Being certified ISO 9001 and ISO 13485 has now become a prerogative to have a solid internal quality management system that is always up-to-date, especially for a medical company like OPT, which wants to be actively involved in an increasingly competitive and demanding market, especially in quality terms.

May was the deadline for the renewal of ISO certifications for us and, this year, also for the transition to the new edition of ISO 9001: 2015 and ISO 13485: 2016, this in particular dedicated to the medical sector. Compared to previous editions, the new certifications required not only an updating of company documentation, but a real change in approach and 360 ° involvement of all quality processes. In fact, the standards required an all-round analysis of the company context, not only as regards the internal parts of it, but also as regards the external sphere: customers, stakeholders, territory, suppliers, and so on.

Risk-based thinking” was another point on which both standards focused: the introduction of the concept of risk within the organization’s choices compared to the size of the checks to be carried out on the processes. Both rules were hard bones and brought us to renew our approach and carry out a group work coordinated by our Quality Team.

May came quickly and also the inspectors of the DNV-GL, a body with which OPT has been certifying for years. The audit, divided into several days, saw the presence of three inspectors who verified the documentary compliance and internal and external processes of the company according to the requirements required by the new editions of the rules.

Among the comments received from the inspectors, it emerged that OPT, thanks to the know-how acquired over the years, continues to produce and invest in a highly technological and strongly consolidated product on the market.

Furthermore, the activities and approaches implemented by the company to the updating of new regulations and the quality management system, which is also strongly consolidated, have been appreciated.

In other words, the overall result was positive and this year OPT passed the inspection obtaining the renewal of both certificates.

ISO 13485_2016
ISO 9001_2015

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