Statistical Techniques Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis.

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Statistical Techniques Procedure

The Statistical Techniques Procedure provides guidance on statistical analysis methods used to support medical device sampling plans, failure analysis and validation data analysis.

Statistical Techniques Procedure - Overview

The Statistical Techniques Procedure is structured in the following manner:

• SECTION 1 - Safety Evaluation/Risk Analysis

• SECTION 2 - Statistical Tolerance Limits - Normal Distribution

• SECTION 3 - Statistical Tolerance Limits - Nonparametric Distribution

• SECTION 4 - Tests of Hypothesis of the Mean and Variance

• SECTION 5 - Tests for Normality

• SECTION 6 - Quality Control Charts

• SECTION 7 - Quality Inspection

• SECTION 8 - Process Capability

• SECTION 9 - Attribute Data

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.