New story The Auditor Who Found Nothing Hidden · A follow-up audit at Ferrolux
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Quality work for regulated manufacturers

Quality work, done right.
From the first prototype test to series release.

CycleQA is a way of doing quality work in manufacturing, with evidence created while people work, not before the audit. We bring the method, the tool that implements it fully, and the support until your team lives it every day.

Talk to Markus Read the new story

CycleQA records what happened. It never scores the people who did it.

Product overview · 3 pages · PDF
Designed around
ISO 9001 ISO 13485 IEC 62304 IEC 60945 IEC 61340 DNV type approval
What CycleQA is

One way of working.
Three parts.

When does your quality process start?

In many companies, the week before the audit. With CycleQA, it starts at the first prototype on the test bench and runs through every change to release, so the evidence already exists when someone asks for it.

First prototype testSeries release
Evidence created along the way, not assembled at the end.

The method

A clear way of doing quality work from prototype to release, built on ISO 9001 and ISO 13485. Everyone knows what to record, when, and why.

The tool

CycleQA implements the method fully: three tiers on one data model, from CQA-CORE to CQA-ENTERPRISE.

See the three tiers

The support

Courses and consulting to introduce the method and live it day to day, including role-play training in which your team plays the real roles, from QA manager to auditor.

Ask about courses
The problem

Your organisation already has the knowledge
it needs to run quality well.

It just has nowhere to live. And when it can't flow, the audit stress builds, the spreadsheets multiply, and the people who should be building products spend their time managing paperwork instead.

"A calibration certificate tells you an instrument was in tolerance on a given date. It tells you nothing about which products were qualified using it — or what happens to your quality chain if it later drifted."
01
Calibration and quality records don't talk to each other Instrument status and product quality status live in separate systems that were never designed to connect them. That's not a process problem. That's an architecture problem.
02
Traceability lives in the QA manager's head The field engineer who spotted the anomaly. The test engineer who knows which instrument was used. Knowledge that exists — but can't find its destination.
03
Too small for enterprise, too serious for Excel Enterprise suites assume a quality department and a consultant budget. Spreadsheets assume nobody will ever ask a hard question. Regulated SMEs sit in between — and every new requirement competes with the engineering talent that makes the product worth selling.
Why it matters now

A well-designed QMS changes
the equation.

Compliance becomes a natural output of work that was already happening — not a parallel job for a dedicated headcount. The experienced engineer stays where they belong. The QA manager gets leverage, not more paperwork.

For regulated SMEs navigating an increasingly demanding environment, this is not an abstract benefit. It is the difference between a quality system that works for you and one that works against you.

½ day
Typical manual effort to work out which products an out-of-tolerance instrument qualified: certificates, spreadsheets, phone calls.
30 sec
The same answer from CycleQA's calibration consequence chain in our demo scenarios. No spreadsheet archaeology.
4 clicks
From customer complaint to corrective firmware to standard clause, in the medtech scenario further down this page.

Figures come from CycleQA demo scenarios, not customer measurements. Your numbers will differ.

Products

One chain. Three ways in.

The tool that implements the method. Every CycleQA tier runs on the same traceability chain, from the product down to the non-conformance, with calibrated instruments as first-class records. The tiers differ in how much of your testing CycleQA takes off your plate.

Product Specification Requirement Test definition Test execution NCR

The instrument speaks directly to the record.

CQA-CORE Full traceability

The complete QMS. Products, requirements, calibration records and non-conformances linked end to end.

  • Calibration with the consequence chain
  • NCRs with 8D methodology
  • Products, specifications, requirements and test definitions
  • Standards, risks and mitigation actions
  • Suppliers, parts and incoming inspection
  • Field reports that work offline
Sounds like you if you are a 40-person precision-parts subcontractor running NCRs and calibration in Excel and on paper, and the hardest part of every audit is proving traceability fast.
CQA-AUTO + automated testing

Everything in CORE, plus scheduled automated tests on standard bench instruments. Configured, not coded.

  • Everything in CQA-CORE
  • Built-in support for standard bench instruments: multimeters, power supplies, oscilloscopes
  • Scheduled test runs, with results written straight into the test record
  • Out-of-limit results raise an NCR automatically
  • Each test node authenticates on its own, with encrypted transport
Sounds like you if you are a test house or contract manufacturer running routine bench validation by hand, and you want it automated and logged without starting a software project.
CQA-ENTERPRISE + your own instruments

Everything in AUTO, integrated with your own mix of instruments, sensors and systems, with integration support and dedicated partners.

  • Everything in CQA-AUTO
  • Integration of your own instrument and sensor combinations
  • Edge nodes that process locally and report structured evidence
  • Integration support and dedicated partners from CycleQA's network
  • Scoped to your standards and your approval path
Sounds like you if you run distributed sensor systems (edge devices, sensor fusion, field-deployed nodes) and your test setup is one of a kind.
Grow into it, not out of it. The same data model runs through all three tiers. No migration, no second vendor.
No price list, on purpose. Instruments, users, standards and integration effort differ too much between manufacturers for one table to be honest. We scope it together, starting with one conversation.
Read the story behind the three tiers
How it works

One system. Every connection already made.

The CycleQA application interface is currently in English.

admin.cycleqa.com/calibration.html
Who it's for

Built for regulated manufacturers with 50–500 people.

