62-579 / Quality Management System of the SALUD Laboratories

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 2009 in the Laboratories from all (9) but one SALUD acute care hospitals. Technical areas implemented: Biochemistry, Pathology, Microbiology, Haematology, Toxicology and Immunology. It is gradually expanded.
To_sustain a quality_management_system which guarantees the technical_competency of all SALUD_laboratories’ workers and also that proper_procedures are used, right_maintenance to the equipment is provided, continuous_training is offered to workers and the compliance with the legal_requirements, and thus SALUD_laboratories play_their_role in the prevention of adverse_events and respond to the needs_and_expectations from their_”clients”.
People requiring an analytical determination or sample taking
ISO 15189 based Quality Management System, externally certified by ENAC:
Process map development
Internal controls
Intercomparative exercises
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 18 months. It varies depending on the number of hospitals, number of laboratories and number of assays certified.
Implementation tools available
Work teams
Implementation cost
-Design and implementation phase (around 18 months): cost of external consulting
-First three years: internal audits were carried out with the support of external consulting. Now with the labs’ own resources
-Regular maintenance after implementation: own resources
-Cost of annual external audits by ENAC (National Accreditation Body)
Method used to measure the results
Objectives and indicators follow-up
Annual system review
Annual internal audits
Annual external audits
3 non-compliances and 43 observations were identified in the last external audit.
The SALUD labs opened 86 non-compliances after the internal audit. The most frequent were related to equipment breakdowns/maintenance/calibration and documentation.
All clinical labs perform internal controls of their processes and take part in intercomparative exercises.
In 2012, 3,939 incidents were identified in the different processes. The higher numbers were associated with test request forms, non-received samples and haemolysed samples. Most incidents take place during the pre-analytic phase.
Analysis of the results
Besides each lab’s specific proposals, it has been agreed:
-to plan actions related to the evaluation of the intercomparative exercises
-to go on with the labs’ own professionals performing the internal audits
-to review the non-compliance template
-to offer the course “Internal auditors ISO 15189”
-to develop a consensus study of indicators for each technical area
-To establish objectives for several areas:
% transport cool-boxes with acceptable temperature registers
% haemolysed samples
% correctly identified samples
Accomplishment of internal and external quality control
% timely delivered reports
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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