ISO 9001:2015 compliant
KMJ pharma® is extremely proud to announce that we have implemented ISO 9001:2015.
To become ISO 9001:2015 compliant, KMJ pharma® endured an evaluation process that included: quality management system development, a management system documentation review, pre-audit, initial assessment, and clearance of non-conformances, all of which work to identify corrective actions that eliminate non-conformances in the quality management standard.
It is an inordinate achievement that shows we are truly endowed in understanding our client’s needs in working with them to deliver high quality solutions, at the same time continuously reviewing and improving the way we work. This certification not only anticipates the demands of our customers, but also reveals our commitment to providing quality products and services to all our existing and prospective customers.
ISO 13485 implemented for Medical Devices
We can proudly announce that our company has successfully implemented the ISO 13485:2016 – Quality Management System for Medical Devices.
ISO 13485 specifies the way a company implements quality management system that focuses on safe and effective products. It also demonstrates organization’s ability to provide software as medical device and related services that consistently meet applicable regulatory requirements as well as customers’ needs. There are certain elements that are especially crucial in the ISO 13485 structure (besides Quality Management System itself): Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement.