ISO 17025 Quality Manual Template
Monday, July 24, 2006
4.11 Corrective action
The lab must have a procedure for implementing corrective action when nonconforming work or departures from policies and procedures in the quality management system or technical operations have been identified. The procedure requires that appropriate authority be designated for the implementation of corrective actions. The procedure includes cause analysis, selection and implementation of corrective action, and monitoring of actions.
Interpretation:
This section deals with correcting a problem that has been evaluated to be either potentially repetitive or that there is a doubt on the procedures. The investigation is a root cause analysis that will ultimately root out all the potential causes of the problem allowing the lab the ability to evaluate different solutions and select the best one to implement to prevent recurrence. The correction of 4.9.1 (c) is the correction of the immediate problem, where the corrective action of 4.11 and the ensuing root cause analysis extends beyond the immediate problem corrected and considers related systems and processes.
Interpretation:
This section deals with correcting a problem that has been evaluated to be either potentially repetitive or that there is a doubt on the procedures. The investigation is a root cause analysis that will ultimately root out all the potential causes of the problem allowing the lab the ability to evaluate different solutions and select the best one to implement to prevent recurrence. The correction of 4.9.1 (c) is the correction of the immediate problem, where the corrective action of 4.11 and the ensuing root cause analysis extends beyond the immediate problem corrected and considers related systems and processes.
