ISO 13485 Quality Management System
Arcis QMS is ISO13485 accredited, this ensures that products satisfy the requirements of regulators and customers alike and commitment to continuous improvements in product safety, quality and performance. Furthermore, all Arcis business processes are guided by ISO14971, ensuring safety and efficiency in all areas.
ISO 13485 compliant and FDA Approved Manufacturing
Arcis products are manufactured in compliance with local and international regulatory requirements. Manufacturing facilities operate under the framework of ISO13485 and FDA 21 CFR Part 820. This ensures that all aspects of product realisation are consistently checked and improved to deliver high-quality products every time.
Manufacturing processes are subject to intensive quality checks at every step. Raw materials are sourced from approved suppliers who are similarly committed to a high-quality approach, with lot specific analysis and certification. All equipment used is fully calibrated and maintained in clean environment, regularly checked and assessed to remain free of DNA/RNA contamination. All vials that contact Arcis products are certified free of DNase and RNase activity.
In-process QC checks ensure that products are on-spec during dispense with every step verified by trained, experienced operators. Finished goods are QC tested to verify that Arcis products meet our stringent performance requirements. All aspects of the supply chain are carefully controlled to guarantee that end-users will receive the best performing products in the best condition.