GLOSSARYGlobal
ISO 13485 Clause 8
Measurement, analysis, and improvement: feedback, complaints, internal audits, nonconforming product, data analysis, and corrective and preventive action.
What each part covers
- 8.1
- Plan and implement the monitoring, measurement, analysis, and improvement processes needed to show product and system conformity.
- 8.2
- Monitor information on whether customer requirements were met, handle feedback and complaints, report to regulators, and conduct internal audits at planned intervals.
- 8.3
- Identify and control nonconforming product so it is not used or delivered unintentionally.
- 8.4
- Collect and analyze data to show the system is suitable, adequate, and effective, and keep records of the analyses.
- 8.5
- Act to remove the causes of nonconformities so they do not happen again, and the causes of potential nonconformities so they do not occur.