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 ISO 13485.

2. Approval

(Version history at end of page)

Signed V22 RB 15.07.2024

3. Scope

The process covers all documents and process and products as defined in the Standard of Procedure. 

4. Responsibilities

Approval: Author of the Document, Marelize Robertson

Changes: Author of the Document, Rachel Belcher 

5. Definitions

External Provider - Supplier or subcontractor that provides materials or services

Principal - Legal manufacturer of the product, whose name appears on the product

Classified - A product that falls within the definition of "Medical Device" as defined by SAHPRA, and thus is class A, B, C or D; is said to be "classified"

6. Abbreviations

SOP – Standard Operating Procedure

COA - Certificate of Analysis

COC - Certificate of Conformance

7. References

ISO 13485 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. Initial Supplier Evaluation

For all new suppliers, the department that the supplier pertains to is responsible for submitting the documentation on behalf of the supplier 

1. Request the supplier to complete the supplier evaluation form the information received from the supplier should be submitted to QMS.

2.  Submit the information received to QMS by completing the External Provider Questionnaire, before any orders are submitted to the external provider.  This questionnaire is to be completed only once per external provider.  The Provider Risk Assessment is used as a reference for the evaluation criteria.

3.  Upon completion of the External Provider Questionnaire, the QMS administrator must evaluate the response using the External Provider Evaluation with reference to the information recorded in Questionnaire Responses, and the risk assessment matrix below.

4.  All the documents that the Supplier has claimed to possess in the above questionnaire must be reviewed for legitimacy, and a digital copy of each document must be kept in the Medical Device File per supplier that is stored on the QMS cloud drive.  If the documents were not submitted with the questionnaire, then they must be added by way of amending the record within 14 days of the questionnaire submission.  

5.  Once the External Provider is approved, the QMS administrator will inform the relevant person if the supplier is approved or if any other documentation is outstanding, the Supplier list is concluded 

6.  The Renewal board on Trello will assist with making sure the certification provided is still valid. To this end, the QMS administrator (Authorised Representative) must notify the Supplier of the deficiency, except in the case of supplier/distributor agreement, which is obtainable from management (being a bilateral agreement)

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. Supplier Evaluation & Re-evaluation 

Suppliers are evaluated by, and where appropriate, as per RISK above

1. Documents reviewed include subcontract agreement, ISO13485 and certificate documents and / or product reports

2. Auditing of the supplier may follow the Internal Audit SOP

3. The SUPPLIER QUESTIONNAIRE is issued and completed by the Supplier and Management perform the SUPPLIER EVALUATION FORM to evaluate new or existing suppliers, if Level 1 or 2

4. Re-evaluate a Supplier if established due to poor service delivery or consistent quality concerns or post supplier monitoring where price, delivery time and quality of product is examined

5. Suppliers are re-evaluated as per the Risk table and / or when there are any changes, when required for critical suppliers if the Internal audit findings substantiate and / or as a result of data analysis of management review

8.6. Product Evaluation

Once the supplier has been approved, a product evaluation must be completed for each product that Envision Africa intends to order, before any orders are placed with the supplier (other than for samples). The product evaluation is to be conducted in accordance with the following procedure:

1. Any member of management can request that a product be added to the list of approved products by completing a New Product Request form

2. The management representative must then review the product using the Product Review Form

3. Should the product be approved, approval will automatically be recorded in the Sheet

4. The management representative will then communicate the approval via email to whoever requested the product

5. The Sheet serves as a database of approved product

8.7. 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 Sterilisation certificates/ COA/ COC.

8.7.1. QA Agreements

Purchasing information includes, as applicable, a written agreement that the supplier notify the organisation 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 record the title 'Contract Giver' and 'Contract Acceptor' the;

Contract Giver - as Envision Africa (Pty) Ltd

Contract Acceptor - the external provider's name

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

8.8. Verification of Purchased Product (7.4.3)

1. The inspection of received goods by the Warehouse personnel, by checking against invoices, certificates of conformance (submitted with delivery) and delivery notes, and where applicable sterilisation certificates and certificates of analysis, to ensure the products (and other items where required) meets specified purchase requirements

2. Where the organisation or its customer intends to perform verification at the supplier's premises, the organisation shall state the intended verification arrangements and method of product release in the purchasing information.

3. All certificates of sterilisation, analysis or conformance to be verified against the batch numbers, expiry dates as applicable and the certificates to be stamped / or written approved, initialed and dated as evidence of verification

4. Certificates are to be filed by the finance department with the financial documents 

8.9.  Essential Requirements

1. The organisation 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 realisation or the final product

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

4. The organisation or sub-contractor evaluates and selects suppliers based on their ability to supply product with the organisation'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.

The Risk Assessment to is found in SOP Preventative 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 22; 15.07.2024 - RB - Change over to SharePoint Site

Revision 21: 24.08.2022 - MR - DK 24.08.2022 - External provider form  added and linked under 8.2

Revision 20; 14.10.2021 - MR - Updated Responsibilities, 8.2 Documentation location

Revision 19; 05/08.2021 - MR - Reviewed

Revision 18, 23.06.2021 - TNA - New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added in the new google site format.  amending links and forms

Revision 17, Digitally signed on 10.05.2020 by WJW

Revision 1-16, unknown due to google site change to new google site

11. Records

Name Retained 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 sheet Google Site indefinite n/a

SUPPLIER QUESTIONNAIRE Google Site indefinite n/a

Supplier list Google Site indefinite n/a