Aerospace and defense suppliers answer to AS9100 and their customers' flow-downs. Keep first article inspections, nonconformances, corrective actions, changes, calibration and suppliers in one workspace, with every change recorded and access limited to exactly who needs it.
People who only need to look, such as managers, auditors and customers, get free viewer seats.
Screens show sample data from a fictional company.
Qualsted gives you the technical controls and the records; your procedures, training and verification of your own configuration complete the picture.
| Clause | How Qualsted helps |
|---|---|
| AS9100D §8.5.1.3 · AS9102 | First article inspection. A first article per part number and revision, with materials, special processes and each design characteristic recorded against its requirement, and approval by quality. |
| AS9100D §7.5 | Documented information. Controlled records with complete history; access limited by folder, table and page, with every change recorded. |
| AS9100D §8.7 | Control of nonconforming outputs. Nonconformances dispositioned (use as is, rework, scrap, return) and approved, linked to corrective action. |
| AS9100D §10.2 | Corrective action. Root cause, actions and effectiveness checks, approved and reminded before due dates. |
| AS9100D §8.5.6 | Control of changes. Changes proposed, assessed and approved before they're made. |
| AS9100D §8.4 | External providers. Approved suppliers with risk, certificates and requalification. |
Working processes with review signatures, reminders and views set up, as ordinary tables and pages you can change.
First article inspection reports following AS9102: part number accountability, materials, special processes and functional tests, and each design characteristic measured against its requirement (pass or fail is calculated), approved by Quality.
AS9102 · AS9100 §8.5.1.3 · IATF 16949 §8.6.2
Product or material that doesn't meet requirements: identify it, decide its disposition, and get it approved.
ISO 9001 §8.7 · ISO 13485 §8.3 · FDA QMSR (21 CFR 820) · AS9100 §8.7 · IATF 16949 §8.7
Record deviations, assess their impact, and open a corrective and preventive action when one is needed. CAPAs are reviewed and approved, with reminders before they fall due.
21 CFR 211.192 · FDA QMSR (21 CFR 820) · ISO 13485 §8.5.2 · ISO 9001 §10.2 · EU GMP Ch. 1
Propose, assess and approve changes to processes, equipment, materials or documents before they're made.
FDA QMSR (21 CFR 820) · ISO 13485 §7.3.9 · ISO 9001 §6.3 · EU GMP Annex 15 · ICH Q10
An equipment register with calibration records reviewed by Quality, and reminders two weeks before calibration falls due.
21 CFR 211.68 · FDA QMSR (21 CFR 820) · ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 · ISO 13485 §7.6
Approved suppliers with their risk, certificates and qualification, approved by Quality and requalified every year.
FDA QMSR (21 CFR 820) · ISO 9001 §8.4 · ISO 13485 §7.4 · AS9100 §8.4 · EU GMP Ch. 5
The assistant answers questions about your tables, draws charts and summarizes long records. It sees only what you can see, never changes or signs anything, and every use is logged.
Which first articles failed a characteristic this quarter?
Summarize NC-0142 and its disposition.
Answers come from the records you can see, with charts and links to them.
Not as certified environments. Qualsted runs in AWS in the United States with access control and audit trails, but it isn't certified for CMMC and isn't a FedRAMP or ITAR-controlled environment. Don't store controlled unclassified information or export-controlled technical data in it.
The first article template follows AS9102's three forms: part number accountability, product accountability (materials, special processes, functional tests) and characteristic accountability, with each characteristic as its own record.
