Publisher: AQA Press
Authors: Jack Kanholm
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ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Publisher: AQA Press |
| ISBN: 1882711270 List Price: $890.00 Amazon Price: $623.00 Usually ships in 4 to 6 weeks |
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ISO 9000 Requirements, 92 Requirements Checklist and Compliance Guide
Publisher: ASQ Quality Press |
| ISBN: 1882711254 List Price: $39.00 Amazon Price: $27.30 Usually ships in 24 hours |
Avg Cusomer Rating: 2 Reviews: Summary: Decent explanation, no examples. The author does a decent job explaining ISO requirements. Contrary to the other reviewer's claims, there are "no" examples in the book. Another useful tool would have been examples of ISO systems / process flowchart. Instead, the author tries to get you to buy his software if you want to see any example at all. I give the book 2 stars because it tries to do marketing instead of doing it's job of giving buyers useful information. Based on the title of the book "ISO 9001 Requirements", the author did do his job explaining what the requirements are. However, if you want to do ISO in order to improve the quality system of your company, as opposed to just getting a piece of paper saying that your company is ISO certified, then look for another book. Summary: Successfully Certified This book is wonderfully written and the author really does a nice job presenting the information clearly. Our company also purchased the software documentation quality manual and procedure package that really complemented the book and its information. The author presents and suggests information throughout the software presentation that is all within the ISO standard. This approach allowed our company to be as flexible in editing the manual and procedures as necessary. During our assessment process, how well written and the structure of our documentation was specifically noted. Jack Kanholm is a foremost authority in the area of ISO standards and their structured approach to organizational improvement. He has several books on the subject to his credit. We were certified to the new standard thanks in part to Jack Kanholm's book, software, and his organization. Summary: Successfully Certified This book is wonderfully written and the author really does a nice job presenting the information clearly. Our company also purchased the software documentation quality manual and procedure package that really complemented the book and its information. The author presents and suggests information throughout the software presentation that is all within the ISO standard. This approach allowed our company to be as flexible in editing the manual and procedures as necessary. During our assessment process, how well written and the structure of our documentation was specifically noted. Jack Kanholm is a foremost authority in the area of ISO standards and their structured approach to organizational improvement. He has several books on the subject to his credit. We were certified to the new standard thanks in part to Jack Kanholm's book, software, and his organization. Summary: |
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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis
Publisher: CRC |
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| ISBN: 0849318467 List Price: $299.95 Amazon Price: $299.95 Usually ships in 24 hours |
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ISO 9000 Quality Systems Handbook, Fifth Edition
Publisher: Butterworth-Heinemann |
| ISBN: 0750667850 List Price: $49.95 Amazon Price: $49.95 Usually ships in 24 hours |
Avg Cusomer Rating: 5 Reviews: Summary: Excellent book on ISO 9000 "ISO 9000 Quality Systems handbook" is an excellent book on the effective implementation of quality management systems. The book is well written in simple/plain English that should make it easy to follow and understand by any reader. The book was written by a very experienced practitioner in Quality Management Systems, the author (David Hoyle) having over three decades of experience in the field. This is an indispensable book for those implementing ISO 9000 Quality Management System. The reader will, among other things, understand the difference between the previous procedure approach to the current process approach to quality management. The reader will learn what the ISO 9000 requirements mean, why they are necessary and how to implement them. The other critical features in the book includes a summary and questionnaire to reinforce the reader's knowledge and understanding as well as comprehensive list of references that should be very useful for those who need to explore the subject more widely. The book is recommended reading for people involved in the implementation of ISO 9000 for enhanced organizational performance, particularly managers, designers, auditors, instructors and students of quality systems. Summary: ISO9001 deeply explained If you consider ISO9001 more than a paper on the wall then you should read this book. The author tells you what to do rather than a detailed prescription of how to do it. But more important he explains the reason of each ISO9001 requirement. This helps anybody that works with this standard to think about what the rational behind and how does this fit in each business. Everybody should understand first and implement after and that's the purpose of this book: to deeply understand the standard in order to create or transform your management system (and by this way the quality system) into a customer driven management system Summary: ISO 9000 Quality Systems Handbook 4th Edition - David Hoyle With the introduction of the ISO 9001:2000 standard, a number of publications offering ideas, advice and assistance to anyone who have been charged with implementing quality systems, have made their appearance on