Accreditation and Quality Assurance in Analytical Chemistry, Softcover reprint of the original 1st ed. 1996

Quality assurance and accreditation in analytical chemistry laboratories is an important issue on the national and international scale. The book presents currently used methods to assure the quality of analytical results and it describes accreditation procedures for the mutual recognition of these results. The book describes in detail the accreditation systems in 13 European countries and the present situation in the United States of America. The editor also places high value on accreditation and certification practice and on the relevant legislation in Europe. The appendix lists invaluable information on important European accreditation organizations.

Significance of Certification and Accreditation Within the European Market.- 1.1 Introduction.- 1.2 The EC Commission’s Global Concept for Testing and Certification.- 1.2.1 From the New Conception for Harmonization and Standardization Towards the Global Concept.- 1.2.2 The Philosophy of the Global Concept (Building Confidence).- 1.2.3 Instruments for Building Confidence.- 1.3 The Result of the Council’s Discussion on the Global Concept.- 1.3.1 On the Council’s Resolution of December 21st 1989.- 1.3.2 The Council’s Modular Resolution of December 13th 1990.- 1.4 The Certification Contents of the New EC Harmonization Guidelines.- 1.4.1 Practising the Modular Concept.- 1.4.2 The Role of the Notified Body.- 1.4.3 CE Labelling.- 1.5 The Influence of the EC Commission’s Global Concept on the Private Sector.- 1.5.1 Foundation of EOTC.- 1.5.2 Further European Groups in the Fields of Certification and Accreditation.- 1.6 Assessment of the European Certification/Accreditation Policy.- 2 The Accreditation of Chemical Laboratories.- 2.1 The European and International Framework.- 2.1.1 Introduction.- 2.1.2 Free Trade in Europe.- 2.1.3 The Global Concept for Testing and Certification in Europe.- 2.1.4 Testing, Certification and Accreditation.- 2.1.5 Objectives of Certification.- 2.1.6 Harmonized Testing Procedures.- 2.1.7 The Significance of the Evaluation of Accreditation Systems.- 2.2 The Basic Principles and the Actual Description of the European and International Framework.- 2.2.1 General Standards for Accreditation and Certification.- 2.2.1.1 General Remarks.- 2.2.1.2 The ISO 9000 Series of Standards.- 2.2.1.3 The ISO/IEC Guide 25.- 2.2.1.4 The EN 45000 Basic Series of Standards.- 2.2.1.5 The Connection between Both Series of Standards.- 2.2.1.6 Quality Management Systems.- 2.2.2 Specific Recommendations for Accreditation and Certification of Chemical Laboratories.- 2.2.2.1 Good Laboratory Practice.- 2.2.2.2 WELAC/EURACHEM Guidelines “Accreditation for Chemical Laboratories”.- 2.2.2.3 CITAC Document.- 2.2.2.4 Other Documents.- 2.2.3 General Scheme for the Accreditation Procedure.- 2.3 The National Accreditation Systems in Europe.- 2.3.1 Laboratoy Accreditation in Austria — Wolfhard Wegscheider.- 2.3.2 The Swiss Accreditation Service — Hanspeter Ischi.- 2.3.3 The German Accreditation System — U. Böshagen.- 2.3.3.1 The BDI Model.- 2.3.3.2 Cooperation between Regulated and Non-regulated Area.- 2.3.4 The Danish Accreditation System — DANAK — H. Jensen.- 2.3.4.1 Structure of DANAK in the Area Concerned with Accreditation of Testing and Calibration Laboratories.- 2.3.4.2 Accreditation of Chemical Laboratories.- 2.3.5 FINAS — The Finnish Accreditation Service: Laboratoy Accreditation — Christina Carlsson.- 2.3.5.1 General.- 2.3.5.2 Operation.- 2.3.5.3 Information.- 2.3.6 The Italian Accreditation System — M. Gracia Del Monte.- 2.3.7 The Irish National Accreditation Board.- 2.3.7.1 Background.- 2.3.7.2 Scope of Operations.- 2.3.7.3 Statistics.- 2.3.8 The National Accreditation Body of Norway — Khalid Saeed.- 2.3.8.1 General History of the Norwegian Accreditation System.- 2.3.8.2 Organisation.- 2.3.8.3 Tasks for Norwegian Accreditation.- 2.3.8.4 Multilateral Agreements (MLA).- 2.3.8.5 Application and Assessment Procedure for Laboratory Accreditation.- 2.3.8.6 Assessment Team.- 2.3.8.7 Collaboration with Other Accreditation Bodies.- 2.3.8.8 Accreditation for the Regulated and Non-Regulated Area.- 2.3.8.9 Sector Committees.- 2.3.8.10 Concluding Remarks.- 2.3.9 The Netherlands Accreditation System — P. van de Leemput.- 2.3.9.1 Introduction.- 2.3.9.2 Objectives and Accreditations.- 2.3.9.3 International Activities.- 2.3.10 The Polish Accreditation System Z. Dobkowski, B. Berdowski.- 2.3.11 Russian System for Analytical Laboratories Accreditation Yu. A. Karpov, I. V. Boldyrev, G. I. Ramendik and G. I. Freedman.- 2.3.11.1 Accreditation Criteria.- 2.3.11.2 Accreditation System Structure.- 2.3.11.3 Accreditation Procedure.- 2.3.12 Accreditation of Laboratories in Sweden — Björn Lundgren.- 2.3.12.1 The Accreditation Body.- 2.3.12.2 The Accreditation Process.- 2.3.12.3 Types of Laboratory Accreditated.