61-579 / Quality Management System of the Sterilization Units in SALUD Hospitals

GOP Information
Organisation sharing the GOP
Related practices from PaSQ database
Servicio Aragonés de Salud (SALUD)
Aragón Healthcare Service


Quality management system

GOP Description
Implementation level
Clinical settings
It has been institutionally implemented since 2007 in the Sterilization Units from all (9) SALUD acute care hospitals
To_sustain a quality_management_system which guarantees that all sterilization units use proper procedures, provide right maintenance to the equipment, offer continuous training to their workers and comply with the legal requirements, and thus play_their_role in the prevention of adverse_events and respond to the needs_and_expectations from their “clients”, mainly the surgery_units
In-patients for whose care sterilized material is used
ISO 9001 based Quality Management System, externally certified:
Process map development
Definition of objectives and indicators
Documentation of procedures and technical instructions
Continuous improvement (monitoring of indicators, detection of incidents, management of non-compliances, corrective and preventive actions)
Internal audits, system review and external audits
Timeframe implementation
Around 12 months
Implementation tools available
Work teams
Implementation cost
-Design and implementation phase (around 12 months): cost of external consulting
-Regular maintenance after implementation: own resources
-Cost of annual external audits
Method used to measure the results
Objectives and indicators follow-up
Annual system review
Annual internal audits
Annual external audits by certification bodies
No non-compliances identified in the last external audit.
The SALUD sterilization units opened 62 non-compliances after the internal audit. The most frequent were found in the process of material preparation and sterilization
The number of incidents collected in the different processes varies from 99 to 368 per year depending on the unit. The highest refer to the processes of reception and sterilization.
Clients highly appreciate the communication with the units and the proper conditions of the material received. The worst valued factor is the time of delivery
Analysis of the results
Besides each unit’s specific proposals, it has been agreed to continue with the project of optimization, management and traceability of surgical equipment.
To implement a new procedure for equipment management, to approve the review of the procedure for non-compliances and to establish some work groups requested by our clients: expiration of sterilized material and controls.
Also to develop SALUD 2012 Training Plan.
Objectives/indicators for 2012:
-To improve the sterilization process achieving invalid cycles <3.5%
-Satisfaction >90%
-Training >92%
-To comply with reception requirements >96,5%
Implementation barriers
Did you find implementation barriers?
Please describe implementation barriers
-Professionals’ difficulty to assimilate ISO languaje
-To achieve rigorous documentary registration
Describe the strategies used to overcome the barriers (If needed)
-Information and Training on ISO
-Simplification of Documentary System
-Quality Coordinators help
-Support to professionals
Other information
Other information about the GOP that you would like to add (Link or attached document)
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