How to Establish a Document Control System for Compliance with ISO 9001 A Comprehensive Guide to Designing a Process-Based Document Control System.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Skipper, Stephanie L.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Milwaukee, WI : Quality Press, 2015.
Temas:
Records > Management > Data processing.
Electronic records > Management.
Quality control.
Information storage and retrieval systems.
Database management.
Quality Control
Information Systems
Archives électroniques > Gestion.
Qualité > Contrôle.
Systèmes d'information.
Bases de données > Gestion.
quality control.
Database management
Electronic records > Management
Information storage and retrieval systems
Quality control
Records > Management > Data processing
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Intro
  • Title Page
  • CIP data
  • Dedication
  • Table of Contents
  • List of Figures and Tables
  • Foreword
  • Applicability to ISO 9001:2015 and ISO 13485:2016 Updates
  • Acknowledgments
  • Chapter 1: Document Control in the Quality Management System
  • Chapter 2: Document Management versus Document Control
  • 2.1 ISO and US FDA Regulatory Document Control Requirements
  • Chapter 3: Manual Document Control Systems versus Electronic Document Control Systems
  • Chapter 4: Foundational Concepts
  • Foundational Concept: Controlled
  • Foundational Concept: Controlled Document
  • Foundational Concept: Proactively Managed
  • Foundational Concept: Document Life Cycle
  • Foundational Concept: Process
  • Foundational Concept: Process Steps
  • Foundational Concept: Procedure
  • Foundational Concept: Document Control
  • Foundational Concept: Standard Operating Procedure
  • Chapter 5: Process-Based Approach
  • Chapter 6: The Document Life Cycle
  • 6.1 Scope of Document Control
  • Chapter 7: Organization of Controlled Documents
  • 7.1 Document Levels and Families: Basic Organization Model
  • 7.2 Document Family Rules
  • 7.3 Purpose and Scope of Controlled Documents by Controlled Document Level
  • 7.3.1 Purpose and Scope of Level 1 Policies (Top Level-Directives)
  • 7.3.2 Purpose and Scope of Level 2 Manuals and Master Plans (High Level-Informative)
  • 7.3.3 Purpose and Scope of Level 3 Standard Operating Procedures (Mid Level-Process)
  • 7.3.4 Purpose and Scope of Level 4 Work Instruction/Procedures (Low Level-Detailed Instructional)
  • 7.3.5 Purpose and Scope of Level 5 Supporting Documents (Specific, Detailed, Functional)
  • Chapter 8: Document Identification: Numbering, Versioning, and Naming
  • 8.1 Numbering
  • Example #1
  • Example #2
  • 8.2 Versioning
  • 8.3 Naming
  • Chapter 9: Incorporating Document Control Objectives and Requirements into the Document Control Procedural Set
  • Chapter 10: Structure, Format, and Content of Controlled Documents
  • 10.1 The Minimum Content Standards
  • 10.1.1 Document Identification
  • 10.1.2 Purpose
  • 10.1.3 Scope
  • 10.1.4 Roles and Responsibilities
  • 10.1.5 Related Documents
  • 10.1.6 Supporting Documents
  • 10.1.7 Document/Version History
  • 10.1.8 Process Steps
  • 10.1.9 Quality Records
  • 10.2 The Minimum Content Standards for External Documents and Other Documented Information
  • Chapter 11: Writing the Document Control Policy, SOPs, and Work Instructions/Procedures
  • Chapter 12: Writing the Document Control Policy (POL)
  • 12.1 Document Identification Information
  • 12.1.1 Header
  • 12.1.2 Footer
  • 12.2 Document Sections
  • 12.2.1 Purpose
  • 12.2.2 Scope
  • 12.2.3 Roles and Responsibilities
  • 12.2.4 References and Related Documents
  • 12.2.5 Supporting Documents
  • 12.2.6 Requirements Section
  • 12.2.7 Exceptions
  • 12.2.8 Quality Records
  • 12.2.9 Document/Version History

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