Quality System
Athena
Maternity Information System
K2MS Portal - Medical Grade Touchscreen PC
K2MS Guardian V2 - Full electronic capture of patient information during childbirth
K2MS Online Fetal Monitoring Training System
K2MS Expert Datacare - Cord Blood Gas Analysis
K2MS CTG Duplication & Restoration Service
Quality System
K2 Medical Systems has consistently implemented and supported the most effective and up-to-date quality control and auditing systems possible. Our approach to quality is encompassed by three systems.
ISO 9001:2008
The International Organisation for Standardisation (ISO) 9000 is a series of international standards that might be fair to claim that they are the most influential and successful standards ever devised. These are quality management standards that are widely used as the first base of good practice and continual improvement. They are viewed as a framework for good management across the whole of a business. This series of standards result from an extensive consultation process and have been carefully drafted to offer a whole range of benefits. The description of this process of implementation is a modernised and enlarged framework that reflects the latest management thinking and takes full account of a wealth of solid, practical experience of ISO 9000 systems. K2 Medical Systems holds ISO9000 accreditation with the LRQA.
ISO 13485:2003
ISO 13485 are standards specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. ISO 13485 are very similar to the European Standards EN 46001/46002, but do contain some additional requirements.
TickIT Guide
By implementing a quality system and gaining certification, an organisation is demonstrating management's commitment to quality and is sending a clear signal to users and competitors that the delivery of quality is a principal management objective. The TickIT logo indicates that the certificated organisation is involved in software development and that TickIT guidance and certification procedures have been followed.
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