Certifications and Quality Management
ISO 9001 : 2015 sets out the criteria for a quality management system and describes best practices for efficiently and effectively achieving high customer satisfaction. This standard is based on a number of quality management principles including a strong customer focus, risk assessment, the motivation and implication of top management, the process approach and continual improvement.
ISO 13485 : 2016 sets out the requirements for a quality management system specific to the medical devices industry.