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Table of Contents
Intro
Preface
Acknowledgments
Contents
Chapter 1: Introduction and ISO17025:2017
1.1 Clause 1: Scope
1.2 Clause 2: Normative References
1.3 Clause 3: Terms and Definitions
1.4 Clause 4: General Requirements
1.4.1 Impartiality
1.4.2 Confidentiality
1.5 Clause 5.0: Structural Requirements
1.6 Clause 6.0: Resources Requirements
1.6.1 General
1.6.2 Personnel
1.6.3 Facilities and Environmental Conditions
1.6.4 Equipment
1.6.5 Metrological Traceability
1.6.6 Externally Provided Products and Services
1.7 Clause 7.0: Process Requirements
1.7.1 Review of Requests, Tenders and Contracts
1.7.2 Selection, Verification, and Validation of the Methods
1.7.3 Sampling
1.7.4 Handling of Test or Calibration Items
1.7.5 Technical Records
1.7.6 Evaluation of Measurements Uncertainty
1.7.7 Ensuring the Validity of Results
1.7.8 Reporting Results
1.7.9 Complaints
1.7.10 Nonconforming Work
1.7.11 Control of Data - Information Management
1.8 Clause 8.0: Management System Requirements
1.8.1 Management System Documentation (Option A)
1.8.2 Control of Management System Documents (Option A)
1.8.3 Control of Records (Option A)
1.8.4 Actions to Address Risks and Opportunities (Option A)
1.8.5 Improvement (Option A)
1.8.6 Corrective Actions (Option A)
1.8.7 Internal Audits (Option A)
1.8.8 Management Reviews (Option A)
Chapter 2: Essentials for Quality Management in a Chemical Testing Laboratory
2.1 Managing the Quality of Laboratory Testing Processes
2.2 Developing a Quality Management System (QMS)
2.2.1 PLAN
2.2.2 DO
2.2.3 CHECK
2.2.4 ACT
2.3 Six Sigma Quality Management System
2.3.1 Define, Measure, Analyze, Improve Stages
2.3.1.1 Define Stage
2.3.1.2 Measure Stage
2.3.1.3 Analyze Stage
2.3.1.4 Improve Stage
2.4 Quality Systems
2.4.1 Quality System, Assurance, Assessment and Control
2.4.2 Principles of Quality Control
2.4.3 Principles of Quality Assessment
2.4.4 System Planning
2.4.5 Investigation Phase
2.4.6 Quality Manager Responsibilities
2.4.7 Steering Team Responsibilities
2.4.8 Task Team Responsibility
2.4.9 Timeline
2.4.10 Implementation Phase
2.4.11 Consolidating the Program
2.4.12 Monitoring and Evaluating the Program
2.4.13 Management Review
2.4.14 Communication and Motivation
2.5 Tips
2.5.1 Tip: 1 - Human Resources
2.5.2 Tip: 2 - Scheduling and Conducting the Gap Analysis
2.5.3 Tip: 3 - Quality Manual
2.5.4 Tip: 4 - Example of Task Assignments
2.5.5 Tip: 5 - Example of Project Gantt Chart
Chapter 3: Preparing for Analysis: The Analytical Method
3.1 Sources of Methods
3.2 Evaluation of Published Methods
3.3 AOAC International (AOACI)
3.4 The Codex Alimentarius Commission
3.5 The European Union
3.6 The European Committee for Standardization (CEN)
3.7 ISO
Preface
Acknowledgments
Contents
Chapter 1: Introduction and ISO17025:2017
1.1 Clause 1: Scope
1.2 Clause 2: Normative References
1.3 Clause 3: Terms and Definitions
1.4 Clause 4: General Requirements
1.4.1 Impartiality
1.4.2 Confidentiality
1.5 Clause 5.0: Structural Requirements
1.6 Clause 6.0: Resources Requirements
1.6.1 General
1.6.2 Personnel
1.6.3 Facilities and Environmental Conditions
1.6.4 Equipment
1.6.5 Metrological Traceability
1.6.6 Externally Provided Products and Services
1.7 Clause 7.0: Process Requirements
1.7.1 Review of Requests, Tenders and Contracts
1.7.2 Selection, Verification, and Validation of the Methods
1.7.3 Sampling
1.7.4 Handling of Test or Calibration Items
1.7.5 Technical Records
1.7.6 Evaluation of Measurements Uncertainty
1.7.7 Ensuring the Validity of Results
1.7.8 Reporting Results
1.7.9 Complaints
1.7.10 Nonconforming Work
1.7.11 Control of Data - Information Management
1.8 Clause 8.0: Management System Requirements
1.8.1 Management System Documentation (Option A)
1.8.2 Control of Management System Documents (Option A)
1.8.3 Control of Records (Option A)
1.8.4 Actions to Address Risks and Opportunities (Option A)
1.8.5 Improvement (Option A)
1.8.6 Corrective Actions (Option A)
1.8.7 Internal Audits (Option A)
1.8.8 Management Reviews (Option A)
Chapter 2: Essentials for Quality Management in a Chemical Testing Laboratory
2.1 Managing the Quality of Laboratory Testing Processes
2.2 Developing a Quality Management System (QMS)
2.2.1 PLAN
2.2.2 DO
2.2.3 CHECK
2.2.4 ACT
2.3 Six Sigma Quality Management System
2.3.1 Define, Measure, Analyze, Improve Stages
2.3.1.1 Define Stage
2.3.1.2 Measure Stage
2.3.1.3 Analyze Stage
2.3.1.4 Improve Stage
2.4 Quality Systems
2.4.1 Quality System, Assurance, Assessment and Control
2.4.2 Principles of Quality Control
2.4.3 Principles of Quality Assessment
2.4.4 System Planning
2.4.5 Investigation Phase
2.4.6 Quality Manager Responsibilities
2.4.7 Steering Team Responsibilities
2.4.8 Task Team Responsibility
2.4.9 Timeline
2.4.10 Implementation Phase
2.4.11 Consolidating the Program
2.4.12 Monitoring and Evaluating the Program
2.4.13 Management Review
2.4.14 Communication and Motivation
2.5 Tips
2.5.1 Tip: 1 - Human Resources
2.5.2 Tip: 2 - Scheduling and Conducting the Gap Analysis
2.5.3 Tip: 3 - Quality Manual
2.5.4 Tip: 4 - Example of Task Assignments
2.5.5 Tip: 5 - Example of Project Gantt Chart
Chapter 3: Preparing for Analysis: The Analytical Method
3.1 Sources of Methods
3.2 Evaluation of Published Methods
3.3 AOAC International (AOACI)
3.4 The Codex Alimentarius Commission
3.5 The European Union
3.6 The European Committee for Standardization (CEN)
3.7 ISO