MANUFACTURE

1. Purpose

This document provides the process for Manufacture

This document covers the procedure for the practices that must be followed for compliance of ISO13485 

2. Approval

(Version at end of page)

Signed V2 NG 25.09.2025

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

Manufacture - Good Manufacturing Practice (GMP) to provide and control Resources to apply activities to produce a product

Resources - People, Materials, Infrastructure, Methods [instructions / test], environment , Money

6. Abbreviations

GMP - Good manufacturing, distribution, storage, stock management practices

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure

7. References

ISO13485 Clause 6.3 & 4

SOP Non-Conformance, Deviations and Concessions & Corrective Action 

SOP Cleanliness, Health & Safety

SOP Infrastructure & Environment

8. Procedure

8.1 Manufacture (ISO13485 7.5 Product realization)

Product realization SOP

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

10. Revision History

Revision 2 NJG 25.09.2025

Revision 1; new 9.09.2024