ASI’s has implemented Statistical Process Control in conjunction with Six Sigma methodology to track the performance of internal processes and customer complaints. SPC and Six Sigma provide a common internal language for the management of ASI manufacturing environment, assurance of Quality and control of operations.
Environmental monitoring is conducted and statically trended to assure compliancy to ISO Class 7 & ISO Class 8 clean room requirements and to assure ASI Single Use Systems are manufactured under controlled conditions. All processes are centrally controlled by a highly customized ERP software system. This system allows the traceability, document control, quality control, and price control of customer part numbers.
Internal/External audits are performed regularly to strengthen the internal Quality Management System and to comply with ISO 13485:2003 and FDA 21 CFR 820 regulatory requirements.
The Quality and Regulatory Compliance Team at ASI ensures compliancy with FDA and Global Regulations. ASI provides assistance in the filing of 510(k)s and assists in the regulatory assesments of product changes.
CONTINUOUS QUALITY IMPROVEMENT
ASI's commitment to manufacturing excellence and our focus on Continuous Improvement provide our customers with superb quality product and unbeatable responsiveness. We put emphasis on ongoing training and development programs for all ASI's employees through industry accepted certification programs. ASI's headquarter site is a full time site member with ASQ, a world leading membership organization devoted to quality.
As an FDA Registered, ISO 13485:2003 Certified contract manufacturer, the ASI team is committed to producing a high quality product. For us, value is the combination of delivering high-quality, functional products, on time, at a competitive price.
ASI uses the Made2Manage system to both execute and monitor all tasks performed within the facility.
Made2Manage is an easy-to-use, high-quality ERP software that improves operational efficiencies, customer satisfaction and financial performance.
Contact ASI at 800-724-4158