Quality Systems Handbook - 1st Edition - ISBN: 9780750616904, 9781483104935

Quality Systems Handbook

1st Edition

Editors: David Hoyle
Authors: David Hoyle
eBook ISBN: 9781483104935
Imprint: Butterworth-Heinemann
Published Date: 18th January 1994
Page Count: 392
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Description

Quality Systems Handbook is a reference book that covers concepts and ideas in quality system. The book is comprised of two parts. Part 1 provides the background information of ISO 9000, such as its origin, composition, application, and the strategies for registration. Part 2 covers topics relevant to the ISO 9000 requirements, which include design control, internal quality audits, and statistical techniques. The text will be useful to managers, auditors, and quality practitioners who require reference in the various aspects of quality systems.

Table of Contents


Preface

Part 1 Preparation for ISO 9000 Registration

Chapter 1 Basic Concepts

Quality

Grade

Class

Quality Characteristics

Quality Parameters

Dimensions of Quality

Achieving, Sustaining and Improving Quality

Quality Control (QC)

Quality Improvement (QI)

Quality Assurance (QA)

Quality Goals

Quality Systems

Chapter 2 What is ISO 9000?

The Parts of ISO 9000

The Origin of ISO 9000

Why Introduce a Quality System at All?

Applying ISO 9000

Scope of Registration

Differences between the Three Assessment Standards

Why Register to ISO 9000?

Self Assessment

A Scenario to Ponder

The Key Requirements

Chapter 3 Quality System Strategies

Unifying Understanding

When Should We Go Ahead?

Choosing the Type of Quality System

What is the next Stage of Our Development?

Part 2 Satisfying ISO 9000 Requirements

Chapter 1 Management Responsibility

Scope of Requirements

Quality Policy

Responsibility and Authority

Verification Resources and Personnel

Management Representative

Management Review

Chapter 2 Quality System

Scope of Requirements

Establishing a Documented Quality System

Maintaining a Documented Quality System

Preparation of Documented Procedures and Instructions

Ensuring Effective Implementation

The Notes in Clause 4.2

Chapter 3 Contract Review

Scope of Requirements

Procedures for Contract Review

Coordinating Contract Review Activities

Ensuring That the Requirements are Adequately Defined and Documented

Resolving Differences

Ensuring That the Supplier has the Capability to Meet Contractual Requirements

Maintaining Records of Contract Reviews

Chapter 4 Design Control

Scope of Requirements

Procedures to Control the Design

Procedures to Verify the Design

Identifying the Responsibility of each Design and Development Activity

Ensuring That Plans are Updated as the Design Evolves

Assigning Design and Verification Activities

Identifying and Documenting Organizational Interfaces

Identifying and Documenting Technical Interfaces

Transmitting Interface Information

Reviewing Interface Information

Identifying and Documenting Design Input Requirements

Reviewing the Selection of Design Input Requirements

Resolving Incomplete, Ambiguous or Conflicting Requirements

Documenting the Design Output

Ensuring That Design Output Meets Design Input Requirements

Defining Acceptance Criteria

Ensuring Conformance to Regulatory Requirements

Identifying Crucial Characteristics

Design Verification Plan

Design Control Measures

Changes and Modifications

Chapter 5 Document Control

Scope of Requirements

Document Control Procedures

Document Review and Approval

Ensuring The Availability of Controlled Documents

Ensuring Removal of Obsolete Documents

Review and Approval of Changes to Documents

Access to Pertinent Background Information

Identifying the Nature of Changes

Identifying the Current Revision of Documents

Reissue of Changed Documents

Chapter 6 Purchasing

Scope of Requirements

Selection of Subcontractors

Records of Acceptable Subcontractors

Control of Subcontractors

Ensuring the Effectiveness of Subcontractor's Quality System

Purchasing Data

Product Identification

Purchasing Specifications

Subcontract Quality System Requirements

Review and Approval of Purchasing Documents

Verification of Purchased Product (by the Purchaser)

