INFRASTRUCTURE & ENVIRONMENT

1. Purpose

This document provides the process for Infrastructure and Environment.

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 01.07.2025 

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

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

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

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 External Providers (Purchasing & Supplier Management)

8. Procedure

8.1 Infrastructure & Environment (ISO13485 6.3, 6.4)

The organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product IN ACCORDANCE WITH THE QA AGREEMENT 

Infrastructure and maintenance are part of the OUTSOURCED arrangements refer OUTSOURCED ACTIVITIES

8.2 Maintenance & PLANNED MAINTENANCE

• 1. Under Infrastructure and Environment the organization provides requirements for the maintenance and planned maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As appropriate, the requirements apply to equipment used in operation, the control of the work environment and monitoring and measurement and records of such maintenance are maintained. This is provided through the Outsourced Subcontract Manufacturer or Outsourced  Activities.

  2. Work environment and contamination control (6.4) follows above however if any maintenance, or preventative maintenance of furnishings, fittings or equipment is required, then it is to be reported to the Manager in order for the maintenance to be arranged. 

  3. This preservation includes identification, handling, packaging, storage, and protection and also applies to the basic parts of a product

  4. Suppliers are approved by SOP External Providers 

In the event of any reported to PMB a non conformance incident can be logged following SOP Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed  

8.3 Control of Monitoring and Measuring Equipment (7.6)

1. Where there is monitoring and measurement  undertaken, the monitoring and measuring equipment needed to provide evidence of conformity of product to determine requirements.

2. This is provided through the Outsourced Subcontract Manufacturer or Outsourced  Activities.

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

An analytical review is reported monthly to management and this forms part of the input through Data Analysis to management review 

The Trend should pick up 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 01.07.2025 changed ownership. PT 8.2.2 removed general manager.

Revision 1 -  New HJM 5.09.2024

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Maintenance Records OSM / OQ