ISO 9001 Can Bring ‘Big Picture’ Approach to Healthcare

Patrick Duffy, PDA Consulting - ISO 9001 Gold Standard in HealthcareQuality in Healthcare – ISO 9001:2008, the Gold Standard

ISO 9001:2008 is the international standard for quality management in over 160 countries for manufacturing and services including Healthcare. Although ISO 9001:2008 has been widely adopted by hospitals and primary care facilities in these countries it has been slow to be adopted in the USA. This is due to the false impression that it relates only to manufacturing – due somewhat to the terminology used!

In “Using ISO 9001 in Healthcare” by Doctors James Levett MD and Robert Burney MD (ISBN-13:978-0-87389-808-9) they make the case that “ISO 9001 could provide the big-picture approach that healthcare needs.” Their discussions with other health organizations confirmed their own experiences – initial reluctance followed eventually by enthusiastic acceptance. One of the major hurdles for healthcare professionals is getting to grips with the terminology – for Patients read “Customers”.

What is ISO 9001:2008?

ISO 9001 is a Customer focused, organization wide, Quality Management System (QMS). The goal is continuous process improvement on W.E.Deming’s principle of Plan Do Check Act (PDCA).

The 8 quality principles of ISO 9001 are:

1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. Systems approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships

How does this fit with modern healthcare?

Already clinicians are more than familiar with the numerous processes and quality measures required for CMS Medicare, Medicaid and health insurance companies. Meaningful Use Stage 2 & Stage 3, along with HIPAA compliance and its requirement for Disaster Planning and Business Continuity, add to those processes. Moreover what is not perceived at this point is the need for integration. Currently many of these processes have grown in silos with the associated complications of maintenance. ISO 9001:2008 being organization, or “Enterprise” wide provides exactly that integration and ease of maintenance. We all live now in a “Customer/Supplier world”. Being an International Standard it enables efficient integration with external organizations such as your suppliers AND your customers. Within even a small rural hospital or clinic you are at any one time, with your patient, being a “supplier” on the one hand and a “customer” of Lab services, specialist services, health insurance and many more on the other. With the growth of the interest in ACOs and PCMH this integration becomes more important to the smooth transition of care, flow of information, quality of care and cost control.

But why would I want an “International Standard” – I run a small rural hospital?

I was talking recently with the Quality Manager of an Acute Hospital in Wyoming certified in ISO 9001 back in 2009. Their initial main driver was the number of international industrial companies operating around their town who are their main customers with staff healthcare plans. Being ISO 9001:2008 certified them selves they expect their suppliers to also be certified, or at least compliant. The hospital’s certification will become evident to the hospital’s contractors, suppliers and outlying PC Providers, who, will likewise be encouraged to follow suit in compliance.

As for the benefits?

They can be quantified in business terms, bottom line, in patient care and in staff efficiency, or as a nurse put it, “now I can find everything I need to do my job!”.

Patrick Duffy is an independent project management consultant trained in 1992 in the ISO 9001 compliant Methodology PRINCE® (Projects IN a Controlled Environment). He was a consultant to the UK NHS for 4 years implementing infrastructure, EMR and Telemedicine projects. He spent the last 2 years implementing Meaningful Use projects. He now lives with his family in Cheyenne Wyoming. His wife, Virginia is an ICU Nurse with over 20 years experience in the UK NHS. H is a member of the American Society for Quality. Contact him at or visit