Book a demo
Manufacturing · ISO 9001:2015 · IATF 16949

Your quality system, without the binder or the spreadsheet maze.

Internal audits, 8D reports, nonconformances, CAPA, controlled documents, training, gauges and suppliers in one workspace, shaped to your process and ready for the registrar.

Book a demo
What you keep in Qualsted
  • Internal audit program, audits and findings
  • 8D problem solving for customer and internal problems
  • Nonconforming outputs and their disposition
  • Corrective action with effectiveness checks
  • Controlled documents (procedures, work instructions)
  • Training and competence; gauges and calibration; supplier approval
Who uses it
  • Quality managers and engineers
  • Production and operations
  • Supplier quality

People who only need to look, such as managers, auditors and customers, get free viewer seats.

In practice

What it looks like.

Nonconformances on a board by stage (Open, Disposition, Closed), with item, lot, quantity and where each was found.
Nonconformances by stage, from finding to approved disposition.
First article inspections on a board by status: Open, Inspected and Closed.
First article inspections for new parts and changes.

Screens show sample data from a fictional company.

How it supports your standard

The clauses your auditor asks about, and what answers them.

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
ISO 9001 §7.5 Documented information. Documents approved before use, versions kept and protected, and records retrievable with their full history.
ISO 9001 §9.2 Internal audit. An audit program, each audit's scope, criteria and auditor, and findings followed up to closure.
ISO 9001 §8.7 Control of nonconforming outputs. Nonconformances identified, dispositioned and approved, linked to corrective action.
ISO 9001 §10.2 · IATF 16949 §10.2.3 Corrective action and problem solving. 8D reports from containment to root cause, permanent corrective action and verification, with team sign-off.
ISO 9001 §7.1.5 Monitoring and measuring resources. Gauges and equipment with calibration records and reminders before calibration falls due.
ISO 9001 §7.2, §8.4 Competence and external providers. Training records with sign-off; approved suppliers with requalification reminders.
Templates

Start from these, installed in one click.

Working processes with review signatures, reminders and views set up, as ordinary tables and pages you can change.

Quality

Internal audits

An internal audit program: each audit's scope, criteria and auditor, the report approved by Quality, and findings followed up to closure with owners, due dates and reminders.

  • Audits 11 columns · IDs like AUD-0001 · signed: Report approved by
  • Findings 13 columns · IDs like FND-0001 · signed: Effectiveness verified by
  • Reminder: Audit in 7 days
  • Reminder: Finding due in 3 days
  • Reminder: Finding overdue

ISO 9001 §9.2 · ISO 13485 §8.2.4 · IATF 16949 §9.2.2 · AS9100 §9.2 · ISO/IEC 17025 §8.8

Quality

8D problem solving

Customer and internal problems worked through the eight disciplines, from the team and containment to root cause, permanent corrective action and preventing recurrence, approved by Quality, with reminders before the due date.

  • 8D reports 16 columns · IDs like PS-0001 · signed: Approved by
  • Reminder: 8D report due in 3 days
  • Reminder: 8D report overdue

IATF 16949 §10.2.3 · ISO 9001 §10.2 · AS9100 §10.2

Quality

Nonconformances

Product or material that doesn't meet requirements: identify it, decide its disposition, and get it approved.

  • Nonconformances 14 columns · IDs like NC-0001 · signed: Disposition approved by
  • Reminder: Nonconformance due in 3 days
  • Reminder: Nonconformance overdue

ISO 9001 §8.7 · ISO 13485 §8.3 · FDA QMSR (21 CFR 820) · AS9100 §8.7 · IATF 16949 §8.7

Quality

Deviations and CAPA

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.

  • Deviations 15 columns · IDs like DEV-0001 · signed: QA approval
  • CAPA 13 columns · IDs like CAPA-0001 · signed: Reviewed by, Approved by
  • Reminder: Deviation due in 3 days
  • Reminder: Deviation overdue
  • Reminder: CAPA due in 3 days
  • Reminder: CAPA overdue

21 CFR 211.192 · FDA QMSR (21 CFR 820) · ISO 13485 §8.5.2 · ISO 9001 §10.2 · EU GMP Ch. 1

Quality

Document control (SOPs)

Controlled documents with versions, review and approval. Each document gets a periodic review date two years ahead, and its owner is reminded a month before it's due.

  • Documents 11 columns · IDs like DOC-0001 · signed: Reviewed by, Approved by
  • Reminder: Periodic review due in 30 days

21 CFR 211.100 · FDA QMSR (21 CFR 820) · ISO 9001 §7.5 · ISO 13485 §4.2.4 · ISO/IEC 17025 §8.3

Operations

Equipment and calibration

An equipment register with calibration records reviewed by Quality, and reminders two weeks before calibration falls due.

  • Equipment 8 columns · IDs like EQ-0001
  • Calibrations 9 columns · IDs like CAL-0001 · signed: Reviewed by
  • Reminder: Calibration due in 14 days
  • Reminder: Calibration overdue

21 CFR 211.68 · FDA QMSR (21 CFR 820) · ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 · ISO 13485 §7.6

See all templates

AI assistant · add-on

Ask your records, in your own words.

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.

How the assistant works

Help · Ask the assistant

Which audit findings are still open past their due date?

Chart 8D reports by customer and stage.

Answers come from the records you can see, with charts and links to them.

Questions

What manufacturing teams ask us.

We're ISO 9001 only. Is this overkill?

No: you use the same tables and signatures, and leave out what you don't need. Electronic signatures and audit trails make audits quicker whether or not a regulation demands them.

Does it do PPAP or control plans?

There's no ready-made PPAP template yet; you can build PPAP elements and control plans as linked tables and pages with approvals.

See it with your own process

Bring one workflow. We'll build it with you in the demo.

Book a demo Other industries