Validation Services for Medical Equipment Manufacturers
Quality you can trust – ISO13485 (medical) and ISO9001 (manufacturing) accreditation
Our commitment to excellence extends to our validation service. We will prepare a bespoke master validation plan and validation protocol for you including a full production part approval process (PPAP). This will include IQ (Installation Qualification) documentation, a process flowchart, OQ (Operational Qualification) trial, metrology report and PQ (Performance Qualification).
Validation Process for Medical Injection Moulding Projects
- Your plastic injection moulding project is assigned a dedicated project manager who oversees the project to successful completion
- A timing plan detailing key milestones is agreed with you at the start of the project
- Regular project status updates are supplied to your nominated contact
- Your dedicated project manager provides a central point of contact for all aspects of your project
Injection Moulding Product Quality Process
- Accredited to ISO9001:2015 & EN ISO13485:2012.
- Dedicated work instructions for each part to include key dimensions and aesthetic requirements as agreed with you
- Cross check to master sample on each batch to ensure product quality is maintained
- First off patrol checks (every 2 hrs) and last off checks as standard
- Batch file for each works order with full traceability of material, drying equipment, machine, patrol check results approved by quality assurance
- Full range of metrology equipment to include CMM, OGP, DTI, micrometres, height gauges and vernier callipers.
- Hand over process on project completion to dedicated QA engineer and account manager for ongoing support