ISO 9001:2000 Applied as a Healthcare Quality Management Tool
Definition of ISO 9000
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ISO means “all sides being equal”. To date, more than 500,000
organizations in 149 countries have implemented the ISO Standards. |
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ISO 9000 was the standard introduced in 1987 which was later replaced by
ISO 9001. 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”). |
Healthcare Quality Management through the Application of ISO 9001
Using the ISO Family of Standards, the organization can establish a
comprehensive Quality / Business Management System which:
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Provides a solid basis for compliance with all imposed requirements and
healthcare quality certifications (e.g., JCAHO, AOA, Federal & State
regulations). |
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Makes all other healthcare quality certifications & accreditations
processes easier and less costly. |
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Facilitates improved understanding of roles & responsibilities among
employees; and enhanced communication and coordination between departments. |
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Requires the establishment of measurable improvement objectives and
accountability to those objectives through monitoring, measuring and
reporting. |
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Results in improved systems, processes, and outcomes. |
Structure of the ISO 9001:2000 Standard
The ISO:9001 2000 Standard is comprised of eight Clauses. The first three are
introductory in nature. The subsequent five clauses include the requirements the
healthcare organization must address. They are as follows:
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Clause 4 – Quality Management System
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Clause 5 – Management Responsibility
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Customer/Patient Focus, Policy, Objectives, Planning, Responsibility
& Authority
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Clause 6 – Resource Management
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Clause 7 – Product / Service Realization
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Planning of New Products & Services, Customer Interface/
Communication, Design, Purchasing/Supplier Management, Production/
Service Operations, Calibration
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Clause 8 – Measurement, Analysis, and Improvement
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Internal Audits, Customer/Patient Satisfaction,
Monitoring/Measurement of Products/Services and Processes, Handling
Nonconformances, Corrective & Preventive Action, Continual Improvement
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Choose SQA
as your ISO 9000 for Healthcare Registrar today.
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