Our Services
Cornerstone Quality & Compliance Consulting LLC partners with companies in highly regulated industries to build, strengthen, and defend the quality systems their business depends on. From a single SOP to a full QMS rebuild, from a pre-audit dry run to leading your quality function on an interim basis — we meet you where you are and get you where you need to be.
We serve clients in:
- Medical devices (FDA 21 CFR 820, ISO 13485, EU MDR)
- Pharmaceuticals and life sciences (cGMP, 21 CFR 210/211)
- Food and beverage (FSMA, HACCP, SQF, BRCGS)
- Automotive (IATF 16949, VDA 6.3, PPAP/APQP)
- Manufacturing (ISO 9001)
- Healthcare and clinical compliance (HIPAA, GCP, accreditation)
Whether you're a startup writing your first SOP or an established manufacturer preparing for a regulatory inspection, we bring the same disciplined, practical approach: build it right, prove it works, and make sure the people doing the work understand it.
Audits & Assessments
Gap Assessments
A focused review of your current quality system against the regulation, standard, or framework you're held to. We identify where you're solid, where you're exposed, and what to prioritize — with findings written in plain language and ranked by risk so your team knows exactly where to start.
Internal Audits
Independent internal audits performed against your applicable standard — ISO 9001, ISO 13485, IATF 16949, 21 CFR 820, cGMP, FSMA, and others. We audit the way regulators and registrars do, but with the goal of finding issues before they do.
Supplier Audits
On-site or remote audits of your suppliers and contract manufacturers. Critical for medical device, pharma, automotive, and food companies where supplier failure becomes your failure in front of regulators and customers.
Mock Regulatory Inspections
A full-dress rehearsal for FDA inspections, notified body audits, registrar surveillance audits, or customer audits. We act as the auditor — asking the questions, requesting the records, and pressure-testing your team's readiness.
QMS Build from Scratch
QMS Build from Scratch
A complete Quality Management System designed for your business, your industry, and the regulations you operate under. We don't hand you a template binder — we build a system your team can actually run, scaled to where you are now with room to grow.
SOP & Work Instruction Development
Targeted procedure writing for specific processes, departments, or regulatory requirements. We work alongside your subject matter experts to capture the way work actually gets done — then document it in a way that's compliant, clear, and trainable.
Remediation & Corrective Action
Response to Regulatory Findings
When you receive an FDA Form 483, Warning Letter, ISO nonconformance, or customer audit finding, the response window is short and the stakes are high. We help you draft a credible, defensible response and build the corrective action plan that backs it up.
CAPA Program Overhaul
Many companies have a CAPA system on paper that doesn't actually drive improvement. We rebuild CAPA programs into something that finds real root causes, closes real issues, and stands up to regulatory scrutiny.
Root Cause Analysis Facilitation
For specific high-stakes issues — recalls, major nonconformances, repeat customer complaints — we facilitate structured root cause investigations using methods like 5 Whys, fishbone, and fault tree analysis.
Training & Coaching
Standards Training
Practical, hands-on training in the standards your team works under — ISO 9001, ISO 13485, IATF 16949, 21 CFR 820, cGMP, FSMA, and others. We focus on what the requirements mean for the work your team actually does, not just clause-by-clause recitation.
Internal Auditor Training
Training and qualification of your internal audit team. We cover audit planning, opening meetings, evidence gathering, objective writing, nonconformance documentation, and the soft skills that separate good auditors from great ones.
Leadership & Quality Culture Coaching
One-on-one or small-group coaching for quality leaders, plant managers, and executives. Quality systems live or die based on what leadership tolerates and rewards — we work with leaders on how to set expectations, run meaningful management reviews, and build a culture where quality issues surface early.
Fractional & Interim Leadership
Fractional Quality Manager / Director
An experienced quality leader embedded in your organization on a part-time, ongoing basis. We hold management review, sign off on documents and CAPAs, represent quality in leadership meetings, and provide the experienced oversight you need without the cost of a full-time hire.
Interim QA Leadership
Short-term coverage when your quality leader leaves, takes extended leave, or is reassigned. We step in immediately, maintain compliance and audit readiness, and hand off cleanly to your permanent hire — including helping you define the role and evaluate candidates if needed.
Regulatory Submissions & Affairs
FDA Submissions Support
Preparation and review of FDA submissions including 510(k)s, De Novo requests, IDEs, establishment registrations, and device listings. We help you build the quality and technical documentation regulators expect and respond to additional information requests.
Technical Files & Design Dossiers
For EU MDR, IVDR, and similar frameworks — technical file construction, gap analysis against the latest regulatory requirements, and ongoing maintenance support.
Certification Preparation
End-to-end preparation for ISO 9001, ISO 13485, IATF 16949, SQF, BRCGS, and similar certification audits. We get your QMS ready, run mock audits, and stand alongside you on audit day.