ISO INTEGRATION, LLC: *ISO Consulting Services: To implement, maintain, and/or improve your Quality Management System for certification to ISO9001, ISO13485, AS9100, or ISO14001. Our Lean-ISO approach assures the system is designed simply and effectively to add value to your business. *Gap Analysis: To determine how closely your Quality Management System is meeting standard requirements. The Gap Analysis report and Project Plan deliverables provide the road map for certification. *ISO Internal Audits: To determine the degree of compliance and effectiveness of your Quality Management System. We will assist in planning and conducting audits to provide your system with valuable inputs to continually improve. *Management Representative Assistance: To provide mentoring and guidance to the Management Representative, including preparation for management reviews, corrective action review, risk management planning, customer feedback processes, and Quality Management System planning. *Process Improvements: To improve current systems using the Lean-ISO approach. Value-stream mapping is used to streamline and improve the effectiveness of the process. *Supplier Audits: To evaluate your suppliers to assure appropriate quality systems are in place to enable them to meet your needs consistently. *Other: Risk Management process development, GMP compliance, Process Validation Planning, Documentation Improvements.

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