Gap analysis
Where you stand against ISO 9001, ISO 13485, or AS9100. Device plants get QMSR mapping, not a generic checklist.
Quality systems that hold up under audit.
We help you get your quality system ready for audit.
We work to ISO 9001, ISO 13485, and AS9100.
We do the work in your plant, not in software you log into.
ISO 9001Quality systems
ISO 13485Lead auditor
AS9100DLead auditor
What we do
Training, NC/CAPA, audit prep, document control.
We have sat on both sides of the audit table. We add capacity and get you audit-ready, not software you log into.
Internal audits
We find process issues, not boxes to check.
Prepare and defend external audits
Registrar, customer, or FDA. Evidence in order before they sit down.
Supplier / second-party audits
An AS9100D lead auditor looks at a supplier or a sister site.
NC-CAPA
Root cause that survives “why won’t this recur?”
Training
People who can speak to the procedure when the auditor sits down.
Procedures, work instructions, forms
Documents people can follow on the floor.
Document-control process
Revision, approval, training impact, and obsolete docs, on the tools you already have.
Who we serve
15–200 people. One or two sites.
You have a certification clock, or a customer just mandated AS9100 or ISO 13485. Plants that run both ISO 13485 and AS9100 are who we work with most. We do not chase primes or 400-person plants with a quality department already in place.
Aerospace, defense & space
Independent shops under AS9100D, with OASIS and customer flow-down, not a prime with a corporate quality staff.
Medical devices
Manufacturers and contract manufacturers under ISO 13485 and FDA QMSR. A 13485 certificate does not replace an FDA inspection.
Precision manufacturing
ISO 9001 shops being told to add ISO 13485 or AS9100 on a customer mandate, not a 400-person quality department.
What we do not do
Not software. Not staffing. Not a 400-person plant.
Software, a portal, or a binder
We work in the tools you already have, not an eQMS you log into.
Staffing, or skipping a quality-manager hire
We add capacity and get you audit-ready, not a replacement for the people who sign.
Primes and 400-person plants
We work with shops of 15–200 people, not plants that already have a quality organization.
How it starts
01
Tell us the standard
ISO 9001, ISO 13485, or AS9100. Registrar, customer, or FDA. Where the system is thin.
02
We find the gaps
A review against the standard you have to meet. Written so process owners can act.
03
We close what the auditor will ask
Training, NC/CAPA, procedures, and document control, so capacity goes back to the quality manager.
For quality managers
Straight answers, not fake case studies.
AS9100 vs ISO 9001. Internal audit in-house vs a consultant. Quality manager vs an outsourced team. Consultant vs DIY.
Do not wait until the week of the audit.
Tell us the standard and the timeline. We will tell you if we can help.