The Importance of ISO 9001 Applied at Akdeniz University ... - EOQ

AKDENİZ UNIVERSITY HOSPITAL
THE IMPORTANCE OF ISO 9001 QUALITY MANAGEMENT
SYSTEM APPLIED IN THE AKDENIZ UNIVERSITY HOSPITAL
DURING TRANSITION TO
JCI- ACCREDITATION STANDARDS FOR HOSPITALS

AKDENİZ UNIVERSITY HOSPITAL
Akdeniz University Hospital is a Health Research and Application Center
which has:
Closed area 150.000 m 2
Number of Staff
Outpatients
Inpatients
Operations
3000 academic and administrative staff
700.000 (annual average)
67.000 (annual average)
27.000 (annual average)
Organ transplantations 2.962 (1982/30.09.2010)
2662 Kidney Transplantation, 195 Liver Transplantation, 46 Heart
Transplantation, 57 Pancreas Transplantation, 2 Arm Transplantation

QUALITY STUDIES IN AKDENIZ UNIVERSITY HOSPITAL
A new hospital building, equipped with new technology and equipment, and
staffed by hospital administrators who want to establish a modern hospital
management system:
-Total Quality Management studies began in 1997.
-Total Quality Management practices applied in Administrative Departments
between 1997 and 2001.
- ISO 9001 Quality Management System (QMS) implementation initiated in all
medical and administrative parts of the hospital in 2001.
- In 2003, the first ISO 9001 QMS Certificated hospital among all university and
public hospitals in Turkey. In 2009, the certificate was renewed for the 3rd time.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
DOCUMENTATION
• Studies began with an assessment of the current situation, and an analysis
of the organization.
• 50 members of staff sitting on 14 committees.
• ISO 9001 QMS and Internal Auditor training was arranged for all committee
members.
• Processes are determined by senior management and committee members.
• Process-based documents prepared. (120 procedures, 374 instructions,
140 workflow diagrams, 345 job descriptions, 2,000 standard forms)
• Documentation can be viewed electronically.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MANAGEMENT RESPONSIBILITY
The most important advantage enjoyed by our hospital is the active
leadership role taken by the top management in implementing
ISO 9001 QMS applications, with the following understandings;
• The mission of the leadership was determined as: “To meet the expectations of our
patients through the efforts of our specialized staff, by following all current scientific
and technological developments in the world at the highest level, using the highestquality
and most effective and efficient methods.”
• The Head Doctor is also the Quality Management Representative of the hospital.
• Creation of a QMS organizational chart to ensure the effective establishment and
maintenance of the system.
• The addition of a Quality Management Department to the hierarchical structure of the
organization.
• The Quality Management Department is responsible for carrying out quality studies.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MANAGEMENT RESPONSIBILITY
• The managers of all medical and administrative departments are identified as being
responsible for the QMS activities of their departments.
• The decision by top management to take QMS certification under objective
evaluation.
• The decision by top management to require the improvement of services and
operational processes from the committees (Hospital Advisory Board, Management
Committee, Quality Council, etc.)
• Decisions are carried out by the project teams, committees and process owners.
• Hospital management goals and Department goals are determined annually.
• Documentation of the objectives is evaluated periodically within hospital management
committees and Management Review Meetings.
• Management Review Meetings are carried out under the chairmanship of the Rector,
and with the participation of Hospital Administrators and Department Heads.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
RESOURCE MANAGEMENT
• Planning of human resources and staff work standards are carried out
by experts belonging to the project team in our hospital.
• Hospital staff training needs are determined, planned and
• Hospital staff training needs are determined, planned and
systematically organized by the Training Department. (Communication
training, fire safety, hospital infection and hand washing, workplace
health and safety, hospital emergency plans, ISO 9001 quality
management system training, etc.)

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
RESOURCE MANAGEMENT
• "Hospital Automation System" was established and operated in order
to facilitate the re-entries of data and information about the availability
of hospital services.
• In our hospital, the necessary building materials and auxiliary plant and
inventory materials are available in order to fulfill the operation of the
processes in the most effective way.
• Conditions related to the work environment are established in
accordance with legal regulations in our hospital.
• For this purpose, Workplace Health and Safety Department has started
its activities.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
SERVICE/PRODUCT REALIZATION
When a new service is requested, this service will be designed and
implemented. When dealing with demands for services the following criteria
will be taken into account;
– Oral and written requests from patients and relatives of patients,
– Legal and regulatory requirements,
– Additional requirements to be determined by the hospital.
The necessary documents are prepared and updated when changes occur
in the system.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
SERVICE/PRODUCT REALIZATION
• Hospital management is responsible for the monitoring and continuous
availability of information about the provision of services at the stage of
realization, as well as products, service providers and patients.
• The automated hospital data system provides the base point through which
diagnostic and therapeutic procedures can be identified and traced, and the
information then recorded and stored.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
SERVICE/PRODUCT REALIZATION
• Design Studies are initiated by top management as a result of:
– Customer feedback,
– Department requests,
– Legislative changes,
– Error rate reduction,
– Saving-oriented changes,
– Willingness to use new technologies.
• Design Studies encompass:
Outpatient Surgery Centre, Private Health Centre, Hospital Security System,
Workplace Health and Safety, Chemotherapy Unit.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
SERVICE/PRODUCT REALIZATION
• Calibration :
In our hospital, all medical devices used for measurements are calibrated in
the following manner;
– Using 15 calibration devices available in the Calibration Centre,
– By trained and experienced technical team,
– Using 16 kinds of calibration methods, (temperature, pressure, weight,
anaesthesia equipment, patient monitors etc.)
– 4,000 calibration and 2,000 electrical safety tests are carried out annually,
– Devices are calibrated in place if necessary,
– Calibration records are monitored by the automated programme,
– The Calibration Centre also provides services to external organizations.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MEASUREMENT, ANALYSIS AND IMPROVEMENT
In our hospital, monitoring, measurement and improvements are made in the
following ways:
• Verification of purchased products,
• Control of services,
• Internal audits,
• Customer feedback, data analysis, corrective and preventive actions.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Patient Satisfaction Measurement Data provided from:
– Surveys,
– Satisfaction, request and complaints boxes,
– Electronical petitions, transmitted from the hospital web page,
– Written petitions,
– Data collected from personal applications.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MEASUREMENT, ANALYSIS AND IMPROVEMENT
• To measure patient satisfaction, 26,000 surveys are carried out
annually, and scanned with optical readers.
• Surveys, other data assessment and improvements are carried
out by the Patient Satisfaction Evaluation Committee.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Internal Audit:
– Planned internal audits of 60 medical and administrative departments are
made at least once a year.
– In internal audits, an auditing committee of the hospital consisting of 150
persons are involved.
– As a result of internal audits, 500 corrective / preventive actions are
implemented annually and improvement studies are carried out.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Apart from internal audits, 120 services and products which do not
confirm to the required standards are identified by hospital employees
and reported to hospital management every year and corrective or
preventive actions are initiated.

