Table of Contents for How to Audit the Process-Based QMS


List of Figures and Tables
xiii
Preface xv
Part I Process-Based Auditing
1(42)
Chapter 1 Audit Concepts, Principles, and Requirements
3(10)
Audit Defined
5(1)
Audit Principles
5(5)
Internal Audit Requirements of ISO 9001:2008
10(1)
Requirements for the Audit Program
10(1)
Requirements for Follow-up on Audit Results
11(2)
Chapter 2 The Process Approach
13(14)
Process Focus for Quality Management Systems
13(2)
The Process Approach as a Concept
15(2)
The Processes of the Quality Management System
17(4)
Process Interactions
21(2)
Improving the Processes of the Quality Management System
23(1)
The Key Processes Concept
23(1)
Process Champions and Process Owners
23(1)
The Processes for Product Realization
24(1)
Summary
25(2)
Chapter 3 Auditing the Process-Based Quality Management System
27(10)
Monitoring versus Measurement
30(1)
Quality Management System
30(1)
Relationship of Documentation to the Process Approach
31(1)
Extent of Documentation
32(1)
System Audits versus Process Audits
33(1)
Alternative Strategies for ISO 9001:2008 Audit Programs
34(1)
Summary
35(2)
Chapter 4 Audit Objectives: Meeting Requirements and Performance Improvement
37(6)
Concepts Related to Auditing to Verify that Requirements are Being Met
37(1)
Concepts Related to Auditing for Improved Performance
38(3)
Auditing for Performance Improvement and Consulting
41(2)
Part II Audit Program Management
43(24)
Chapter 5 The Audit Program
45(10)
Chartering of the Audit Program
45(1)
Decisions that Should be Made During the Chartering Process
46(1)
Disseminating the Audit Charter
47(1)
Establishing an Audit Process
48(1)
Preparing an Audit Procedure
48(1)
Annual Audit Scheduling
49(1)
Maintenance of the Audit Schedule
49(2)
Assignment of Auditors
51(1)
Monitoring and Measuring the Audit Process
51(2)
Management Review
53(2)
Chapter 6 Auditors
55(8)
Number of Auditors
56(1)
Selection of Auditors
57(2)
Auditor Competence
59(2)
Auditor Certification
61(1)
Ethics---Again
62(1)
Chapter 7 Use of Audit Information and Results
63(4)
Performing Analyses
64(1)
Presenting the Results of the Analysis
65(2)
Part III The Process of Auditing
67(64)
Chapter 8 The Audit Planning Phase
69(18)
Four Phases of the Audit
69(1)
Seven Items for Audit Planning
70(1)
Define the Audit Objectives
70(2)
Define the Audit Scope
72(3)
Define the Audit Team
75(1)
Define the Audit Criteria
76(5)
Prepare the Audit Plan
81(1)
Review, Study, and Understand the Documents
82(4)
The Preparation Package
86(1)
Chapter 9 Audit Performance Phase
87(16)
Process and Personal Aspects
87(1)
Process Aspects of the Performance Phase
88(1)
Keep Audit Objectives in Mind
89(1)
Personal Aspects of the Performance Phase
89(1)
Opening Meeting
90(1)
Observe the Processes
91(1)
Observe Activity Result
92(1)
No Documented Procedures Available
92(1)
Pause for Reflection
93(1)
Ask Questions
94(1)
Gather Objective Evidence
94(1)
Keep Great Notes
95(1)
Analyze Information
95(1)
Synthesis of All That is Seen and Heard and Reaching Conclusions
95(1)
Hold a Closing Meeting
96(1)
Personal Characteristics
97(2)
Caution Areas
99(2)
Summary
101(2)
Chapter 10 Audit Reporting Phase
103(12)
Output of the Audit
103(1)
Components of the Report
103(1)
How to Write a Finding
104(4)
How to Write a Positive Practice
108(3)
Delivery of Oral Report (Exit Meeting)
111(1)
Delivery of Written Report
112(3)
Chapter 11 Audit Closure Phase
115(12)
Transfer of Audit Issues to Action Requests
116(1)
Three Situations
117(1)
Development of Corrective Action Requests from the Audit Report
118(1)
Correcting Identified Nonconformities or Problems
119(1)
The Corrective Action Process
119(1)
Development of Preventive Action Requests from the Audit Report
120(1)
The Preventive Action Process
121(1)
Documenting Examples of Excellence or Best Practices from the Audit Report
122(3)
The Audit Boss's Responsibility for Follow-up
125(2)
Chapter 12 Reinventing the Audit Process
127(4)
Signs of QMS Maturity
127(1)
Reevaluate Your Use of Audit Data
128(1)
Re-charter the Audit Program
128(1)
Don't Forget the Basic Principles
128(1)
The Audit Boss Needs to Act
129(2)
Part IV Aids for Audit Program Implementation
131(50)
Chapter 13 Tools, Checklists, and Questions
133(48)
Item 1 Worksheet: Audit Approaches (Horizontal, Vertical, Combination of Horizontal and Vertical)
135(3)
Item 2 Worksheet: Audit Objectives and Criteria
138(2)
Item 3 Worksheet: Audit Program Charter
140(1)
Item 4 Checklist: Items to Consider when Preparing an Auditing Procedure
141(1)
Item 5 Worksheet: Developing an Overall Audit Schedule for an Organization
142(1)
Item 6 Checklist: Auditor Characteristics
143(1)
Item 7 Checklist: Responsibilities of Audit Personnel
144(1)
Item 8 Checklist: Training and Experience to Ensure Auditor Competence
145(1)
Item 9 Checklist: Areas to Consider when Reviewing Data Resulting from Audits
146(1)
Item 10 Checklist: Examples of Requirements to Consider When Planning an Audit
147(1)
Item 11 Worksheet: Audit Plan Development Worksheet
148(1)
Item 12 Form: Columnar form Audit Checklist
149(1)
Item 13 Form: Free Form Audit Checklist
150(1)
Item 14 Checklist: Activities to be Performed Prior to Starting an Audit
151(1)
Item 15 Checklist: Activities that Should be Considered for Each Audit
152(1)
Item 16 Checklist: Things to do in Every Opening Meeting
153(1)
Item 17 Checklist: Examples of Areas to Consider When Observing any Process or Function
154(2)
Item 18 Form: Audit Interview Form
156(1)
Item 19 Checklist: Minimum Things to Include in Closing Meetings
157(1)
Item 20 Form: Audit Report
158(1)
Item 21 Form: Findings Sheet
159(1)
Item 22 Form: Positive Practice Record
160(1)
Item 23 Form: Best Practice Record
161(1)
Item 24 Questions: Typical Audit Items for Compliance with ISO 9001:2008
162(19)
Further Reading List
ISO/TC 176 Product Introduction and Support Packages for ISO 9001:2008
181(2)
Index 183