How Can ISO 9001:2000 be Applied to Healthcare?

Definition of ISO:

 

• ISO means “all sides being equal”. To date, more than ½ a million organizations in 149 countries have implemented the ISO Standards.
• ISO 9001:2000 is a fundamental quality management system standard that requires an organization to identify, define, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address all imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

 

Application of ISO in Healthcare:

Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

• Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
• Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
• Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
• Results in improved systems, processes, and outcomes.

 

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

 

• Clause 4 – Quality Management System
  Process Management, Documentation Requirements, Records Control
• Clause 5 – Management Responsibility
  Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
• Clause 6 – Resource Management
  Human Resources, Infrastructure, Work Environment
• Clause 7 – Product / Service Realization
  Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
• Clause 8 – Measurement, Analysis, and Improvement

   

  Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

 

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

 

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 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

 

Sample Key Improvement Objectives

 

• Improve Patient Satisfaction
  Goal: Improve to 70th Percentile
  Department Goal: Reduce Wait time for Outpatient Registration to < 4 minutes
• Improve Patient Safety
  Goal: Reduce Medication Error Rate to < .3%
  Goal: Reduce fall rate to < 2.6 per 1,000 patient days

 

Sample Process Interaction Diagram
See =>http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html

Sample Quality Policy

We will strive to be the leading provider of healthcare services in Southern Ohio. We will accomplish this through

 

• Consistent compliance with all imposed requirements;
• Our focus on Patient Safety and Satisfaction; and
• Continual improvement of our products, services, and processes.

  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 Akron, Youngstown, Cleveland and Columbus. Renee Mallett, Vice President, Healthcare Division, may be contacted at 614-855-0008 or email: reneem@iqsconsulting.net