A thorough verification process confirmed the total absence of non-conformities for Moretti SpA as regards requirements under the ISO 13485:2016 certification procedure for quality management systems in the field of medical devices.
The regulations, aimed at harmonising the global standard requirements for devices, are in addition to those of ISO 9001:2015.
The changes envisaged by the new standard and already taken on board by Moretti SpA include a closer link with the regulatory requirements throughout the life cycle of the medical device.
For each stage of a product’s life, the roles and responsibilities of the various entities that provide a significant contribution in the pre- and post-sales process are taken into consideration.
Alessandro Berti, Chief Regulatory and Public Affairs Officer of Moretti SpA commented positively on the certification award acknowledging that Moretti has the merit of “knowing how to dynamically comply with the regulatory requirements demanded by the market” thanks to its ongoing commitment to quality and the continuous improvement and streamlining of processes at all levels of the organisation.
Alessandro Berti also highlighted the current specific characteristics of the sector in which the company operates with “a transition that began last May with the release of the new regulations on the subject of medical devices, and that will only reach a conclusion in 2020”. In addition, he underlined the extraordinary contribution in terms of coordinated timing and planning provided by all the company’s divisions in order to acquire both certifications.
Filippo Fabbrini, Chief Operations Officer, also expressed his views about the extraordinary teamwork displayed and congratulated the whole company “for the exceptional record achieved as a result of an organisation capable of proactive self-development and improvement in line with market expectations””.
The auditing process that lasted five days, involved the heads of a number of company departments – design, research and development, management control, production, purchasing, order management and finance, marketing and sales – ensuring compliance with the rules and processes within every company division and, said Filippo Fabbrini, “providing additional stimuli towards further improvement.”
