This guidance document is intended for medical device manufacturers and regulatory authorities. It is intended for educational purposes and is not intended to be used to assess or audit compli-ance with regulatory requirements. It is expected that the reader is familiar with regulatory Qual-ity Management System (QMS) requirements within the medical devices sector.
For the purposes of this document it is assumed that the medical device manufacturer has a QMS which requires the manufacturer to have documented processes to ensure that medical devices placed on the market are safe and effective. For example ISO13485 Medical Devices â€“ Quality Management Systems â€“ ...view middle of the document...
Regardless of the nature of the data source, if there is a decision to escalate the information to further evaluation and investigation, the steps of investigation, identification of root causes and actions needed, verification, implementation, and effectiveness checks will be similar.
This guidance document will describe measurement, analysis and improvement as complete and integrated processes.
This document provides guidance for establishing adequate processes for measurement, analysis and improvement within the QMS as related to correction and/or corrective action for noncon-formities or preventive action for potential nonconformities of systems, processes or products.
The references to clauses in this section refer to ISO 9000:2005.
Action to eliminate a detected nonconformity (3.6.2)
Note 1 A correction can be made in conjunction with corrective action (3.6.5)
Note 2 Corrections can be, for example, rework (3.6.7) or re-grade (3.6.8)
2.2 Corrective action
Action to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situ-ation
Note 1 There can be more than one cause for nonconformity
Note 2 Corrective action is taken to prevent recurrence whereas preventive ac-tion (3.6.4) is taken to prevent occurrence
Note 3 There is a distinction between correction (3.6.6) and corrective action
2.3 Data Sources
The processes within a...