Quality System Development, Implementation and Gap Assessment
Quality System Development
Our team is experienced in the development, authoring and implementation of complete Quality Management Systems with a successful track record in ISO 9000, ISO 13485, and FDA requirements. For new companies with no existing Quality Management System we can analyze your business and design and implement a complete system from the ground up. We can perform a gap analysis of your current Quality Management System and identify, author, implement and train your employees on these areas for improvement.
Quality System Implementation
We can lead you through the entire development, implementation, training and certification process. The systems we have developed have successfully passed ISO 9001, ISO 13485 and FDA audits.
Quality System Auditing and Gap Assessment
Our auditors are certified by the American Society for Quality and we are experienced in performing first, second and third party audits to ensure compliance with general industrial ISO 9000 requirements as well as more stringent ISO 13485 and FDA 21 CFR 820 requirements for the Medical Device Industry.
We have experience in performing internal system, process, and product level audits as well as performing supplier audits and have successfully lead multiple companies through the successful registrar and governmental audits.
Regulatory Agency and Registrar Audit Preparation and Support
We can assist you in preparing for a registrar or FDA audit, including auditee training, and mock audit practice sessions and documentation and record reviews. We can also act as your representative at these audits. We can also assist you in the development of corrective actions to any findings identified during the audit.