A look at what’s often missed when labs say they ‘do QC’

 

In many microbiology labs, QMS is treated like a checklist.

Equipment calibrated? ✅
QC run? ✅
Documents filled? ✅

But here’s the question no one wants to ask:
Are we doing quality work — or just completing tasks that look like quality?

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🎯 The Surface vs. the System

It’s easy to assume that if you're:

• Calibrating equipment

• Running control samples

• Recording results in a logbook

...then you’re fulfilling your quality obligations.

But real QMS goes deeper than that.

It’s not just about equipment performance — it’s about the entire environment that affects your data integrity.

For example:

✅ You calibrate your balance.
But ❌ how often do you check environmental conditions like air drafts or humidity?

✅ You run daily QC samples on analyzers.
But ❌ do you ensure the workspace is decontaminated, staff are trained, and SOPs are being followed — not bypassed?

✅ You document deviations.
But ❌ do you perform actual root cause analysis, or just write “operator error” and close the case?

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🧪 Common Misconceptions

Here are some issues seen in real labs:

• Calibration = Control
  → Not true. Calibration checks accuracy. Quality control checks consistency under routine conditions.

• QC = Running control samples
  → Also incomplete. QC involves assessing the full process — from sample prep to environment to operator competency.

• Documentation = Compliance
  → Only if it reflects what’s truly happening. If SOPs aren’t being followed, documentation alone doesn’t protect quality.

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🧠 So What Is Real QMS, Then?

True QMS means your lab environment, staff, process, and mindset are aligned.
It means quality isn’t just an audit season activity — it’s how your lab breathes every day.

That includes:

• Regular review of why procedures exist

• Involvement of staff in process improvement

• Treating sanitation and documentation with equal seriousness

• Audits that feel like feedback — not threats

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🚀 The Goal of This Series

This article is part of the new QMS from Scratch series — made for lab professionals who are tired of pretending QMS is “just documents.”

We’ll talk about:

• What QMS actually looks like in daily practice

• How to fix small habits that damage big systems

• And how to grow from checklists… to culture

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💡 Want a real-world starting point?
Download my free Internal Audit Checklist for Labs — a tool to help you self-assess before an auditor walks in.
👉 ISO 17025 : Internal Audit Checklist

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Let’s build labs that don’t just pass audits — but deserve trust.

#QMS #ISO17025 #Microbiology #LabQuality #AuditReady #DocumentControl #CAPA #LabTraining #ScientificIntegrity