Inify Laboratories, a unique laboratory service that provides cancer diagnostics in pathology, has received accreditation as a medical laboratory according to the ISO 15189 standard.
"To be accredited within five months of launching a completely unique laboratory service for cancer diagnostics must be some kind of record. It is yet another confirmation of the ability, quality awareness, and breadth of knowledge that Inify possesses," says Fredrik Palm, CEO of Inify Laboratories.
"For Inify, this is proof that our business lives up to the high standards we set for ourselves. Going through the accreditation process has involved the entire organization, where the whole team has contributed with expertise and commitment to get every piece in place. We intend to proudly maintain and further develop what this accreditation means for us, namely a culture of quality thinking and continuous improvement, which permeates all parts of the business," says Johanna Karling, Chief Quality Officer at Inify Laboratories.
Accreditation is an international system with common legislation within the EU.
It can be issued to businesses and establishments that carry out sampling and controls, such as medical laboratories. In Sweden, the authority that issues accreditation is Swedac. A competence assessment is carried out through an independent quality review of the organization.
Inify has undergone the audit, which includes a review of the business's routines and processes for quality management, competence requirements and documentation, to verify that the business meets applicable requirements and standards. Now that Swedac has confirmed that Inify Laboratories meets the requirements set for a medical technology laboratory, an accreditation certificate has been issued.
Healthcare institutions, especially within the public sector, often have internal requirements to primarily source their laboratory services from accredited medical laboratories.
"This is one of the main keys to the market, enabling us to accelerate our journey towards offering high-quality cancer diagnostics with short, predictable response times to as many patients as possible," says Palm.