Profound Quality Systems
Profound Quality Systems is a company specializing in quality management systems (QMS) consulting, auditing, and training. They aim to form seamless, long-lasting partnerships with clients by delivering world-class quality auditing and consulting services, including internal and supplier audits, QMS implementation, optimization, and training, primarily in ISO 9001, ISO 13485, and cGMP standards. Their services are tailored to meet regulatory standards such as ISO, FDA, and EU regulations, with a focus on industries requiring strict quality compliance.
Industries
Nr. of Employees
small (1-50)
Profound Quality Systems
San Jose, California, United States, North America
Services
Independent internal auditing of quality management systems to relevant international and regulatory standards.
Audits of critical suppliers to verify compliance with applicable regulations and contractual quality requirements.
Consulting services for QMS implementation, optimization and remediation to support regulatory compliance.
Training on quality management system standards and auditing practices delivered by experienced, certified auditors.
Independent internal auditing of quality management systems to relevant international and regulatory standards.
Audits of critical suppliers to verify compliance with applicable regulations and contractual quality requirements.
Consulting services for QMS implementation, optimization and remediation to support regulatory compliance.
Training on quality management system standards and auditing practices delivered by experienced, certified auditors.
Expertise Areas
- Quality Management Systems (ISO 9001, ISO 13485)
- Regulatory compliance auditing (FDA 21 CFR, EU-MDR)
- Supplier quality management and supplier audits
- QMS implementation, optimization and remediation
Key Technologies
- Internal and supplier auditing methodologies
- QMS implementation and process optimization methods
- Audit reporting and CAPA recommendation practices
- Regulatory standard assessment (ISO, FDA, EU-MDR)