Company Regulatory Compliance

Company Quality Management System

ITL is committed to strive for the improvement of our quality management system. This is demonstrated by our policy of continual improvement to keep pace with changes in accreditation.

FDA

ITL first introduced a quality management system into its business plan in 1982, at which time our involvement with the USA medical market necessitated our registration with the FDA.

ITL was assessed and registered as a contract manufacturer to the requirements of FDA CFR 21 part 820 for medical diagnostic electronic instrumentation in June 1984. ITL was one of only five such establishments in the UK at that time.

The company was reassessed for conformance to FDA QAS CFR 21 part 820 in March 2003 and successfully sustained the standard required to remain as an assessed registered contract manufacturer.

ISO / BS EN

ITL operates a registered ISO 9001 management system assessed by BSI.

Accreditation was first obtained in 1992 to the requirements of BS 5750 part 1 : 1987 and reassessed in 1994 to ISO 9001-1994.

ITL obtained compliance to BS EN 46001 in 1998, and the transfer of this status to BS EN 13485:2001 was successfully completed in 2002.

With the introduction of the amended ISO 9000 series, ITL gained accreditation to ISO 9001:2000 in May 2003.

In August 2004, ITL achieved compliance with BSEN 13485:2003.

In Brief :

ITL operates a Quality Management System registered to, and assessed by :

BSI	-	BSEN ISO 9001:2000
	-	BSEN ISO 13485:2003
F.D.A.	-	FDA QAS CFR 21 part 820