The ISO 9001-2000 Quality Management System

Content of ISO 9001-2000
  Key Methodologies Considerations| The Scope of ISO 9001-2000| What Is It & What will It Do For Me| Consistency of Operating Processes & the Products| DDMS Process Improvement Model of ISO 9001-2000| DDMS Quality Management Principles & Process| Capabilities of Interest|
Benefit of Adapting ISO 9001-2000| DDMS Expertise| Benefit of ISO 9001-2000|

 

Key Methodologies Considerations
  • Technical Capabilities:
  • Discus how your approach is scalable, portable, and interoperable.
  • Tools and Technologies:
  • Discuss methodologies, processes, and products or services, both existing and emerging in your approach.
  • Reuse:
  • Where applicable, discuss how your approach leverages existing capabilities and those not on the market.
  • Maturity:
  • Discuss the maturity of your approach i.e., distinguish between existing capabilities and those not yet on the market.
  • Cost and Benefits:
  • Highlight the costs and benefits of your approach.
  • Data Security & Privacy:
  • Data owners/producers/managers are responsible for ensuring adequate security and privacy protections. If your approach adds value in this area please elaborate however, you are not required to address such issues.
  • Accessibility:
  • Discuss compliance with Section 508 accessibility standards of the Rehabilitation Act.
  • Records Management:
  • Discuss how your approach could simplify the activities, systems and processes of records creation, maintenance, and use to ensure efficient and effective preservation and disposal of record.


    The Scope of ISO 9001-2000

    The Scope Specifies...

    The Scope of ISO 9001-2000:

    Specifies requirements for a quality management system (QMS) Where an organization needs to:

    • Demonstrate its ability to provide consistently product that meets customers and applicable regulatory requirements of safety and quality
    • Address customer satisfaction through the effective application of the system, including progressess for:
      • Continuous Improvement
      • Prevention of nonconformity
     

    What Is It & What will It Do For Me
  • International Standard for Quality Management System

  • It keeps track and account of products, processes, services, hardware, and software tools, machines, labs, documents, record, data and metrics.


  • ISO 9001-2000 IS ...

    Say What You Do = Documentation
    Do What you Say = Implementation
    Prove it = Objective Evidence (record/Audits)

    Maintain and improve it
  • Ongoing Management Commitment
  • Adequate Resource
  • Continuous improvement of the system
  •  

    Consistency of Operating Processes & the Products

    ISO 9001-2000 deals with auditable trail throungh documentation & process improvement shown in figure below:

     

    DDMS Process Improvement Model of ISO 9001-2000
    Being able to change as customer needs change & as the new technology change in the continuous improvement process
     

    DDMS Quality Management Principles & Process