the bookshelves. The ISO 9000 Quality Systems Handbook 4th Edition, by David Hoyle is one of the best I have read on this subject. In this 4th edition, David analyzes each section, clause and requirement of the ISO 9001:2000 standard in detail. David Hoyle has over 30 years experience in quality Management and has authored or co-authored more than five books on ISO 9000. He is also the director of Transition Support, a firm that provides training and consulting in business improvement. The book is easy to understand and is suitable for students, managers, instructors as well as auditors. The novice ISO practitioner as well as the seasoned ISO 9000 enthusiast will find this book a valuable tool when implementing ISO 9000 quality management systems. For those making the transition from the 1994 version of the standard, this book helps to point out the changes from the 1994 to the 2000 standard. The standard has changed considerably. In the 4th edition, the meaning of each of the requirements of the ISO 9001:2000 standard is explained in detail and some of the sometimes confusing ISO language is clarified. The author explains why each of the requirements is necessary. He shows how each requirement links to the eight quality management principles on which the ISO 9001:2000 standard was based. The book gives practical guidance on implementing each requirement. This is the strong point of the book. After introducing some basic quality concepts, the book explains the role, the origins and application of the ISO 9000 family. The succeeding chapters, 4 through 8, correspond to each of the five sections of the standard. This makes it easy when looking for help in understanding and implementing a certain requirement of the standard. The 4th edition has a summary, a questionnaire that provides food for thought for the reader, and a list of references at the end of each chapter. A glossary and a list of related websites are included in the appendix. The 4th edition of ISO 9000 Quality Systems Handbook will find a permanent place on your desk. Auditors will find this book indispensable. Summary: |
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Achieving Quality Through Continual Improvement
Publisher: Wiley |
| ISBN: 0471092207 List Price: $122.95 Amazon Price: $122.95 Usually ships in 24 hours |
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ISO 14001 Environmental Certification Step by Step: Revised Edition
Publisher: Butterworth-Heinemann |
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| ISBN: 0750661003 List Price: $49.95 Amazon Price: $49.95 Usually ships in 24 hours |
Avg Cusomer Rating: 4 Reviews: Summary: Step by step ISO 14001 I would advise anyone who needs assistance implementing an environmental system to ISO 14001 to read this publication. It is clearly written and has an associated website where examples of registers and procedures are available. It takes you through each stage of the planning, implementation, auditing and what to expect. A very useful book for any environmental manager of a small company. Summary: |
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Process Assessment Standard ISO/IEC 15504: A Reference Book (The International Series in Engineering and Computer Science)
Publisher: Springer |
| ISBN: 0387231722 List Price: $99.00 Amazon Price: $99.00 Usually ships in 24 hours |
Avg Cusomer Rating: 5 Reviews: Summary: Excellent for quality professionals, especially assessors This is a technical reference book of the ISO/IEC 15504 standard for process assessment. The author provides lots of guidance based upon his personal experience on the standard and clarifies several aspects that are not always clear to the new process assessors and organizations starting to perform assessments. He provides a reader guide at the start to direct readers of varying experience and roles to what may interest them most. The author poses some rhetorical questions about standards in general and process assessment standards in particular. He then starts to discuss process models in an easy to read way, with lots of diagrams illustrating his text. The author eases into the requirements for process assessment so that reader unfamiliar with the standard are gradually introduced to increased detail as needed. The author then explains the capability dimension, and how to interpret it with lots of good reference and comparison to the standard. He uses a neat analogy of a home to illustrate the increasing utility of the capability dimension measurement scale. Readers are then taken through a variety of well-illustrated process assessment models and process lifecycle models. The author covers lots of existing standards that are related to ISO/IEC 15504, including software lifecycles, ITIL, SEI CMMI and FAA iCMM. Although this is a technical reference book, it contains enough generally useful information to be readable for anyone interested in or involved in organizations that are planning or using process assessment to improve their business. See also my review of the companion Practical Guide, which describes the uses of results of assessments. A good technical reference book with some solid and readable advice for less technical readers. I recommend this book for quality professionals, especially assessors, but also anyone deciding upon the way they want to assess their business. Summary: |
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Internal Quality Auditing
Publisher: Paton Press |
| ISBN: 0971323100 List Price: $39.00 Amazon Price: $24.57 Usually ships in 2 to 3 weeks |
Avg Cusomer Rating: 5 Reviews: Summary: Terrific Guide to Auditing! This is a very comprehensive yet easy-to-understand guide to auditing. It's ideal for anyone who has to perform ISO 9000 internal audits. Highly recommended! Summary: |
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