Standards for Management Systems (eBook)

Preface 7
What Is in the Book and How to Navigate Through It 10
Declaration 14
Contents 15
About the Author 23
Abbreviations 24
1 Standards for Management Systems: Overview and Main Ingredients 26
1.1 Does the World Need Management System Standards? 26
1.1.1 General Motivation 26
1.1.2 Global Supply Chains 28
1.1.3 Robust Processes and Reliable Process Management 29
1.1.4 Globally Accepted Requirements for Management Systems 29
1.1.5 Genuine Versus Industry-Specific Models for Quality Management Systems 30
1.1.6 Certification Schemes 31
1.2 Where Do All These Management System Standards Come from? 32
1.2.1 Why Are Most Management System Standards Global? 32
1.2.2 ISO—International Organization for Standardization 32
1.2.3 National Organizations for Standardization 33
1.2.4 The Role of Industry Organizations and Other Interested Parties 34
1.3 Processes: Why Are They in the Focus of Management Systems? 35
1.4 Risk-Based Thinking: A Cornerstone of Management System Standards 40
1.5 Universal Design: The Architecture of Management System Standards 41
2 Generic Standards for Management Systems: An Overview 43
2.1 Introduction 44
2.2 ISO 9001—QMS—Quality Management System 45
2.2.1 Introductory Remarks 46
2.2.2 The Principles Behind ISO 9001 48
2.2.3 Discussion of the Clauses of ISO 9001 51
2.2.4 Shortened Checklist for ISO 9001 83
2.2.5 Frequently Asked Questions 83
2.2.6 Examples for Illustrational Purposes 96
2.2.7 Some Supportive Standards for Quality Management Systems 100
2.3 ISO 14001—EMS—Environmental Management System 101
2.3.1 Introductory Remarks 103
2.3.2 Discussion of the Clauses of ISO 14001 105
2.3.3 Other Important ISO Standards in the ISO 140XX-Series 113
2.3.4 Shortened Checklist for ISO 14001 113
2.3.5 Frequently Asked Questions 116
2.4 ISO/IEC 17025—Laboratory Management 116
2.4.1 Introductory Remarks 116
2.4.2 Discussion of the Clauses of ISO 17025 125
2.4.3 Frequently Asked Questions 136
2.5 ISO 21001—EOMS—Management Systems for Educational Organizations 140
2.5.1 Introductory Remarks 140
2.5.2 Discussion of the Clauses of ISO 21001 141
2.5.3 Frequently Asked Questions 164
2.6 ISO 22301—BCMS—Business Continuity Management System 165
2.6.1 Introductory Remarks 165
2.6.2 Discussion of the Clauses of ISO 22301 168
2.6.3 Frequently Asked Questions 179
2.7 ISO 27001—ISMS—Information Security Management System 180
2.7.1 Introductory Remarks 180
2.7.2 Discussion of the Clauses of ISO 27001 181
2.7.3 Frequently Asked Question 195
2.8 ISO 31000—RM—Risk Management 197
2.8.1 Introductory Remarks 197
2.8.2 Discussion of the Clauses of ISO 31000 198
2.8.3 Implementation Hints 206
2.8.4 Frequently Asked Questions 211
2.9 ISO 44001—CBRMS—Collaborative Business Relationship Management System 212
2.9.1 Introductory Remarks 212
2.9.2 Discussion of the Clauses of ISO 44001 213
2.9.3 Frequently Asked Questions 226
2.10 ISO 45001—OH& SMS Occupational Health and Safety Management System
2.10.1 Introductory Remarks 227
2.10.2 Discussion of the Clauses of ISO 45001 229
2.10.3 Frequently Asked Questions 242
2.11 ISO 50001—EnMS—Energy Management System 244
2.11.1 Introductory Remarks 244
2.11.2 Discussion of the Clauses of ISO 50001 245
2.11.3 Frequently Asked Questions and Implementation Hints 255
2.12 ISO 55001—AMS—Asset Management System 257
2.12.1 Introductory Remarks 257
2.12.2 Discussion of the Clauses of ISO 55001 259
2.12.3 Frequently Asked Questions 266
2.13 ISO 22316—Organizational Resilience 267
2.14 Finishing This Chapter and Looking Forward to Chap. 3 272
3 Industry-Specific Standards for Management Systems 274
3.1 Introduction and Overview 274
3.2 Automotive Industry 275
