Process Optimisation & Validation (ISO13485)
The key to our service is a detailed validation plan covering various levels of optimisation and qualification, all of which is overseen by a Senior Process Engineer. This process takes into account all of the known variables across defined areas such as; materials, mould tooling, moulding machines and settings – ensuring the tool and process achieve the correct level of capability.
The plan will typically cover:
- Process Optimisation
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Once validated, the corresponding documentation will be released for further analysis by the client.