References
The following list is provided for your convenience to identify resources that are useful for learning about laboratory management systems and accreditation. The list includes individual guides, as well as, links to websites of organizations that publish various guides on many topics such as Measurement Uncertainty, Traceability and Accreditation. To keep up to date, we recommend you visit these sites regularly because the organizations update their sites to include the most recent, revised and newest guides.
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.org
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
Eurachem Guide: Use of uncertainty information in compliance assessment. (2007).
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, Quality Management and Quality Assurance—Vocabulary
ISO 9001, Quality management systems – Requirements
ISO 9004, 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
International Vocabulary of Metrology – Basic and General Concepts and Associated Terms VIM, 3rd edition, JCGM 200:2008
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
Various guides are available on the NMS Chemical and Biological Metrology Web Site: http://www.nmschembio.org.uk/
A user login is required but there is no charge.
ILAC: http://www.ilac.org/
ILAC-G3:1994 Guidelines for Training Courses for Assessors
ILAC-G8:03/2009 Guidelines on the 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 17025
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)
References on Sampling
Enell, J.W. (1984) J. Qual. Technol. 16, 168–171
Eurachem Guide: Measurement uncertainty arising from sampling: A guide to methods and approaches (2007).
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
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