SERVICE PROVISION OPERATION

1. Purpose 

This document provides the the process for Product / Service Realization.  This document covers the procedure for the practices that must be followed for compliance of ISO13485 

2. Approval

(Version at end of page)

Signed V10 SZ 29.04.2024

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, Henry Manyike

Changes: Author of the document, Simangele Zungu

5. Definitions

Product/ Service realization - Enabling the service process or workflow to be realized through quality assurance, quality control and following a documented and recorded quality management system

Infrastructure - building, lights, floors, windows, perimeter, equipment relevant to the operations / SHEQ

Environment - the working condition appropriate to GMP / requirements of the product e.g. cleanliness, storage conditions

Rework - the action of redoing a production procedure for an item / batch in order to correct a defective / faulty aspect/s (eg: packaging /  labelling / out of specification) mainly in regards to disposable products

Repair - is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again

Maintenance - this is required for preserving the condition of an item (infrastructure, machinery, products) 

Refurbishment - the process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration (eg: sharpening scissors)

6. Abbreviations

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure

7. References

ISO13485 Clause 7.5

SOP Non-Conformance, Deviations and Concessions & Corrective Action 

8. Procedure

8.1- 7 Product / Service realization

8.1.1- 7.1 Planning of Product/ Service realization

The organization plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system and one or more processes for risk management in product realization may be documented within the SOP or separately

Process

• 1. Supplier Principal Stock Receipt

  2. Stock Management

  3. Marketing and Sales

  4. Sales Order Processing (through Sage refer to document on Google Drive)

  5. repairs & Maintenance

  6. User Training and Advertising

  7. Warehousing and Logistics

  8. Financial Transactions / Administration (no specific SOP)

In planning product realization, the following is determined, as appropriate and documented below:

a) quality objectives and requirements for the product;

b) the need to establish processes and documents and to provide resources specific to the product, including infrastructure and work environment;

c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet requirements 

The output of this planning is documented within the google site for the organization’s method of operations.

8.2 Related Procedures

Located in Operational Procedures TAB

refer:   SOP 7.2 Customer-related processes; 

                7.2.1 Determination of requirements related to product & 

                7.2.2 Review of requirements related to Product

refer to SOP 7.2.3 Communication 

7.3 Design and development - excluded as the company is not a manufacturer

7.4 Purchasing / External Providers

7.5 Production and service provision

7.5.1 Control of production and service provision

7.5.2 Cleanliness of product

7.5.3 Installation activities - not applicable as not part of the operations

7.5.4 Servicing activities - not applicable as not part of the operations

7.5.5 Particular requirements for sterile medical devices - not applicable as not the manufacturer of sterile products

7.5.6 Validation of processes for production and service provision - not applicable as not the manufacturer of sterile products

7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems - not applicable as not the manufacturer of sterile products

refer to SOP 7.5.8 Identification, 

                  7.5.9 Traceability, 

                  7.5.10 Customer property,

                 7.5.11 Preservation of product, 

refer to SOP 7.6 Control of monitoring and measuring equipment

In the event of and non conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action 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 10, 29.04.2024 - SZ - approval by HM

Revision 9, 18.05.2022 - NT - approval by HM

Revision 8, 16.11.2021 - NT - signed off from TNA

Revision 7, 27.08.2021 - TNA - updating responsibilities / addition of 4 new definitions

Revision 6, 04.02.2021 - TNA - New format with Responsibilities, Risk based approach, Approval and Records added and new google site format.   Amending links and forms

Revision 5, Digitally signed on 04.10.2019 by TNA

Revision 1-4, unknown due to google site change to new google site

11. Records

Name                               Retained by/ in Retention period Hard copies Destroyed by

Refer to relevant SOP or work instruction Google Site         indefinite                 n/a