What a Working QMS Looks Like in a Laboratory?
In Part 1 of this series, we asked: Is your lab actually practicing QMS, or just doing paperwork?
That question revealed a common reality: Many labs have a Quality Management System (QMS) on paper, but the real test is whether it’s alive in daily work.
Now, let’s go one level deeper. What does a working QMS actually look like in practice — the kind that runs smoothly every day, not just during audit week?
🧪 The 3 Layers of a Living QMS
1️⃣ Foundation – The Standards & Structure
Every strong QMS starts with a framework — ISO 17025, ISO 9001, GMP, or industry-specific equivalents. These define:
- The requirements your lab must meet
- The language everyone uses (so “non-conformity” means the same thing to everyone)
- The documentation hierarchy — policies, SOPs, work instructions, forms
But here’s the truth: having a standard isn’t the same as living it. I’ve seen labs that proudly display ISO certificates, yet half the staff couldn’t explain the standard’s main clauses.
The foundation is important — but without the next layer, it’s just a frame with no walls.
2️⃣ Integration – Quality in the Daily Workflow
This is where many systems break. Quality isn’t something the QA officer does in the office — it should be embedded into every routine task.
In a well-integrated QMS:
- Equipment calibration isn’t a standalone task — it’s accompanied by environmental checks, operator verification, and correct record entry.
- Sample handling follows the SOP every time, even on the busiest days.
- Deviations aren’t ignored because “we’re short on time” — they’re addressed immediately to prevent recurrence.
In a weakly integrated QMS:
- Procedures are skipped if they slow down production.
- Records are filled after the fact — sometimes from memory.
- Staff assume quality is “someone else’s responsibility.”
Integration means QMS isn’t a separate activity — it’s how the work is done.
3️⃣ Feedback – Continuous Checks & Improvements
Even with structure and integration, no system is perfect. That’s why the third layer — feedback loops — is critical.
Strong feedback mechanisms include:
- Internal audits that actually look for weaknesses, not just confirm compliance.
- CAPA systems where root cause analysis is done thoroughly, not just labelled “operator error.”
- Management reviews that act on audit findings and trend data, not just file them.
Without feedback, a QMS becomes static — and a static system is one step away from becoming obsolete.
🔍 How You Know Your QMS Is Actually Working
Signs of a healthy QMS include:
- Consistency without supervision — staff follow procedures correctly without being reminded.
- Alignment between documents and reality — the SOP says what’s actually done, not what should be done in theory.
- Shared responsibility — everyone understands their role in maintaining quality.
- Proactive problem-solving — deviations lead to improvement, not just paperwork.
🚫 Red Flags That It’s Only on Paper
If you see these patterns, your QMS might look fine in audits but fail in practice:
- “Audit week” panic — cleaning, calibrations, and updates happen only before auditors arrive.
- Repeated non-conformities across multiple audits.
- Records filled to meet a deadline, not at the time of the activity.
- Staff who say, “That’s the quality team’s job.”
🧭 Moving From Paper to Practice
If you recognize gaps, here’s where to start:
- Walk the process yourself — Choose a lab activity and observe it from start to finish. Does it match the documented SOP?
- Involve staff in reviews — The people doing the work often know exactly where the gaps are.
- Run micro-audits — Small, targeted checks on one area per month keep systems healthy without overwhelming the team.
- Explain the ‘why’ in training — People follow rules better when they understand their purpose.
📅 What’s Next in the Series
In Part 3, we’ll look at one of the most underestimated strengths of a QMS — risk management — and why it should be built into every process, not treated as a side activity.
Until then, take one process in your lab this week, trace it step-by-step, and see if the way it’s done matches the way it’s documented. The results might surprise you.
📥 Free Tool: Download my Internal Audit Checklist for Labs — designed for real lab environments, so you can find gaps before the auditor does. 👉ISO-17025
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