Quality Management Systems

Understanding your Quality Assurance requirements and building custom solutions adapted to your current and future needs

We implement Quality Management Systems and customized services that meet each of our clients’ specifications and help to achieve compliance with the following standards:

  • Implementation of quality management systems
  • Document production (i.e. normalized procedures, quality manuals, work instructions)
  • Gap analysis (existing processes compared to requirements such as ISO 13485 and 21 CFR  Part 820)
  • Qualification and audit of suppliers
  • Audit preparation (mock trial of internal audits)