Quality Management Solutions

Quality Management Solutions Built on Aerospace and Nuclear Standards

In industries where quality failure means recalls, regulatory action, or worse, quality isn't a department. It's the operational discipline that keeps you in business. We build the quality management systems, supplier oversight, internal audit programs, and continuous-improvement frameworks that let aerospace, nuclear, healthcare, and manufacturing organizations meet the standards their customers and regulators demand.

How We Work

Six Phases to a Working QMS

Our engagements follow a proven sequence: understand the operation, close the gaps, and build systems your team can actually run without us.

1
Current-State Assessment

A structured review of your existing QMS, supplier oversight, inspection protocols, and documentation. We find the gaps between what your standards require and what your operation actually does.

2
Standards Alignment

Whichever framework your customers require, ISO 9001, AS9100, IATF 16949, ISO 13485, FDA QMSR, we build the documentation, procedures, and controls that pass certification and stand up to real audits.

3
Process Design & Controls

Statistical process control, first-article inspection, in-process verification, and outgoing quality checks calibrated to the risk your operation actually carries.

4
Supplier Quality Management

Supplier qualification, source inspection, quality agreements, and corrective action programs that keep supplier defects from reaching your production floor.

5
Internal Audit & Improvement

Structured internal audit programs that surface real problems, not just documentation gaps. Corrective and preventive action systems that actually change how work gets done.

6
Training & Handoff

Your quality team owns the system when we leave. We build the training, work instructions, and audit-readiness discipline your operation needs to run without us.

Standards We Build To

Quality Standards & Frameworks

Whichever framework your customers or regulators require, your QMS documentation is built to survive the audit and reflect how your operation actually runs.

ISO 9001:2015
AS9100
IATF 16949
FDA QMSR
ISO 13485
API Q1 / Q2
VDA 6.3
NADCAP

Same Standards Trusted By

Quality Failures Compound Fast

In aerospace, nuclear, healthcare, and precision manufacturing, quality problems rarely stay contained. A missed inspection at one supplier becomes a defective part at your dock. That part becomes a scrap event or a rework cycle. A miss at production becomes a customer escape. A customer escape becomes a regulatory investigation, a lost contract, or a headline. The organizations that hold up in these industries treat quality as an operational discipline, not a department that owns paperwork.

Our Quality Management Solutions build the systems that catch problems at the source: supplier qualification and audits, inspection protocols calibrated to real risk, statistical process control that surfaces drift before it becomes escape, and internal audit programs that find issues before customers or regulators do.

The Standard
In quality management, "compliance" isn't the goal, it's the floor. The floor is FDA QMSR, ISO 13485, ISO 9001:2015, AS9100, IATF 16949, or whichever framework your customers require. The ceiling is what shows up in the field when your product performs under real-world conditions.

Every framework we build is calibrated to the actual risk your operation carries. Aerospace and defense manufacturers get AS9100-grade documentation and supplier controls. Medical device manufacturers get ISO 13485 and FDA QMSR-aligned systems. Automotive suppliers get IATF 16949-compliant PPAP and supplier quality programs. Nuclear operators get systems built for the reliability standards that industry demands.

Regulatory Frameworks We Live Inside

Every industry we serve operates inside a defined regulatory or standards framework. ISO 9001:2015 is the baseline for organizations that need generalized QMS discipline. AS9100 adds aerospace-specific requirements around risk management, product safety, and configuration control. IATF 16949 layers automotive-specific customer requirements onto ISO 9001, including PPAP, APQP, and OEM-specific supplier expectations. FDA QMSR and ISO 13485 govern medical devices, with stringent design controls, risk management, and post-market surveillance.

Nuclear operators work inside 10 CFR 50 Appendix B and NQA-1. API Q1 and Q2 govern oil and gas equipment and services. NADCAP addresses special processes in aerospace. Each framework carries specific documentation requirements, audit protocols, and evidence expectations. We build documentation systems that satisfy the framework while reflecting how work actually gets done, so audits validate real practice, not fabricated evidence trails.