Medical devices. Precision manufacturing. Maritime electronics. Industrial systems. Hidden champions across DACH and Scandinavia managing quality under ISO 9001, ISO 13485, IEC standards or type approval — today in spreadsheets, or in a system never designed for their industry.

QA manager

The traceability chain is already there when the auditor asks. No spreadsheet archaeology before every survey.

Test engineer

Every instrument linked to the products it qualifies. Calibration status visible before you run the test, not after the surveyor asks.

Field engineer

Submit field reports from site in 2 minutes. Works offline. Already linked to the product and the open NCR when you get back online.

Inspector

Structured incoming inspection workflows. Findings linked directly to supplier records and open non-conformances.

Engineering manager

Know your calibration risk exposure before the type-approval campaign begins. No surprises during the test.

CEO / general manager

Quality stops competing with engineering for the same people. Compliance becomes an output of work that is already happening.

Illustrative scenario

One digit. Fourteen instruments.
Five countries.

A fictional medtech company — illustrating how CycleQA connects a field complaint to root cause to standard compliance. Every record shown here exists in a live CycleQA demo database. All company names, persons, and scenarios on this page are fictitious.

Nov 2025
Incoming inspection
Reference artifact reads +0.048D — inside ±0.05D limit, at 96% of it. Accepted. Recorded.
Dec 2025
Vague field report
No serial number. No firmware version. No data. A WhatsApp voice message, effectively.
Jan 2026
Formal complaint — Munich
+0.12D systematic offset confirmed via structured wizard report. Firmware v2.4.1 flagged.
Feb 2026
Second report — offline, Eindhoven
Submitted from a motorway rest stop. Synced when network restored. Two countries, same firmware, same offset.
8 days later
Root cause confirmed
Config file: refractive index 1.3385 instead of the ISO 11979-2 measurement medium specification. One digit. Introduced by a contractor. Not caught in code review.
Apr 2026
All 14 sites resolved
Firmware v2.4.2 validated: +0.003D deviation. Field campaign complete. FSCA filed with Notified Body.
Jun 2026
ISO 13485 certificate
The incident became the evidence package. The QMS had recorded everything — including the borderline inspection from three months before anyone noticed the problem.
1.3385 in the firmware
1.3375 ISO 11979-2 measurement medium
Δn = 0.001  ·  systematic offset +0.12D across all IOL power ranges
Field report
NCR + 8D
Risk register
Standard clause
Cal record
The auditor's traceability question — from customer complaint to corrective firmware to standard compliance — was four clicks. No spreadsheet archaeology. No emergency documentation sprint the week before the survey.
Stories

Quality events, followed end to end.

Each story follows one incident or one workflow through CycleQA. Companies and people in the scenario stories are fictional; the records behind them exist in live demo databases.

Audit story The Auditor Who Found Nothing Hidden A follow-up audit, one hard question, and a QA manager who answers it from the record. With a look back at Zeiss and Abbe in Jena. Products Three ways in. One CycleQA. How CQA-CORE, CQA-AUTO and CQA-ENTERPRISE fit three very different manufacturers. Medtech · PDF OptiLens: one digit, fourteen instruments A field complaint traced to one wrong digit in a configuration file, across fourteen instruments in five countries.
Mobile-first

Quality from anywhere.
In seconds.

Every CycleQA module runs in any mobile browser — no app installation required. Open a secure link, scan a QR code, file a structured field report offline. The record is there when the auditor asks.

  • PWA — open admin.cycleqa.com in any browser, add to home screen
  • Offline-first — field reports queue locally, sync automatically
  • Secure token links — field engineers reach records directly from HQ notifications
  • Night & Day mode — ship bridges, labs, offices, outdoors
  • JWT auth · EU servers · full audit log — every action traceable
See all modules on mobile
Architecture

Built right, not bolted on.

Traceability by design

The calibration-to-product chain lives in the data model itself, not retrofitted onto forms that were built for something else.

A modern stack

Designed for what a QMS needs today, not carried over from a decade-old codebase. New modules arrive without breaking the chain.

Full parity in the field

The same features at the same speed on a phone on the shop floor as at a desk in the office.

Security as a habit

EU servers, encrypted backups and a full audit log on every action.

Get in touch

Let's look at your setup together.

MH
My grandfather spent forty years at Carl Zeiss keeping his gauge blocks true. Precision was always worth preserving. What has changed is how hard it has become to hold onto as a company grows.

CycleQA is my answer: a way of working where the workflow carries the standard, and a tool built to keep it, so compliance becomes a byproduct of good work instead of a parallel job.

If this problem is familiar from your own organisation, I'd genuinely welcome a conversation.
Markus Hein · Founder, CycleQA AS · Moss, Norway

How we start

  1. A conversation. Your products, your instruments, your standards, and the audit question that worries you most.
  2. A tier recommendation and a scoped proposal. Built for your setup, not taken from a price list.
  3. Onboarding and training. The method introduced with your roles, your equipment list and your real data.
  • Direct access to the founder, not a helpdesk ticket
  • Your data, with a full export at any time. No lock-in.
  • Genuine influence over what gets built next
Email Markus Download product overview (PDF) Connect on LinkedIn Follow CycleQA on LinkedIn
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Our office

CycleQA AS c/o Kjeller Innovasjon
Brogata 7
2000 Lillestrøm, Norway

Visits by appointment. Lillestrøm station is a short walk away, with direct trains from Oslo S and Oslo Airport.

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Kjeller Innovasjon CycleQA is a member company of Kjeller Innovasjon.