ISO definition:

• ISO means “all sides are equal”. To date, more than half a million organizations in 149 countries have implemented ISO standards.
• ISO 9001:2000 is a fundamental quality management system standard that requires an organization to identify, define, document, implement (monitor), control/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 their organizational performance by modifying systemic aspects (for example, those traditionally associated with “hand-offs”).

Application of ISO in Health:

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

• Provides a solid foundation for compliance with all imposed requirements (eg, JCAHO, AABB, federal and state regulations). It makes all other certification and accreditation processes easier and less expensive.
• Facilitates a better understanding of roles and responsibilities among employees; and improved communication/coordination between departments.
• It requires the setting of measurable improvement goals and accountability to those goals through monitoring/measuring and reporting.
• It results in improved systems, processes and results.

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is made up of 8 Clauses. The first 3 are introductory. The following 5 clauses include the requirements that the organization must comply with. They are:

• Clause 4 – Quality Management System

Process Management, Documentation Requirements, Records Control

Clause 5 – Responsibility of the Administration

Client/patient focus, policy, goals, planning, responsibility and authority

Clause 6 – Resource Management

Human Resources, Infrastructure, Work Environment

Clause 7 – Realization of the Product/Service

Planning of new products and services, communication/interface with the client, design, purchasing/supplier management, production/service operations, calibration

Clause 8 – Measurement, Analysis and Improvement

Internal Audits, Client/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Management of Non-Conformities, Corrective and Preventive Action, Continuous Improvement

Process / Methodology

While the standard does not prescribe the approach or methodology an organization should use, the following is recommended.

Obtain the commitment of the Management of support, understanding, involvement, provision of resources

Educate management and staff on ISO 9001:2000, scope of work, organizational impact

Define key improvement objectives

Identify and Map Organizational Processes, both key and support. Address all imposed requirements.

Develop the Quality Policy and the Quality Manual of the organization.

Establish an approach to control and access to documents.

Develop, review/revise, and incorporate all required supporting documentation (eg, 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.

Carry out a management review of the QMS.

Undergo a pre-assessment or “mock survey” to assess system implementation and readiness

Make the required corrections

Send Document Review to the Registrar (Quality Manual, Processes)

Submit to the Certification Audit

Examples of key improvement objectives

• Improve patient satisfaction

Goal: Improve to 70th percentile

Department Goal: Reduce waiting time for outpatient registration

1. Improve patient safety

Goal: Reduce the rate of medication errors to

Goal: Reduce fall rate to Note: Hospital-wide/organizational goals are then translated into individual, departmental, and related process goals/objectives
Process Interaction Diagram Example See => http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html
Example of quality policy We will strive to be the leading provider of health care services in southern Ohio. We’ll make it through

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