---
title: GEMBA Walks in MedTech Manufacturing Under MDR
description: GEMBA walks in MedTech manufacturing under MDR: frequency, what to observe, and how to record findings as continuous-improvement evidence.
authors: Tibor Zechmeister, Felix Lenhard
category: Quality Management Under MDR
primary_keyword: GEMBA walks MedTech manufacturing MDR
canonical_url: https://zechmeister-solutions.com/en/blog/gemba-walks-medtech-manufacturing
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# GEMBA Walks in MedTech Manufacturing Under MDR

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **A GEMBA walk is a structured visit by management to the place where value is created — the cleanroom, the assembly line, the inspection bench — to observe processes directly. Under EN ISO 13485:2016+A11:2021, GEMBA walks are a legitimate source of continuous-improvement evidence and a practical way for top management to meet clause 5 management responsibility obligations, provided observations are recorded and fed into management review.**

**By Tibor Zechmeister and Felix Lenhard.**

## TL;DR
- GEMBA ("the real place" in Japanese) means managers go see processes with their own eyes instead of relying on reports.
- Lean practices like GEMBA do not replace the QMS — they fold into EN ISO 13485:2016+A11:2021 clause 5 (management responsibility), clause 8.2.1 (customer satisfaction), and clause 8.2.6 (monitoring of process).
- MDR Article 10(9) requires a QMS that ensures effective compliance. Direct management observation is one of the most effective monitoring activities a small team can run.
- Frequency for a startup: weekly for cleanroom and assembly, monthly for back-office QMS processes, tied to a recurring calendar slot.
- What makes a GEMBA walk audit-grade is the record: a dated observation log that feeds management review under clause 5.6.
- GEMBA is not an inspection, not a blame exercise, and not a replacement for internal audits.

## Why this matters

The cleanroom is where reality lives. Procedures live in a document management system; nonconformities live on the shop floor. In small MedTech manufacturers, the distance between the two is often just a few metres — but we still see founders who have not walked the line in weeks, relying on dashboards and exception reports.

We worked with a Class IIa manufacturer outside Vienna who had a clean set of KPIs, a passing internal audit, and a nagging trend of visual inspection escapes. The dashboard said everything was green. A thirty-minute GEMBA walk revealed that the inspection lamp had been moved six weeks earlier to accommodate a new workstation layout, the operators had adapted, and nobody had logged the change. The process was still "validated on paper" but executed differently in reality. That is exactly the gap GEMBA closes.

Notified body auditors know this. When they walk through production, they are doing their own GEMBA. If your management team has never done the same walk, you will find out about the gap during stage 2.

## What MDR actually says

**MDR Article 10(9)** obliges manufacturers to establish, document, implement, maintain, keep up to date, and continually improve a QMS proportionate to the risk class. The article explicitly lists "verification, validation and design" controls, "product realisation," and "resource management" among the QMS aspects. Continual improvement is not optional — it is written into the text.

**EN ISO 13485:2016+A11:2021** provides the structure:

- **Clause 5 (Management responsibility)** requires top management to demonstrate commitment to the QMS, to ensure customer requirements are determined and met, and to review the QMS at planned intervals. Commitment is not a slide in the induction deck. It is visible, repeated behaviour.
- **Clause 8.2.1 (Feedback)** requires the organisation to collect and monitor information on whether requirements have been met. Shop-floor observation is a direct feedback channel.
- **Clause 8.2.6 (Monitoring and measurement of processes)** requires the organisation to apply suitable methods for monitoring processes, and when planned results are not achieved, correction and corrective action shall be taken as appropriate.

Neither MDR nor ISO 13485 prescribes GEMBA by name. They prescribe the outcome: effective monitoring, visible management commitment, and continual improvement. GEMBA is one of the cheapest, fastest, highest-signal ways to meet all three at once.

## A worked example

A twelve-person manufacturer of a Class IIa orthopaedic device runs GEMBA walks on the following cadence, owned by the head of operations and attended by a rotating second observer (CEO, head of quality, head of R&D, PRRC):

- **Weekly (Thursday, 09:00):** cleanroom and final assembly. Duration: 30 minutes. Focus rotates each week — week 1 material flow, week 2 operator interaction with work instructions, week 3 visual inspection stations, week 4 packaging and labelling.
- **Monthly:** goods-in and supplier quality interface, incoming inspection.
- **Quarterly:** back-office QMS processes (document control, CAPA handling, complaints triage).

Each walk produces a single-page observation sheet with four fields: date, route, observations (bullets), actions or questions raised. The sheet is filed under document ID QMS-8.2.6-01.

During one weekly walk, the observer noted that a batch record template had a field — "pre-use cleaning verified" — that operators were ticking without a visible reference to which SOP version they were executing against. Not a nonconformity. A signal. The observation went into the sheet. Two days later, the head of quality confirmed that the batch record template had not been updated when the cleaning SOP was revised in Rev 4. A controlled document change closed the loop.