3.3 Aerospace Industry 282
3.4 Railway Industry 283
3.5 ICT—Information and Communication Technology Industry 285
3.6 Quality Management Schemes for Food Industry and Agriculture 290
3.6.1 General Introduction 290
3.6.2 ISO 22000—FSMS—Food Safety Management System 296
3.6.3 More Standards for Food Industry and Agriculture 308
3.6.4 Concluding Remarks: Which Scheme to Choose? 313
3.7 Forestry and Chain of Custody 313
3.7.1 General Introduction 313
3.7.2 PEFC and FSC 314
3.7.3 ISO 38200: Chain of Custody of Wood and Wood-Based Products 315
3.8 Healthcare 317
3.8.1 General Introduction 317
3.8.2 International ISO Standards for Healthcare 317
3.8.3 The European Standard EN 15224 318
3.8.4 JCI—Joint Commission International 322
3.8.5 Case Study: Quality Management Initiatives in German Healthcare 326
3.9 ISO 20121—ESMS—Event Sustainability Management System 328
3.9.1 Introduction to the Standard 328
3.9.2 Discussion of the Clauses of ISO 20121 329
3.9.3 Example to Illustrate Some Concepts of the ESMS 333
3.9.4 Beyond Event Sustainability 335
3.10 ISO 28000—SCSMS—Supply Chain Security Management System 336
3.11 ISO 41001—FMS—Facility Management System 342
3.11.1 Introductory Remarks 342
3.11.2 Discussion of the Clauses of ISO 41001 343
3.12 ISO 39001—RTSMS—Road Traffic Safety Management System 354
References 357
4 Standards for Compliance, Anti-bribery and Corporate Social Responsibility (CSR) 358
4.1 Introductory Remarks 358
4.2 ISO 19600—CMS—Compliance Management System 359
4.2.1 Introduction 359
4.2.2 Discussion of the Clauses of ISO 19600 360
4.3 ISO 26000—Guidance on Social Responsibility 370
4.3.1 General Description of ISO 26000 370
4.3.2 Integrating ISO 26000 into the Organization’s Management System 374
4.4 ISO 37001—ABMS—Anti-bribery Management System 375
4.4.1 Introductory Remarks 375
4.4.2 Discussion of the Clauses of ISO 37001 376
4.5 CSR—Corporate Social Responsibility 385
5 Special Purpose Audit Schemes and Quality Awards 387
5.1 Special Purpose Audits Schemes 387
5.2 Quality Awards 390
5.2.1 The Deming Prize 391
5.2.2 MBNQA—Malcolm Baldridge National Quality Award 391
5.2.3 The Continuum of National Quality Awards 392
6 How to Get Things Done: A Practitioner’s Toolbox 394
6.1 Introduction and Overview 394
6.2 DMAIC: Define-Measure-Analyze-Improve-Control 396
6.2.1 General Description of the DMAIC Approach 396
6.2.2 Detailed Steps of the DMAIC Approach 397
6.3 Integrated Management Systems 403
6.4 Tools and Concepts in Alphabetical Order 404
6.4.1 Introduction 404
6.4.2 5S Method 405
6.4.3 5 Whys 408
6.4.4 5W2H—5 Whys and 2 Hows 409
6.4.5 8D-Reports 410
6.4.6 Acceptance Sampling 413
6.4.7 Affinity Diagrams 420
6.4.8 ALARP—As Low as Reasonably Practicable 422
6.4.9 ANOVA—Analysis of Variance 423
6.4.10 Balanced Scorecards 430
6.4.11 Bayesian Analysis 432
6.4.12 Bow-Tie Analysis 433
6.4.13 Brainstorming 434
6.4.14 Brainwriting—6-3-5 Method 435
6.4.15 Causal Mapping and Relationship Diagrams 437
6.4.16 CBA—Cost Benefit Analysis 439
6.4.17 Checklist 440
6.4.18 Check Sheet 441
6.4.19 C& E Matrix—Cause-and-Effect Matrix
6.4.20 CIA—Cross-Impact Analysis 443
6.4.21 Control Charts, Process Capability and Process Sigma 445
6.4.22 Correlation Analysis 463
6.4.23 CTQ—Critical to Quality 470
6.4.24 CVAM—Customer Value Assessment Matrix 474
6.4.25 Data Collection and Presentation 475
6.4.26 Decision Tree Analysis 478
6.4.27 Delphi Technique 481
6.4.28 DOE—Design of Experiments 482
6.4.29 Estimation of Parameters and Confidence Intervals 486
6.4.30 ETA—Event Tree Analysis 511
6.4.31 Five Max Method 514
6.4.32 FMEA—Failure Modes and Effects Analysis 515
6.4.33 Force Field Analysis 520
6.4.34 FTA—Fault Tree Analysis 521
