QUALITY & CERTIFICATIONS

For Device Quality & Safety

George Philips Medical Engg. Pvt. Ltd., is committed to providing the highest quality medical disposables that meet or exceed our customer’s requirements and expectations. We will strive to maintain compliance with ISO 9001:2008; ISO 13485:2003, CE under Directive MDD/39/42/EEC and US FDA 21CFR Part 820 with a focus on continuous improvement as well as continual monitoring and measurement of our core process to ensure effectiveness.

All our products are designed and manufactured to meet the requirements of relevant ISO and EN standards. We have been accredited with the following,
Quality Certifications: CE, ISO 13485, ISO 9001, FDA (Schedule M), WHO GMP, USFDA (Facility Registration), ISO 14001, OSHAS 18001 for our Products, Quality Systems, Manufacturing Facility, and Environmental & Occupational Safety.

Quality Assurance
George Philips has developed, documented, implemented, maintained and continually improves its Quality System to ensure compliance with national and international Quality Systems standards and regulations and to ensure that products adhere to specified requirements, including: the FDA Quality Systems Regulations (QSR) 21 CFR Part 820; MDD 93/42/EEC, ISO 9001:2008 and ISO 13485:2003.

We employ Good Manufacturing Practices throughout every stage of the manufacturing process and continue to invest in state-of-the-art engineering and technological resources to ensure consistency in product quality.

Quality Control
George Philips provides the design, development, and testing for the manufacture of world-class medical devices focused on customer-driven solutions for the safety of patients. We monitor efficiency in every stage of product development and are committed to provide zero percent defect free product with stringent testing protocols.

Routine in-process quality tests are conducted to ensure that the necessary standards (ANSI / ISO / ASTM / USP / BP, Ph. Eur) as per the International Guidelines are met. These tests are carried out through all the different stages of the manufacturing processes, including process validations, until the final product is packed, sterilized & validated for sterility.

Our Quality Certifications: