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Maree Stuart
Written by Maree Stuart
Maree Stuart is a Analytical Chemist, a Quality expert and a person who thrives on solving challenging conundrums. She has qualifications and over 30 years of experience in science, quality, and management of labs. She helps lab people with gaining and maintaining accreditation, with her no nonsense, practical and innovative approach. And did you know she is also a lawyer?

ISO/IEC 17025 Accreditation: What Laboratories Actually Need to Know

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If you run a testing, calibration, or sampling laboratory, ISO/IEC 17025 accreditation can feel like a mix of science, paperwork, and stress. But at its core, 17025 is simple. It is an international standard that helps laboratories show technical competence and the ability to produce valid, reliable results. It is not “quality theatre”. It is proof that your lab can be trusted.

In Australia, ISO 17025 accreditation is most commonly pursued through NATA, and it applies across almost every sector you can think of, from environmental and food testing to building products, electrical safety, animal health, and research.

This article cuts through the noise and explains what labs actually need to know to get accredited and to stay accredited without burning out.

 

Accreditation is not certification, and it’s not “just ISO 9001”

ISO 17025 is about competence. That includes your methods, equipment, traceability, uncertainty (where relevant), sampling, staff capability, and how you control the technical validity of results, not just whether you have a set of documents.

You will often hear that ISO 17025 “covers ISO 9001”. There is truth in that, because ISO 17025 includes management system requirements and aligns with ISO 9001 concepts. But don’t let that mislead you. ISO 9001 is broad and business wide. ISO 17025 goes deep into laboratory technical controls and decision-making.

A good mental model is for understanding what each of these standards deliver is:

  • ISO 9001: “Can you run a consistent management system?”
  • ISO/IEC 17025: “Can your lab produce technically valid results, consistently?”

 

Why labs pursue ISO/IEC 17025 accreditation in the real world

Most labs don’t wake up one day inspired by standards. They pursue accreditation because one (or more) of these forces applies:

  1. Market access and credibility: Accreditation is internationally recognised and boosts confidence with customers and regulators.
  2. Regulatory or contractual requirement: For many sectors, NATA accreditation is effectively the ticket to play.
  3. Risk reduction: Better control of methods, competence, equipment and reporting reduces mistakes, rework, customer complaints, and technical failures.
  4. Operational improvement: Done properly, ISO 17025 accreditation can improve efficiency and reduce “quality friction” across the lab. That leads to labs working “better and smarter”, not heavier and slower.

The two halves of ISO/IEC 17025 that people forget

ISO/IEC 17025:2017 was updated to reflect modern lab realities, including stronger alignment with ISO 9001 thinking and the impact of changing technology and IT practices.

What labs often miss is that ISO 17025 has two equally important halves:

A. Technical competence (the part technical assessors lean into)

This includes:

  • validated methods and fit-for-purpose approach
  • equipment control, calibration, maintenance, verification
  • metrological traceability (where applicable)
  • measurement uncertainty (where applicable)
  • sampling plans and controls (if it’s in your scope of accreditation)
  • competence and authorisation of staff
  • ensuring validity of results (QC, checks, trends, PT/ILC where appropriate)
  • reporting and decision rules where relevant
  • how labs identify threats to impartiality

B. A management system that supports the technical work

This includes:

  • document and record control
  • dealing with nonconforming work
  • corrective action that actually fixes causes
  • internal audits that test reality, not paperwork
  • management review that makes decisions, not minutes
  • risk and opportunities applied sensibly, not as a giant risk register no one reads

While a “quality manual” is no longer mandatory in the same way under modern standards, many labs keep one because it provides structure, supports training, and helps demonstrate how the system fits together. The key is to make it useful, not repetitive.

 

What the accreditation process looks like (in plain English)

Different bodies and sectors will have nuances, but a typical NATA pathway looks like the following.

