Advisory across six governance domains. Delivered three ways.
Qualisphere works the seams between quality, compliance, security, operations, AI governance, and decision framing — for organizations operating in regulated industries. We advise and build, we audit and assess, and we take you to certification.
Three ways to engage us. Each scoped and priced its own way.
Pick the model that fits the problem — each carries its own pricing basis. The six domains below are the areas we apply them across.
Advise & Build
We assess, design, and build the system — then hand your team the keys.
Audit & Assess
We tell you where you stand — with the evidence to prove it. Assessment, not certification.
Certification Pathway
We get you audit-ready. An accredited partner certifies — the separation the standards require.
Six domains. Any of the three models works across all of them.
Whichever way we engage — advise and build, audit and assess, or certification pathway — the work happens across these six domains. Most engagements touch more than one; the value is often in the seams between them. Select a domain to explore.
Quality
QMSQuality systems built and operated under the standards your regulators recognize. ISO 9001, ISO 13485, IEC 62304, and the GxP families — implemented as operating disciplines, not document repositories. Design controls, CAPA, post-market surveillance, and the audit-ready evidence trails that prove the system is running.
- Preparing for an FDA inspection or notified body audit
- Building a QMS for a medical device, biologic, or regulated software product
- Closing CAPA backlog or remediating audit findings
- Scaling quality discipline from clinical-stage to commercial
Compliance
CMSRegulatory posture maintained across federal, accreditation, and sector-specific regimes — observation through enforcement. HIPAA, FDA 21 CFR Part 11, BSA/AML, Joint Commission, DNV, HFAP. Translating regulatory language into operational discipline a working team can execute and an auditor can verify.
- Regulatory inquiry, observation, or warning letter response
- Joint Commission, DNV, or HFAP accreditation prep
- HIPAA compliance program build-out or remediation
- BSA/AML program design for fintech or capital markets
- Coverage gap surfacing in a due-diligence review
Security
ISMSInformation security management as an operating system — not a control catalogue. ISO 27001, SOC 2, NIST CSF, plus the M365 / Entra ID / Intune compliance configuration regulated organizations actually need. Controls implemented, evidenced, defensible under audit — and operated by a discipline your team can sustain.
- Building toward ISO 27001 certification or SOC 2 attestation
- SOC 2 finding surfaced in customer due-diligence
- Security posture upgrade required by an enterprise customer contract
- Audit response across SOC 2, ISO 27001, NIST CSF, or HIPAA Security Rule
Operations
OMSDay-to-day operational governance — the rhythms, escalation paths, and validated software lifecycle work that keeps regulated environments auditable. OSHA, EPA, NFPA, Life Safety. HEICS / ICS / NIMS for emergency operations. Enterprise SDLC, regulated agile, CSV. The operating discipline that holds when the senior team isn’t in the room.
- SDLC governance program build or remediation
- Validated software lifecycle (CSV) implementation
- Life Safety, EHS, or emergency operations program build
- Operational risk surfaced in audit or board review
AI Governance
ISO 42001 · MRMModel risk, AI validation, lifecycle controls, and responsible-AI posture for organizations deploying AI in regulated environments. ISO 42001 implementation. Approved tools list governance. Human-on-the-Loop architecture. AI compliance work that holds under regulator and auditor scrutiny — and under the board’s questions.
- Deploying AI in a regulated workflow (healthcare, financial services, regulated software)
- Standing up an AI governance program from zero
- ISO 42001 implementation or audit readiness
- Model risk question that’s become a board question
Decision Framing
Board · Audit · Risk ManagementTranslating operational reality into language that boards, audit committees, and acquirers can act on — and back again into work that actually moves. The decision-framing memo: a specific decision the leadership team has to make, with operational and regulatory consequences mapped, in a form an executive can underwrite without a presentation.
- Board or audit committee facing a regulatory escalation
- Capital event readiness assessment (Series funding, M&A, IPO)
- Acquirer due-diligence response requiring multi-domain framing
- Specific risk management decision needing senior practitioner framing
Tell us what’s on the table. We’ll tell you how we can help.
A short discovery conversation. We listen for the operational shape of the work, ask the three questions a senior operator would ask, and tell you straight whether this is a Qualisphere engagement — and whether it’s something we build, assess, or ready for certification. Exploratory, not sales. If we’re not the right partner, we’ll tell you that too.