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  • ISO 9001 Applied As A Healthcare Quality Management Tool

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    ISO 9001 is a fundamental quality management system standard. It requires an organization to identify, define, document, implement (follow), monitor / measure, and continually improve the effectiveness of its processes. ISO 9001 was the standard introduced in 1987 which was later replaced by ISO 9001.

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    ISO 9001 is a fundamental quality management system standard. It requires an organization to identify, define, document, implement (follow), monitor / measure, and continually improve the effectiveness of its processes. ISO 9001 was the standard introduced in 1987 which was later replaced by ISO 9001.

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    81 views1 page

    ISO 9001 Applied As A Healthcare Quality Management Tool

    Uploaded by

    onatbross
    ISO 9001 is a fundamental quality management system standard. It requires an organization to identify, define, document, implement (follow), monitor / measure, and continually improve the effectiveness of its processes. ISO 9001 was the standard introduced in 1987 which was later replaced by ISO 9001.

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    23 11 2013

    ISO 9001 applied as a healthcare quality management tool

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    Saturday, 23 November 2013

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    ISO 9001 applied as a healthcare quality management tool


    Definition of ISO 9001
    ISO means all sides being equal. To date, more than 500,000 organizations in 149 countries have implemented the ISO Standards. ISO 9001 was the standard introduced in 1987 which was later replaced by ISO 9001. ISO 9001 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).

    ISO 13485 Menu


    Overview Benefits Quality Standard Details Certification Process Additional Resources
    Develop a quality improvement plan ISO 9001 applied

    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:

    Structure of the ISO 9001 Standard


    Provides a solid basis for compliance with all imposed requirements and healthcare quality certifications (e.g., JCAHO, AOA, Federal & State regulations). Makes all other healthcare quality certifications & accreditations processes easier and less costly. Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication and 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. The ISO 9001 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: Clause 4 Quality Management System Process Management, Documentation Requirements, Records Control Clause 5 Management Responsibility Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority Clause 6 Resource Management Human Resources, Infrastructure, Work Environment Clause 7 Product / Service Realization 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

    Choose SQA as your ISO 9001 for Healthcare Registrar today.


    A representative from SQA would like to discuss your certification needs. Contact us at 330-762-4231 today.

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