ISO Certification and LEAN Management

Quality Control and ISO Certification


HealthLink is 100% dedicated to the medical device industry. Our dedicated warehouse locations in the USA and the Netherlands are audited and certified on a yearly basis by the BSI. Our ERP system Exact Globe is validated according to FDA: CFR 21 part 11.

HealthLink has a professional solid QA team lead by our Sr. QA manager who is RA certified, PhD and MsC. Together with our QA manager they are leading constant quality awareness programs, under the umbrella of the ISO13485 certificate.


LEAN management

  • All employees are trained by an official lean management company with trainers  at a master black belt level.
  • All newcomers follow the same program and, training includes: Value Stream, Flow, Pull, Perfection, Waste, Tools (5s), standardization, Kaizen, improvements and visual management. 
  • Our Director of Customer Care Division leads the LEAN management program and committee.                                     
  • We have three Green Belt certified employees currently working for HealthLink.
  • The improvements made are on a customer specific level, driven by each Team Lead for their individual teams and part of the yearly evaluation of each employee.

We are actively stimulating a critical view on the day-to-day operations to keep improving the activities. These improvements are leading to cost and/or to process changes.

BSI Assurance Mark

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