Equipment & Calibration Management System (ISO 13485 Clause 7.6)

Equipment and calibration controls often become fragmented between spreadsheets, service providers, and paper stickers, leaving no clear record of status or impact. This system gives you the structure to control equipment identification, calibration status, checks, and impact decisions in line with clause 7.6. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Equipment Management SOP.docx
• Calibration Request and Result Form.docx
• Equipment Data Sheet.docx
• Calibration Master Register.xlsx
• Equipment Check Log.xlsx
• Equipment Impact Assessment.xlsx
• Equipment Status Labels.pdf
• Consolidated Equipment Register.xlsx
• Implementation Guide.pdf

Best suited to: Quality manager, Production lead, Maintenance lead, and Regulatory consultant.

Useful in audit situations where you need to:

• Show a structured equipment and calibration control process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to equipment and calibration control.
• Support EU MDR technical documentation or quality-system reviews where equipment and calibration control records need to be complete, controlled, and consistent.

Use this system to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 framework.