ISO 9001 Healthcare Overview
Healthcare Certification Capabilities - Quality Management Systems
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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