EN 15224 2016 – ISO 9001 for Healthcare

EN 15224, Quality management systems. EN ISO 9001:2015 for healthcare, 2016 Edition has just been released.  It replaces the previous 2012 Edition which is now obsolete.  Changes are extensive.  If you use this standard in your organization, you’ll want to get a copy of the new Edition right away.

EN 15224 is used to establish and certify quality management systems in healthcare organizations in Europe.  For those of you in the U.S., you may find the 88 page document to be an excellent addition to your compliance documentation.  It is an extensive review of the requirements for quality processes and performance in hospitals, nursing facilities, and the like.

The previous 2012 Edition was based on the previous edition of the ISO 9001.  This update supports the new 2015 Edition of the core QMS requirements standard.  To this end, changes are apparent with regards to risk management, a process approach, and the relationship between EN 15224 and the other management system standards.  The standard has been modified to make it easier to manage it within the context of the broader set.

What separates quality in healthcare organizations from the generic model of the ISO 9001:2015?  To me, a major difference is the inclusion of the WHO (World Health Organization) description of “health.”  This is defined by the five health components – body function, body structure, activity, participation, and environmental factors.  This gives a formal goal for quality efforts.  Additionally, the EN 15224 includes 11 basic quality aspects that have evolved from clinical experience.  They are:

• Appropriate, correct care.
• Availability.
• Continuity.
• Effectiveness.
• Efficiency.
• Equity.
• Evidence/knowledge based care.
• Patient-centered care.
• Patient involvement.
• Patient safety.
• Timeliness/accessibility.

Many hospitals and other healthcare facilities are moving towards standards-based quality management systems to improve both patient outcomes and better use of resources.  And the processes of QMS have given many healthcare organizations a structure for real improvements in the delivery of services.  If you’re involved in improving your facilities performance, you’ll want a copy of this new standard.

Order from Document Center Inc., a leader in the distribution of compliance documentation.  You can search for and order standards at our webstore www.document-center.com.  For the EN 15224, you’ll need to purchase the standard in one of the national editions from Europe.  Currently, Document Center offers you two options: BS EN 15224 and SS EN 15224.  The DIN EN 15224 should be released soon.

If you need any assistance or would like information on other standards of interest, please get in touch with us.  We can be reached by phone (650-591-7600) or email (info@document-center.com).  We have been selling standards since 1982 and have an array of support services to improve your documentation protocols.  Make us your Standards Experts!