Accreditation and Quality Assurance in Analytical Chemistry

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• Significance of Certification and Accreditation Within the European Market.- 1.1 Introduction.- 1.2 The EC Commission’s Global Concept for Testing and Certification.- 1.3 The Result of the Council’s Discussion on the Global Concept.- 1.4 The Certification Contents of the New EC Harmonization Guidelines.- 1.5 The Influence of the EC Commission’s Global Concept on the Private Sector.- 1.6 Assessment of the European Certification/Accreditation Policy.- 2 The Accreditation of Chemical Laboratories.- 2.1 The European and International Framework.- 2.2 The Basic Principles and the Actual Description of the European and International Framework.- 2.3 The National Accreditation Systems in Europe.- 3 Quality Assurance in Analytical Chemistry.- 3.1 On Quality Assurance.- 3.2 Quality Policy and Quality Management.- 3.3 Quality Planning, Quality Control, Quality Inspection.- 3.4 Quality Assurance in Analytical Chemistry.- 3.5 QA Measures in Analytical Practice.- 3.6 Process Capability and Machine Capability.- 3.7 Certification of Quality Management Systems and Accreditation of Analytical Laboratories.- 3.8 References.- 4 Proper Sampling: A Precondition for Accurate Analyses.- Abstract.- 4.1 Sampling Within the Analytical Process.- 4.2 There Is No “Correct” Sampling Without A Clear Problem Definition!.- 4.3 Managing Without Sampling?.- 4.4 Planning Sampling Procedures.- 4.5 Aspects of Measurement Uncertainty Caused by Sampling.- 4.6 Conclusions.- 4.7 References.- 5 Significance of Statistics in Quality Assurance.- 5.1 Types of Errors Associated With Analytical Measurements.- 5.2 Systematic Errors.- 5.3 Random Errors.- 5.4 Significance Tests.- 5.5 Statistical Quality Assurance.- 5.6 Calibration of Analytical Procedures.- 5.7 References.- 6 Validation of Analytical Methods.-Summary.- 6.1 Introduction.- 6.2 Development of Analytical Procedures and Tasks of Basic Validation.- 6.3 Validation: Definitions.- 6.4 Scope and Sequence of Validation.- 6.5 Performance Characteristics.- 6.6 The Relation Between Purpose of the Procedure and Scope of Validation.- 6.7 Frequency of Validation.- 6.8 Special Technique of Validation.- 6.9 Conclusions.- 6.10 References.- 7 Traceability of Measurements to SI: How Does It Lead to Traceability of Quantitative Chemical Measurements?.- Preface.- 7.1 Introduction.- 7.2 Traceability of Chemical Measurements: The Problems.- 7.3 Physical and Chemical Measurements: Is There a Difference in Principle?.- 7.4 Traceability of Measurements: Are There Precedents?.- 7.5 Traceability of Amount Measurements: Present Status.- 7.6 The “Intersection” Points in a Traceability System.- 7.7 Purposes of Traceability of Amount Measurements.- 7.8 Criteria for Traceability of Amount Measurements to the Mole.- 7.9 How can Traceability to the Mole Be Established?.- 7.10 Conclusions.- 7.11 References.- 8 Reference Materials for Quality Assurance.- 8.1 Introduction.- 8.2 Definitions.- 8.3 Requirements for the Preparation of RMs and CRMs.- 8.4 The Use of RMs and CRMs in Chemical Analysis.- 8.5 References.- 9 Accreditation and Interlaboratory Studies.- 9.1 Introduction.- 9.2 Types of Interlaboratory Studies.- 9.3 Laboratory-Performance Studies in Accreditation Practice.- 9.4 Laboratory-Performance Studies and Quality of Testing.- 9.5 References.- 10 Accreditation Competence: Requirements for Accreditation Bodies.- 10.1 Standard Fundamentals.- 10.2 Organisation and Quality Management System.- 10.3 Arrangements for Accreditation.- 10.4 Operation.- 10.5 Sectoral Committees.- 10.6 Assessment.- 10.7 Assessors.- 10.8 Decision on Accreditation.-10.9 Diligence and Protective Duties.- 10.10 Surveillance.- 10.11 Accreditation and Standardization.- 10.12 National and International Agreements on Mutual Recognition.- 11 The Significance of Accreditation in Comparison with GLP.- 11.1 Introduction.- 11.2 GLP — Good Laboratory Practice.- 11.3 Accreditation.- 11.4 Comparison of GLP and Accreditation.- 11.5 Summary and Future Trends.- 12 EURACHEM Organization for the Promotion of Quality Assurance in Analytical Chemistry and the Accreditation of Analytical Laboratories in Europe.- 12.1 Foundation of EURACHEM.- 12.2 Objectives of EURACHEM.- 12.3 Structural Organization of EURACHEM.- 12.4 Tasks.- 12.5 Cooperation with Other Committees.- 12.6 Summary.- 12.7 References.- 13 The Accreditation of Environmental Laboratories in the United States.- 13.1 Introduction.- 13.2 Policy Development.- 13.3 Program Development.- 13.4 Conclusion.- 13.5 References.