Quality & Compliance Services. Short - and midterm projects. Flexible hourly support. Understanding the overall deliverables and interfaces are key for adjusting a LEAN and efficient process landscape.
Quality Management
Certified *QM Manager* (ISO 9001 : 2015)
QMS Implementation
QMS Tracking and Managing
Quality Assurance Management
Overall Quality Management. Assessment of processes and interfaces, increase efficiency by LEAN Management.
Understanding the overall deliverables and interfaces are key for adjusting a LEAN and efficient process landscape.
Compliance Management
Certified *Compliance Officer* (ISO 19600 : 2016)
Risk Management (ISO 14971 : 2020)
Regulatory Support (Post Market Surveillance and Vigilance)
Ensuring aligned Compliance for the processes, interfaces and the overall business.
Audit Management
Certified *QM Auditor* (ISO 19011 : 2018)
1st and 2nd party Auditing
Internal Audits
CMO Auditing
Selfassessment and status quo to ensure succesful 1st and 2nd party Audits.
Supplier assessment and Auditing.
