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 V12  HJM.  26.03.2024

3. Scope

The process covers all documents and process and products as defined in the SOP

4. Responsibilities

Approval: Author of the document, Alexi Arhondonis, SCR RP

Changes: Author of the document, Alexi Arhondonis 

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

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

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 

8. Procedure

8.1 Infrastructure & Environment (6.4)

Infrastructure Definition
Infrastructure Requirements

8.2 Layout Diagram for premises

Infrastructure & Environment

001 Site Plan.pdf
002 Ground Floor Layout RevB.pdf
003 Mezzanine Floor Layout RevB.pdf

8.3 Maintenance

Maintenance requirements: -

In the event of a non conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed  


Maintenance Requirements

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 12, 26.03.2024 - HJM - Deleted duplicate point 8.3 Maintenance

Revision 11, 15.03.20221 - AA, SCR RP - new floor plan/updated maintenance schedule for Pharmacy

Revision 10, 19.08.2021 - AA - new floor plan/updated maintenance schedule(forklift) and addition of 4 new definitions

Revision 9, 01.07.2021 - TNA - updating responsibilities

Revision 8, 03.05.2021 - AA Approved

Revision 7, 28.04.2021 - TNA - New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new google site format.  Amending of Links and forms

Revision 6,  Digitally signed on 06.07.2020 by AA

Revision 1-5, unknown due to google site change to new google site

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

None n/a n/a n/a