- 2.3.12.4 Accredditated Laboratories inDifferent Areas (December 1994).- 2.3.13 The United Kingdom Accreditation System — D. Galsworthy.- 2.3.13.1 History.- 2.3.13.2 The Objectives of NAMAS.- 2.3.13.3 The Formation of UKAS.- 2.3.13.4 Legislative Support for Accreditation in the United Kingdom.- 2.3.13.5 Relationship between Laboratory Accreditation and Certification to ISO 9000.- 2.3.13.6 Co-operation between UKAS Laboratory Accreditation and the UK Good Laboratory Practice (GLP) Monitoring Unit.- 2.3.13.7 Areas for Development.- 2.3.13.8 Current Concerns.- 2.3.13.9 Case Study: NAMAS Accreditation and the “Additional Measures Directive”.- 3 Quality Assurance in Analytical Chemistry.- 3.1 On Quality Assurance.- 3.2 Quality Policy and Quality Management.- 3.2.1 Corporate Quality Policy and Quality Strategy.- 3.2.2 Quality Management and Quality Assurance.- 3.2.3 Total Quality Management (TQM).- 3.2.4 Quality Costs.- 3.3 Quality Planning, Quality Control, Quality Inspection.- 3.4 Quality Assurance in Analytical Chemistry.- 3.4.1 The Significance of Quality Assurance For and In Chemical Analysis.- 3.4.2 Consequences for Quality Assurance in Analytical Laboratories.- 3.4.2.1 Compiling a Quality Manual.- 3.4.2.2 Personnel Qualifications and Equipment.- 3.5 QA Measures in Analytical Practice.- 3.5.1 Checking Measuring and Test Equipment.- 3.5.2 Test Control.- 3.5.3 Testing (Test Instructions).- 3.5.4 Analytical QA Measures.- 3.5.4.1 Control Analyses.- 3.5.4.2 Reference Materials.- 3.5.4.3 Interlaboratory Studies.- 3.5.4.4 Internal Quality Audits.- 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.- 4.5.1 Integration Error.- 4.5.2 Materialization Error.- 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.- 5.3.1 Frequency Distributions of Measurement Values.- 5.3.2 Error Propagation.- 5.3.3 Confidence Intervals and Uncertainty Ranges.- 5.4 Significance Tests.- 5.4.1 Tests for Measurement Series.- 5.4.2 Comparison of Two Standard Deviations.- 5.4.3 Comparison of Several Standard Deviations.- 5.4.4 Comparison of Two Means.- 5.4.5 Comparison of Several Means.- 5.5 Statistical Quality Assurance.- 5.5.1 Statistical Quality Criteria.- 5.5.2 Attribute Testing.- 5.5.3 Sequential Analysis.- 5.5.4 Quality Control Charts.- 5.6 Calibration of Analytical Procedures.- 5.6.1 Linear Fit.- 5.6.2 Limit of Decision and Limit of Detection.- 5.6.3 Validation of Calibration 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.- 6.8.1 Precision and Trueness.- 6.8.2 Calibration.- 6.8.3 Recovery Studies.- 6.8.4 Comparison of Methods.- 6.8.5 Ruggedness.- 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.- 7.6.1 Are Reference Materials at the “Intersection” Points?.- 7.6.2 How are RMs in Fact Used in Practice?.- 7.6.3 The Real Role of Reference Materials: Validation.- 7.6.4 Are Reference Measurements at the Intersection Points?.- 7.6.5 The Place of Reference Materials in a Traceability Scheme.- 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.- 8.3.1 Selection.- 8.3.2 Preparation.- 8.3.3 Homogeneity.- 8.3.4 Stability.- 8.3.5 How to Obtain Reference Values.- 8.3.6 How to Obtain Certified Values.- 8.4 The Use of RMs and CRMs in Chemical Analysis.- 8.4.1 The Role of Reference Materials.- 8.4.1.1 The Use of RMs in Statistical Control Schemes.- 8.4.1.2 The Use of RMs in Intercomparisons.- 8.4.2 The Role of Certified Reference Materials.- 8.4.2.1 Calibration.- 8.4.2.2 Achieving Accuracy.- 8.4.2.3 Other Uses of CRMs.- 8.4.3 Suppliers.- 8.4.4 CRMs for Environmental Analysis.- 8.4.5 CRMs for Food Analysis.- 8.4.6 CRMs for Clinical Analysis.- 8.4.7 Other CRMs.- 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.- 9.3.1 Objectives of Participation in Laboratory-Performance Studies.- 9.3.2 Assessment of Laboratory Performance.- 9.3.3 The Implementation of Laboratory-Performance Studies.- 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.- 11.2.1 Origin.- 11.2.2 Legal Fundamentals.- 11.2.3 GLP Principles.- 11.2.4 GLP Certificate.- 11.2.5 Personnel.- 11.2.6 Time Needed.- 11.3 Accreditation.- 11.4 Comparison of GLP and Accreditation.- 11.4.1 Quality Assurance.- 11.4.2 Study Plan.- 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.- 13.1.1 Monitoring Systems.- 13.1.2 Challenges.- 13.1.3 Concerns for Data Quality.- 13.2 Policy Development.- 13.2.1 Background.- 13.2.2 Initial Perspectives.- 13.2.3 Assessment of the Need for a National Environmental Laboratory Accreditation Program.- 13.2.4 Evaluation of Alternatives to National Environmental Laboratory Accreditation.- 13.2.5 Elements of a National Environmental Laboratory Accreditation Program.- 13.2.6 Scope of the Program.- 13.2.7 CNAEL’s Conclusion and Recommendation.- 13.2.8 Next Steps.- 13.3 Program Development.- 13.3.1 Setting Standards.- 13.3.2 Scope of the Program.- 13.3.3 Federal Role and Responsibility.- 13.3.4 Accrediting Authority Review Board.- 13.3.5 State Implementation.- 13.3.6 Reciprocity.- 13.4 Conclusion.- 13.5 References.