Quality Management
  We implement your quality management system based on EN ISO 9001:2008 or EN ISO 13485:2003 and accordingly based on EG guideline 93/45/EWG in the healthcare sector e.g. for health practitioners, manufacturers / distributors of medicinal products or medical devices, pharmacies, retirement homes or hospitals.
We offer the following services:
 
  • Weak point analysis and target/actual comparison
  • Systematic analysis of the work flow in terms of effectiveness and efficiency
  • Support in preparation of process and working instructions
  • Development, documentation, maintainance and permanent improvement of QM-systems
  • Training of your employees in quality management
  • Management of your QM-system from certification to re-certification
  Services especially for medical devices:
 
  • Certification of products
  • Risk analysis based on EN ISO 13971
  • Conformance to essential requirements
  • Preparation of technical documentation
  • Selection of the conformity assessment procedure

Systematic analysis of all operating procedures and activities identifies resources and potentials even in very efficient companies.

The initial training of new employees as well as the employment of part-time workers and trainees will be remarkably eased.

Standardized processes as well as consequent use of realized time potentials result in measurable business improvements.
© Dr. Robert Heinz & Partner GmbH, Medical Consulting, A-1070 Vienna, Kaiserstrasse 84/10
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