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ISO 9001:2015: Understand, Implement, Succeed!

Book Description

ISO 9001:2015 improves on the world’s most widely used Quality Management Standard (QMS), reflecting current trends in economics, innovation, technology, business, and customer requirements. Using ISO 9001:2015, organizations can prevent and quickly address quality problems, deliver better customer experiences, and improve both profitability and sustainability.

This guide combines a complete critical explanation of ISO 9001:2015’s contents, as well as indispensable expert guidance for effective implementation. Two members of the Technical Committee that developed ISO 9001:2015 and ISO 9000:2015 show exactly how it affects your organization, so you can efficiently pass audits and gain or maintain registration.

In modular, building-block format, Alka Jarvis and Paul Palmes clearly present each requirement and the value it delivers. They also offer a logical, structured process for applying ISO 9001:2015 to improve product or service quality.

If you have already implemented ISO 9001:2008, the authors identify each key change, so you can locate gaps and plan an efficient migration. Practical appendixes include reusable templates and audit meeting agendas, plus essential information on documentation. Coverage includes

  • ISO 9001:2015’s business relevance and role in operational excellence

  • Why revisions were necessary, and how they impact and benefit you

  • Deepening your understanding of customer/stakeholder needs and expectations

  • Scoping your QMS in the context of ISO 9001:2015

  • Understanding leadership’s key role

  • Identifying risks, opportunities, objectives, resources, and competencies

  • Performing operational activities related to planning, control, requirements, design, and development

  • Measuring QMS performance

  • Addressing non-conformities and analyzing their root causes

  • Promoting ongoing improvement

  • This guidewill be indispensable to every leader and professional concerned with quality, throughout any organization that holds or seeks ISO 9001 certification.

