Abstract
Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results.
 Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; Plan changes in our quality management system and processes and Qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company. 
 Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard.
 Conclusions: The UGTS is authorized by the Ministry of Popular Power for Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.
Highlights
Medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates; the use of medical devices has an associated risk
The UGTS met with all staff in January 2014 and assumed the commitment over the quality management system as its work philosophy
Two courses were held on this Standard, totaling 112 hours of classes to become "International Organization for Standardization (ISO) 9001 Auditors." Subsequently, in 2015, the same personnel carried out three courses on ISO 13485 with a duration of 60 hours
Summary
Medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates; the use of medical devices has an associated risk. (ii) Carry out an external audit, to make proposals for improvement; (iii) Plan changes in our quality management system and processes and qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company; (iv) Submit our capabilities and to the Ministry of Health, and (v) Execute the protocol to certify medical devices.Medical devices certification includes the analysis of the devices itself but the manufacturer, distributor, and post-market services. All these stages and stakeholders are evaluated in the certification process per the guidelines established by the ISO 9001 standard.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
