Accreditation and Quality Assurance in Analytical Chemistry

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.