Top QM Systems

Medical Technology

Introduction and optimization of your QM-Systems

We at TopQM-Systems have over 10 years of experience with various customer projects from the Medical Technology industry involving the introduction, training, and optimization of IMS-System.  Early on we developed  an understandable, simple and meaningful QM-System with the proven 5 TopQM-Systems project phases leading up to a successful certification.  
The criteria for your and our success are low use of paper, meaningful QM-tools and a customized, practical QM-System. 
We not only show the necessary potential for improvement, but also bring proposals for solutions and their implementation.

We support you with the following norms and standards:

• ISO 9001 (process oriented quality management system)
• ISO 14001 (environmetal management)
• OHSAS 18001 (Health and occupational safety)
• ISO 13485 (QM-System for Medical Technology)
• EG-guidlines 93/42/EWG about Medical Devices
• EU-change request 2007/47/EG
• Risk analysis
• Project Management, Scheduling
• Ramp up management
• IMS integrated management system (combination of process oriented and industry sector specific norms and standards)

Independent TopQM-Certification Service

Trust TopQM-Systems for the implementation and further development of your desired IMS.
You can concentrate on your daily business and we will concentrate on your IMS-System. A huge advantage for our customers is that we at TopQM-Systems work independently with worldwide accredited certification companies based on which one is the most suitable for your company.

We organize the entire certification activities at a guaranteed fixed price up to a successful certification.

• Project Management and Planning of Milestones
• Creation of complete QM documentation
• Implementation of existing QM forms
• Employee training
• Internal auditor training
• RFQs and selection of certification company and the respective auditors
• Hand-over of certificates

Competence + Experience = TopQM-Systems

TopQM-Systems can refer to numerous successfully completed projects with management systems combined in a meaningful way in various industry sectors.
The following list contains several project examples which we implemented to the highest satisfaction of our customers.

• Manufacturing and marketing of general medical products for their respective product class
• Sales office and import of medical products
• Manufacturer and supplier of implants
• Sales office for orthopedic technology
• Original equipment manufacturer of emergency service vehicles

You will find more project examples in our current reference liste here >>>

Trainings and Workshops

Next to project and certification support we at TopQM-Systems also offer customized in-house training.  The training content is constantly updated and is based on our experience, our know-how and our daily active customer projects. In that way we guarantee interesting and up-to-date training content and consequently a high degree of learning success for your employees.

Training topics and project support:

• Fundamentals of ISO 9001 (Quality management)
• Fundamentals of ISO 13485
• Internal auditor training
• Technical cleanliness
• Risk analysis according to FMEA, HAZOP or HACCP
• CIP (Continuous Improvement Process)
• Defect management and complaints processing
• customer satisfaction survey

Upon request you can receive further attractive short seminars customized to your specific requirements.