Management Systems

To assure that your company as well as your products and services comply with the regulatory requirements of your customers and the (health) authorities we support you during development and improvement of your management system with following services:

• Derivation of measurable goals from your vision and strategy
• Analysis, optimization and documentation of your processes
• Compilation of management reviews for assessment of your processes, products, services and your management system

considering the relevant industry sector specific standards:

• GMP
• GDP
• GLP
• GCP
• MDD / MPG

according to the requirements of the responsible authorities:

• CH / Swissmedic

• EU / EMEA

• USA / FDA

considering the guidelines of the following committees:

• ICH
• PIC/S

additionally we support you regarding:

• Quality management (ISO 9001)
• Quality management for medical devices (ISO 13485)
• Quality management for packaging (ISO 15378)
• Environmental management (ISO 14001)
• Industrial safety (e.g. Swiss EKAS Guidelines)
• TQM (EFQM Excellence)