Domain Development, Not Off-the-Shelf Templates
Most maturity frameworks hand you a generic rubric and wish you luck. Coherence Frameworks works differently. Each capability domain is developed for your specific context — your regulatory requirements, your organizational structure, your industry standards, your operational reality.
The setup phase is where the real value lives. We work with your organization to build a capability maturity model that maps precisely to your world: which standards govern your operations, which functions own which capabilities, how maturity is defined at each level, and what evidence proves you're actually there.
Once built, that domain becomes a permanent intelligence layer inside your AI conversations — not a static document, but a living system that tracks, measures, and guides improvement over time.
Domain Landscape
Where Organizations Need Structured Capability
Domains span cross-industry fundamentals and industry-specific requirements. Each one is developed to your organization's specific context — not deployed as a generic template.
Quality Management
ISO 9001 · ISO 13485 · QMSR (21 CFR 820)
Process control, CAPA management, supplier quality, management review, document control, internal audit — the full QMS lifecycle. Including QMSR transition readiness for medical device organizations harmonizing to ISO 13485.
Cross-industry
Cybersecurity
NIST CSF · ISO 27001
Identify, protect, detect, respond, recover — risk-based security maturity mapped to your threat landscape and control environment.
Cross-industry
Data Governance
DAMA-DMBOK · GDPR
Data quality, metadata management, privacy, lineage, stewardship, lifecycle management — structured data capability from policy to practice.
Cross-industry
Operational Excellence
Lean · Six Sigma · TPM
Process optimization, waste reduction, continuous improvement, performance measurement — operational maturity from shop floor to C-suite.
Cross-industry
Regulatory Compliance
Industry-specific
Regulatory mapping, change management, audit readiness, training effectiveness — compliance as a capability, not just a checkbox.
Cross-industry
Workforce Readiness
Competency frameworks
Skill mapping, training effectiveness, succession planning, role-capability alignment — people capability measured structurally.
Cross-industry
AI Governance
NIST AI RMF · EU AI Act
Model risk, bias detection, explainability, data provenance, human oversight — AI maturity beyond the hype cycle.
Cross-industry
Medical & Patient Safety
ISO 14971 · IEC 62304
Post-market surveillance, risk management, complaint handling, vigilance reporting — safety capability for regulated healthcare and medtech.
Industry-specific
See It In Action
Real Scenarios, Real Conversations
These walkthroughs show what it actually looks like when capability intelligence is embedded in your AI conversations. Every response is drawn from your organization's governed data — nothing generic, nothing hallucinated.
Scenario: Assessment Discovery
A Quality Director connects to the platform for the first time and asks where they stand.
Complaint Handling — currently Level 1 (ad-hoc), target Level 3. Your SOP was only approved last month and training isn't complete across all participating functions.
CAPA Management — currently Level 1, target Level 3. No formal process exists beyond the quality team. ISO 9001 Section 10.2 requires systematic root cause analysis across all functions that participate.
Supplier Quality — currently Level 0, target Level 2. No documented qualification process exists. I can show you the advancement prerequisites for any of these.
Regulation: ISO 13485:2016 Section 8.2.2 requires a documented procedure for timely complaint handling with records of investigations.
Your policy: QMS-POL-007 Section 4.1 implements this as mandatory 48-hour triage with documented root cause.
Your SOP: SOP-QMS-019 was approved 3 weeks ago but training records show only 4 of 12 relevant staff have completed it.
That's the gap — the process exists on paper but isn't operational across your organization yet. That's a strong Level 2 trajectory, not Level 1 forever.
Scenario: Sprint Progress Check
A Sprint Owner checks in mid-cycle to see what's blocking their improvement targets.
Risk Identification (target: L2 → L3) — Blocked. Advancement to Level 3 requires training completion for all participating functions. Medical Safety participates in Risk Identification, but 3 team members haven't completed PMS Process training. This is required because ISO 14971:2019 Section 4.2 requires demonstrated competency for all personnel in risk management.
