CUSTOMER FOCUS, FEEDBACK and COMPLAINTS

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, 8.2.3, 8.3, 8.5.2, 8.5.3

SOP Regulatory Control

SOP Non Conformance Corrective Action

SOP Product Recall

SOP Post Market Surveillance

Management Review

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 .

Any Medical Complaints received will be evaluated to determine whether the issue constitutes a Reportable Adverse Incident, with appropriate reports being filed with the relevant Regulatory Bodies.

Should any complaint lead to a Reportable Adverse Incident refer SOP Regulatory Control and / or , SOP Adverse event & Recall. Any further investigation required will be performed without delay. Should any physical investigation of a device or sample of a batch be required, this will be done with reference to Compliance to ensure that the relevant Competent Authorities are informed about any testing that may affect any subsequent evaluation of the causes of the incident.

Complaints that have triggered an Adverse Incident Report, will be clearly identifiable in the Google Folder - refer SOP Adverse event & Recall.

All confirmed Technical and Medical complaints will be further evaluated by the relevant manufacturing site, with a determination made as to the need for further containment and/or corrective actions.

Information relating to Customer Complaints will be tracked/trended and communicated through periodic reports and Management Review.

Access to Customer Complaint records in the Google Folder is restricted to personnel with appropriate training.

8.2 Customer Focus (5.2)

Top management ensure that customer requirements and applicable regulatory requirements are determined and met refer Quality Manual

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. 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. This report is submitted to the Director

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 on a monthly 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 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.

8.5 New Products

In the event of a new product then a Motivation is completed by the sales representative.

In the event of non-conformances then the procedure Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed

9. Risk Based Approach

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

Risk Based Approach Report

[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 2 NG 13.02.2025 PT 8.1 Added hyperlink to Adverse Event and Recall in sentence. PT 8.3 changed weekly to monthly.

Revision 1 New, HJM 5.09.2024

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Complaints refer NCCA SOP

Customer Feedback input to management

review

Page updated

Google Sites

Report abuse