Quality Management System

Medical Device suppliers need to have  a Quality Management System, QMS, that complies with quite a number of standards such as the Medical Device Directive, ISO 13485, 21CFR and ISO 14971.

Moreover, a lean (efficient) and effective QMS becomes more and more a key success factor for good business results:

  • First time wright submissions.
  • No cost of poor quality due to safety and reliability related product issues.
  • No unnecessary documentation effort.
  • No unnecessary QMS training effort.
  • No QMS maintenance effort related to changes organization structure.
  • No audit findings or CAPA’s that drain scarce resources from innovation projects.

Although the content of the QMS is prescribed by the applicable standards the actual implementation varies significantly between organizations.

The basic rules for a lean QMS are:

  • Make a clear distinction between the “What, Who, When” (processes, procedures and records) and the “How” (Work Instructions and templates).
  • In principle only include processes, procedures and work instructions that are mandated by the applicable standards.
  • Make the templates “self explaining” and thus reducing the number of required work instructions.
  • Decouple the QMS from the organization structure.
  • Use a “language” that can be understood by external assessors.

The basic rules for an effective QMS are:

  • Walk the talk.
  • The QMS describes the actual way of working of the employees.
  • Structural problems and issues are solved by a managed improvement program.
  • Records are in-dependable readable and comply with good documentation practices.

My first assignment as consultant was to lead a  team which was tasked to define a lean QMS for Philips Healthcare iXR. Taking the above mentioned basis rules as a guiding principle a “new” QMS was defined and released within 8 month’s.  Some key numbers:

  • Reduction of 60% of the number of QMS assets.
  • Reduction of 50% of the capacity required for maintenance of the QMS.
  • Reduction of 70% of the number of roles/functions in the QMS. As a consequence a significant reduction of QMS training effort is realized.
  • Independent of the organization.