Our Mission
We bring to the world health care products that improve lives and deliver outstanding value to our customers and shareholders.
ITL is committed to bringing products to the market that consistently prove to be market leaders in safety and innovation.
Quality and Environmental Management
ITL’s senior management and its personnel are committed to the adherence and implementation of a quality management system and maintaining its effectiveness in line with ITL’s customers’ and stakeholders’ expectations.
ITL has established, documented, and implemented a quality and environmental management system that is reviewed continuously for effectiveness in accordance with ISO 9001, ISO 13485, EC Directive 93/42/EEC, FDA QSR 21 CFR part 820 and ISO 14001.
The established quality manual and supporting procedures (SOPs) of ITL and its subsidiaries define the quality management system that meets the requirements of:
- ISO 9001:2000
- ISO 13485:2003
- EC Directive 93/42/EEC Annex V
- FDA QSR 21 CFR part 820
- ISO 14001:2004 (to be obtained in 2005)
The quality manual covers ITL’s development and manufacturing of medical procedure kits, single-use sterile and non-sterile medical devices, and reusable medical devices.
Where applicable, ITL’s products are CE marked according to the Medical Device Directive (EC Directive 93/42/EEC) or registered with the FDA (510k). Current highest product classification developed and manufactured by ITL are as per MDD class 2a and as per FDA QSR class 2 respectively.
Products are manufactured in clean rooms class 3,500 and 350 respectively.
ITL’s quality and environmental management system is audited annually by TUV Product Service (Germany) since 2000.
Our Quality Policy
ITL and its employess are committed to:
- Deliver quality medical products to its customers;
- Meet customer and relevant regulatory requirements;
- Advance products and processes though continuous improvements.
Our Environmental Policy
ITL takes a responsible approach to voluntarily protecting the environment by implementing a scaleable Environmental Management System to prevent pollution of our environment that complies with relevant country, regulatory and legal requirements throughout its product realization process.
Our Diversity Policy
Diversity is the variety of differences in people who make up our employee base and our Board, including such differences as life experience, work and educational experience, language, gender, nationality, personality profile, age, ethnicity, cultural background and work status. ITL is committed to creating an environment in which equity and diversity are recognised as being essential to the high performance of ITL and incorporated into ITL's day to day business.
Download the complete Quality and Environmental Management Policy for Customers as a pdf (2.1mb).