QM Consulting with Vision!
We offer customized solutions in quality management in accordance with various standards and regulations such as:ISO 9001, ISO 13485, ISO 14001, ISO 22716, ISO 14971, GAMP 5, IFS HPC and many more.
Our expertise covers companies in medical technology and other regulated as well as non-regulated industries.
Practice meets know-how!
Our goal is to support you sustainably through sound consulting, precise implementation, and ongoing support.
We assist you in the implementation, optimization, and further development of your quality management systems, as well as in the validation and qualification of processes and machinery.
From creating procedural instructions to preparing for audits – we are your competent partner.
Our Vision and Mission
Our Vision
Fox Quality’s vision is to set new standards as a leading partner in quality management and to establish innovative, forward-looking benchmarks in the industry. The company aims to develop cross-functional solutions that enable companies to sustainably optimize their processes and achieve excellent quality standards. This is not only about technical implementation of quality management systems, but also about shaping a future-oriented corporate culture in which continuous improvement and innovation merge.
Our Mission
Fox Quality’s mission is to offer hands-on support and consulting to help customers sustainably strengthen their quality management. With a team of experts that combines scientific knowledge and practical experience, the company implements tailored concepts that address individual challenges and enable measurable improvements in daily operations. As a reliable partner, Fox Quality supports its clients from analysis through implementation to continuous optimization – ensuring long-term success and sustainable competitiveness.
Our Portfolio
Expert consulting and support in all areas of quality management!
QM Services
Tailored QM Systems!
- ✔ Consulting & implementation of QM systems
- ✔ Internal audits & supplier audits
- ✔ Validations & qualifications
- ✔ Risk and CAPA management
- ✔ Technical documentation in line with regulatory requirements
- ✔ Post-market surveillance (PMS) & clinical evaluation
- ✔ Trainings & workshops
- ✔ Supplier management & qualification
- ✔ Audit preparation & support during certifications
Our Standards & Topics Overview
Regulatory requirements – clearly structured
✅ QM Systems & Management Standards
Standards for building, controlling, and evaluating quality management systems.
- ISO 9001 – Quality Management
- ISO 13485 – QM for Medical Devices
- ISO 14001 – Environmental Management
- ISO 19011 – Audit Guidelines
✅ Product-Specific Requirements
Guidelines for safety, performance, and compliance of medical products.
- MDR (EU) 2017/745
- IVDR (EU) 2017/746
- ISO 14971 – Risk Management
- IEC 60601, ISO 10993, ISO 15223-1
✅ Process Validation & Control
Standards for safe manufacturing, packaging, and sterilization.
- ISO 11607 – Packaging Validation
- ISO 11135 – EO Sterilization
- ISO 11137 – Gamma / Radiation Sterilization
✅ Machinery, Test Methods & Materials
Standards for material testing and machine safety – also outside of medical technology.
- ASTM F1980, F88, D4169
- EN ISO 12100 – Machine Safety
- ISO/TR 24971 – Risk Lifecycle
✅ IT, Documentation & Interfaces
Standards for software validation, documentation, and digital QM requirements.
- ISO 13485 Annex Z
- GAMP 5 – Software Validation
✅ Cosmetics & Product Safety
QM & compliance in the cosmetics industry and for private label products.
- Regulation (EC) No. 1223/2009 – Cosmetics
- ISO 22716 – GMP for Cosmetics
- Safety Assessment & PIF (Product Information File)
- IFS HPC, HACCP & Codex Alimentarius
Current News & Updates
Stay informed about the latest developments