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A gap analysis is a specific work activity that highlights where the serious “gaps” or “holes” are in your Quality/Business System. Axeon compares your actual work practices to an international standard such as ISO 9001, AS9100, ISO 13485 or any other desired requirements document.

Axeon completes gap-analysis work at the beginning of an implementation or improvement project. This is usually performed for clients who are just beginning (or considering) their business improvement or quality/business system efforts.

Competent implementers will conduct a gap analysis and identify missing areas or those that are seriously deficient; e.g., if there is no real system of internal audits, no formal corrective action system, or the document control system is seriously deficient, these would be discovered and reported as a result of the analysis.

At the end of the analysis all information gathered from observations will be used to write a comprehensive report telling you where your organization complies and where it does not.


  • A formal open meeting
  • A full evaluation of the quality system
  • Identification of the gaps in the system
  • A formal closing meeting along with a written report that points out any places were your system needs strengthening or is non-compliant

Whether you are seeking registration or transitioning to a new Quality/Business Management System Axeon can assess your needs and provide the assistance required for implementing or improving your Quality/Business System. The end result is a positive benefit to your customers and you!