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?

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?

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.

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

 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

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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