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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.
Autorentext
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.
Inhalt
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 Produ…