Application of ISO/IEC 17025

Transcription

1 Application of ISO/IEC A Testing Perspective Colleen M. Cotter, Accreditation Manager

2 Outline An overview of CALA Application of ISO/IEC Specific requirements for Testing Laboratories ( ) Reference materials 1

3 CALA Canadian Association for Laboratory Accreditation, Inc. Three (3) programs: Accreditation Proficiency Testing Training 2

4 Accreditation Program 202 Laboratories Areas of Testing Environmental Food Mineral Petroleum Coal 3

5 Accreditation Program Laboratories must: demonstrate conformance to ISO/ IEC every two (2) years; and, meet Proficiency Testing Requirements 4

6 Proficiency Testing Program Accredited by A2LA to ISO/IEC Disciplines: inorganic chemistry, organic chemistry, toxicology, occupational health, microbiology Matrices: water, waste oil, soil/sediment, air collection, food 5

7 Training Program In-class and on-line courses Courses on: ISO/IEC Laboratory Leadership Technical (e.g., internal calibration*, measurement uncertainty, control charting*) 6 *on-line and in-class

8 International Laboratory Accreditation Cooperation Three (3) accreditation bodies in Canada that are signatory to the International Laboratory Accreditation Cooperation (ILAC): CALA (testing) QM-PLS (medical testing ISO 15189) SCC (testing, calibration) 7

9 Requirements of an accreditation body ISO/IEC Conformity assessment general requirements for accreditation bodies accrediting conformity assessment bodies provide the CAB with suitable ways to obtain traceability of measurement results. 8

10 Requirements of an accreditation body ILAC Policies: P10 - Traceability of Measurement Results P14 Uncertainty in Calibration Regional cooperation policies and guidance documents ISO/IEC

11 The net result A61-01 CALA Traceability Policy A61-02 CALA Guidance on Traceability 10

12 Specific Requirements for Testing Laboratories Requirements for testing labs are stated in ISO/IEC 17025, All the requirements for calibration apply unless the associated contribution from the calibration contributes little to the total uncertainty of the test result. 11

13 CALA Policy = All equipment used for tests, including equipment for subsidiary measurements (e.g., for environmental conditions) having a significant effect on the accuracy or validity of the test result (e.g., significant contributor to overall test uncertainty, etc ) shall be calibrated before being put into use. 12

14 Practically speaking, this means Is the associated contribution from the calibration contributing to the total uncertainty of the test result? Evaluation of significance 13

15 External Calibration When using external calibration providers, laboratories must acquire services from accredited calibration laboratories or a National Metrology Institute (NMI) that is covered by the CIPM MRA Challenges: Calibration labs have scopes, too! Requirements for calibration certificates (needed to train labs and assessors) Specialized equipment (e.g., flow rate meter) 14

16 Internal or In-House Calibrations A calibration laboratory establishes traceability of its own measurement standards and measuring instruments to the SI by means of an unbroken chain of calibrations or comparisons. Can testing labs do this? 15

17 Internal or In-House Calibrations Yes, if: there a procedure that is appropriate and based on a reference method (5.4.2) Staff are trained (5.2) Considerations Still need a reference standard Calibration is not on the scope 16

18 Internal or In-House Calibration Challenges Estimate of MU Cost (in human resources) Frequency Reference vs working instruments 17

19 The second requirement under testing ( ). What if calibrations cannot be strictly made in SI units? Use of certified reference materials by a competent supplier Use of specified methods and/or consensus standards Participation in a suitable programme of comparisons, where possible 18

20 Reference Materials Accredited laboratories shall acquire reference materials from accredited Reference Material Producers (RMPs), where available, appropriate, and practicable (A61-01) More and more RMPs are accredited by accreditation bodies (ISO Guide 34) 19

21 Challenges/Gaps Cost May be readily available but are they available in the appropriate concentration or matrix (e.g., is a clean Ottawa sand really appropriate for a soil matrix?) 20

22 Challenges/Gaps (Cont d) Emerging compounds (e.g., alkyl PAHs) Some parent compounds are available; very few alkyl versions (and if available, can be expensive) Biota High vol filters CALA PT samples are not RMs! 21

23 Solutions Use a well characterized RM or CRM for other analytes it may be suitable for what is needed and the data has not yet been accumulated Example: bitumin characterized for metals the lab could start analyzing for hydrocarbons Find a more applicable matrix (e.g., corn oil for a high lipid matrix) 22

24 Steps to Consider Is the RM or CRM stable and useful? Is it the correct concentration and a suitable matrix? If not, need the raw material and need to characterize it 23

25 Characterizing a matrix Approach Pros Cons Consensus value Reference value Length of time may be decreased Length of time Bias? Cost 24

26 Reference APLAC TC 012: Guidelines for acceptability of chemical reference materials and commercial chemicals for calibration of equipment used in chemical testing 25

27 Summary CALA is providing CABs (labs) with suitable ways to obtain traceability Accredited labs are meeting ISO/IEC and policies related to traceability Challenges and gaps for some specialized equipment and reference materials 26

28 Thank you! Colleen Cotter Accreditation Manager, CALA 27