This document provides the process for the practices that must be followed for handling, reporting and recording of customer complaints. This procedure will describe the process used for communicating with customers and reviewing information from the customer, including customer feedback in compliance with ISO 13485.
(Version at end of page)
Signed V26 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, Rachel Belcher
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
Non-Conformance - Failure to conform to accepted standards of behaviour. Non-fulfilment of specified requirements
CA - Corrective Action
NCCA – Non Conformance Corrective Action
SOP – Standard Operating Procedure
ISO 13485 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 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 to the Quality Manual.
The procedure for collecting feedback is as follows:
As one of the measurements of the effectiveness of the quality management system, the organisation needs to gather and monitor information relating to whether the organisation 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 realisation or improvement processes.
If applicable regulatory requirements require the organisation to gain specific experience from post production activities, the review of this experience forms part of the feedback process.
Marketing, Customer Service, Representatives, Technical Services and other departments that may have access to post production information will collect the information about the performance and quality of devices in the post-production phase.
Information regarding post production device experience and feedback may be collected from any credible source, such as:
a). Field service reports
b). Clinical evaluations
c). Customer complaints
d). Reporting to regulatory authorities
e). In-house and independent testing
f). Comparison against similar devices
g). Customer surveys (A Customer Survey is conducted annually to record feedback from Customers)
h). Optometrists and ophthalmic surgeons provide feedback and queries through congress attendance, personal visits, on instant messaging feedback and attendance in theatre
i). Feedback can also be communicated informally to the Managing Director
Information that is directly submitted or provided to any of the sources listed above will be recorded through the Internal Customer Feedback Form. Subsequently this feedback will be accessible in the internal feedback register for review and action.
Customer have the option to submit complaints or compliments using the Envision Africa Feedback button located on the company's website. Any feedback provided through this channel will be directed to the quality@envisionafrica.co.za email address for appropriate handling.
The feedback received will serve as input to the management review meeting and the Customer feedback Trello Board is the processing platform used.
The following process is followed when creating a survey to ensure that the survey is constant with our brand:
a). The survey is drafted by the Marketing department
b). Reviewed by the SBU leaders and the back-office members identified
c). The final review and approval will be done by the COO and CEO
d). Once approved the survey is sent to marketing to make the survey presentable and bring it in line with our branding guidelines.
e). The survey is returned to the customer service manager to distribute to our clients.
The feedback received will serve as input to the management review meeting and the Customer feedback Trello Board is the processing platform used.
Complaints are handle 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.
g) Exchanging of information with external parties when they contribute to the complaint
When a complaint is received the person responsible must evaluate the complaint and decide if it is a non-conformance or not. Any correction or corrective action resulting from the complaint handling process is documented and recorded through SOP Non conformance corrective action
If an investigation determines activities outside the organisation contributed to the complaint, relevant information is to be exchanged between the organisation and the external party involved.
If any complaint is not investigated, justification is to be documented.
All complaints/issues raised by customers that are not non-conformances will be recorded as feedback.
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 realisation or improvement processes. If applicable regulatory requirements require the organisation to gain specific experience from postproduction activities, the review of this experience forms part of the feedback process. Feedback will be presented at the management review meeting
New product requests are handled by the External Providers SOP and the Product Manager
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.
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 26; 15.07.2024 - RB - Change over to SharePoint Site
Revision 25; 20.02.2024. MR - 20.02.2024 - RB - 7. References updated and records linked, 8.3 Removed Customer Service Manager as the primary pathway, 8.5. Updated Customer Complaints, 11. Re-linked records, 8.4. Customer Facing Survey Updated
Revision 24; 30.01.2023 - MR - 30.01.2023 - DK - 8.4. Customer Surveys procedure added
Revision 23; 19.07.2022 - MR - DK 19.07.2022 Customer feedback added from ""SALES, CUSTOMER RELATED PROCESSES & RETURNS"" to "CUSTOMER FOCUS, FEEDBACK and COMPLAINTS""
Revision 22; 25.05.2022 - MR - Updated purpose, 8.5. New Product; updated; 8.3. Customer Feedback updated;
Revision 21, 01.04.2022 - MR - Customer Feedback 8.3. Updated
Revision 20, 19.10.2021 - TNA - updated links for the customer feedback form; V20 MR Approved 20.10.2021
Revision 19, 05.08.2021 - MR - Reviewed
Revision 18, 23.06.2021 - TNA - Updating the SOP to the new format. Approval / Scope / Responsibilities / Risk Based Approach / Records and Revision History.
Revision 17, Digitally signed on 20.08.2020 by WJW
Revision 1-16, unknown due to google site change to new google site
Name Retained in Retention period Hard copies Destroyed by
Customer Survey Records SharePoint Indefinite N/A
Management review Sharepoint indefinte N/A
Internal Feedback Form Google Drive indefinite N/A
Internal feedback Register Google Drive indefinite N/A
Feedback button Company's website N/A
quality@envisionafrica.co.za indefinite
Customer Feedback Processing Trello indefinite N/A
Complaints refer NCCA SOP indefinite N/A