OTD Packing Service ApS documents quality
with ISO 9001: 2015
with ISO 9001: 2015
“We obtained offers from various certifying bodies. Out of the three we had on visits, there was no doubt in our minds that we should choose Bureau Veritas. It meant something to us that the name and logo are known globally and of course also that the employee who visited us seemed completely competent, ”says Yvonne Danielsen, OTD Packing Service ApS.
As the company receives their ISO 9001: 2015 certificate in November 2019, they also have no single moment of doubt that it was the right decision to be certified according to the international quality standard. In addition to the fact that OTD Packing Service ApS can now document its quality, the path to the goal has also been a learning process.
“Through the certification process, we got to dive into the nooks and crannies of our company, which we had not actually had a significant eye for before. Processes and business procedures were meticulously reviewed, and we were able to discuss, describe and distribute responsibilities on top gear in the months it took to get through it all, ”says Yvonne Danielsen.
At the same time as OTD Packing Service ApS wanted a general increase in competence, the decision to set sail towards the ISO 9001: 2015 standard was also made on the basis that the company was facing increased regulatory and customer requirements for production and documentation.
“The structure that is incorporated in the company via the certification has enabled us to fully live up to regulatory and customer requirements and thus we can welcome new customers. With our ISO certification, we now have a card on hand, which we know means a lot to companies that want to ensure professional and competent handling of their products, ”says Yvonne Danielsen.
The many benefits that the ISO 9001: 2015 standard has brought have only made OTD Packing Service ApS want to jump into more certification processes, and if you ask about the future of the company, there is no doubt that there are more ISO standards on the way.
“In connection with the implementation of ISO 9001, we have largely considered ISO 13485 and are thus, in practical terms, already well on our way to an ISO 13485 certification for medical devices. For the final certification, we will no doubt choose Bureau Veritas again, ”says Yvonne Danielsen.
OTD Packing Service ApS was founded 25 years ago by Tommy Danielsen. Today, the family-owned company from Møn focuses on producing, assembling and packaging items within medico, electronics and audio with the help of 19 permanent employees and a handful of temporary staff.
The international standard for quality, ISO 9001: 2015, helps companies meet increased customer and regulatory requirements by implementing streamlined processes and improving operational efficiency. This makes the ISO 9001: 2015 standard a valued stamp of quality in the customer dialogue.
The International Standard for Medical Devices, ISO 13485: 2016, specifies the requirements for a quality management system that can be used by an organization involved in one or more stages of the pharmaceutical industry, including design and development, production, storage and distribution, installation, servicing, etc.