IPS Quality Systems
Current Good Manufacturing Practices for Medical Devices
21 CFR Part 820
IPS has evolved a quality assurance system to meet the requirements of the U.S. Food & Drug Administration Current Good Manufacturing Practices (cGMP) for Medical Devices as outlined in 21 CFR Part 820. To keep current in cGMP, IPS follows ASTM and ISO method standards for nonwovens and medical device testing.
Quality assurance responsibilities for work performed at IPS reside with all employees conducting that work. Likewise, all IPS employees are involved in the IPS Quality System. Employees are all encouraged to provide input and recommendations to enhance our system and improve our quality of service.
Our Quality Assurance staff members perform audits of our system, reporting their findings to our President, who conducts an annual Management Review of the Quality System.