ISO 9001:2000 : a new paradigm for healthcare /
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| Author / Creator: | Carson, Bryce E. |
|---|---|
| Imprint: | Milwaukee, Wis. : ASQ Quality Press, 2004. |
| Description: | xx, 187 p. : ill. ; 26 cm + 1 CD-ROM (4 3/4 in.) |
| Language: | English |
| Subject: | |
| Format: | Print Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/5712404 |
Table of Contents:
- List of Figures
- Foreword
- Introduction
- Chapter 1. Eight Keys to Creating a Sustainable Quality Management System
- The Process Model for Continual Improvement
- The Eight Keys
- Summary
- Chapter 2. Background and Introduction to the ISO 9001:2000 Family of Standards
- Introduction to ISO 9001:2000
- ISO 9000 Series (ISO 9000, ISO 9001, and ISO 9004)
- Restructuring and Consolidation of the ISO 9000 Family of Standards
- ISO 9000:2000
- ISO 9001:2000 and ISO 9004:2000
- ISO 9001:2000: Clauses 0-3
- Chapter 3. ISO 9001:2000 Clause 4--Quality Management System
- 4.1. General Requirements
- 4.2. Documentation Requirements
- Quality Policy, Goals and Objectives
- 4.2.1(b) and 4.2.2. The Quality Manual
- Quality System Level Procedures and Documentation
- Rules for Writing Procedures
- The Quality Plan
- Writing How-To Documents: Work Instructions and Protocols
- 4.2.1(e). Records Required
- 4.2.3. Control of Documents
- Forms Control
- Control of Documents of External Origin
- 4.2.4. Control of Records
- Chapter 4. ISO 9001:2000 Clause 5--Management Responsibility
- 5.1. Management Commitment
- 5.2. Customer Focus
- Customer Focus--Who Is the Customer?
- 5.3. Quality Policy
- 5.4. Planning
- 5.4.1. Quality Objectives
- 5.4.2. Quality Management System Planning
- 5.5. Responsibility, Authority and Communication
- 5.5.1. Responsibility and Authority
- 5.5.2. Management Representative
- 5.5.3. Internal Communication
- 5.6. Management Review
- 5.6.2. Review Input
- 5.6.3. Review Output
- Records of Management Review
- Chapter 5. ISO 9001:2000 Clause 6--Resource Management
- 6.1. Provision of Resources
- 6.2. Human Resources
- 6.3. Infrastructure and 6.4 Work Environment
- Chapter 6. ISO 9001:2000 Clause 7--Product Realization
- 7.1. Planning of Product Realization
- 7.2. Customer-Related Processes
- 7.2.2. Review of Requirements Related to the Product
- 7.2.3. Customer Communication
- 7.3. Design and Development
- 7.4. Purchasing
- 7.4.1. Purchasing Process
- 7.4.2. Purchasing Information
- 7.4.3. Verification of Purchased Product
- 7.5. Production and Service Provision
- 7.5.2. Validation of Processes
- 7.5.3. Identification and Traceability
- 7.5.4. Customer Property
- 7.5.5. Preservation of Product
- 7.6. Control of Monitoring and Measuring Devices
- Chapter 7. ISO 9001:2000 Clause 8--Measurement, Analysis and Improvement
- 8.1. General
- 8.2.1. Customer Satisfaction
- 8.2.2. Internal Audit
- 8.2.3 and 8.2.4. Monitoring and Measurement of Processes and Product
- 8.3. Control of Nonconforming Product
- 8.4. Analysis of Data
- 8.5.1. Continual Improvement
- 8.5.2. Corrective Action
- 8.5.3. Preventive Action
- Chapter 8. Conclusion
- Putting All the Pieces Together
- Appendix A. ISO 9001:2000 Self-Assessment Tool
- Scoring the Self-Assessment Instrument
- Appendix B. Sample Quality Systems Manual and Procedures
- Appendix C. Sample Flowcharts and Process Maps
- References
- About the Author
- Index