IMPLEMENTATION OF ISO 9001 QMS STANDARDS IN OUR HOSPITAL
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Improvement:
Improvement activities are carried out through the joint efforts of Quality
Department employees and process owners, then reported to top
management. (Reduction of the waiting period in receiving biological
samples, Prevention of false samples sent to the Central Laboratory etc.)

The examples we give above show how it is possible to
create a management model for a hospital of this size using
the ISO 9001 quality management system.
Application of the ISO 9001 Quality Management System
Standards in our hospital over a period of 10 years has also
given a more detailed and specific approach to the functioning
of the health services, and there are now plans for the
implementation of JCI-Accreditation standards for hospitals.

WHY JCI-ACCREDITATION STANDARDS FOR HOSPITALS ?
• In general, issues mentioned in JCI accreditation standards for hospitals
are also given in the ISO 9001 quality management system standards.
• JCI-accreditation standards for hospitals are include organizational
standards and as well as the patient-oriented standards.
• Patient-focused standards are emphasized medical care, more specific and
detailed.
• Because of this feature provides ease of implementation in hospitals.

CONSISTENCY OF ISO 9001 QUALITY MANAGEMENT SYSTEM
STANDARDS AND JCI-ACCREDITATION STANDARDS FOR HOSPITALS
Studies in accordance with ISO 9001 quality management system standards and JCI- accreditation standards for
hospitals.
ISO 9001 STANDARDS AND JCI-ACCREDITATION STANDARDS FOR HOSPITALS
ISO 9001:2008 QUALITY MANAGEMENT SYSTEM
STANDARDS
Subject
JCI-ACCREDITATION STANDARDS FOR HOSPITALS
Subject
Quality Management System
Management of Communication and Information
Management Responsibility
Governance, Leadership, and Direction
Management of Communication and Information
Resource Management
Product Realization
Measurement, Analysis and Improvement
Staff Qualifications and Education
Facility Management and Safety
Access to Care and Continuity of Care
Patient and Family Rights
Assessment of Patients
Care of Patients
Patient and Family Education
Anesthesia and Surgical Care
Medication Management and Use
Quality Improvement and Patient Safety
Prevention and Control of Infections

FACILITIES IN THE IMPLEMENTATION OF JCI-ACCREDITATION
STANDARDS FOR HOSPITALS
THE IMPORTANCE OF ISO 9001 QUALITY MANAGEMENT SYSTEM
• Culture and quality consciousness of ISO 9001 quality management system
in senior management and employees,
• Employee participation and the establishment of effective communication,
• Quality organization to be ready,
• System and organizational documents to be ready,
• All processes and tasks to be defined,

FACILITIES IN THE IMPLEMENTATION OF JCI-ACCREDITATION
STANDARDS FOR HOSPITALS
THE IMPORTANCE OF ISO 9001 QUALITY MANAGEMENT SYSTEM
• Elimination of non-conformities with using the quality management system
by all employees,
• The system is self-controlled and staff to be familiar with the culture of
audit,
• All departments identify goals and accomplish their work in this direction,
• Made the documentation and transition to implementetion of JCIaccreditation
standards for hospitals easier for us,

FACILITIES IN THE IMPLEMENTATION OF JCI-ACCREDITATION
STANDARDS FOR HOSPITALS
• Within the framework of JCI accreditation standards for hospitals, the new
documents are produced about medical care, by the doctors and nurses
involved in committees (International Patient Safety Procedure , Medical
Authorization Procedures, Doctor Order Procedure etc. ),
• Documents generated with in the JCI-accreditation standards for hospitals
• Documents generated with in the JCI-accreditation standards for hospitals
and applications are integrated to the ISO 9001 quality management
system.

RESULT
In our hospital, the ISO 9001 Quality Management System has been
successfully implemented since 2001. We believe that now we have
achieved this standard, our institution is an appropriate candidate for
modern and innovative standards projects or pilot applications.

AKDENİZ UNIVERSITY HOSPITAL
THE IMPORTANCE OF ISO 9001 QUALITY MANAGEMENT
SYSTEM APPLIED IN THE AKDENIZUNIVERSITY HOSPITAL
DURING TRANSITION TO
JCI- ACCREDITATION STANDARDS FOR HOSPITALS