Quality Management System


Quality Management System

AranBiotech are intelligently designed and our products are manufactured with validated production processes in clean controlled environment following cGMPs. The raw material is carefully selected, tested and controlled based on international standards and guidelines such as ISO-13845, US 21 CFR Part 810, 21 CFR Part 820, EU MDR (2017/745), the USP and Ph. Eur. Our sterilization

process complies with ISO 11137-2 and best industry standards. Together, all of these ensure production of consistently high quality assemblies.

Our production processes are backed by the ISO-9001 Certified Quality Management System which ensures:

• Complete customer satisfaction
• Defining management responsibility and leadership engagement
• Engaging Employees through empowerment
• Decision making driven by facts and data
• Inculcating a culture of innovation and continuous improvement
• Deploying documented processes that ensure performance enhancement
• Managing relationships to optimize performance

Our documentation system guarantees full lot traceability down to a single roll from a single batch. All quality related documents, production records and test reports are retained for not less than 2 years from date of release for commercial distribution. Raw materials, intermediate products and final products are thoroughly tested in our laboratory for different chemical parameters and cytotoxicity.

Test results for the final product are registered on a Certificate of Analysis supplied with every batch of bags.