“Biomed” cluster seminar meeting begins in Penza
Penza, 22 October 2015. PenzaNews. The two-day seminar meeting for heads and professionals of enterprises in the engineering and production cluster “Biomed,” organized by the Center for Cluster Development, began at the Penza technopark “Rameev” on Thursday, October 22.
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The event is dedicated to adapting and upgrading the current QC systems for medical products to make them ISO 9001:2015 and ISO 13485-2003 compliant.
In a welcoming word, Sergei Matyukin, deputy general director of the Center for Cluster Development, pointed out that additional professional education for cluster companies is a priority in the Penza region.
“Practically half a year ago, we held a big seminar on pre-clinical and clinical testing, with a Roszdravnadzor representative and related institutes invited,” he reminded, adding that the feedback from the participant shows the knowledge helped them in their work.
Following that, the microphone was passed to Igor Zvyagintsev, consultant, expert, head auditor on ISO 9001, ISO 13485, ISO/IEC 27001, ISO 31000 and European CE directives.
He began right away with setting the audience for easy dialogue, urging them to ask questions as they appear during the seminar.
Igor Zvyagin also noted that the topic of the event is a big field, so the two-day event will focus on the key points and directions for self-education afterwards.
“The new version of 9001, ‘the new Nine,’ is radically different from the structure and the philosophy of ‘the old Nine.’ While the 13485 [standard] is related in its structure, its ideology to ‘the old Nine’ and the new one based on ‘the new Nine’ doesn’t exist yet,” the host explained.
According to him, the Penza seminar will include an attempt to simulate the new standard that will likely take a couple of years to be created.
Igor Zvyagin also asked to never mix up the terms “standardization” and “certification,” saying that the QC system is unique in each organization.
The seminar will continue until Friday, October 23.