Measurement and Analysis Procedure Template - ISO 13485
Measurement and Analysis Procedure Template - ISO 13485
Template Overview
Template Overview
Ensure effective monitoring, measurement, and analysis of your Quality Management System (QMS) with our ISO 13485:2016 Clause 8.4 Measurement & Analysis Procedure Template. Systematic data collection and analysis are critical for identifying trends, improving product quality, and ensuring regulatory compliance in medical device manufacturing. This ready-to-use procedure template provides a structured approach to defining measurement methodologies, analyzing performance data, and ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.
Key Features
Key Features
✔ Pre-Formatted Measurement & Analysis Procedure – Covers key ISO 13485:2016 Clause 8.4 requirements.
✔ Performance Monitoring & Data Collection Methods – Define KPIs, process control metrics, and data sources.
✔ Trend Analysis & Statistical Techniques – Ensure effective identification of quality and compliance trends.
✔ Customer Feedback & Complaint Data Assessment – Integrate post-market surveillance insights.
✔ Risk-Based Approach & CAPA Link – Align with ISO 14971 risk management and corrective action requirements.
✔ Audit-Ready Reporting & Documentation – Maintain records for regulatory inspections and QMS reviews.
✔ Editable Digital Format – Fully customizable for various medical device business models.
Why choose a QMS Template?
Why choose a QMS Template?
This structured measurement & analysis procedure is ideal for quality managers, compliance teams, and regulatory professionals, ensuring data-driven decision-making and continuous improvement.
Download the ISO 13485:2016 Measurement & Analysis Procedure Template today and enhance your quality management system!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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