9781574443080

ISO 9001: 2000 Document Development Compliance Manual: A Complete Guide and CD-ROM

by ;
  • ISBN13:

    9781574443080

  • ISBN10:

    1574443089

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2001-06-27
  • Publisher: CRC Press

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Supplemental Materials

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Summary

Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series standards. It supplies ready to use ISO 9001:2000 Template Quality Manuals and applicable Standard Operating Procedures with year 2000 revisions for documentation management in text and on CD ROM. You will understand how to: Build quality into your products and services Achieve ISO 9001 certification with time, money, and resources optimization Supply products that are totally fit for use Satisfy user/customer expectations Edge out the competitors Achieve a defined level of quality Prevent defects and provide value Yield profits from your invested resources

Author Biography

Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over 10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing

Table of Contents

Objective
What is Quality?
8(4)
Correspondence between ISO 9001:1994 and ISO 9001:2000
12(10)
The Basic Changes
22(4)
Documentation and Registration Certification
26(6)
Quality Manuals
Quality Manual ISO 9001:2000
32(90)
Quality Manual ISO 9001:2000
122(64)
Quality Manual ISO 9001:2000
186(62)
Quality Manual ISO 9001:2000
248(60)
Standard Operating Procedures
Management Responsibility
308(6)
Quality Systems
314(10)
Contract Review
324(6)
Design Control
330(10)
Document and Data Control
340(8)
Purchasing
348(4)
Control of Customer - Supplied Product
352(4)
Product Identification and Traceability
356(4)
Process Control
360(6)
Inspection and Testing
366(6)
Inspection, Measuring, and Test Equipment
372(4)
Inspection and Test Status
376(4)
Control of Nonconforming Product
380(4)
Corrective Action
384(4)
Handling, Storage, Packaging, and Delivery
388(4)
Quality Records
392(4)
Internal Quality Audits
396(6)
Training
402(4)
Servicing
406(4)
Statistical Techniques
410

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