At the next management review, the walks produced three data points: 48 walks completed in 12 months, 19 observations raised, 17 closed with action (11 minor document updates, 4 work-instruction clarifications, 2 CAPAs). That is exactly the kind of input clause 5.6.2 asks for — not a narrative, a set of numbers with traceable records behind them.

## The Subtract to Ship playbook

Do the minimum that makes GEMBA real and evidence-generating. Subtract everything that turns it into theatre.

**Step 1. Put it on the calendar.** A recurring, same-time-every-week slot. If it is not on the calendar, it will not happen. We recommend early morning, before the day's firefighting starts.

**Step 2. Define one route.** Start with one physical route through production. Rotate focus each week, not the route. Changing the route every week means you will never build pattern recognition.

**Step 3. Use a one-page sheet.** Controlled document. Four fields: date, route, observations, actions raised. Do not build a GEMBA app. Do not buy a GEMBA platform. A PDF or a Google Doc under version control is enough until you outgrow it.

**Step 4. Separate observation from correction.** The walk is for observation. If you see a genuine nonconformity during the walk, log it in the nonconformance system as you would any other finding — GEMBA is a source, not a substitute. Do not use the walk as an excuse to start giving instructions on the line. That undermines the supervisor chain.

**Step 5. Feed management review.** Clause 5.6.2 lists required inputs to management review. Your GEMBA summary (number of walks, number of observations, closure status) should appear as a single row in that input pack. This is what turns a nice habit into audit evidence.

**Step 6. Rotate the observer.** The head of operations owns the cadence, but each walk should include a second pair of eyes drawn from a rotating pool. This is how management commitment under clause 5 becomes visible — the CEO physically walking the cleanroom once a month is worth more than three pages of quality policy.

**What not to do.** Do not call it an "inspection." Do not use it to assign blame. Do not skip the sheet because "it was a quick walk." Do not let it replace internal audits — internal audits are a separate requirement under clause 8.2.4 with their own cadence and independence requirements. GEMBA complements, it does not substitute.

## Reality Check

1. When was the last time a member of top management physically walked the production floor with the explicit purpose of observing?
2. Is that walk recorded anywhere your auditor could find it?
3. Do GEMBA observations feed into your management review input pack?
4. Can you show a closed-loop example where a GEMBA observation led to a documented corrective action in the last six months?
5. Is the walk on a recurring calendar slot, or does it happen when someone remembers?
6. Have you confused GEMBA with internal audit? (Internal audit is independent, planned, and scoped against clause requirements — clause 8.2.4. GEMBA is not.)
7. Who rotates into the second-observer seat? Is the CEO on that rotation?
8. Does your observation sheet have a document ID?

If more than two of these answers are "no," your lean practices are not yet integrated with the QMS. The fix is one calendar invite and one controlled template.

## Frequently Asked Questions

**Are GEMBA walks required by MDR or ISO 13485?**
Neither document names GEMBA. Both require the outcomes that GEMBA produces: visible management commitment (clause 5), process monitoring (clause 8.2.6), and feedback collection (clause 8.2.1). GEMBA is a recognised method; the obligation is the outcome.

**Can GEMBA walks replace internal audits?**
No. Internal audits under clause 8.2.4 must be independent, planned, and executed by personnel not directly responsible for the area being audited. GEMBA is led by operational management and is a continuous-improvement tool, not a compliance verification tool. They run in parallel.

**How long should a GEMBA walk be?**
For a small manufacturer, 20 to 40 minutes is typical. Longer than an hour and the observer loses focus; shorter than 15 minutes and pattern recognition collapses.

**What if a serious nonconformity is found during a walk?**
Log it immediately in the nonconformance system under the normal procedure. Do not let the GEMBA context reduce the rigour of the response. The walk is the detection; the response goes through the standard CAPA process.

**Do GEMBA walks apply to pure software companies?**
Yes, with a different meaning of "floor." For SaMD teams, the equivalent is walking the development environment: looking at the current board, the open defects, the CI pipeline, the deployment pipeline, the active work-in-progress. The principle — go and see, do not rely on the dashboard — transfers directly.

**Who should own the GEMBA cadence?**
The head of operations or head of manufacturing for physical product. For software-only companies, the head of engineering. The PRRC should participate but should not be the owner — ownership belongs to line management.

## Related reading
- [Management responsibility under MDR](/blog/management-responsibility-mdr) — how clause 5 obligations translate into visible behaviour.
- [MDR QMS management review for startups](/blog/mdr-qms-management-review-startup) — where GEMBA observations enter the formal record.
- [Continual improvement under MDR and ISO 13485](/blog/continual-improvement-mdr-iso-13485) — the clause 8.5 context.
- [Production controls ISO 13485 clause 7.5](/blog/production-controls-iso-13485-7-5) — the process controls that GEMBA is observing.
- [CAPA under MDR and ISO 13485](/blog/capa-mdr-iso-13485) — the system that closes the loop on observations that escalate.

## Sources
1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 10(9).
2. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes. Clauses 5, 5.6, 8.2.1, 8.2.4, 8.2.6, 8.5.

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*This post is part of the [Quality Management Under MDR](https://zechmeister-solutions.com/en/blog/category/quality-management) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*