Living documentation that stays in sync with engineering, cloud, AI, and compliance activity. Documents update themselves as the organization changes.
Top-level QMS Manual describing UBC's quality policy, process architecture, and integration of ISO 9001:2015 with CMMI-DEV v2.0 Level 3 practices.
The UBC Quality Management System (QMS) applies to all services delivered by UBC's AI Solutions, Patient Access, Pharmacovigilance, and Platform Engineering organizations, including client-facing hub services, voice agents, and data platforms.
The QMS is certified against ISO 9001:2015 and appraised against CMMI-DEV v2.0 Maturity Level 3. It integrates with the Information Security Management System (ISMS, ISO 27001) and the Project Management framework (PMBOK 7 / PRINCE2-aligned).
UBC is committed to delivering pharmaceutical support services that are safe for patients, compliant with applicable regulations (21 CFR Part 11, HIPAA, GDPR), and continuously improved through evidence-based measurement. Every employee is empowered — and required — to stop work when quality is at risk.
The QMS is organized into four process groups, mapped to ISO 9001 clauses:
The QMS satisfies the following CMMI process areas at Maturity Level 3:
| CMMI Process Area | UBC Implementation |
|---|---|
| Requirements Development & Management (RDM) | SOP-SDLC-01, SOP-AIDLC-01 |
| Technical Solution (TS) | SOP-SDLC-02, SOP-AIDLC-04 |
| Product Integration (PI) | SOP-SDLC-04 |
| Verification (VER) | SOP-SDLC-05, SOP-AIDLC-05 |
| Validation (VAL) | SOP-AIDLC-06 |
| Configuration Management (CM) | SOP-SDLC-06 |
| Process & Product Quality Assurance (PPQA) | SOP-QMS-09 |
| Measurement & Analysis (MA) | SOP-QMS-10 |
| Organizational Process Definition (OPD) | This Manual |
| Organizational Process Focus (OPF) | Management Review |
All QMS documents are controlled by the Auto-Doc Engine. Every controlled document has an owner, approver, version, review cadence, and evidence trail. See the Document Control SOP for details.
The Quality Council meets monthly. Management Review is conducted quarterly by the SVP Operations and Quality Director, per ISO 9001 §9.3.
This Manual is reviewed annually. Amendments require sign-off by the SVP Operations and the Quality Director.