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How can ISO 9001 be applied to Healthcare?
[PDF VERSION]
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 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 Standard:
The ISO 9001 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 Standard,
Scope of Work, Organizational impact
- Define Key Improvement Objectives (*see next page)
- Identify and Map Organizational Processes, key as well as
support. Address all imposed requirements. (*see next page
Sample Process Interaction Diagram)
- Develop the organization’s Quality Policy and Quality Manual
(*see next page, Sample Quality Policy)
- 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
Sample Process Interaction Diagram
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.
"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. Paula Fyda, President may be
contacted at 330.725.9927 or email:
paulaf@iqsconsulting.net
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