Services

Capacity and audit readiness.

Training, NC/CAPA, internal and external audit prep, and document control. We work on the tools you already have, not software we sell.

Gap analysis

We walk the floor, read the procedures, and talk to process owners. Then we map the gaps to the standard you actually have to meet. Device plants get QMSR mapping, not a generic checklist. You leave with a list you can close.

Internal audits

Process-based audits of production, purchasing, design, CAPA, and document control. Findings name the owner and the evidence. You stay accountable; we do not audit our own work as if it were yours.

Prepare and defend external audits

We rehearse interviews and tighten objective evidence. We sit with your team if you want a second set of eyes. The goal is a boring audit.

Supplier / second-party audits

We audit against the standard and your customer requirements. Findings come back in language your team can act on.

NC-CAPA

We help you write, investigate, and close NCs, not a rewrite of the symptom. Customer escapes, SCARs, audit findings, internal issues. You still sign disposition and closure.

Training

We train process owners on the documents they actually use. Training records tie to the current revision. A quiz score is not competence for critical work, so observation still belongs to you.

Procedures, work instructions, forms

We draft and revise manuals, SOPs, work instructions, and forms so they match the work. Then we map them to ISO 9001, ISO 13485, or AS9100D.

Document-control process

Revision control, approval routing, training impact, and obsolete documents off the floor. We use your eQMS, shared drive, or paper, not a new system of record we sell.

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.

If the auditor is already booked, start there. We will tell you what fits the time you have.

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