EXTERNAL PROVIDERS (Purchasing & Supplier Management)

1. Purpose 

This document provides the process for that all purchases of goods and services are authorised and purchased from Approved Suppliers and to provide for the evaluation of suppliers.

This document covers the process for Purchasing / Control of External Providers and provide the basis for selection, evaluation, re-evaluation of suppliers and the procedure and documentation for purchasing and product verification in compliance of ISO13485.

2. Approval

(Version at end of page)

Signed V31  ML 17.10.2022    

3. Scope

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. 

4. Responsibilities

Approval: Author of the document, Monica Lucas

Changes: Management Team

5. Definitions

External Provider - Supplier or subcontractors that provide materials or services

PRINCIPAL - Legal and Labelled manufacturer of the product

6. Abbreviations

SOP – Standard Operating Procedure

COA - Certificate of Analysis

COC - Certificate of Conformance

7. References

ISO13485 Clause 7.4

Provider Supplier Contracts Quality Agreements

8. Procedure

8.1 Purchasing Procedure (7.4.1)

1. Process: 

a) Supplier Evaluation, 

b) Supplier Selection, 

c) Purchasing Information (and acquisition), 

d) Incoming Goods verification, 

e) Supplier monitoring and 

f) Supplier re-evaluation if required

2. The process covers acquisition of materials and / or products which require specifications and verification activities that affect product Quality, safety and performance of the medical device

3. Outsourced activities e.g. Pest Control, Safety equipment, Auditing via a consultant are through contracts or appointment, as relevant

4. The procedure does not cover Consumables, capital items and auxiliary items, which do not require specifications and verification activities and do not affect product Quality, safety and performance

8.2 Supplier Management

1. Once a critical supplier is approved by management, their details are recorded, as are non-critical suppliers where appropriate 

2. Critical suppliers are the suppliers of critical components, products or components that affect quality, safety and / or performance or are the only supplier - refer RISK

3. The evaluation is as per the SUPPLIER  EVALUATION FORM and re-evaluation may be based on quality, price and delivery and as per SUPPLIER  EVALUATION FORM

4. Records are maintained as reports and / or copies of the ISO certification retained.

5. The supplier evaluations / re-evaluations are followed in Monthly Quality Objectives Measurement as an input to SOP Management Review  to analyse supplier performance

6. Auditing of the supplier may be decided and follows the Internal Audit SOP

7. Any Non-conforming findings follow the same route as for the Non Conformance SOP

8. SUPPLIER MONITORING is done on incoming inspection and the Non Conformance SOP

8.3 Supplier Selection

Before a supplier is listed, the management member will take the following into consideration where relevant:

1. On site assessment and / or evaluation report of the supplier's capability and/or quality systems

2. Evaluation of product samples

3. Past history with similar supplies

4. Inspection / Test results of similar supplies

5. Published experience of other users

6. Service suppliers – skills evaluation

7. On time delivery

8. Price

8.4 Provider Risk Assessment

Suppliers of manufactured products where the supplier is set and monitored as per an exclusive contract agreement, the  Level 0  is assigned where no selection, evaluation and re-evaluation; including a QA agreement, is followed.

Risk is classified as Level 1 (Significant/Critical), Level 2 (Medium) and Level 3 (Low) where the criteria is:

* Top Management reserved the right to conduct on-site audits but with communication to the supplier

8.5 Purchasing Documentation (7.4.2)

1. Purchasing documents contain information to describe the product to be purchased, including where appropriate;

   • requirements for approval of product, procedures, processes and equipment, 

   • requirements for qualification of personnel, and 

   • quality management system requirements

2. The above 3 items are covered in the by the sub-contractor agreements and part of financial practices e.g. Purchase Order, Delivery Notes. 

3. The purchasing records must be sufficient to provide for traceability; which may include Sterilization certificates/ COA/ COC.

8.5.1 QA Agreements

Purchasing information includes, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements.

This aspect also applies to OUTSOURCED activities (ISO 13485 4.1.5)

The template QA Agreement  can be applied

Note that the contract must specify roles and responsibilities;, although not actually recorded the title 'Contract Giver' and 'Contract Acceptor' the;

Contract Giver - as Werkomed (Pty) Ltd / Klinica SA

Contract Acceptor - the external providers name

The contract maybe in the format of the External Provider as the contract giver to Werkomed (Pty) Ltd / Klinica SA as the contract acceptor in term as of financial obligations however,  Werkomed (Pty) Ltd / Klinica SA will ensure any aspects related to  safety and performance/ efficacy of the health product is covered.

8.6 Verification of Purchased Product (7.4.3)

1. The inspection of received goods by the Warehouse personnel, by checking physical goods against the supplier invoices (submitted with delivery). Any certificates of Sterilization, conformance or analysis, if any, are kept on file.

2. All certificates of sterilization, analysis or conformance to be verified against the batch numbers, expiry dates as applicable and as referenced on supplier invoice. 

3. Supplier Invoices are to be filed by the finance department, as the the supplier invoice number if referenced against the GRV (goods received voucher) on Pastel.

8.7 Essential Requirements

1. The organization provides this procedure to ensure that purchased products and materials specified purchase requirements generally in the format of agreed specifications.

2. The type and extent of control applied to the supplier and the purchased product  depends on the effect of the purchased product on subsequent product realization or the final product

3. For subcontract manufactured products and sterilization activities this is covered by the sub-contract agreements, where ISO13485 is a pre-requisite

4. The organization or sub-contractor evaluates and selects suppliers based on their ability to supply product with the organization's requirements. Criteria for selection, evaluation and re-evaluation are defined and the results of evaluations and any necessary actions arising from the evaluation are reported

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

The analytical reviews of supplier performance, and any other quality related matters, are reported to management and as part of the input to management review refer Data Analysis

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 31; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML.

Revision 30; 06.10.2021 - ML - Digitally signed by ML.

Revision 29; 05.10.2021 - NH - updated items 8.6 Verification of purchased products (7.4.3)

Revision 28; 14.09.2021 - TNA - amended links

Revision 27;  02.08.2021 - ML -  POPI act information included. Digitally signed by ML

Revision 26;  10.05.2021 - ML -  Digitally signed by ML

Revision 25,  06.05.2021 - TNA - addition of item 8.5.1

Revision 24, 30.04.2021 - TNA - New format with Approval / Scope /Responsibilities, Risk based approach and Records and revision history added and new google site format.  Amending links and Forms

Revision 23,  Digitally signed on 28.01.2020 by ML

Revision 1-22, unknown due to googlesite change to new googlesite

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Suppliers Orders, Delivery notes, Certificates Finance 5 years n/a

SUPPLIER  EVALUATION FORM Google Site indefinite n/a

SUPPLIER  EVALUATION record FORM Google Site indefinite n/a

SUPPLIER QUESTIONNAIRE   Google Site indefinite n/a

SUPPLIER RECORD SHEET Google Site indefinite n/a