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

ISO 9001:2000 offers a framework by which to pursue an overall healthcare quality improvement plan. ISO offers a framework for organizations to evaluate processes at a macro level and then evaluate the interactions of the processes. Finally, ISO 9001:2000 offers a means of maintaining the healthcare quality management system through an internal audit process.

Recommended Approach for Developing a Healthcare Quality Improvement Plan

While the ISO 9001 standard does not prescribe the approach or methodology to be utilized by an organization, the following is the recommended approach for utilizing ISO 9001 to develop a healthcare quality improvement plan.

1. Obtain Management commitment to support, understanding, involvement, provision of resources

2. Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact

3. Define Key Improvement Objectives

4. Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.

5. Develop the organization’s Quality Policy and Quality Manual.

6. Establish approach to document control and access.

7. Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms)

8. Educate Staff on Quality Management System (QMS) documentation

9. Establish and implement monitoring/measurement for each process

10. Train internal auditors. Implement an Internal Audit Process.

11. Conduct a Management Review of the QMS.

12. Undergo a Pre-Assessment or “Mock Survey” to assess system implementation, readiness

13. Make required corrections

14. Submit Document Review to Registrar (Quality Manual, Processes)

15. Undergo the Certification Audit

Why ISO 9001:2000 certification for healthcare? What are the benefits of ISO 9001:2000 for healthcare organizations? Why did one hospital pursue certification to ISO 9001:2000? Are there many hospitals certified for the ISO 9001:2000 standard? Are employees and physicians involved with the hospital certification process? How do you know if your documented healthcare processes are effective? Give an example of the significant accomplishments that a hospital achieved by pursuing the ISO 9001:2000 standard as a Healthcare Quality Management System.

Status of Quality Improvement Movement in Healthcare ISO 9001:2000 Applied as a Healthcare Quality Management Tool Process for Using ISO 9001:2000 to Develop a Healthcare Quality Improvement Plan Key ISO 9001 Improvement Objectives for Healthcare ISO 9001:2000 as a Healthcare Quality Management System Benefits of ISO 9001:2000 as the Framework for Managing All Healthcare Quality Certifications Linking ISO 9001:2000 requirements to Product/Service Quality