    Table of Contents

    1. About This E-Book
    2. Title Page
    3. Copyright Page
    4. Contents
    5. Preface
    6. Acknowledgments
    7. About the Authors
    8. 1. Quality Management Systems: Adding Business Value
      1. ISO 9001 and Innovation
      2. The Business Call for ISO 9001
    9. 2. Executive Overview of Changes Within ISO 9001:2015
      1. Revision Process and Rationale for Structural Changes
      2. Understanding Changes: Variance Between ISO 9001:2008 and ISO 9001:2015
      3. Impact of Changes on Implementation
      4. Constraints of the Revised Structure
      5. Benefits of the Revised Structure
      6. Transition to ISO 9001:2015
    10. 3. Opportunities to Reevaluate Your Quality Management System
      1. Value-Added Restructuring of Your Quality Management System
      2. Focus on Competence versus Paperwork
        1. Competence
        2. Paperwork
      3. Customer Expectations and Quality Certifications
      4. Operational Excellence: The Process Approach
      5. Operational Excellence: Enabling Business and Innovation
      6. Developing a Restructuring Plan: Who, How, and Focusing on “Output Matters!”
      7. Self-Assessment Form
    11. 4. Making a Compelling Case for Leadership and Governance
      1. The Compliance Model
      2. Cost Avoidance
      3. Key Performance Indicators
      4. A Last Word on Cost
      5. Return on Investment
      6. Tools, Techniques, and Strategies for Obtaining Management Buy-In
      7. Cost of (Poor) Quality
      8. Corrective Action and Nonconformance Costs
      9. Balanced Scorecard
    12. 5. Clause 4: Context of the Organization
      1. Clause 4.1: Understanding the Organization and Its Context
        1. Reason
        2. Implementation Guidelines
        3. SWOT Analysis
      2. Clause 4.2: Understanding the Needs and Expectations of Interested Parties
        1. Reason
        2. Implementation Guidelines
      3. Clause 4.3: Determining the Scope of the Quality Management System
        1. Reason
        2. Implementation Guidelines
      4. Clause 4.4: The Quality Management System and Its Processes
        1. Reason
        2. Implementation
        3. Objectives
        4. Risk
    13. 6. Clause 5: Leadership
      1. Clause 5.1: Leadership and Commitment
        1. Reason
        2. Implementation
      2. Clause 5.1a: Accountable for Effectiveness
      3. Clause 5.1b: Develop and Maintain the Quality Policy and Objectives to Be Compatible with Context (4.1) and Strategic Direction
      4. Clause 5.1c: Ensuring the Integration of QMS Requirements into Your Business Processes
      5. Clause 5.1d: The Process Approach and Risk-Based Thinking
        1. The Process Approach
        2. Risk-Based Thinking
      6. Clause 5.1e: Availability of Resources for the QMS
      7. Clauses 5.1f–j
      8. Clause 5.2: Quality Policy
        1. Reason
        2. Implementation: Statutory and Regulatory Requirements
        3. Risks and Opportunities
        4. Customer Satisfaction
      9. Clause 5.2.1: Policy
        1. Reason
        2. Implementation
      10. Clause 5.2.2: Communicating the Quality Policy
        1. Reason
        2. Implementation
      11. Clause 5.3: Organizational Roles, Responsibilities, and Authorities
        1. Reason
      12. Clauses 5.3a–e
    14. 7. Clause 6: Planning for the Quality Management System
      1. Clause 6.1: Actions to Address Risks and Opportunities
        1. Reason
        2. Implementation Guidelines
      2. Clause 6.2: Quality Objectives and Planning to Achieve Them
      3. Clause 6.3: Planning of Changes
        1. Reason
        2. Implementation Guidance
    15. 8. Clause 7: Support
      1. Clause 7.1: Resources
        1. Reason
        2. Implementation Guidance
      2. Clause 7.2: Competence
        1. Reason
        2. Implementation Guidance
      3. Clause 7.3: Awareness
        1. Reason
        2. Implementation Guidance
      4. Clause 7.4: Communication
        1. Reason
        2. Implementation Guidance
      5. Clause 7.5: Documented Information
        1. Reason
        2. Implementation Guidance
    16. 9. Clause 8: Operation
      1. Clause 8.1: Operation Planning and Control
        1. Reason
        2. Implementation Guidance
      2. Clause 8.2: Requirements for Products and Services
        1. Clause 8.2.1: Customer Communication
        2. Reason
        3. Implementation Guidance: Clauses 8.1–8.2.4
      3. Clause 8.3: Design and Development of Products and Services
        1. Reason
        2. Implementation Guidance
        3. Design and Development Planning
        4. Design and Development Inputs
        5. Design and Development Controls
        6. Design and Development Outputs
        7. Design and Development Changes
      4. Clause 8.4: Control of Externally Provided Processes, Products, and Services
        1. Reason
        2. Implementation Guidance
      5. Clause 8.5: Production and Service Provision
        1. Reason
        2. Implementation Guidance
      6. Clause 8.6: Release of Products and Services
        1. Reason
        2. Implementation Guidance
      7. Clause 8.7: Control of Nonconforming Outputs
        1. Reason
        2. Implementation Guidance
    17. 10. Clause 9: Performance Evaluation
      1. Clause 9.1: Monitoring, Measurement, Analysis, and Evaluation
        1. Reason
        2. Implementation Guidance
      2. Clause 9.2: Internal Audit
        1. Reason
        2. Implementation Guidance
      3. Clause 9.3: Management Review
        1. Reason
        2. Implementation Guidance
    18. 11. Clause 10: Improvement
      1. Clause 10.1: General
        1. Implementation
      2. Clause 10.2: Nonconformity and Corrective Action
        1. Reason
        2. Implementation
      3. Clause 10.3: Continual Improvement
        1. Reason
        2. Implementation
    19. 12. Restating the Value Added and Enablement Perspective
      1. Managing the Quality System
      2. Further Improvement Opportunities for Implementers: Business Excellence Methodologies
        1. Six Sigma
        2. The Six Sigma Process
        3. Lean Six Sigma
        4. Total Quality Management
        5. ISO 9004
        6. Malcolm Baldrige Award
      3. ISO 9001 as a Foundation and Enabler
    20. A. The Quality Management Principles
    21. B. Other Standards
    22. C. Documentation
    23. D. Templates
      1. Quality Policy
      2. Nonconformance Report
      3. Internal Audit Report
      4. Opening Meeting of an Audit
      5. Audit Interviews
      6. Daily Discussion Meetings
      7. Closing Meeting