The difference between a QMS that survives audit and one that doesn't isn't the documentation, it's whether the documentation matches operational reality. Auditors are trained to spot the disconnect. We build systems where the disconnect doesn't exist.

Quality management systems built on aerospace and nuclear standards
Built For Real Operations

The Standards That Certified DSV ALVIN, Applied to Your QMS

Show Me Quality Consulting brings decades of aerospace, nuclear, and submarine quality experience to commercial manufacturers, medical device makers, and industrial operators. Same rigor, calibrated to your customers, your framework, and how your operation actually runs.

Supplier Quality Is Where Programs Live or Die

Most quality escapes originate upstream. A supplier qualification that missed a red flag. A source inspection that got skipped under schedule pressure. A supplier corrective action closed without validating the actual fix. Our supplier quality management work focuses on the whole lifecycle: qualification, ongoing performance monitoring, source inspection, quality agreements, and corrective action discipline that actually changes supplier behavior.

The frameworks we deploy pull directly from the environments we've worked inside. NAVSEA-grade supplier oversight for defense and aerospace. AS9100 supplier requirements for aviation manufacturers. ISO 13485 supplier controls for medical device makers. IATF 16949 PPAP and supplier quality manuals for automotive tier-1 and tier-2 suppliers. Every framework calibrated to what your customers require and how much risk your operation can absorb.

Industries We Serve

Quality Management Across Regulated Industries

From aerospace primes to medical device manufacturers, we build QMS programs where compliance is the floor and operational discipline is the goal.

Aerospace & Defense

AS9100 compliance and quality systems that meet the rigorous demands of aviation and defense manufacturing.

Airfield Management

Quality management for airfield operations, from rates and fees assessments to inspection protocols and compliance documentation aligned to FAA and ICAO standards.

Nuclear Power

Uncompromising quality standards for nuclear facilities where failure isn't an option and regulatory requirements are absolute.

Healthcare & Medical Devices

ISO 13485 and FDA QMSR-aligned systems for medical device manufacturers, hospital systems, and healthcare operators.

Manufacturing

Quality frameworks for precision manufacturers, industrial equipment makers, and contract manufacturers serving high-consequence customers.

Automotive

IATF 16949 compliance, PPAP submissions, and supplier quality management for tier-1 and tier-2 automotive manufacturers.

Deep Submergence Operations

DSS-SOC and SUBSAFE-grade quality documentation for organizations operating in the most demanding underwater environments.

Federal Contractors

Quality documentation and audit-ready systems for organizations serving NASA, NAVSEA, DoD, and other federal agencies.

Why Choose SMQC

The Standards That Built Submarines

Our team spent careers inside the environments where quality failures aren't an option. That's the lens we bring to every engagement.

AS9100
Lead Auditor Credentials

AS9100 and ISO 9001 Lead Auditor training. We know what auditors look for because we've been on both sides of the table.

NAVSEA
Quality Engineering Roots

Documentation types and inspection discipline built for submarine and surface ship programs, applied to your operation.

CEO
Amber Rowson Leadership

Direct leadership from a CEO with decades of hands-on quality engineering experience across submarine, aerospace, and manufacturing programs.

ISO
9001:2015 Compliant

Our internal management systems hold the same standard we help our clients reach.

Why This Work Matters

The Cost of Quality Failures vs. The Outcome of Doing It Right

Every organization lives with both columns. QMS is the discipline that shifts the balance.

What Failure Looks Like

Recalls & Field Actions

Defective product reaches customers, triggering retrieval costs, warranty exposure, and regulatory attention.

Failed Audits

Customer, registrar, or regulatory audits surface findings that put certifications, contracts, and revenue at risk.

Lost Customer Contracts

Repeated quality escapes or documentation gaps cost you the next program award, not just the current PO.

Scrap & Rework Cost

Quality problems caught late in the process burn labor, material, and schedule that could have been prevented.

