Meeting the needs of our customers and stakeholders is our top priority and, by implementing a fully accredited Quality Management System, K2 are confident that we can not only meet but exceed the expectations of our customers, as well as surpass statutory and regulatory requirements whilst laying firm foundations for future development.
K2 are proud to hold both ISO 9001:2015 and ISO 13485:2016 which, as the most widely recognised Quality Management standards for business and medical devices worldwide, demonstrates K2’s ongoing commitment to supplying world-class products and services that consistently achieve exceptional utility and efficiency.
Our approach to quality is encompassed by two systems:
The International Organisation for Standardisation (ISO) 9000 is a series of international standards that 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 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.
With all K2 staff dedicated to the highest quality of service, we are committed to delivering a proactive, informed, consistent and reliable support service to ensure all our customers’ needs and expectations are fully met.
Working closely with customers and stakeholders to understand their requirements, the K2 support team have the experience to communicate knowledgeably, clearly and correctly in order to support and resolve any issues that may need addressing for both individual licence holders as well as Trust wide systems.
We continually review and develop our client service strategies to ensure the on-going success of your K2 installation through the provision of timely, consistent and professional support. We take pride in our services and any problems or queries are dealt with as a priority and are seen through to resolution and complete customer satisfaction.
Offering a variety of contact methods to suit client needs, including telephone, email and on-site visits, we are confident that through our professional and collaborative support mechanisms we will not only meet but exceed the expectations of all our customers.
For customer support contact details please click here.
K2 Athena™ provides an electronic Personal Health Record system spanning the whole of pregnancy, covering: Community Services and Remote Connectivity, Antenatal Hospital Services, Labour and Delivery Services, Postnatal Services, Support, CNST and Governance.
K2 INFANT-Guardian® is an intelligent system that offers comprehensive Risk Reduction Technology for Labour and Delivery, ensuring the capture of quality data to hospital and national guidelines, supporting clinicians in best practice so to reduce errors and poor birth outcomes.
K2 PTP™ (Perinatal Training Programme) is an interactive, online, e-learning tool, offering certification for fetal monitoring and maternity crisis management, with a CTG training simulator, Competency Assessments and Learning Pathways, enabling tailored learning to improve core knowledge and test skills.