A Quality Management System has been identified as a key method to assist in the achievement of Exactech’s business objectives. Accordingly, Exactech has established a Quality Management System in compliance with ISO 9001:2015 and ISO 13485:2016.
As part of the Quality Management System, Exactech is committed to complying with all the relevant regulatory and legal requirements expected from a medical device company.
The Quality Management System signifies Exactech’s commitment to quality in the medical device industry.
Exactech is focused on achieving the following objectives which are regularly monitored and reviewed:
- Foster a “quality culture” within Exactech, through a systematic approach and an ethos of continuous improvement.
- Ensure the provision of medical devices meets quality and service standards.
- Increase opportunities for key stakeholders to provide feedback.
- Grow our network of business relationships.
- Assure our customers that Exactech complies with all relevant product standards, service standards and regulations.
To reach these goals, Exactech has established corresponding quality objectives, which it reviews and re-establishes through management review. This activity, along with others in the Quality Management System, aims to continually improve the system and the business at large.
Exactech recognises that quality is the responsibility of each employee. In order for Exactech to achieve its organisational quality objectives, it will ensure that all staff members are made aware of Exactech’s commitment to quality as part of their induction and throughout their time at Exactech.