Quality Systems Handbook

Quality Systems Handbook

1st Edition - January 18, 1994

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  • Author: David Hoyle
  • eBook ISBN: 9781483104935

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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

Product details

  • No. of pages: 392
  • Language: English
  • Copyright: © Butterworth-Heinemann 1994
  • Published: January 18, 1994
  • Imprint: Butterworth-Heinemann
  • eBook ISBN: 9781483104935

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

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

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