Steps the chemical laboratory should follow to prepare for an ISO/IEC 17025 technical assessment Chris Fouché ( Laboratory Quality Cure(Pty) Ltd) www.labqualitycure.co.za.

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Presentation transcript:

Steps the chemical laboratory should follow to prepare for an ISO/IEC technical assessment Chris Fouché ( Laboratory Quality Cure(Pty) Ltd) NLA Conference : 09 October 2013

Two types of Assessments: Management requirements Technical requirements NLA Conference : 09 October 2013

Management Requirements: Quality Documentation Sub clauses 4.1 to 4.15 (Organization, Complaints to Management review) NLA Conference : 09 October 2013

Technical Requirements: Quality Documentation Sub clauses 5.1 to 5.10 (General, Equipment to Reporting of results) NLA Conference : 09 October 2013

Technical Assessment: Witnessing( F15) Vertical(F44) General Technical (F49) NLA Conference : 09 October 2013

Witnessing Activity(F15): Equipment Calibration Standards Quality Control Standards Method Validation Uncertainty of measurement Proficiency Testing Quality Control Charts Competence Environmental Conditions NLA Conference : 09 October 2013

Witnessing quality verification: Laboratory water quality Glassware volume-Grading Balance Calibration Daily verification Temperature Thermometers Ovens Furnaces Waterbaths NLA Conference : 09 October 2013

Vertical Assessment(F44): Report traceability Technical Signatory NLA Conference: 09 October 2013

Vertical Traceability: Data transfer Training competence Method validation Assurance of results( QC) Proficiency Testing Calibration Standards Equipment calibration Accommodation Laboratory consumables Test item handling Reporting of results NLA Conference: 09 October 2013

Non Conformance(F03): Detailed observation Classification-Major/Minor Sub clause reference Signatures : Laboratory staff Lead/ Technical Assessor Corrective Action Root Cause Preventative Action Time frame NC-25 working days Technical Assessor clearance Next assessment clearance NLA Conference: 09 October 2013

Recommendation Report(F04): Continued accreditation Scope of accreditation Effective clearance of NC Positive & negative aspects around quality Different assessments: Pre- assessment Full assessment(5y cycle) Surveillance (18months x 2) NLA Conference: 09 October 2013

Acceptance Approvals Committee: Final evidence of all data verification Final approval by Technical/ Lead assessor Final approval by Field Programme Manager Updated scope of accreditation certificate NLA Conference: 09 October 2013

Conclusion: Recommendation & Approval: Methods Technical Signatory Final Accreditation Status SANAS laboratory reference T number NLA Conference: 09 October 2013

References: ISO/IEC SANAS R03- Technical Signatory Requirements SANAS R04- Logo requirements SANAS P30-Scope of testing SANAS R51- Suspension status SANAS R80-Proficiency Testing SANAS TG07-Method Validation NLA Conference: 09 October 2013

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