quality management system
QMS that fits your organization needs
qualityworks. QMS services:
- Establish a staged quality system implementation during product development all the way to ensuring compliance readiness at the time of registration and listing
- Establish, maintain or upgrade quality systems to ensure compliance with ISO 13485, FDA Quality System Regulations, EU MDR, MDSAP, and other global requirements (as applicable)
qualityworks. has the knowledge and experience to write it right, train your staff and implement an effective quality system that works for you.
maintain and improve an efficient and effective QMS
maintaining the quality management system after product launch requires tireless follow-up and tracking of regulatory compliance, followed by updates of documentation, verification and validation, and notifications of significant changes to regulatory authorities.
qualityworks. can help you maintain and improve an efficient and effective quality management system that is continuously compliant with the applicable regulatory requirements.
Our QA/RA consulting services include, but not limited to:
- Internal and/or supplier quality audits
- CAPA system oversight and management
- Monitoring quality metrics and key performance indicators for Management Review
- Quality system training (1-on-1, group training, awareness trainings, etc.)
- Complaint handling and Adverse Event Reporting
- Mentoring and coaching junior QA or RA staff
- Improving QMS
We have the expertise to help you maintain an efficient and effective quality management system that is continuously compliant with relevant market requirements.