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
