Cracking the Case of ISO 9001:2008 for Manufacturing: A Simple Guide to Implementing Quality Management in Manufacturing

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ASQ Quality Press, 2009 - Business & Economics - 208 pages
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This handy pocket guide gives tools and resources to make ISO 9001 seem like less of a mystery in manufacturing organizations. It explains the essential elements of each clause of the ISO 9001:2008 standard, providing an overview of what each requirement means for your organization and how to carry out the various tasks of those requirements. It's also a simple, inexpensive way to explain ISO 9001 to everyone in an organization, thus helping garner the support critical for any successful ISO 9001 initiative
 

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Contents

735 DESIGN AND DEVELOPMENT VERIFICATION
83
736 DESIGN AND DEVELOPMENT VALIDATION
85
737 CONTROL OF DESIGN AND DEVELOPMENT CHANGES
87
741 PURCHASING PROCESS
88
742 PURCHASING INFORMATION
90
743 VERIFICATION OF PURCHASED PRODUCT
92
751 CONTROL OF PRODUCTION AND SERVICE PROVISION
94
752 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
98

Implementing ISO 90012008
17
2008 FROM ISO 90012000
18
1 SCOPE
21
2 NORMATIVE REFERENCE
23
42 GENERAL REQUIREMENTS
24
42 DOCUMENTATION REQUIREMENTS
27
422 QUALITY MANUAL
29
423 CONTROL OF DOCUMENTS
30
424 CONTROL OF RECORDS What Is the Requirement?
32
51 MANAGEMENT COMMITMENT
35
52 CUSTOMER FOCUS
38
53 QUALITY POLICY
39
541 QUALITY OBJECTIVES
41
542 QUALITY MANAGEMENT SYSTEM PLANNING
43
551 RESPONSIBILITY AND AUTHORITY
45
552 MANAGEMENT REPRESENTATIVE
46
553 INTERNAL COMMUNICATION
48
56 MANAGEMENT REVIEW
50
562 REVIEW INPUT
52
563 REVIEW OUTPUT
54
61 PROVISION OF RESOURCES
56
62 HUMAN RESOURCES
58
622 COMPETENCE AWARENESS AND TRAINING
60
63 INFRASTRUCTURE
62
64 WORK ENVIRONMENT
63
71 PLANNING OF PRODUCT REALIZATION
65
721 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT
68
722 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT
70
723 CUSTOMER COMMUNICATION
73
73 DESIGN AND DEVELOPMENT
74
732 DESIGN AND DEVELOPMENT INPUTS
76
733 DESIGN AND DEVELOPMENT OUTPUTS
78
734 DESIGN AND DEVELOPMENT REVIEW
81
753 IDENTIFICATION AND TRACEABILITY
101
754 CUSTOMER PROPERTY
103
755 PRESERVATION OF PRODUCT
104
76 CONTROL OF MONITORING AND MEASURING DEVICES
106
8 MEASUREMENT ANALYSIS AND IMPROVEMENT
111
82 MONITORING AND MEASUREMENT
114
822 INTERNAL AUDIT
117
823 MONITORING AND MEASUREMENT OF PROCESSES
121
824 MONITORING AND MEASUREMENT OF PRODUCT
123
83 CONTROL OF NONCONFORMING PRODUCT
126
84 ANALYSIS OF DATA
128
85 IMPROVEMENT
131
852 CORRECTIVE ACTION
133
853 PREVENTIVE ACTION
135
Tools
139
FLOWCHART
140
PROCESS MAPPING
144
BRAINSTORMING
148
GANTT CHART
150
RUN OR TREND CHART
153
HISTOGRAM
156
PARETO CHART
160
FAILURE MODES AND EFFECTS ANALYSIS
162
RELIABILITY ANALYSIS
165
SAMPLING INSPECTION
166
PROCESS CAPABILITY STUDIES
173
CAUSEANDEFFECT DIAGRAM FISHBONEISHIKAWA DIAGRAM
175
PROBLEM SOLVING
179
HOW TO CONDUCT AN IMPROVEMENT PROJECT
181
Glossary
187
Additional Reading
203
Index
205
Copyright

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About the author (2009)

Charles A. Cianfrani is a U.S. Expert representative to ISO/TC 176/SC2/ WG 18, the Working Group that wrote ISO 9001:2008 and the revision of ISO 9004 2000, which will be released in 2009. He is vice president and managing director of the Quality Consulting Group at ResCare, Inc. in Media, PA, and has led implementation of ISO 9001 -compliant processes on six continents. He is an ASQ Fellow, holds BS, MS and MBA degrees; and is an ASQ CQE, CRE and CQA, as well as an RAB Certified Auditor and a Certified Workforce Development Professional (CWDP)
John E. (Jack) West is immediate past chair of the U.S. Technical Advisory Group for ISO/TC 176 and a U.S. delegate to the ISO committee responsible for the ISO 9000 family of quality management standards. He is a business adviser who helps organizations improve their growth and profitability. West has more than 30 years of experience in various industries around the world

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