6.4.35 HACCP—Hazard Analysis and Critical Control Points 526
6.4.36 Hazard Level Matrix 527
6.4.37 HAZOP—Hazard and Operability Studies 528
6.4.38 HRA—Human Reliability Analysis 532
6.4.39 Involvement Matrix 533
6.4.40 Interested Parties—Selection Criteria 535
6.4.41 Interviews 535
6.4.42 Ishikawa Diagrams—Root-Cause Analysis 537
6.4.43 Kaizen 540
6.4.44 Kappa Index Calculation and Inter-Rater Agreement 542
6.4.45 Markov Analysis 545
6.4.46 MEP—Maximum Entropy Principle and Probability Distributions 549
6.4.47 Mind-Mapping 552
6.4.48 Monte Carlo Simulation 554
6.4.49 NGT—Nominal Group Technique 561
6.4.50 Order Statistics and Distribution of Extreme Values 563
6.4.51 Pareto Analysis and Pareto Charts 565
6.4.52 PDCA: Plan-Do-Check-Act 568
6.4.53 PESTLE Analysis 568
6.4.54 PHA—Preliminary Hazard Analysis 569
6.4.55 PMI—Plus-Minus-Interesting 571
6.4.56 Poka-Yoke 572
6.4.57 Prioritization Matrix 573
6.4.58 Process Flow Tools 574
6.4.59 RACI Matrix 583
6.4.60 Regression Analysis 585
6.4.61 Reliability Theory 596
6.4.62 Sampling of Data and Surveys 617
6.4.63 Scenario Analysis 621
6.4.64 SIPOC Diagrams 623
6.4.65 Solution Selection Matrix 624
6.4.66 Stakeholder Profile Matrix 627
6.4.67 Strategy Alignment with Operational Capabilities and Needs 628
6.4.68 SWIFT—Structured What-IF Technique 629
6.4.69 SWOT Analysis 631
6.4.70 Taguchi Loss Function 633
6.4.71 Teams and Meeting Guidelines 634
6.4.72 Testing of Hypotheses 637
6.4.73 To-Do-List 664
6.4.74 Tree Diagrams 665
6.4.75 Visual Management 667
6.4.76 VOC—Voice of the Customer 668
6.4.77 VSM—Value Stream Mapping 670
6.4.78 Y = F(X) 672
Reference 673
7 Auditing the Management System 674
7.1 Introduction: The Need for Performance Control and the Role of Audits 674
7.2 Audits: A Means to Control the Performance of Management Systems 675
7.2.1 The Role and Content of ISO 19011:2018 675
7.2.2 Auditors: General Requirements 681
7.2.3 Audits: General Process 683
7.2.4 Determining Audit Time and Some Related Issues 685
8 Certification and Accreditation: Types and Rules 689
8.1 Why This Chapter? 689
8.2 Types of Certification 690
8.3 Accreditation: Organizations, Rules and Achievements 691
8.4 Organizational Requirements for Organizations Certifying Management Systems 694
8.5 How to Select the Right Certification Body? 708
9 Mathematical Methods and Statistical Tables 709
9.1 Introduction 709
9.2 Why Logic Is Important 710
9.3 Sets 713
9.3.1 Introduction to Sets 713
9.3.2 Definition and Basic Properties of Sets 713
9.3.3 Combinatorics and Principles of Counting 715
9.4 Analysis 718
9.4.1 Numbers 718
9.4.2 Sequences and Limits 721
9.4.3 Maps and Functions 722
9.4.4 Differential Calculus 724
9.4.5 Integral Calculus 728
9.5 Algebra 733
9.5.1 Introductory Remarks on Algebra 733
9.5.2 Matrices and Vectors 733
9.5.3 Determinants 738
9.5.4 Derivatives of Matrices and Vectors 738
9.5.5 Boolean Algebra 740
9.6 Probability and Statistics 741
9.6.1 Why Is Probability Theory Important in Our Context? 741
9.6.2 The Intuitive Versus Formal Approach to Probability 742
9.6.3 Conditional Probabilities 744
9.6.4 Bayes’ Theorem 746
9.6.5 Random Variables, Probability Distribution Functions and Expected Values 748
9.6.6 Functions of Random Variables and Their Distributions 752
9.6.7 Approximations of Important Expectation Values 752
9.6.8 Inequalities for Probabilities 754
9.6.9 Law of Large Numbers 756
9.6.10 Characteristic Functions and Moment Generating Functions 757
9.6.11 CLT—Central Limit Theorem 760
9.6.12 Important Discrete and Continuous Probability Distributions 764
9.7 Statistical Tables 792
9.7.1 Quantiles and Percentiles 792
9.7.2 Description and Usage of the Tables 793
Suggested Further Reading 813
Index 814