our services
Production Qualification & Validation
At Kazileo, we specialize in production qualification and validation in accordance with the strict requirements of IATF 16949, ISO 13485, and FDA standards.
Our goal is to ensure that every injection molding process is stable, repeatable, and fully documented — meeting the highest global expectations for quality and traceability.
Our engineering team conducts Design of Experiments (DOE) studies directly on injection molding machines to define, verify, and optimize critical process parameters such as melt temperature, injection pressure, cooling time, and clamping force.
Design of Experiments (DOE) is a structured statistical method recognized by the FDA as a key element of process validation.
It allows engineers to systematically evaluate how process variables affect part quality and to identify a robust, validated operating window that guarantees dimensional stability and product consistency.
In medical production validation, Kazileo follows the structured qualification process defined by ISO 13485 and FDA guidelines, which includes:
IQ (Installation Qualification) – Verification that the injection molding equipment, molds, auxiliary systems, and measurement instruments are properly installed, calibrated, and documented according to predefined specifications.
OQ (Operational Qualification) – Validation that the process operates within established limits and that machine parameters consistently produce parts meeting all dimensional and functional requirements.
PQ (Performance Qualification) – Confirmation that the entire production process, under routine conditions, consistently yields compliant parts over multiple consecutive runs — demonstrating long-term process stability and reproducibility.
Through this systematic qualification approach, Kazileo ensures that both automotive and medical production processes meet not only engineering expectations but also full regulatory compliance and audit readiness under IATF 16949, ISO 13485, and FDA 21 CFR Part 820.
Within the IATF 16949 framework, production qualification for plastic components includes:
- Process Flow & Control Plan – complete documentation of every production step and control activity.
- PFMEA (Process Failure Mode and Effects Analysis) – risk analysis identifying and mitigating potential process failures.
- Process Capability Studies (Cp, Cpk) – statistical verification that the process meets dimensional and performance tolerances.
- Initial Sample Inspection Report (ISIR / PPAP) – submission of dimensional and material conformity data.
- Validation of Machine and Tool Parameters – confirmation that all settings produce stable, compliant parts.
By combining IATF discipline with FDA validation methodology, Kazileo ensures that each production process is optimized, documented, and compliant with global quality systems — from first mold trials to full-scale serial production.
Kazileo engineers compliance — through precision, data, and proven process stability.
OUR SERVICE BENEFITS
Ensuring Compliance, Stability, and Process Reliability
At Kazileo, every qualification and validation project is built on measured data, statistical analysis, and proven engineering expertise.
By combining practical knowledge of polymer processing with the strict requirements of IATF 16949, ISO 13485, and FDA, we deliver solutions that meet the highest technical and regulatory standards.
Our goal is to ensure that every injection molding process is stable, validated, and fully audit-ready, regardless of product complexity or industry requirements.
Key Benefits of Working with Kazileo:
- Full Quality Compliance – Qualification and validation conducted in accordance with IATF 16949, ISO 13485, and FDA 21 CFR Part 820 standards.
- Process Stability & Repeatability – Validation of machine, mold, and cooling system parameters to ensure full control over production consistency.
- DOE Methodology (Design of Experiments) – Statistical process analysis recognized by FDA as a fundamental element of process validation.
- IQ / OQ / PQ Qualification – Complete validation pathway from equipment installation to full-scale serial production.
- Integrated Engineering Approach – Seamless collaboration between design, process, and quality teams within a unified validation system.
Kazileo – validating processes through data, precision, and proven production stability.
Testimonials
What our
clients say
Stable process and full IATF compliance
“Kazileo conducted the complete qualification of our injection molding line in full compliance with IATF 16949 requirements.
Machine and mold parameter validation ensured a stable process and full alignment with customer quality standards.
The validation report was detailed, accurate, and successfully passed the OEM audit.”
— Quality Manager, Automotive Components Supplier
Professional validation for medical production
“The Kazileo team supported us through a full IQ/OQ/PQ qualification program under ISO 13485.
Their documentation, process data, and statistical reports were accepted by the certification body with no remarks.
Their understanding of FDA validation principles was key to the success of our project.”
— Validation Engineer, Medical Device Manufacturer
Process optimization and reduced production cost
“Kazileo performed DOE studies that optimized our injection parameters and reduced cycle time by more than 15%.
The process validation confirmed stability and repeatability under serial production conditions.
As a result, we achieved higher efficiency and lower tooling maintenance costs.”
— Technical Director, Industrial Plastics Manufacturer
OUR SERVICE BENEFITS
Experience Innovation
the Professional Way
Our research phase is very important. We do our best to plan every possible outcome, which would affect the budget and time of finishing the project:
- Based on your project, get only what's needed
- Cost effective, to secure construction process
- Premium quality. We always get the best people
Through this experience Warmhouse has acquired a high level of expertise in the design and realisation of high-profile and luxury schemes.
Testimonials
What our
clients say
Let’s Get in Touch
Contact details
Phone: +48 793 155 050
E-mail: info@kazileo.pl
Address: 27 Grudnia 3, 61-737 Poznań, Poland
Opening hours:
Monday — Friday 08:00 – 16:00