quality expertise
Willow Tree Quality Consulting provides the services listed below.
Pricing is made available upon request.
Implementation & Improvements
- Process creation and updates
- Compliance Audits, Supplier Audits & Gap Assessments for ISO 9001, ISO 13485 & 21 CFR Part 820
- Remediation plan definition, including full Root Cause Analysis and implementation of corrective and preventive actions
- FDA 483 and Warning Letter responses
- ISO 13485 and ISO 9001 Finding remediation and responses
Training & Coaching
- QMS training for all employees
- Company culture shift and engagement solutions
- Coaching, mentorship and development plans for all team members, including Leadership
- Focused training for CAPA/Problem Solving/RCA, Risk Management, Change Control, and Deviation Management
Project Management
- Full QMS implementation or scope change updates
- Implementation of software solutions, such as Document Control and Nonconformance Tracking systems
- Establishment of Business Continuity Plans and Site Safety Programs
- Facility and Team preparation for ISO audits and FDA inspections