Vigilance Reporting (target: L1 → L2) — Blocked. Level 2 requires an approved SOP. SOP-MS-031 is in draft but hasn't entered the approval workflow. It's been in draft for 6 weeks.
Scenario: Board-Level Strategic Review
An executive sponsor prepares for a board presentation on organizational capability posture.
Overall maturity: 2.1 average (up from 1.7 last quarter). 68% of capabilities are at Level 2 or above.
Strongest area: Document Control — Level 3 across all BUs. Consistent execution with audit trails.
Highest risk: Post-Market Surveillance in BU-Europe — Level 0. No formal process exists, and EU MDR Article 83 requires a functioning PMS system. This is your most significant regulatory exposure.
Best practice transfer opportunity: BU-North America is at Level 3 for CAPA Management. BU-Europe and BU-APAC are at Level 1. The NA team's process could serve as a model.
I can generate the full layered report — board summary, executive detail, or functional breakdown. Which would you like?
Scenario: QMSR Transition Readiness
A Regulatory Affairs Director at a medical device company needs to understand their readiness for the FDA's QMSR transition — the shift from 21 CFR 820 to ISO 13485 harmonization.
Design Controls — High risk. Your current process follows 21 CFR 820.30 but hasn't been reconciled to ISO 13485:2016 Section 7.3. The QMSR eliminates prescriptive design control requirements in favor of the ISO framework. Your design history files reference 820 subsections that no longer apply. 3 SOPs need revision.
Management Responsibility — Moderate risk. ISO 13485 Section 5.1–5.6 requires a broader management commitment structure than 820 Subpart B. Your management review SOP covers quality objectives but doesn't document resource commitment or communication processes required by 13485.
CAPA — Low risk. Your CAPA process already aligns with ISO 13485 Section 8.5.2–8.5.3. Minor documentation updates needed but the process is substantially equivalent.
Purchasing Controls — High risk. 21 CFR 820.50 is being replaced by ISO 13485 Section 7.4, which requires documented supplier evaluation criteria and re-evaluation schedules. Your current supplier qualification process doesn't include periodic re-evaluation.
SOP-DC-001 (Design Planning) — References 820.30(b) for design planning requirements. Needs to reference ISO 13485:2016 Section 7.3.2 instead. The ISO standard requires explicit planning outputs including review, verification, and validation stages.
SOP-DC-004 (Design Verification & Validation) — Currently structured around 820.30(f) and 820.30(g) as separate processes. ISO 13485 Section 7.3.6–7.3.7 uses different acceptance criteria language. Your V&V templates need updated regulatory citations.
SOP-DC-007 (Design Transfer) — References 820.30(h) for transfer requirements. ISO 13485 Section 7.3.8 covers design and development transfer but includes explicit requirements for production specification verification that your current SOP doesn't address.
The CAPA team's SOP-QMS-012 is clean — no changes needed there. Want me to flag these three SOPs to the document control workflow for revision?
How Domain Development Works
Each domain engagement follows a structured process that builds your organization's specific capability intelligence from the ground up.
Source corpus assembly. We identify the regulations, standards, policies, and SOPs that govern your operational area. These become the controlled document repository — the closed system the AI draws from. No open internet sources. Every citation is traceable.
Capability maturity model authoring. Working from your source corpus, we develop the domain spine — the logical structure of stages and capabilities that reflects how your work actually flows. Each capability gets maturity definitions (Levels 0–5) with specific evidence thresholds.
Ownership confirmation. Every capability is assigned to a specific function and team. This is a hard gate — the platform won't let you assess until ownership is confirmed. Because ownership determines which SOPs the AI references, which RACI applies, and whose management review the evidence feeds into.
Deployment and assessment. Once built and confirmed, the domain is live. Your organization can assess immediately, track maturity over time, run improvement sprints, and access the intelligence conversationally — all governed, all evidenced, all persistent.