external audit at the dialysis centre · certi˛ cation is valid for all dialysis centres in the...

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EXTERNAL AUDIT AT THE DIALYSIS CENTRE Helena Jeřábková | B. Braun Avitum | Litoměřice | Czech Republic INTRODUCTION The subject of this poster is to present our experience with the execution of the international external audit at our dialysis centre. Our quality management system has been certified since 2006 by TÜV SÜD Product Service GmbH, and since 2012 it has also been certified as an environmental management system. A unified integrated management system (IMS) is implemented in the B. Braun Avitum group, and the Czech Republic is included in the so-called multisite certification group with 9 other countries. AIM The aim of the external audit was to prove that our dialysis centre meets the strict requirements for obtaining a certificate confirming an effective quality management and environmental management system, which includes the full implementation of proper, safe, and environmentally-friendly practices. METHODOLOGY External audits on the quality management and environmental management system are conducted annually at randomly selected dialysis centres within the B. Braun Avitum group. Certification is valid for all dialysis centres in the group. The language of the external audit is English. The external audit was performed in the following phases: preparation for external audit, realisation of the external audit itself, and the definition of corrective measures after the external audit. The preparation for the external audit was carried out in cooperation with the company headquarters and included the verification of the full implementation of all management, main, and support processes. The external audit was performed by TÜV SÜD Product Service GmbH. Auditors emphasised compliance with the quality and safety rules of care provided in accordance with „Good Dialysis Practice“ and environmental protection. Quality of care has been assessed from two points of view: by meeting individual nursing standards/medical quality indicators and monitoring the overall quality of care through IMS documentation, health documentation, a patient satisfaction survey, the fulfilment of defined quality objectives, EMS, and much more. CONCLUSION The external audit was motivating for us. We obtained an evaluation of the level of the quality of care at our dialysis centre and its comparison at an international level. The audit also allowed us to compare the quality of care within the respective field. Upon the successful completion of our external system audit, we have fulfilled the requirements for obtaining the ISO 9001:2008, ISO 14001:2004, and IEC/TR 62653:2012 Good Dialysis Practices certificates issued by TÜV SÜD Product Service GmbH. The entire team at our dialysis centre has demonstrated that the individual processes are properly set up and fully implemented for the benefit of our patients. B. Braun Avitum s.r.o. | www.bbraun-avitum.cz

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Page 1: EXTERNAL AUDIT AT THE DIALYSIS CENTRE · Certi˛ cation is valid for all dialysis centres in the group. The language of the external audit is English. The external audit was performed

EXTERNAL AUDIT AT THE DIALYSIS CENTREHelena Jeřábková | B. Braun Avitum | Litoměřice | Czech Republic

INTRODUCTIONThe subject of this poster is to present our experience with the execution of the international external audit at our dialysis centre. Our quality management system has been certi� ed since 2006 by TÜV SÜD Product Service GmbH, and since 2012 it has also been certi� ed as an environmental management system. A uni� ed integrated management system (IMS) is implemented in the B. Braun Avitum group, and the Czech Republic is included in the so-called multisite certi� cation group with 9 other countries.

AIMThe aim of the external audit was to prove that our dialysis centre meets the strict requirements for obtaining a certi� cate con� rming an e� ective quality management and environmental management system, which includes the full implementation of proper, safe, and environmentally-friendly practices.

METHODOLOGYExternal audits on the quality management and environmental management system are conducted annually at randomly selected dialysis centres within the B. Braun Avitum group. Certi� cation is valid for all dialysis centres in the group. The language of the external audit is English.

The external audit was performed in the following phases: preparation for external audit, realisation of the external audit itself, and the de� nition of corrective measures after the external audit.

The preparation for the external audit was carried out in cooperation with the company headquarters and included the veri� cation of the full implementation of all management, main, and support processes.

The external audit was performed by TÜV SÜD Product Service GmbH. Auditors emphasised compliance with the quality and safety rules of care provided in accordance with „Good Dialysis Practice“ and environmental protection. Quality of care has been assessed from two points of view: by meeting individual nursing standards/medical quality indicators and monitoring the overall quality of care through IMS documentation, health documentation, a patient satisfaction survey, the ful� lment of de� ned quality objectives, EMS, and much more.

CONCLUSIONThe external audit was motivating for us. We obtained an evaluation of the level of the quality of care at our dialysis centre and its comparison at an international level. The audit also allowed us to compare the quality of care within the respective � eld. Upon the successful completion of our external system audit, we have ful� lled the requirements for obtaining the ISO 9001:2008, ISO 14001:2004, and IEC/TR 62653:2012 Good Dialysis Practices certi� cates issued by TÜV SÜD Product Service GmbH. The entire team at our dialysis centre has demonstrated that the individual processes are properly set up and fully implemented for the bene� t of our patients.

B. Braun Avitum s.r.o. | www.bbraun-avitum.cz