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International Standards Organization (ISO)

Quality Systems Essentials in ISO 15189 contains the following standards:

  • 4.9 Identify and control nonconformities requires the documentation of the occurrence, performance of root cause analysis, and corrective action to be taken.
  • 4.10 Indicates corrective actions must be documented and monitored for effectiveness of the actions over time.
  • 4.11 Preventative Action Plan must be in place for quality improvement.

Examples of occurrences given in the standards include:

  • testing performed on the wrong sample type
  • use of expired reagent
  • modification of a procedure without approval
  • incorrect incubation time
  • tap water used when distilled water is required
  • improper preservation of a sample saved for later testing