» 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.

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

Business Hours: Mon-Fri: 9:00am-5:00pm


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