements.
This feedback process includes provisions to gather data from production 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 product realization or improvement processes.
A report from Sales provides feedback on the activities performed by the representative, including customer feedback. This report is submitted to the Departmental Manager, or the General Manager, whichever is applicable.
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 on a weekly basis, this can then be included as input in the management review.
Complaints are handled through the SOP Non conformance corrective action to have timely complaint handling and in accordance with applicable regulatory requirements.
NOTE: that not all complaints result in NON CONFORMING Product or CORRECTIVE ACTION
These procedures include responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the appropriate regulatory authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective actions.
If any complaint is not investigated, justification is to be documented.
Any correction or corrective action resulting from the complaint handling process is documented through SOP Non conformance corrective action
If an investigation determines activities outside the organization contributed to the complaint, relevant information is to be exchanged between the organization and the external party involved.
Customers must be informed that their information will be reported to the authorities (SAHPRA) and manufacturer should the complaint be as a result in the establishment of an Adverse event or quality issue.
In the event of a new product request then a Motivation is completed by the sales representative. The form is linked - FORM
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
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 17; 15.10.2024 - ML - Checked and Confirmed. Digitally Signed by ML
Revision 16; 24.08.2023 - HJM - Removal of duplication within 8.3
Revision 15; 17.10.2022 - ML - Checked and Confirmed. Digitally Signed by ML
Revision 14; 02.08.2021 - ML - Updated SOP to include correct reporting channels.
Revision 13; 02.08.2021 - ML - POPI information included. Digitally signed by ML
Revision 12; 10.05.2021 - ML - Digitally signed by ML
Revision 11, 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 10, Digitally signed on 16.01.2020 by ML
Revision 1-9, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
Complaints refer NCCA SOP
Customer Feedback input to management
review