A quality management system (QMS) is a formalized system that documents processes & procedures for achieving an organization’s quality policy and objectives.

Having a sound QMS helps to not only coordinate and direct an organization’s activities to meet customer and regulatory requirements, but also goes hand-in-hand with Lean and Continuous Improvement to help improve organizational effectiveness and efficiency.

Quality Management

Services We Provide


  • Total Quality Management System (QMS) Implementation (ISO 9001, ISO 13485, AS9100)
  • Outsourced Internal Auditing Services
  • Internal Auditor Training
  • Assistance in developing compliant documentation (Manual, Procedures, Forms & Records)
  • Quality Management Representative Training & Coaching
  • QMS Gap Analysis
  • Management Review Facilitation & Documentation
  • All-inclusive Awareness Training

Elements of a typical QMS

Requirements of a QMS

Each client’s needs are different, so our team will work closely with yours to develop the framework that will meet the requirements of your required standard, without going overboard and being restrictive.

From designing and building an entire QMS from scratch to performing the required Internal Audits and everything in between, the Quality Team at New England Lean has got you covered to help your organization meet its requirements.

Quality Management