WHY REGISTRATION

• ISO 9001:2015 certification is utilized in a variety of ways as a vehicle for healthcare organizations to:
• Identify systemic break-downs and close gaps or loopholes
• Define key interfaces between processes, departments and staff
• Streamline work flow and maximize resource utilization
• Proactively prevent problems from occurring
• Provide ways to detect and correct errors and problems
• Ensure conformance to and effectiveness of documented processes
• Focus on patient and provider needs and expectations
• Maximize customer satisfaction
• Facilitate compliance to healthcare quality certifications, accreditation      standards and regulatory requirements

ISO 9001:2015 offers a means for evaluating processes at an organizational level. It also enables the organization to define organization specific goals and methods for quality management. Finally, ISO 9001:2015 offers a monitoring or audit system for maintaining the healthcare quality management system.

• If a healthcare provider is certified to ISO 9001, any other survey process for healthcare quality certifications will be much simpler and less costly regarding both preparation and compliance demonstration
• Systemic breakdowns are recognized and addressed
• Development of “Best practice” hospital-wide processes, with reference to supporting documentation
• Ensures conformance to and effectiveness of documented processes
• Focuses on Patient Care, Satisfaction, and Safety
• Reduce errors associated with ”hand-offs”
• Improve documentation and records
• Improve employees’ understanding of roles and responsibilities within the healthcare quality management system
• Strengthen customer/community confidence and relationships
• Alignment of Hospital-wide, Departments, Individual objectives
• Foundation for on-going improvement initiatives

One hospital was looking to enhance its healthcare quality management system. What makes ISO unique is that it relies on the individual organization to establish, document, implement and maintain a quality management system and continually improve its effectiveness. ISO assists the organization in designing and ensuring its documented processes are effective and support its mission. How do you know if your documented healthcare processes are effective?

• One hospital who has implemented ISO 9001:2015 has provided resources in training individuals in the organization to be internal auditors. This hospital has about eight internal auditors that audit all thirty-seven patient care and support processes continuously. Further, each documented process has established monitors and measures that are evaluated twice a year in senior management meetings. The senior management team critiques the effectiveness, suitability and adequacy of all thirty-seven processes twice a year.
• Examples of the significant accomplishments that a hospital achieved by pursuing the ISO 9001:2015 as a Healthcare Quality Management System.
• Policy and Procedure Clean-up
• Forms and Document Clean-up – Index per Department and Hospital Wide
• All physician orders sets and protocols reviewed at least once a year
• On-line Risk Occurrence Entry Implemented
• Centralized the Product Recall Process which includes medication, equipment, devices, food
• Capital Request – Reviewed process & policy, enhanced checklist
• Need for Unit Clerks Identified and identified other needed resources