  1. Work out what your customers and regulators actually need. You can expand later once systems are stable. Remember, your scope and claims about competence matter.
  2. Develop your quality system and technical controls
  3. Arrange a NATA Advisory Visit (a reality check that saves time)
  4. Schedule the assessment (technical assessor plus lead assessor focus)
  5. Close out findings properly (with evidence, not essays)

Our recent article on the NATA accreditation  process (in plain English) gives lots of tips for achieving this.

The advisory visit is relatively informal compared to an assessment, but extremely useful for finding gaps and getting clarity on how criteria apply in your context.

This is where many labs either:

  • save months of rework, or
  • ignore advice, push to assessment, and pay for it later.

 

What assessors really look for (and what they don’t)

Most accreditation pain comes from one misunderstanding: labs think they are being assessed on how much documentation exists. In reality, assessors are looking for evidence that:

  • you do what you say you do
  • staff are competent and authorised for the work they perform
  • results are technically valid and controlled
  • issues are detected early and handled properly
  • management understands risks, resourcing, impartiality, and system performance

On the flip side, assessors are not impressed by:

  • 40-page procedures nobody follows
  • “copy/paste” templates that don’t match your lab
  • corrective actions that are really just retraining with no evidence of cause
  • internal audits that only confirm documents exist

ISO 17025 and accreditation should support operating efficiently and effectively, not create a culture of box-ticking compliance.

 

The three traps that derail labs (even experienced ones)

Trap 1: Overbuilding the system
A bigger system is not a better system. A lean system that people use wins every time. Avoid creating quality manuals and documentation that become repetitive or overwhelming.

Trap 2: Treating internal audits like a formality
Internal audits are supposed to find reality gaps before the assessor does. If your audit program never finds issues, it’s not “mature”. It’s probably blind.

Trap 3: Confusing corrective action with activity
“Updated procedure” and “retrained staff” are actions. They are not automatically corrective actions. Corrective action means the underlying cause is addressed and the effectiveness of the action is checked.

 

What “good” looks like for a sustainable accredited lab

Accreditation becomes easy when the system is built around how the lab actually works. This means that your lab has the following in place.

  • Scope is tight and intentional. You are not trying to accredit everything at once if you don’t need it all covered by accreditation.
  • Technical records tell the story. This means traceability to who, when, and what is clear, checks on records and any data transfers are done, authorisations are documented and adhered to, and controls are in place for managing records.
  • Competency is proved, not assumed.
  • Data is used, not just collected. As Dr W Edwards Deming famously said, “Without data, you’re just a person with opinions.” In an effective ISO 17025 system, data exists to support decisions, not simply to satisfy reporting requirements. Useful data comes from across the laboratory, including quality control results, proficiency testing and interlaboratory comparisons, complaints, rework, nonconforming work, and audit outcomes. What matters is not the volume of data, but whether it is reviewed, trended, and acted on to support technical decisions, identify emerging risks, and demonstrate that the system is under control.
  • Management review makes decisions. The decisions are about resourcing, risks, changes, and priorities for the lab.
  • Staff don’t fear audits because the system reflects real practice.

That is the “better and smarter” outcome MAS aims for: accreditation that supports the business, reduces frustration, and improves performance.

 

A practical way to start this week

If you’re beginning (or resetting) your accreditation journey, start here.

  1. Define your scope based on customer needs.
  2. Build a simple map of your process from sample to report.
  3. List your critical controls: competence, equipment, methods, and validity checks.
  4. Do a gap analysis check against ISO/IEC 17025:2017 and the relevant NATA requirements for your lab.
  5. Book an advisory-style review before you “go live” with an assessment. Sometimes, a set of external eyes is what’s needed with this, so you don’t get blindsided.

Accreditation is achievable, but it is much easier when you treat it as a competence system, not a paperwork project.

 

Want some help? That’s what we’re here for!

Whether you are starting the accreditation journey, part of the way along the path, or already have accreditation, we are here to help. Contact Maree at maree@masmanagementsystems.com.au or 0411 540 709 for a confidential, obligation-free conversation.

 

Remember, you don’t have to do this alone!

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