Tabla de Contenidos:
  • 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; ; P