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.
Thursday, July 20, 2006
4.10 Improvement
The laboratory continually improves the effectiveness of its management system through the use of the:
- quality policy
- quality objectives
- audit results
- analysis of data
- corrective actions
- and management review
Interpretation:
This element was added to the 2005 revision of ISO 17025. The addition of this element was squeezed between "Control of nonconforming testing and calibration work" and "Corrective Action". The reason why it was included in the revision was to bring ISO 17025 in line with ISO 9001:2000.
A helpful resource on continual improvement is as follows:
- quality policy
- quality objectives
- audit results
- analysis of data
- corrective actions
- and management review
Interpretation:
This element was added to the 2005 revision of ISO 17025. The addition of this element was squeezed between "Control of nonconforming testing and calibration work" and "Corrective Action". The reason why it was included in the revision was to bring ISO 17025 in line with ISO 9001:2000.
A helpful resource on continual improvement is as follows:
Thursday, July 13, 2006
4.9 Control of nonconforming testing and/or calibration work
4.9.2
Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 must be be promptly followed.
Section 4.11 covers the new requirements for Corrective Actions.
Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 must be be promptly followed.
Section 4.11 covers the new requirements for Corrective Actions.
Wednesday, July 12, 2006
4.9 Control of nonconforming testing and/or calibration work
It is clear that the work of the laboratory is the production of test data. Therefore, nonconforming work is test data that, for some reason, does not meet specifications. Test data may not meet specifications for a variety of reasons, including:
- discovery of defective test equipment
- errors in testing technique
- improper storage of test item
- improper test item preparation; and
- faulty environmental conditions during testing.
When it is discovered that nonconforming work exists, the lab must follow its established procedures to ensure that the deviation is evaluated for significance, and that the customer is notified where necessary. It may also be necessary to halt further work in that area until the problem is eliminated.
- discovery of defective test equipment
- errors in testing technique
- improper storage of test item
- improper test item preparation; and
- faulty environmental conditions during testing.
When it is discovered that nonconforming work exists, the lab must follow its established procedures to ensure that the deviation is evaluated for significance, and that the customer is notified where necessary. It may also be necessary to halt further work in that area until the problem is eliminated.
Tuesday, July 11, 2006
4.9 Control of nonconforming testing and/or calibration work
4.9.1 (c)
The term "corrective action" in this clause actually means "remedial action" and does not mean the same as the "corrective action" in Section 4.11. Apparently this term in this clause was inadvertently not corrected by the ISO/IEC 17025 drafting committee. The final draft standard that was submitted for voting had the term remedial action in the clause.
The term "corrective action" in this clause actually means "remedial action" and does not mean the same as the "corrective action" in Section 4.11. Apparently this term in this clause was inadvertently not corrected by the ISO/IEC 17025 drafting committee. The final draft standard that was submitted for voting had the term remedial action in the clause.