Regulatory Enforcement

FDA warning letters, EASA findings, FAA action, or DoD contract remediation change your business overnight.

Supplier-Origin Escapes

Weak supplier quality controls mean defects arrive at your dock and become your problem to catch or ship.

What Doing It Right Looks Like

Audit-Ready Documentation

AS9100, IATF 16949, ISO 13485, FDA QMSR, or whichever framework your customers require, ready before auditors arrive.

Reduced Defect Rates

Quality problems caught at the source with documented supplier corrective actions and validated fixes.

Supplier Quality Discipline

Qualification, source inspection, and corrective action programs that keep supplier defects from reaching your floor.

Internal Audit That Finds Issues

Audit programs that surface real problems ahead of customers, registrars, or regulators.

Customer Confidence

Predictable quality, on-time delivery, and the audit posture that wins the next program.

Continuous Improvement

CAPA systems that actually close the loop, driving measurable improvement rather than closing tickets.

QMS Questions

Common Questions From Quality Leaders

If your question isn't here, the fastest path to an answer is a 30-minute call.

Which quality management standards do you support?
We build QMS programs to ISO 9001:2015, AS9100, IATF 16949, ISO 13485, FDA QMSR, API Q1/Q2, VDA 6.3, NADCAP, and customer-specific flow-down requirements. Every framework we deploy is calibrated to how your operation actually runs, not just what the standard says on paper.
How do you build internal audit programs that actually find issues?
Most internal audit programs devolve into paperwork exercises that check boxes but don't surface actual problems. We build audit programs that focus on high-risk processes, use structured sampling techniques, and train auditors to look for the leading indicators of quality problems, not just documentation gaps. The goal is internal audits of higher caliber than third-party registrar runs, so external surveillance visits hold no surprises, and internal audits verify process effectiveness.
Can you help us pass a customer or registrar audit?
Yes. Pre-audit readiness reviews are one of the fastest engagements we run: we walk your QMS documentation and operational practice against the framework, identify the gaps auditors typically hit, and help you close them before the audit. For organizations facing enforcement actions or high-stakes customer audits, we deploy more intensive engagements to rebuild the underlying discipline.
How do you approach supplier quality management?
Supplier qualification, source inspection, quality agreements, and corrective action discipline. We build supplier oversight programs calibrated to how much risk each supplier carries: tier-1 aerospace suppliers get one level of scrutiny, tier-2 commodity suppliers get another. The goal is stopping supplier defects from reaching your production floor without burying your quality team in paperwork.
Do you provide QMS training?
Yes. We develop training for internal auditors, quality engineers, and operations personnel. Training is delivered in the context of your actual QMS and your actual operational realities, not generic textbook material. The goal is a quality team that can operate the system without our ongoing involvement.
Can you help with FDA QMSR compliance for medical devices?
Yes. FDA QMSR aligns closely with ISO 13485, and both frameworks emphasize design controls, risk management, CAPA, and post-market surveillance. We build medical device QMS programs that satisfy both frameworks and hold up in FDA inspections.
What's your experience with CAPA and continuous improvement?
Corrective and preventive action systems that actually work require root cause discipline. We help organizations move beyond documentation-only CAPA to systems that identify true root causes, implement corrective actions that actually change how work gets done, and verify effectiveness before closing the case.

Building Quality Discipline That Holds Up

Effective quality management isn't a department, it's an operational discipline. Whether you're aligning to ISO 9001, AS9100, IATF 16949, ISO 13485, FDA QMSR, or a customer-specific flow-down, the goal is the same: systems that catch problems at the source, documentation that reflects real practice, and audit posture that wins the next contract.

Contact Show Me Quality Consulting to discuss how we can strengthen your quality management systems and build the operational discipline your customers, regulators, and organization require.

Contact Us For
Free Consultation Call

Your supply chain challenges require proven expertise. Connect with our team today and let us show you how decades of experience across aerospace, nuclear, healthcare, and manufacturing can solve your toughest problems.