A higher standard. Quality assured
Ozette’s Quality Management System (QMS) ensures consistency, reliability, and excellence across all facets of the organization — a structured framework that integrates quality principles into all of our business processes, facilitates regulatory compliance, and fosters continuous improvement.
By establishing clear standards, protocols, and metrics for quality assurance, our QMS not only enhances product and service quality but also cultivates a culture of accountability and excellence. It is maintained by a dedicated Quality team with decades of industry expertise, facilitates compliance with regulatory requirements, and fosters continuous improvement.
Regulatory Affairs
Ozette is dedicated to ensuring our products meet or exceed applicable guidelines, standards, and regulations. Current applicable guidelines, standards, and regulations implemented into Ozette’s QMS include:
U.S. regulations
- 21 CFR Parts 11, 50, 54, 56, 812, 820 (FDA)
- 29 CFR Part 1910 (OSHA)
- 45 CFR Part 164 (HIPAA)
- Washington Administrative Code (WAC), WA Dept. of Labor & Industry
Clinical and laboratory practice
- WHO GCLP & DAIDS GCLP Guidelines
- ICH E6 Good Clinical Practice
- GAMP5
Standards and attestations
- IEC 62304
- ISO 13485
- ISO 14971
- ISO 27001
- ISO 9001
- SOC 2
Data privacy
- EU 2016/679 GDPR
Labeling (FDA): The data provided by Ozette is for research/investigational use only, not for use in diagnostic procedures; the performance characteristics of this product have not been established for diagnostic procedures.
Information Security
Ozette’s IT infrastructure employs robust industry best practices to ensure the confidentiality, integrity, and availability of customer data. We prioritize information security compliance by implementing encryption protocols, access controls, training, and regular security updates to mitigate potential risks and vulnerabilities.
- Dedicated information security staff
- Formal, documented security policies reviewed on a scheduled cadence
- Company-wide training on security, cybersecurity, and HIPAA/GDPR
- Strict controls keep customer data separate; access restricted to authorized personnel
- Data encrypted at rest and in transit
- Network and wireless connections monitored and controlled
- Penetration tests and network scans performed regularly
- Infrastructure hosted by Amazon Web Services with best-in-class security
Compliance & Continuous Monitoring
Continuous monitoring enables our organization to meet regulatory requirements and maintain the highest standards of data protection. Additional details on continuous monitoring of Ozette’s security infrastructure are available via our Drata Trust Center. Ozette complies with all legal requirements for handling personally identifiable data, including US HIPAA and EU/UK GDPR.
Data Protection Officer (DPO): Contact dpo@ozette.com for all EU/UK Right to Erasure, Right to Restrict Processing, Right to Data Portability, and Right to Object requests.
EU GDPR Representative
Osano International Compliance Services LimitedATTN: JYTM
3 Dublin Landings, North Wall Quay
Dublin 1, D01C4E0
UK GDPR Representative
Osano UK Compliance LTDATTN: JYTM
42-46 Fountain Street
Belfast, Antrim, BT1-5EF