ISO 13485 and ISO 27001 certifications for Axitare – Quality and information security at an international level
Axitare received an early Christmas present in the form of ISO 13485 and ISO 27001 certifications! To be honest, this was expected piece of news, as the audits according to the ISO 13485 and ISO 27001 standards were completed in early December with good results and no non-conformities.
This is a big deal both for our customers and for us! It is not just about two pieces of paper on the wall, but proof that we have done things right and that our operations withstand external scrutiny in the light of the criteria set by the standards.
What do these standards actually mean?
ISO 13485 is a quality standard for manufacturers of medical devices. It ensures that our products – the medication dispensers that already serve in over 5,000 homes – meet safety and regulatory requirements. The standard defines requirements on risk management and ensures that the entire life cycle of the product and service is controlled, starting from design and ranging to use and maintenance. It emphasizes patient safety and handling of customer feedback.
ISO 27001, on the other hand, shows that our information security is well managed and controlled. When we process the customer data required by the medication dispensers in our system, we must be absolutely certain that the information is secure. This standard is important to us because it is an internationally recognized way to demonstrate that we take information security seriously.
“We did things right from the start”
Our Quality Manager, Mika Laitinen, has played a key role in the certification process, in preparing the organization for the audits, and in creating and documenting good practices. Mika comments:
“These certificates confirm that we have done things right from the very beginning. The practices that comply with the requirements of ISO 13485 and ISO 27001are visible in our everyday work. They truly define how we approach questions of quality and safety.”
Mika says that the audits provided a valuable learning experience: “We received valuable feedback but also confirmation that we are on the right track. The certificates are not the end goal – continuous improvement will remain part of our work.”
What does this mean in practice?
Our CEO, Jukka Penttinen, sums it up:
“The audit results show that Axitare’s continuous work and attitude have shaped the company in the right direction. Our operations comply with the requirements of both standards, and this has built a strong foundation for the future.”
Jukka also looks at the matter from the perspective of our customers: “The wellbeing services counties and municipalities outside Finland with can trust that we meet the highest quality and information security standards. When we talk about medication safety and the care of senior citizens, errors must be minimized.”
The journey continues
ISO standards require regular surveillance audits. We continuously keep our ways of working up to date and develop our procedures further.
At Axitare, the aim has always been to be a forerunner in the digitalization of home care. These certificates strengthen the trust of our customers and partners – and give us confidence that we can continue our growth internationally as well.
Thanks to everyone who has been part of this journey. And thank you to our customers for your trust. Together we can build a safer tomorrow!
Further information:
Axitare Oy
Malminkaari 10, 3rd floor
00700 Helsinki
info@axitare.fi
ISO 13485 is a globally recognized standard for quality management of medical devices and supplies. It helps manufacturers reduce risks and improve reliability throughout the entire product life cycle.
ISO 27001 is an international standard for information security management systems. It helps organizations protect information from cyber threats and demonstrate their commitment to information security.