Chapter 7 Purchaser Supplied Product

Scope of Requirements

Verification of Purchaser Supplied Product

Storage of Purchaser Supplied Product

Maintenance of Purchaser Supplied Product

Reporting Problems to the Customer

Chapter 8 Product Identification and Traceability

Scope of Requirements

Procedures for Identifying Product

Traceability

Chapter 9 Process Control

Scope of Requirements

Planning Production and Installation Processes

Ensuring That Work is Carried Out under Controlled Conditions

Documented Work Instructions

Suitable Production and Installation Equipment

Suitable Working Environments

Compliance with Reference Documents

Controlling Process and Product Characteristics

Approval of Processes and Equipment

Workmanship Criteria

Special Processes

Ensuring Compliance with Unverifiable Characteristics

Qualification of Special Processes

Records of Special Processes

Chapter 10 Inspection and Testing

Scope of Requirements

Receiving Inspection and Testing

Premature Release of Product

In-process Inspection and Testing

Process Monitoring and Control Methods

Held Product

Identifying Nonconforming Product

Final Inspection and Testing

Completing the Evidence of Conformance

Ensuring no Incomplete Product is Dispatched

Inspection and Test Records

Chapter 11 Inspection, Measuring and Test Equipment

Scope of Requirements

Control of Inspection, Measuring and Test Equipment

Calibration of Inspection, Measuring and Test Equipment

Maintenance of Inspection, Measuring and Test Equipment

Ensuring Measurement Uncertainty is Known

Identifying Measurements to be Made and Accuracy Required

Selecting Appropriate Inspection, Measuring and Test Equipment

Devices That can Affect Product Quality

Identifying, Calibrating and Adjusting Devices against Certified Equipment

Documenting the Basis for Calibration

Documenting Calibration Procedures

Ensuring the Capability of Inspection, Measuring and Test Equipment

Identifying Inspection, Measuring and Test Equipment

Maintaining Calibration Records

Action on Equipment Found Out of Calibration

Ensuring That Environmental Conditions are Suitable

Ensuring That Accuracy and Fitness for Use is Maintained

Safeguarding Inspection, Measuring and Test Equipment

Proving Test Hardware and Test Software

Measurement Design Data

Chapter 12 Inspection and Test Status

Scope of Requirements

Identifying Inspection and Test Status

Maintaining Inspection and Test Status

Identifying the Inspection Authority

Chapter 13 Control of Nonconforming Product

Scope of Requirements

Classifying Nonconformances

Ensuring That Nonconforming Product is not Used

Identifying Nonconforming Product

Documenting Nonconforming Product

Evaluation of Nonconforming Product

Segregation of Nonconforming Product

Disposition of Nonconforming Product

Defining Disposition Responsibility

Review of Nonconforming Product

Use of Nonconforming Product

Recording the Actual Condition of Nonconforming Product

Re-Inspection of Repaired and Reworked Product

Chapter 14 Corrective Action

Scope of Requirements

Corrective Action Procedures

Investigating the Cause of Nonconforming Product

Detecting and Eliminating Potential Causes of Nonconforming Product

Initiating Preventative Actions

Ensuring That Corrective Actions are Effective

Implementing and Recording Changes in Procedures

Chapter 15 Handling, Storage, Packaging and Delivery

Scope of Requirements

Handling, Storage, Packing and Delivery Procedures

Handling

Storage

Receipt and Dispatch from Stores

Stock Condition Assessments

Controlling Packaging, Preservation and Marking Processes

Identifying, Preserving and Segregating Product

Delivery

Chapter 16 Quality Records

Scope of Requirements

Types of Quality Records

Identification of Quality Records

Collection of Quality Records

Indexing of Quality Records

Filing Quality Records

Storage of Quality Records

Maintenance of Quality Records

Disposition of Quality Records

Pertinent Subcontractor Quality Records

Retention of Quality Records

Availability of Quality Records

Quality Records Procedures

Authentication of Records

Chapter 17 Internal Quality Audits

Scope of Requirements

Ensuring the Quality Audits are Comprehensive

Planning Quality Audits

Verifying Compliance with Planned Arrangements

Determining the Effectiveness of the System

Scheduling Quality Audits

Procedures for Carrying Out Audits and Follow-up Action

Reporting the Results of Audits

Taking Timely Corrective Action

Chapter 18 Training

Scope of Requirements

Identifying Training Needs

Providing for Training

Qualification of Personnel

Chapter 19 Servicing

Scope of Requirements

Performing Servicing

Verifying That Servicing Meets Specified Requirements

Chapter 20 Statistical Techniques

Scope of Requirements

Identifying Statistical Techniques for Process Capability Acceptability

Identifying Statistical Techniques for Product Acceptability

Appendices

A Glossary of Terms

B Procedures Required by ISO 9001

C Bibliography

D List of Related Standards

E Relationship of Clauses

F National Equivalents to ISO 9000

Index

Details

No. of pages:
392
Language:
English
Copyright:
© Butterworth-Heinemann 1994
Published:
Imprint:
Butterworth-Heinemann
eBook ISBN:
9781483104935

About the Editor

David Hoyle

David Hoyle is an international management consultant with over 30 years' experience in quality management. He has held senior positions in quality management with British Aerospace and Ferranti International and worked with such companies as General Motors, the UK Civil Aviation Authority and Bell Atlantic on their quality improvement programmes. As well as delivering quality management and auditor training courses throughout the world, he has participated in various industry councils and committees, including the Institute of Quality Assurance.

Affiliations and Expertise

International management consultant with over 30 years' experience in quality management

About the Author

David Hoyle

David Hoyle is an international management consultant with over 30 years' experience in quality management. He has held senior positions in quality management with British Aerospace and Ferranti International and worked with such companies as General Motors, the UK Civil Aviation Authority and Bell Atlantic on their quality improvement programmes. As well as delivering quality management and auditor training courses throughout the world, he has participated in various industry councils and committees, including the Institute of Quality Assurance.

Affiliations and Expertise

International management consultant with over 30 years' experience in quality management