SALES, CUSTOMER RELATED PROCESSES & RETURNS

1. Purpose 

This document covers the process for sales and returns in compliance of ISO13485. This procedure provides the process for Customer requirements, Sales, Returns and determining and reviewing the needs of the customer and receiving customer feedback for input into management review and post market surveillance 

2. Approval

(Version at end of page)

Signed V2 NG 13.02.2025

3. Scope

The process covers all documents and process and products as defined in the SOP

4. Responsibilities

Approval: Bruce Manuel

Changes: Nicholas Gilbert

5. Definitions

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

Internal Quality Feedback (QFB) - Methodology used for communicating quality / process issues between sites and departments within the company.

Returns – Products that are returned for various reasons e.g. not ordered, damaged, faulty, customer complaint.

6. Abbreviations

SHEQ - Safety, Health, Environment and Quality

SOP - Standard Operating Procedure

NCCA – Non Conformance Corrective Action Record

7. References

ISO13485 clauses 7.1, 7.2, 8.2.1

Change Control SOP

Warehousing, Preservation, Identification and Traceability SOP

Non-Conformance, Deviations and Concessions & Corrective Action SOP 

Management Review SOP

Regulatory Control

Promotional & Training Material

8. Procedure

8.1 Essential Principles

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.

8.2 Customer Related Processes

Sales process follows the standard order receipt, pick and pack, dispatch and invoice financial process.

Purchase order received from customer, admin department confirms the order with the client and generate a sales order once the order has been confirmed. Stores department checks stock availability and dispatch if stock is available, upon receipt of invoice and delivery note from finance department.

Stores department liaise with ordering department to order if no stock available and orders are placed with suppliers.  Once stock is received from suppliers then verification and recording of stock is done into the system. Once stock has been verified and recorded then invoice and delivery note are generated for stores department to dispatch.

8.3 Returns

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

Incase of a faulty unit the following procedure is to be followed:

1. Fault identification by the technical department 

2. Non conformance generated (internal) and corrective action deadline identified 

3. Supplier returns sheet completed by Admin Department documenting all details 

4. Faulty component booked into non conformant materials section and labelled with customer name and supplier returns reference form document number

5. Return to supplier scheduled 

6. Supplier either replaces component under warranty or formulates estimate for repairs 

7. Quotation received from supplier 

8. Quotation formulated to customer 

9. Approval – repairs are given go ahead or replacement part ordered via email

10. New component / repaired part delivered to PMB Health  premises or collected from supplier

11. Component labelled and technical department advised to repair the equipment 

12. Equipment placed in outgoing bay  

13. Return to customer scheduled

14. Component monitored in system over period of two days to verify fully functional 

15. Non conformance case closed and follow up corrective action completed 

Warehousing, Preservation, Identification and Traceability SOP to be followed

8.4 New Products

In the event of a new product the SOP Change Control and the SOP Regulatory processes for product registration and safety & performance processes are followed

8.5 Non Conformances

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

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.

10. Revision History

Revision 2; NG 13.02.2025 Change ownership

Revision 1 New, HJM 9.09.2024

 11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Sales   As required by the SOP / FICA           5 years Management Representative

Customer Feedback Sales staff transferred verbally or in reports   5 years       Management Representative

stored on the Google Drive