ISO 13485 Procedure 840-Statistical Techniques

Describes and defines the techniques utilized in statistical analysis used to monitor and measure the QMS and related sub-systems.

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Format: Word
Language: English
Product Type: Procedures
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  • Both the Statistical Techniques Procedure and the Root Cause Analysis Procedure are used to address the requirements of section 8.4.
  • This procedure is used to analyze data and make improvements.
  • Includes information on Variability, Statistical Process Control (SPC), Specifications and Process Capability.
  • The Root Cause Analysis Procedure is used to look into non conformance's.


  • Customizable ISO 13485 Statistical Techniques Procedure

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