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 AA. 20.06.2024
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)
8.2 Layout Diagram for premises
Site Layout,
Ground Floor
Mezzanine Floor
Quarantine Area
Infrastructure & Environment
001 Site Plan.pdf002 Ground Floor Layout RevB.pdf
003 Mezzanine Floor Layout RevB.pdf8.3 Maintenance
Under Infrastructure and Environment the organization provides requirements for the 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.
Work environment and contamination control follows above however if any maintenance, or preventative maintenance of furnishings, fittings or equipment is required, then it is to be reported to the General Manager or Warehouse Manager in order for the maintenance to be arranged.
This preservation includes identification, handling, packaging, storage, and protection and also applies to the basic parts of a product
Supplier are approved by SOP External Providers
Preventive maintenance activities include equipment , vehicles, computers, facility checks by management on a regular basis. The ideal preventive maintenance program would prevent all equipment failure before it occurs.
Maintenance requirements: -
In the event of a non conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed
9. Risk Based Approach
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
[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, 20.06.2024 - AA - 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