ISO 13485:2016
San Antonio, TX, November 5, 2020 --(PR.com)—JANA Life Sciences, a division of JANA, Inc., announced today that it has been officially certified to ISO 13458:2016 after completing an extensive application and preparatory effort, including a series of mock audits. This certification provides life science and medical device companies with the assurance that their outsourcing partner is able to work in a fashion congruent to their needs and aligned to the requirements of the FDA and other regulatory authorities around the world.
“JANA’s business is built on producing technical documentation of the highest quality, which can only be assured through a sound quality management system,” says JANA, Inc. President Ean Niland. “While JANA has been certified to ISO 9001 for over 20 years (in addition to AS9100D), being certified to ISO 13485 demonstrates the same commitment we aim to bring to the life sciences, though especially in the area of medtech.”
JANA Life Sciences President Ronald B. (Ron) Niland conveyed that, “It not only demonstrates our commitment to excellence, but it also gives us the North Star that will guide the build out of our division for years to come. We are no doubt undergoing a technological revolution, but especially in the life sciences. We are proud to be able help accelerate a broad array of cutting-edge technological developments. We’re most proud of the work we’re doing in the areas of radiography and radiotherapy, especially when it comes to treating cancer patients globally.”
ISO 9001:2015
JANA has a proven dedication to providing quality services to our customers, and this dedication is demonstrated daily through our internally developed and independently certified production processes.
JANA’s management system and production processes are AS9100D and ISO 9001:2015 certified.