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    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.

     

    Specialties: ISO 9001 Consulting, ISO Implementation, ISO Gap Analysis, ISO 9001 Internal Auditing, Lean ISO, AS 9100, ISO 13485

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