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ISO 9001

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ISO in Healthcare

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Deltas Between AS9000 and ISO 9001:2000

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Deriving value from certification

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Value of ISO 14001 Whitepaper

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The Status of Quality Improvement Movement in Healthcare

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Traditionally healthcare has been a heavily regulated industry, subject to numerous Federal and State requirements, healthcare quality certifications and various accreditations

There are various quality improvement initiatives in place within most healthcare organizations, however, it’s often fragmented and typically doesn’t yield the desired, sustainable benefits. Due to the critical nature of the products and services being delivered, identifying and addressing related errors is essential.

For example, the Institute of Medicine (IOM) estimates that medical errors cost the nation approximately $37.6 billion per year. Approximately $17 billion of that amount are associated with preventable errors. Additionally, more than 44,000 deaths occur annually due to error, which could make medical errors the 8th leading cause of death. At an estimated 90,000 deaths per year, hospital acquired infections kill as many people in the U.S. as Aids, breast cancer, and car accidents combined.

Healthcare Quality Management

It is proven that most mistakes and errors occur during the “hand-offs” of information, requests, requirements, etc. Currently, most organizations have in place documented healthcare quality management systems that address requirements and responsibilities at the department or functional level; however, the quality system doesn’t speak to the “hand-offs”/transfers/or process breakdowns that occur between the functions and/or departments.

A healthcare quality management system needs to identify the potential system breakdowns and address them through proactive, defined, assigned responsibilities. These documented responsibilities then need to be verified on a regular basis. This type of system is called a comprehensive quality management system (QMS) in that it accounts for the interactions of the processes. By implementing a comprehensive healthcare quality management system, healthcare organizations and their patients will benefit greatly.
 

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

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Frequently Asked Questions

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Why ISO 9001:2000 certification for healthcare?

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What are the benefits of ISO 9001:2000 for healthcare organizations?

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Why did one hospital pursue certification to ISO 9001:2000?

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Are there many hospitals certified for the ISO 9001:2000 standard?

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Are employees and physicians involved with the hospital certification process?

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How do you know if your documented healthcare processes are effective?

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Give an example of the significant accomplishments that a hospital achieved by pursuing the ISO 9001:2000 standard as a Healthcare Quality Management System.

Additional Resources for ISO 9001

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Status of Quality Improvement Movement in Healthcare

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ISO 9001:2000 Applied as a Healthcare Quality Management Tool

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Process for Using ISO 9001:2000 to Develop a Healthcare Quality Improvement Plan

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Key ISO 9001 Improvement Objectives for Healthcare

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ISO 9001:2000 as a Healthcare Quality Management System

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Benefits of ISO 9001:2000 as the Framework for Managing All Healthcare Quality Certifications

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Linking ISO 9001:2000 requirements to Product/Service Quality