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
Products
ISO 13485 Auditor
Professional auditing services tailored for medical device quality management systems under ISO 13485.
ISO 9001 Auditor
Professional auditing services for ISO 9001 Quality Management Systems.
Internal Auditing
Outsourced internal auditing services performed by experienced professionals certified in quality auditing to ensure internal and regulatory needs are met.
Supplier Auditing
Comprehensive supplier auditing services to evaluate regulated suppliers and ensure compliance with international quality system standards.
QMS Training
Training services for companies looking to implement or optimize ISO 9001 or ISO 13485 Quality Management Systems.
Quality Consulting
Consulting services covering quality systems, quality assurance, compliance, QMS implementation, optimization, and remediation.
ISO 13485 Auditor
Professional auditing services tailored for medical device quality management systems under ISO 13485.
ISO 9001 Auditor
Professional auditing services for ISO 9001 Quality Management Systems.
Internal Auditing
Outsourced internal auditing services performed by experienced professionals certified in quality auditing to ensure internal and regulatory needs are met.
Supplier Auditing
Comprehensive supplier auditing services to evaluate regulated suppliers and ensure compliance with international quality system standards.
QMS Training
Training services for companies looking to implement or optimize ISO 9001 or ISO 13485 Quality Management Systems.
Quality Consulting
Consulting services covering quality systems, quality assurance, compliance, QMS implementation, optimization, and remediation.
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)