The Quality Management System
Since its foundation M.A.R.C.O. has a quality management system in place.
In the current quality management system (established 2008) internal management, core and supportive processes are
well-documented and single steps comprehensively defined. The quality management
system includes a quality management manual (QMM) and standard operating procedures (SOPs).
QMM and SOPs are reviewed every two years. However, employees are encouraged to comment on the SOPs at any time. The comments are taken into account during the planned review at latest. If processes have to be changed, the respective SOP is adapted and implemented directly.
M.A.R.C.O. has an independent quality assurance. The quality manager is not involved in the core processes.
In all of our core processes the products are proofread by a "second set of eye".
All processes conducted are internally audited once a year.
Our quality management system has been audited at least once a year by external auditors of our sponsors and cooperation partners.
Project audits also took place by regulatory authorities (e.g. EMEA).
There were no critical findings in any case (internal or external audits).
A change management data base is generated to manage all findings from audits, results from risk analysis, customer feedbacks, SOP comments and results from the steering committee meetings. Once a year the quality manager generates a quality management report including all these results.
This report is reviewed and assessed by the steering committee (management review).