PROVEN BENEFITS OF ISO 9001 FOR HEALTHCARE ORGANIZATIONS

ISO 9001 for Healthcare Organizations serves as a basis to:

• Achieve better understanding of all processes throughout the organization and health
system
• Improve understanding of employees and medical staff’s roles and responsibilities within
those processes
• Ensure consistency of practices, protocol, policies and procedures
• Assess the effectiveness of the hospital and health system-wide processes in achieving
desired results
• Drive improvement and/ or correction in healthcare operations
• Improve documentation and records management
• Improve patient safety awareness
• Strengthen both supplier and customer confidence and relationships
• Align Hospital-wide, Department, and Individual objectives
• Form a foundation for improvement activities within the business/quality management
system

Complying with the ISO 9001 Standard does not indicate that every product or service meets
requirements, only that the quality/business management system in use is capable of meeting
them.

ISO 9001 requirements describe what must be done to make up a quality/business management
system, not how to set it up.

Once ISO 9001 is implemented, the very nature of the process ensures continual quality
improvement, whereby problems and process variations are dealt with quickly and permanently.
With periodic audits to monitor continued compliance, there is relatively little interruption in the
delivery of care.

If a healthcare provider is certified to ISO 9001, any other survey process will be much simpler
and less costly regarding both preparation and compliance demonstration. While ISO is not
intended to replace JCAHO, HFAP, URAC, NCQA, or CAP, it does make the compliance
demonstration process much easier to manage, less time consuming, and less costly. Additional
benefits for blood banking organizations exist because the AABB standards are based on the
same principles and concepts as the ISO 9000 Standards. Amongst others, insurers/payors may
realize the benefits simply by applying the general business concepts and principles inherent in
the ISO 9000 Standards to their daily operations to improve overall efficiency and effectiveness.

Other benefits reported by companies that have successfully implemented ISO 9000 are:

• Improves Competitive Advantage

• Defined and documented Hospital/Health system-wide Processes
• Makes Operations/Processes Consistent
 • Helps Establish a “Quality Culture” and a culture for “Patient Safety”
• Encourages Self-Assessment
• Empowers Employees
• Establishes Internal Trust
• Improves Communication

Preliminary results of a worldwide survey recently sent out to a large number of registered
healthcare organizations reveals the following aspects of business to be favorably impacted via
ISO 9000 registration:

• Consistency of services during times of change

• Patient/customer/physician satisfaction
• Competitiveness in the healthcare market
• Accountability and Empowerment of employees
• Ability to evaluate effectiveness of processes through internal audits
• Communications within the facility
• Compliance with regulations, contract requirements, codes

"Our success is measured by the success of our clients."

100% first-time success in Initial Registration Audits, many with zero nonconformities.

Innovative Quality Solutions Company is a full service training and consulting firm focused on
total customer satisfaction, performance improvement and achievement of organizational
objectives. Innovative Quality Solutions provides all aspects of support to organizations seeking
certification and compliance to the ISO 9001, ISO 14001, AS 9100 and ISO/TS 16949 (TS
16949) Standards. Since 1995, the firm has lead more than 250 organizations to successful first
time certification/registration.

Innovative Quality Solutions is located in Cleveland and Columbus.