QM System hands-on and cost-optimized
A quality management system according to ISO 9000ff and ISO13485 is a challenge for small and medium sized enterprises. The effort at the start phase is significant and the maintaining of the quality system is considered to be too strenuous. Often deemed being necessary it is left behind that the products are becoming more competitive through certification, because quality following the ISO standards are easier to understand for the customers and are more and more required. The added value of the own organisation is underestimated and easily falls into oblivion, considering the efforts that have to be undertaken to deliver and maintain the required quality.
The advantage of external support by Beatrice Schroetter QM Consulting from Hagenbach for the implementation of a QM system in small and medium sized or newly established enterprises is that professional experience from global big players is being transferred into their own enterprise. Through my vast knowledge and my professional experience in quality management consumer electronics, medical devices/pharmaceuticals and production mistakes are being avoided in the implementation if the quality system – always keeping an eye on the costs. Alongside with that with Beatrice Schroetter QM Consulting as a temporary external consultant the QM system is being implemented in a hands-on, qualified, communication related and cost-optimized way with a foresight on certification and customer audits.
The planning of the QM system is customized for your enterprise. Existing processes are being documented and the gaps with regard to the ISO norm will be identified. The necessary steps and costs are being identified and reported to the board in detail. Through jointly planning and involving the people the acceptance and the collaboration of all parties affected is a guarantee for the success of the system.
The implementation itself will be carried out through involvement by all parties affected. At this stage my experience as a project manager in complex projects comes into effect. Being strong in communication and well experienced in change management I implement the QM system into your enterprise step by step. Processes are designed efficiently and matching with hands-on requirements.
The certification by a national accredited body will be supported through the Aachen office of Beatrice Schroetter QM Consulting. Before accreditation I supervise the internal audit and the approval on site.