Quality Management System

Understanding your Q/A requirements and building custom solutions adapted to your current and future needs…

We offer customized services that meet each of our client’s specifications and help to achieve compliance to the following standards:

  • ISO 13485 – Medical devices – Quality management systems
  • 21 CFR 820;
  • ISO 9001 – Quality management Systems
  • ISO 15189 – Medical laboratories
  • ISO 17025 – General requirements for the competence of testing and calibration laboratories
  • ISO 22716 – Cosmetics – Good Manufacturing Practices (GMP)

We also offer a full range of services, leading each time to the implementation of a customized
quality assurance system, including the following:

  • Gap analysis (existing system vis-à-vis ISO 13485, FDA Quality Systems Regulations, etc.)
  • Implementation of quality systems (ISO 13485, FDA Quality Systems Regulations, etc.)
  • Development of SOPs and Quality Manuals
  • Audit Preparations (mock audits)
  • Functioning as a virtual Reg/QA department, including onsite staffing
  • Supplier Qualification and Audit
  • Selection of certification body auditors