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Quality Assurance Consulting

Standards expertise that raises how you work

Hands-on quality consulting led by a quality executive with a Ph.D., an MBA, and Six Sigma Black Belt (CSSBB) credentials and 15+ years across diagnostics, medical devices, food safety, and manufacturing. Choose a standard to see how we help.

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Standards we work in

Quality management systems

ISO 9001

QMS design, gap assessment, and certification readiness for any industry.

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Automotive quality

IATF 16949

Core tools, CSR alignment, and audit readiness for automotive suppliers.

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Medical devices

ISO 13485

Device QMS aligned with FDA 21 CFR 820, EU MDR/IVDR, and ISO 14971.

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Testing & calibration labs

ISO 17025

Accreditation readiness, method validation, and measurement uncertainty.

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Occupational health & safety

ISO 45001

Hazard and risk management systems and certification readiness.

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Environmental management

ISO 14001

EMS design, aspects and impacts, and compliance obligations.

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ISO 22000 / FSSC 22000 / HACCP

Food Safety

Food safety management systems and GFSI audit readiness.

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Process improvement

Lean Six Sigma

DMAIC projects, SPC, root-cause problem solving, and belt coaching.

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OSHA / construction / chemical

Safety & Industrial Hygiene

OSHA compliance, hazard & exposure assessment, and industrial hygiene programs — CSP-led.

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Cybersecurity / vCISO / AI governance

Cybersecurity & Information Security

Virtual CISO, NIST & HIPAA compliance, SIEM/SOC, incident response, and AI governance — led by Richard Phung.

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Information security management

ISO 27001

ISMS design, risk treatment, Statement of Applicability, and certification readiness.

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Fractional security leadership

Virtual CISO (vCISO)

Executive security strategy, risk, and compliance leadership without a full-time hire.

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Healthcare security & privacy

HIPAA Compliance

Security Rule risk analysis, safeguards, workforce training, and breach readiness.

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Medical device risk management

ISO 14971

Risk management file, hazard analysis & FMEA, integrated with ISO 13485.

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OSHA / general industry / construction

OSHA Compliance

Written programs, exposure assessment, training, and mock-audit readiness — CSP-led.

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How we work

From gap assessment to certification

Every engagement starts by understanding where you are today — a clause-by-clause gap assessment against the standard and your customers' requirements. From there we build or remediate a right-sized management system, train your team, run a mock audit, and support you through certification and beyond.

We don't hand you a binder and leave. The goal is a system your team actually uses and can maintain — because improvement never stops.

Not sure which standard applies?

Tell us about your product, customers, and goals and we'll point you to the right path — no obligation.

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