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ISO 13485 Procedure 841-Root Cause Analysis

Provides a method to assist assigned individuals in performing consistent, complete, satisfactory root cause analysis.

File Size: 149 KB
Format: Word
Language: English
Product Type: Procedures
Provider: 13485 Store

Price: $24.50
Product Details

Features/Benefits:

  • Both the Root Cause Analysis Procedure and the Statistical Techniques Procedure are used to address the requirements of section 8.4.
  • This procedure is used to look into nonconformances.
  • Addresses Cause, Event, Condition, Barrier, Contributing Factor, Organizational Factors, and Root Cause Analysis.
  • The Statistical Techniques Procedure is used to analyze data and make improvements.

Contents:

  • Customizable ISO 13485 Root Cause Analysis Procedure
  • Root Cause Analysis and Action Plan Form

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