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ISO 17025 Accreditation/Quality Management Systems Panel Discussion

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Page 1: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

ISO 17025 Accreditation/Quality Management SystemsPanel Discussion

Page 2: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

ISO 17025

Presented by Louise Ogden

Minnesota Department of Agriculture 

Reference Materials Reference StandardsMeasurement Traceability

Page 3: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

4.6 Purchasing and Supplies

5.4 Test and Calibration Methods and Method Validation

5.6 Measurement Traceability

Relevant sections of the standard

Page 4: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

• Measurement Traceability 

• Reference Standard – shall be calibrated by a body that can provide traceability

• Reference Materials – shall where possible be traceable to SI units of measurement or to a Certified Reference Material

• SI units – International System of Units 

Definitions

Page 5: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

Traceability

• Competency• Reference to SI

Units• Calibration

intervals

• Unbroken chain of comparisons

• Uncertainty of Measurement

• Documentation

Page 6: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

• Volumetric (non‐Class A) flasks, burettes, pipettes

• Balances / Weight sets

• Centrifuge

• Microscopes

• Safety Cabinets

• DI/RO Water

• Thermometers

• Temperature Monitoring Systems

• Timers

• Chemicals

• Media

• Pipettes – mechanical, multi‐channel, electronic

Examples of items to trace IF qualitycritical to the method

Page 7: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:

Example Forms

Page 8: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:
Page 9: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:
Page 10: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date:
Page 11: ISO 17025 Accreditation/Quality Management Systems … · Sterile Vitek Tubes Equipment Steam Box ... Procedure Ste Add 45 or dro sis ... AAFCO Lab QA/QC Workgroup Created Date: