On June 12, SGS Adriatica d.o.o. certification company completed the audit of the Belupo quality system and decided to award the ISO 9001:2015 certificate, as part of the international Quality Management System standard.
On June 12, SGS Adriatica d.o.o. certification company completed the audit of the Belupo quality system and decided to award the ISO 9001:2015 certificate, as part of the international Quality Management System standard.
This major acknowledgment confirms the harmonization of the Belupo quality system with the aforesaid standard and fully certifies the applied „process-based“ way of thinking and the focus on customer. By winning the certificate, the Company has repeatedly proven its capacity of consistent delivery of products and provision of services meeting the customer requirements. The Company will raise its efficacy and competitive level on both domestic and international markets on which we are present and enable better understanding of the processes and interactions among the business processes. The certificate also affects the system improvement and provides harmonization with the requirements of customers, laws and regulations.
ISO 9001:2015 defines various requirements regarding product design, planning, support, work process, evaluation, improvement, but with a specific emphasis on the role of the organisation management i.e. environment in which the organization operates. The introduction of ISO 9001:2015 standard in Belupo began in mid last year, with the formation of a project team of twenty or so people directly involved in the certification process. In addition to them, employees from other sectors also took part in the process of obtaining the certification and system harmonization, primarily those of the Croatian Market, International Markets, Business Development and Registrations, Quality Management, Production, R&D, Procurement, and Quality Control.
The next step after obtaining the ISO9001:2015 certificate is continuous work on permanent improvement of the quality management system as one of the basic tasks in the Company. After this initial procedure, constant awareness raising is needed to make such way of thinking and acting routine and usual. For that reason, all employees must be trained and apply this way of thinking in the performance of their work tasks.
The following step is obtaining the ISO 13485:2016 certificate, which is in progress. The process is expected to be completed in several months and will make possible our production and marketing of Class II medical devices in the future period.