Equipment & Calibration Management System (Clause 7.6)

Who This Kit Is For

Metrology, QA and production teams who must manage measuring and monitoring equipment and calibration under clause 7.6.

The Compliance Problem It Solves

• Scattered equipment lists and inconsistent calibration records.
• No clear criteria for equipment criticality, calibration intervals or actions when equipment is found out of tolerance.
• Audit concern around traceability of measurements to standards and impact assessment on product.

What You Get In This Kit

• Equipment management and calibration SOP aligned with ISO 13485 clause 7.6.
• Equipment register, calibration schedule and calibration record templates.
• Impact assessment and nonconforming equipment handling forms.

How This Kit Reduces Your Audit Risk

• Provides full visibility of measuring equipment, status and calibration history.
• Ensures equipment is calibrated on time and nonconformities are investigated for product impact.
• Supports traceability and confidence in product measurements and test results.

How To Implement It (Step-by-Step)

1. Download the system and create a complete inventory of monitoring and measuring equipment.
2. Assign criticality, calibration intervals and responsibilities using the templates.
3. Track calibration events and record results using the standard forms.
4. When issues arise, document impact assessment and actions using the provided forms and link them to CAPA if needed.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 clause 7.6.
• Typical use: manufacturing, laboratory and service equipment control.
• Document type: equipment and calibration management system.