SINGAPORE, April 21st, 2022
Austrianova (the SG Austria group, Austrianova Singapore and Austrianova Thailand) is pleased to announce that it has been awarded ISO 9001:2015 certification for the production of encapsulated and non-encapsulated cells at its facility in Thailand. ISO 9001:2015 is an internationally recognized standard that ensures that products and services meet the needs of customers through an effective quality management system.ISO 9001:2015 is in addition to the company’s Good Manufacturing Practice (GMP) compliance.
GMP is a product quality standard, with a focus on getting products with reproducible quality to the customer and it applies to all products such as pharmaceutical products (including cell therapies) and medical devices but also food and beverages, dietary supplements and cosmetics. In contrast, ISO 9001 is more focused on quality standards for running a whole business. This means that it includes manufacturing products of the right quality reproducibly but it also includes many other business goals. Thus ISO 9001:2015 certification is based on several quality management principles, including having a strong customer focus, involvement of high-level company management in quality, an outlined process-based approach, and ongoing improvement of these procedures and approaches.
Austrianova’s decision to work towards ISO 9001:2015 accreditation demonstrates theCompany’s commitment to continually improving its products and services. Certification is only granted after an extensive company-wide audit that includes quality management system development, a management system documentation review, pre-audit, initial assessment, and clearance of non-conformances if any.