If you are still developing your first product or service but know that your investors and clients expect an effective, risk-based, quality management effort, weekly coaching services can begin with a QMS Gap Assessment. I will help you prepare for Quality Management System Certification, help you establish a Strategic Quality Plan, implement Documentation and Document Controls, prepare Product and Process Development Risk Assessments, establish Production Quality Plans and Process Controls, including requirements for Monitoring, Measurement and Test equipment, guide you through Special Process Qualifications or Validations, help formally Qualify your Suppliers, establish an Approved Supplier List (ASL) and establish written Quality Agreements with the most critical ones, establish Customer Feedback Systems, including Complaint Management and Nonconforming Material Controls. I will help you train your Team for Audit Readiness and implement Key Performance Indicators to ensure you meet your near term quality, regulatory and organizational excellence objectives. I will help you select a Registrar, perform your internal audits and prepare documented Corrective Action responses to identified QMS Nonconformities.