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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Supplied as one editable Microsoft Word document in a digital download.
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
Sampling plans and acceptance methods
Statistical analysis for product and process data
Documentation and interpretation of results
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.
Statistical methods for sampling and validation data
Choose this procedure when you need documented statistical techniques to support medical device sampling plans, failure analysis or validation data analysis. Its listed sections cover normal and nonparametric statistical tolerance limits, hypothesis tests for means and variances, normality tests, control charts, quality inspection, process capability and attribute data.
Connect the method to the study
Use the section list and document previews to check whether the procedure addresses the analysis you need. Sampling and inspection decisions, validation data analysis and ongoing process monitoring have different objectives. Select and justify the method for your study, data and acceptance criteria before applying it.
For the wider manufacturing validation workflow, see the separately sold Medical Device Process Validation Procedure. The statistical procedure supports method selection and analysis; the process-validation procedure addresses the broader validation strategy.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Process Validation: Protocols, Statistics and Mold Processes for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in ISO 13485 Process Validation Procedure Bundle. Explore the bundle for the related documents.
