I am working to build an integrated QMS for a calibration lab and an inspection body which are established under the same company.
The proposed accreditation scope of the calibration lab is as below:
1. Heat cells
3. Pressure (up to 75 bar)
4. Non-automatic weighing scales (up to 150 kg)
The inspection body's scope is inspection of clean rooms and zones according to ISO 14664-1, -2 and -3.
Anyway, I have constructed a QMS documentation as belows:
2. Procedure 1 - Control of documents and Records
3. Procedure 2 - Sales
4. Procedure 3 - Purchase
5. Procedure 4 - Customer Relations
6. Procedure 5 - Corrective and Preventive Action
7. Procedure 6 - Control of Nonconforming Operation
8. Procedure 7 - Management Review
9. Procedure 8 - Internal Audit
10. Procedure 9 - Training
11. Procedure 10 - Quality Assurance
12. Procedure 11 - Clean Room Inspections and Tests
13. Procedure 12 - Calibration
14. Procedure 13 - Control of Data
15. Procedure 14 - Control of Reference Equipment
The system structure is based on ISO 9001 plus 17020's and 17025's additional requirements.
So... My questions to 17020 and 17025 experts are as follows (begining from the most important):
ISO IEC 17025 clause 5.9 Assuring the quality of test and calibration results requires a procedure. The requirement states (in short);
5.9.1 There must be a quality control procedure where data are recorded, and, statistical methods are applied for the review of the results. That monitoring must be planned and reviewed. Monitoring can contain,
a. Building of internal quality control system by using certified reference materials,
b. Joining inter-lab test programmes, conducting proficiency tests etc.
c. Re-conducting of tests or calibrations with the same or different methods,
d. Re-conducting of tests or calibrations on the preserved material,
e. Research on the different specs of the material.
5.9.2 Quality control records/data must be analysed and planned operations are applied to correct the problem or to prevent reporting of nonconforming results when data are out of limits.
Okay, I clearly understand 5.9.1. I will write down the method for proficiency tests (where two of our employess will conduct the same calibration) and joining inter-lab test programmes (where our AB, TURKAK, or any other accredited laboratory plans a test programme we will join, too), however, the problem is about 5.9.2.
I understand there must be analysis if PT/ILC demonstrates a nonconformity. But, I have also seen some statistical methods (t-distribution, f test, z score, q test, chi square test, x cards) in a sample procedure.
So, shall I apply statistical methods on client's calibration results?
1. Shall I apply statistical methods on each calibration step of an individual calibration of any client? For example, if we calibrate a T/C and use 10 calibration points, so I have 10 deviation values and an uncertainty value, shall I apply t-distribution on 10 deviation values?
2. And, shall I compare the uncertainty value to similiar T/C calibrations which we have conducted before?
Thanks in advance for answers.
P.S. I have checked the thread Compliance with ISO/ IEC 17025:2005 Clause 5.9 for Calibration Laboratories
That doesnot help me, I think.