Distributors, Importers, and Manufacturers have different roles and responsibilities in regards to regulatory and quality compliance.  Procedures for manufacturers are conservative and bureaucratic and can they be simplified for distributors and importers.  High level pathway to reach quality management system (QMS) compliance and procedure solutions are available to support a to do it yourself approach.

Simply adding requirements for compliance leads to bureaucracy and requires more resources.  What that means is that you have higher overhead and potentially never achieve your budget or gross margin targets. Worse still, when you remove the resources, you get more issues because of the new procedures and there is more visibility to issues. Every time you add bureaucracy and remove resources, you repeat this cycle increasing your compliance liability.

Adding requirements without efficient tools and processes is like adding weight by eating empty calories and then trying to go on a diet.  The flowcharts and procedures have been developed to provide a roadmap to success and is several iterations and evolutions from starting with gap assessments.