Quality & certifications
Audited systems, documented builds, defensible compliance
Our machines are accepted by regulators and corporate auditors across the EU, Gulf, Africa and the Americas.
Certifications
Certified management systems and product conformity
ISO 9001:2015
Quality Management System
ISO 14001:2015
Environmental Management
ISO 45001:2018
Occupational Health & Safety
CE
European Conformity Marking
cGMP
Pharmaceutical Manufacturing Practice
UL / CSA
Panel Component Compliance
Quality standards
Quality is a process, verified at every gate
Testing process
- Incoming material certification and traceability
- In-process CMM and gauge inspection
- Dry run and wet trials with customer product
- Witnessed FAT followed by on-site SAT
Safety procedures
- Risk assessment to ISO 12100 at design stage
- Safety circuits engineered to PL d / Category 3
- Interlocked guarding and validated stop times
- Operator safety training at commissioning
Compliance documentation
- Technical file and Declaration of Conformity
- DQ / IQ / OQ qualification packs
- EPLAN electrical drawing sets
- Material and calibration certificates