Quality Systems Handbook

PrefacePart 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 AcceptabilityAppendices 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 9000Index