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How to Meet ISO 17025 Requirements for Method Verification

ALACC Definitions

ALACC FAQ

Training Course -- An Introduction to ISO 17025

References

AOAC INTERNATIONAL Quality Assurance Principles for Analytical Labs 3rd Ed, available for purchase from www.aoac.org

Brown, M.R.W., & Gilbert, P. (1995) Microbiological Quality Assurance, A Guide Towards Relevance and Reproducibility of Inocula, CRC Press, Boca Raton, FL

Eurachem: http://www.eurachem.ul.pt/

Eurachem Guide: Traceability in Chemical Measurement (2003)

Eurachem Guide: The Selection and use of Reference Materials (2002)

Eurachem Guide: Guide to Quality in Analytical Chemistry: An Aid to Accreditation (2002)

Eurachem Guide: Accreditation for Microbiological Laboratories (2002)

Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing (PT) Schemes by Laboratories (2000)

Eurachem Guide: Quantifying Uncertainty in Analytical Measurement, 2nd Edition (2000)

Eurachem Guide: The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics (1998)

Eurachem Guide: Harmonised Guidelines for the Use of Recovery Information in Analytical Measurements (1998)

Eurachem Guide: Quality Assurance for Research and Development and Non-routine Analysis (1998)

Eurachem Guide: Selection, Use and Interpretation of Proficiency Testing

ICH: http://www.ich.org/cache/compo/276-254-1.html

International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use ICH Harmonised Tripartite Guideline VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)

ISO: http://www.iso.org/iso/en/ISOOnline.frontpage

ISO/IEC Guide 2:2004 Standardization and related activities –General Vocabulary

ISO/IEC 17025:2005, General Requirements for the Competence of Calibration and Testing Laboratories

ISO/IEC Guide 30: 1992, Terms and Definitions Used in Connection with Reference Materials

ISO 9000: 2000, Quality Management and Quality Assurance—Vocabulary

ISO 9001:2000, Quality management systems – Requirements

ISO 9004:2000, Quality management systems -- Guidelines for performance improvements

ISO/TR 10013:2001, Guidelines for quality management system documentation

ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing

ISO 10012:2003, Measurement management systems -- Requirements for measurement processes and measuring equipment

ISO/DGuide 99999, International vocabulary of basic and general terms in metrology (VIM) -- Third edition

USP United States Pharmacopeia

USP: http://www.usp.org/

EP European Pharmacopoeia

EP: http://www.pheur.org/site/page_628.php

CITAC: http://www.citac.cc/

Eurachem/CITAC Guide 2003 Traceability in Chemical Measurements. A guide to achieving comparable measurement results

LGC/VAM: VAM Guides can be downloaded from the VAM website http://www.vam.org.uk A user login is required but there is no charge.

LGC/VAM/2003/016, New Eurachem/CITAC guidance on traceability of chemical measurements: A paradigm for practical traceability

LGC/VVAM, Meeting the Traceability Requirements of ISO 17025, An Analyst's Guide 2nd Edition, November 2003

References on Sampling

Enell, J.W. (1984) J. Qual. Technol. 16, 168–171

Feder, P.I. (1975) J. Qual. Technol. 7, 53–58

Garfield, F.A. (1989) J. Assoc. Off. Anal. Chem. 72, 405–411

Horwitz, W. (1976) J. Assoc. Off. Anal. Chem. 59, 1197–1203

Horwitz, W. (1990) Pure Appl. Chem. 62, 1193–1208

ISO 7002:1986, Agricultural food products -- Layout for a standard method of sampling from a lot

ISO 8213:1986, Chemical products for industrial use -- Sampling techniques -- Solid chemical products in the form of particles varying from powders to coarse lumps

ISO 6206:1979, Chemical products for industrial use -- Sampling -- Vocabulary

ISO 2859-1:1999, Ed. 2 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 2859-2:1985, Ed. 1 Sampling procedures for inspection by attributes -- Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection

ISO 2859-3:2005, Ed. 2 Sampling procedures for inspection by attributes -- Part 3: Skip-lot sampling procedures

ISO 2859-4:2002, Ed. 2 Sampling procedures for inspection by attributes -- Part 4: Procedures for assessment of declared quality levels

ISO 2859-5:2005, Ed. 1 Sampling procedures for inspection by attributes -- Part 5: System of sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 2859-10:2006, Ed. 1 Sampling procedures for inspection by attributes -- Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes

ISO 3951-1:2005, Ed. 1 Sampling procedures for inspection by variables -- Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL (available in English only)

ISO 3951-2:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics (available in English only)

ISO 3951-5:2006, Ed. 1 Sampling procedures for inspection by variables -- Part 5: Sequential sampling plans indexed by acceptance quality limit (AQL) for inspection by variables (known standard deviation) (available in English only)

Kratochvil, B., & Taylor, J.K. (1981) Anal. Chem. 53, 924A–938A

Kratochvil, B., Wallace, D., & Taylor, J.K. (1984) Anal. Chem. 56, 113R–129R

Smith, R., & James, G.V. (1981) The Sampling of Bulk Materials, The Royal Society of Chemistry (Analytical Sciences Monographs No. 8), London, UK

ILAC: http://www.ilac.org/

ILAC-G3:1994 Guidelines for Training Courses for Assessors

ILAC-G8:1996 Guidelines on Assessment and Reporting of Compliance with Specification

ILAC-G9:2005 Guidelines for the Selection and Use of Reference Materials

ILAC-G10:1996 Harmonised Procedures for Surveillance & Reassessment of Accredited Laboratories

ILAC-G11:07/2006 Guidelines on Assessor Qualification and Competence of Assessors and Technical Experts

ILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material Producers

ILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 1702

ILAC-G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing

ILAC-G20:2002 Guidelines on Grading of Non-Conformities

ILAC-G22:2004 Use of Proficiency Testing as a Tool for Accreditation in Testing

Additional Web Sites:

European Co-operation for Accreditation: http://www.european-accreditation.org/default_flash.htm

Standards Council of Canada: http://www.scc.ca/

A2LA: http://www.a2la.org

AIHA: http://www.aiha.org

ANSI: http://www.ansi.org

IAAC: http://www.iaac.org.mx (Inter-American Accreditation Cooperation)




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