in the last decades , in the health sector but especially in the clinical laboratories , the implementation of management systems under requirements of international standards has increased and improved the knowledge and functioning of processes with increasing the results , information and data which provide to the health care process and help to enhance the quality of life and generate a positive impact in health facility in terms of costs ( decrease the need of unnecessary diagnostic procedures ) . likewise , the management system has been a tool , which has improved its operative and technical processes and adopted systemic methodologies for resolving problems on a day to day basis and give answers to questions in the actual context , where the quality and security of the results is increasingly under scrutiny . in the past 2 decades , latin - american professionals of clinical laboratory have focused their efforts to meet demands of patients , the requirements from the clinicians and regulatory organisms , and have focused on implementing international certified standards , for example the iso 9001:2008 ( 1 , 2 ) . despite limited resources , professionals of clinical laboratory have worked relentlessly to implement management systems for the achievement of organizational goals . today , in the xxi century , in the year 2015 , we understand that the management system helps answer the needs of a process and have been flexible , dynamic , and simple with contribution to the organization in order to achieve an internal balance that guarantees sustainability . it has been realized that implementation of quality management benefits patient care , and it may not be promptly evident , but such an investment results in long - term sustainability . the management of quality can be defined as a set of activities that is developed with which an organization can operate and promotes fulfillment of its mission and reach its vision , through a systemic methodology that permits continual improvement under excellent planning of all its processes , including execution and verification . the implementation of corrective and preventive actions is a must ; the subsequent improvement is evidence of organizational learning . it is the authors personal experience of 20 years in implementing quality managements systems that the eventual end benefactor is the patient . in latin - america , for many years , the clinical laboratories implemented the iso 9001:2008(1 ) standard for their management system , this constituted a true challenge because this standard is not specific for clinical laboratory processes and in some requirements was short in the  must  for the particularities of laboratory . however , the model was implemented and with the iso 9001:2008(1 ) our laboratories gained experience with registry , methodology for documenting their procedures , control mechanism and follow - up . they implement very important components like program of internal audits that result in management indicators ; these are elements that were not materialized in the iso standards . additionally , with the follow - up of measuring instruments , for first time , the phrase metrology  is real in the clinical laboratories and inside the language of our professionals , the traceability , calibration , reference materials are part of the day to day procedures of all laboratories ( 3 ) . the iso 15189:2012(2 ) specific standard for quality requirements and competence for clinical laboratories is widely delineated . the accreditation for our quality management system in clinical laboratories with conformity to quality requirements and competence of iso 15189:2012(2 ) standards is a real context and the correct way for us that we have been committed with the quality of results and security of the process in clinical laboratory . this standard iso 15189:2012:2012(2 ) implies a system of management of quality with risk approach ; this guarantees migration from a reactive approach to a preventive and proactive model . with the exhaustive incorporation of  musts  toward patient security , identification of technology risks and reactivity , we have succeeded in confirming to the global guidelines of the world health organization ( who ) as regards to patient security , techno vigilance , and reactive vigilance and hemovigilance as applicable . in terms of clinical effectiveness , it streamlines the responsibility of clinical laboratory in the notification of critical results , definition , communication and impact measurement , as well as tied all the aspects related with the information system and the mechanisms of verification , control and security of auto verification process or auto validation through mild ware ; this was beyond contention in previous versions . additionally , the requirement of validation / verification/ evaluation of methods , insurance of quality , the obligation to participate in programs with other laboratories accredited with iso 17043(4 ) the need of measure the uncertainty e.g. , parameter of exactness in the result , have been the challenge in the academy for our analysts and has generated an improvement of competences . as such , today we have the professionals of best domain and empowerment , not only in statistical tools but also in knowledge of assay tools and control of variables . the management systems have contributed significantly to decrease the variability of procedures through the standardization and the possible use of means available with eventual benefit to patient care . added to this , the goal that is possible , visible and quantifiable in the transformation towards the culture of improved quality and security of patient care . the actions towards continued improvement , the search of excellence and zero mistakes is invaluable for attainment of precise information to professionals in this discipline .
the implementation of management systems in accordance with standards like iso 9001:2008 ( 1,2 ) in the clinical laboratories has conferred and added value of reliability and therefore a very significant input to patient safety . as we know the iso 9001:2008 ( 1 ) a certification standard , and iso 15189:2012 ( 2 ) an accreditation standard , both , at the time have generated institutional memory where they have been implemented , the transformation of culture focused on correct execution , control and following , evidence needed and the importance of register .