Quality Control
Kingdom Industry | Quality Control
Kingdom Industry – Product Quality Control
Dedication to Quality
Kingdom Industry is committed to providing customers with the highest quality products and services. We foster a culture of continuous learning, innovation, and improvement, empowering our team to reach their full potential and contribute valuable ideas. By consistently striving to be better than yesterday, we remain dedicated to excellence in manufacturing, exceeding customer expectations, and promoting employee development through a strong quality-focused culture.
Our commitment to quality is supported by internationally recognized quality management systems and regulatory compliance, including:
- European Authorized Representative (EC REP) Certification
- EU Medical Device Regulation (EU MDR) Compliance
- Quality Management System (QMS) Compliance
- Good Manufacturing Practices (cGMP) Compliance
- ISO 9001 Certified Quality Management System
- ISO 13485 Certified Medical Device Quality Management System
- ISO 14001 Certified Environmental Management System
- ISO 45001 Certified Occupational Health & Safety Management System
In addition, we strictly adhere to internationally recognized quality and regulatory standards to ensure product safety, performance, and customer confidence. Certifications and compliance with ISO 7151 support our quality management framework, ISO 7153-1, ISO 11135, ISO 13402, ISO 17664, ISO 17664-1, ISO 21850-1, ISO 14971, ISO 15223-1, ISO 20417, ISO 11607-1, ASTM A380-06, ASTM F899-20, and REACH Regulation (EU).
Our Capabilities
Kingdom Industry combines a personalized approach with scalable manufacturing capabilities. Through continuous product development and strategic expansion, we have built a diverse portfolio that offers a unique range of high-quality products. Our expertise enables us to provide both standard and customized solutions, tailored to meet the specific requirements of individuals, businesses, and healthcare professionals worldwide.
Critical Dimensions
The quality assurance tests are performed to ensure that every instrument being manufactured, perform its function during critical surgical procedures.
Surface Inspection
All instruments are visualized for defects in material and surface finish. They must have a flawless satin finish and be free of excess lubricants and foreign substance.
Dimensions Verification
Critical dimensions are measured with calipers, micrometers, or other specialty gauges and compared to technical drawings to ensure pattern consistency.
Function Tests
In addition to general inspections, function tests are used to verify instrument quality.
Cutting tests are performed on testing material. Scissors must not snag or bind when cutting appropriate layers of material. The heavier the scissors, the more layers of material they must cut. Blades must close smoothly without hesitation. Visual inspection is performed for burrs, especially on the cutting edge. Screw lock must be secure and slight amount of hinge play should exist when opened.
Ratchets are checked for proper holding action. Tips are verified as either sharp, blunt or semi-sharp. Ratchet mechanisms must close smoothly. Holding power is tested to make sure ratchet remain engaged during use. Ratchet teeth must align properly.
Closed jaws are checked against a light source to ensure that no substantial amount of light passes through. Jaws are clamped on plastic testing material. The impression should be clean and consistent. Teeth must mesh together closely . Jaws must be properly aligned. Ratchets must engage crisply and smoothly. While engaged at the first ratchet tooth, instruments should not open when tapped lightly against the edge of a table.
Cutting tests are performed with the appropriate test material. Forceps must cut cleanly with the front half of the jaws. Tips must close properly from the top to the middle of the jaws.
Jaws must close tightly so that no light shines through the front 2/3 of closed jaws tested against a light source. Must hold suture material, and pass similar tests as outlined under forceps.
Cutting tests are performed according to the recommended maximum capacity of each instrument.
To strengthen our position in the medical instruments manufacturing industry, Kingdom Industry is committed to the continuous enhancement of its workforce, products, technologies, and operational processes. Our manufacturing and management systems are supported by advanced ERP and SAP solutions, enabling efficient workflow management, real-time quality control, and accurate production tracking to ensure consistent performance and timely delivery.
Our workforce is trained to perform every step of production in such a manner that guarantees perfect results with complete traceability. Constant checks during manufacturing and at the end of a production process also ensures a long service cycle. The QA team of Prowa Medical Instruments regularly updates its documentation & policies to make sure that the company comply with the latest international regulations.