K2 Medical is proud to announce that we have been awarded ISO13485 accreditation for design, development, manufacture and distribution for our products.
We embarked on this huge undertaking over a year ago to ensure that we would could demonstrate our ability to provide medical devices and related services that would consistently meet our customer’s requirements and the regulatory requirements of the new Medical Device Regulations.
In preparation for the audit, K2 Medical underwent a thorough evaluation process that included the development of a Quality Management System, the review of all Management System Documentation, a pre-audit, initial assessment and corrective actions of any non-conformances.
An enormous amount of work went into documenting the processes and procedures of all the various departments within K2 Medical and ensuring that these are followed to the letter so that they become a seamless part of the K2 Medical way.
The internationally recognised ISO13485 certification is a validation of the Quality Management System that underpins K2 Medical’s position as a manufacturer and distributor of premium quality medical devices.
We believe that our decision to become ISO 13485 Certified reaffirms and demonstrates our commitment to providing quality products and services to all our customers and clinicians and ultimately benefits the lives of the patients that utilise our devices.