ForgePilot is an AI workspace built for design and manufacturing engineers. It generates FMEA reports, runs tolerance stack-up analysis (worst-case and RSS), reviews CAD files, and answers engineering questions with first-principles reasoning — not generic textbook answers.

How is ForgePilot different from ChatGPT?

ForgePilot is purpose-built for engineering workflows. It understands CAD files (STL, STEP, DXF, IGES), produces ranked FMEA tables with specific RPN numbers, runs tolerance stack-up calculations, and maintains full session context across an entire project — things general-purpose AI cannot do reliably.

Does ForgePilot support FMEA generation?

Yes. ForgePilot generates structured FMEA reports from your design inputs — with ranked failure modes, severity, occurrence, and detection scores, RPN values, and recommended corrective actions. No template to fill in manually.

What file formats does ForgePilot support?

ForgePilot supports STL, STEP, IGES, DXF, PDF datasheets, CSV test logs, GCode, VTK simulation results, and Abaqus .inp files — up to 10 files per analysis session.

Is there a free plan?

Yes. ForgePilot has a free plan with 10 analyses per day — no credit card required. A Pro plan at $9/month unlocks unlimited analyses, multi-file uploads, PDF export, and advanced AI reasoning for FMEA, design review, and tolerance stack-up.

ISO 9001 Checklist for Manufacturing and Design Teams

Most ISO 9001 checklists read like they were written for a compliance officer, not the engineers who actually generate the evidence an auditor asks for: drawings, revision records, inspection data, nonconformance reports.

This checklist is organized the way ISO 9001:2015 is actually structured, ten clauses, with clauses 4 through 10 being the ones that get audited, and it flags specifically where design and manufacturing engineering carry the workload, not just quality management.

The Ten Clauses, What They Actually Require

Clause 4: Context of the Organization

Establishes the scope of your quality management system and who it needs to satisfy.

[ ] Documented QMS scope, what products, sites, and processes are covered
[ ] Interested parties identified (customers, regulators, certification bodies) and their requirements documented
[ ] Process interactions mapped, how design, purchasing, production, and inspection hand off to each other

Clause 5: Leadership

Top management has to demonstrably own the QMS, not delegate it entirely to a quality department.

[ ] Quality policy exists, is communicated, and is understood at the working level, not just posted on a wall
[ ] Roles and responsibilities for quality-related decisions are assigned and documented
[ ] Management review meetings actually happen and are recorded, not just scheduled

Clause 6: Planning

Risk-based thinking is the core addition in the 2015 revision. Auditors specifically look for evidence that risk was considered, not just documented after the fact.

[ ] Risks and opportunities identified for key processes, design changes, supplier changes, capacity constraints
[ ] Quality objectives are measurable and tracked, not aspirational statements
[ ] Change management process exists for planned changes to the QMS or product design

Clause 7: Support

Resources, competence, and documentation control. This is where most audit findings against small manufacturers land.

[ ] Training records exist for anyone performing work affecting product quality, including design engineers
[ ] Calibration records for measurement equipment (calipers, CMMs, gauges) are current and traceable
[ ] Document control: drawings, specs, and work instructions are version-controlled with a clear latest-revision indicator
[ ] Records are retained per a defined schedule and are retrievable, not just stored somewhere

Clause 8: Operation — where design and manufacturing live

This is the largest clause and the one design and manufacturing engineers generate the most evidence for.

Design and development controls (8.3):

[ ] Design inputs (functional requirements, applicable standards, regulatory requirements) are documented before design starts
[ ] Design reviews happen at defined stages, with records of who reviewed and what was found
[ ] Design verification confirms outputs meet inputs, tolerance stack-up, FEA, test data, not just a sign-off
[ ] Design validation confirms the part works in its actual use case, not just on paper
[ ] Design changes are controlled: reviewed, approved, and their impact on already-released parts assessed

Production and service provision:

[ ] Work instructions exist for production steps where their absence would affect quality
[ ] Process parameters (speeds, feeds, torque specs, cure times) are documented and monitored, not tribal knowledge
[ ] Traceability: parts and materials can be traced back to the batch, drawing revision, and inspection record that produced them
[ ] Preservation of product through handling, storage, and shipping is defined for anything sensitive to damage or contamination

Nonconforming outputs (8.7):

[ ] A defined process exists for identifying, segregating, and dispositioning nonconforming parts
[ ] Root cause is investigated for recurring nonconformances, not just the immediate part is scrapped or reworked

Clause 9: Performance Evaluation

Auditors want to see the QMS is actually being measured, not just operated.

[ ] Internal audits are scheduled and completed against a documented audit program
[ ] Customer satisfaction data is collected and reviewed, not assumed
[ ] Key process metrics (scrap rate, on-time delivery, first-pass yield) are tracked and reviewed at management review

Clause 10: Improvement

[ ] Corrective action process exists for nonconformances, with root cause analysis, not just a fix and move on
[ ] Evidence of continual improvement, process changes driven by data, not just claimed in the quality manual

Where This Actually Gets Missed

Two patterns show up repeatedly in small and mid-size manufacturing audits:

Design controls exist on paper but not in practice. A design review checklist gets filled out, but the tolerance stack-up or FEA it references either doesn't exist or isn't retrievable when the auditor asks for it. The QMS documentation says design verification happens, the actual verification evidence, the calculation, the test data, is what auditors ask to see.

Nonconformance data doesn't connect back to design. Clause 8.7 requires investigating nonconforming outputs, but if the root cause is a design tolerance that was too tight for the process capability, that finding needs to flow back into clause 8.3 design controls, not just close out as a one-off rework. Auditors specifically probe for this feedback loop.

Summary

ISO 9001:2015's seven certifiable clauses (4 through 10) cover context, leadership, planning, support, operation, performance evaluation, and improvement. For manufacturing and design engineering teams specifically, clause 8.3 (design and development) and clause 8.7 (nonconforming outputs) generate the most audit evidence, and the most findings, because they require retrievable, specific records: verification calculations, review records, and root cause investigations, not policy statements.

The most common gap is documentation that describes a process without evidence the process actually produced retrievable, specific records. If your design verification is a tolerance stack-up done in a spreadsheet that gets overwritten every revision, that's a real audit risk, not just a workflow inconvenience.

Check a design against a standard directly: ForgePilot's Compliance Check tool audits a design clause-by-clause against ISO 9001 or whatever standard governs your part, with a pass, fail, or needs-more-info verdict and the specific clause cited, so the evidence trail exists before an auditor asks for it.