CUSTOMER FOCUS, FEEDBACK and COMPLAINTS

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.

4. Responsibilities

Approval: Managing Director, HM

Changes: HR, SZ

5. Definitions

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

6. Abbreviations

CA - Corrective Action

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure

7. References

ISO13485 Clause 7.2, 8.1, 8.2.2, 8.3, 8.5.2, 8.5.3

SOP Regulatory Control

SOP Non Conformance Corrective Action

SOP Product Recall

SOP Post Market Surveillance

8. Procedure

This procedure provides the process for managing Customer, feedback and customer complaints.

8.1 Essential Principles

The company establishes the customer requirements related to product refer SALES, CUSTOMER RELATED PROCESSES & RETURNS.

8.2 Customer Focus (5.2)

Top management ensure that customer requirements and applicable regulatory requirements are determined and met refer SALES, CUSTOMER RELATED PROCESSES & RETURNS

8.3 Customer Feedback (8.2.1)

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, where only SA market feedback is covered as this is not a manufacturer.

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.

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.

A report from Sales provides feedback on the activities performed by the representative, including customer feedback FORM. This report is submitted to the Managing Director.

The staff are to follow;

a) Staff in theatre fill out a customer feedback FORM (can be through their phone & CRISE permit required)

b) Staff attending congress or Exhibition to fill out customer feedback FORM

c) Staff that deliver / collect products to fill out a customer feedback FORM

Data form Feedback forms are collected in the SHEET

Feedback is therefore reviewed by management on a weekly basis, (???) this can then be included as input in the management review.

8.4 Customer Complaints (8.2.2)

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 requires:

a) the quality system administrator to record the receiving of the complaint and recording information;

b) the information is evaluated to determine if the feedback constitutes a complaint;

c) the complaint is then investigated to determine the cause to determine if an incident has occurred in regards to the product. If any complaint is not investigated, justification is to be documented.

d) the quality system administrator advises the MD to determine the need to report the information to the appropriate regulatory authorities;

e) any complaint-related product is handled as per SOP WAREHOUSING, PRESERVATION, IDENTIFICATI0N & TRACEABILITY and placed in QUARANTINE until resolved

f) the quality system administrator determines the need to initiate corrections or corrective actions. 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.

9. Risk Based Approach

In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]

9.1 Trend Analysis and Continual Improvement

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.

10. Revision History

Revision 15, 17.02.2026 - HJM - Pt 8.1 Correction of SOP name on hyperlink. Pt 8.2 Correction of SOP name on hyperlink. Pt 8.3 Adding of info to this section together with the amendment of info in the paragraph. Naming of documents from DRIVE to SOP corrected. Post Market Surveillance not done so sentence removed. Pt 8.4 Tidying up of the detail under this pt including the Procedure Requirements (a - f). Pt 8.5 Correction of last sentence in this section wrt NCCA. Removed and pasted into Sales, Customer Related Processes & Returns SOP

Revision 14, 05.03.2024 - SZ - 8.3. new feedback form added - approved

Revision 13, 18.05.2022 - NT - approval by HM

Revision 12, 16.11.2021 by NT - adding the Customer Satisfaction Survey link

Revision 11, 30.09.2021 by NT - adding information on New Products and links to the Google Drive.

Revision 10, 03.03.2021 by NT - updating Responsibilities and New Products

Revision 9, 04.02.2021 (TNA) Updating the SOP to the new format. Approval / Risk Based Approach / Records and Revision History. Amending Links and Forms

Revision 8, Digitally signed on 01.07.2019 by TNA

Revision 1-7, unknown due to googlesite change to new googlesite

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Complaints refer NCCA SOP

Customer Feedback Sheet input to management review

Page updated

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