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    artments.
  • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
  • Results in improved systems, processes, and outcomes.
  • Structure of the ISO 9001:2000 Standard:

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    Definition of ISO:

    • ISO means “all sides being equal”. To date, more than ? a million organizations in 149 countries have implemented the ISO Standards.
    • ISO 9001:2000 is a fundamental quality management system standard that requires an organization to identify, define, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address all imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

    Application of ISO in Healthcare:

    Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

    • Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
    • Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
    • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
    • Results in improved systems, processes, and outcomes.

    Structure of the ISO 9001:2000 Standard:

    <
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    e, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address all imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

    Application of ISO in Healthcare:

    Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

    • Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
    • Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
    • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
    • Results in improved systems, processes, and outcomes.

    Structure of the ISO 9001:2000 Standard:

    New Year's Resolutions - Executive Compensation Style
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    e.g. those traditionally associated with the “hand-offs”).

    Application of ISO in Healthcare:

    Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

    • Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
    • Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
    • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
    • Results in improved systems, processes, and outcomes.

    Structure of the ISO 9001:2000 Standard:

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    all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
  • Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
  • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
  • Results in improved systems, processes, and outcomes.
  • Structure of the ISO 9001:2000 Standard:

    History of ISO 9000
    ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997.The history of ISO 9000 dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration)
    artments.
  • Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
  • Results in improved systems, processes, and outcomes.
  • Structure of the ISO 9001:2000 Standard:

    The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

    • Clause 4 – Quality Management System
      1. Process Management, Documentation Requirements, Records Control
    • Clause 5 – Management Responsibility
      1. Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
    • Clause 6 – Resource Management
      1. Human Resources, Infrastructure, Work Environment
    • Clause 7 – Product / Service Realization
      1. Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
    • Clause 8 – Measurement, Analysis, and Improvement

      Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

    Process / Methodology

    While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recomm

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