Quality policy
Quality is not created by inspection. It is created in design and manufacture, and inspection only confirms it.
Our quality function is kept separate from production. The Quality Control Director has to be able to judge without pressure from the build schedule, and the authority to hold a shipment sits with quality. The arrangement is sometimes inconvenient, but it is what helps when a customer is inspected.
Certifications and conformity
GMP compliant design
Annex 1 ready
Quality management
Environmental management
Safety and health
Machinery directive
| Standard | Scope | Note |
|---|---|---|
| ISO 9001 | Quality management system | First certified in 2004, maintained since |
| ISO 14001 | Environmental management system | Certified in 2014 |
| ISO 45001 | Occupational health and safety | Certified in 2023 |
| CE | Machinery directive conformity | Applied to relevant models since 2012 |
| GMP alignment | KGMP, cGMP, EU GMP Annex 1 | Addressed in design and documentation |
Copies of the certificates are available on request. Certificate numbers and validity dates are published once confirmed.
Quality activities by stage
| Stage | Main activities |
|---|---|
| Design | User requirement review, design qualification, risk assessment, material selection |
| Purchasing | Supplier assessment, material certificate checks, incoming inspection |
| Machining and assembly | In process inspection, weld records, surface roughness measurement |
| Piping and wiring | Pressure testing, drainability check, insulation and earth testing |
| Commissioning | Function testing, safety interlock checks, software verification |
| Shipment | Factory acceptance test, customer witness, handover of documents |
Traceability
- Every machine gets a unique number, and certificates for key materials are stored against that number.
- For product contact parts we record the material, the surface finish and the supplier history together.
- Software versions and changes are controlled, and the installed version is recorded against the machine.
- Records are kept for at least ten years after delivery.