The Article provided below shows you exactly what you will receive when you purchase our Facility, Plant and Equipment Maintenance Procedure (SYS-005)
The purpose of this procedure is to establish requirements for infrastructure and ensure its maintenance.
This procedure covers buildings, workspace, associated utilities, process equipment and supporting services.
This is the primary document meeting the applicable regulatory requirements for Infrastructure as defined in the Quality System Manual (POL-001).
The documents included within this procedure are shown below. These documents are updated for ISO 13485:2016 and the new European Regulations. The following is a list of documents included:
- SYS-005 A, Facility, Plant and Equipment Maintenance Procedure
- LST-006 Equipment Register
Below is a sampling of text from within the procedure;
|Record||Description||Storage and Retention|
|Equipment File||A file for an item of equipment, plant or infrastructure. Contains a copy of the Requisition, maintenance and calibration records, manuals and other related documents.||Set of folders by equipment number, under the Equipment Folder in default record location. Retained according to record retention requirements and the trigger for starting period is obsolescence of equipment.|
|Equipment Register, LST-006||Sequential list of equipment number assignments requiring maintenance records.||Log maintained by Quality Manager. Retained indefinitely.|
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SYS-005 Facility, Plant and Equipment Maintenance Procedure
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