Developing a Healthcare Quality Improvement Plan utilizing ISO 9001:2000 as the quality managem
Process for using 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.
- Obtain Management commitment to support, understanding, involvement, provision of resources
- Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
- Define Key Improvement Objectives
- Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
- Develop the organization’s Quality Policy and Quality Manual.
- Establish approach to document control and access.
- Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms)
- Educate Staff on Quality Management System (QMS) documentation
- Establish and implement monitoring/measurement for each process
- Train internal auditors. Implement an Internal Audit Process.
- Conduct a Management Review of the QMS.
- Undergo a Pre-Assessment or “Mock Survey” to assess system implementation, readiness
- Make required corrections
- Submit Document Review to Registrar (Quality Manual, Processes)
- Undergo the Certification Audit
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