Why Medical Laboratories Get Stuck With NATA & ISO 15189 (And How to Move Forward)

ISO 15189 accreditation through NATA requires medical laboratories to demonstrate both technical competence and an effective quality management system. Now that Australia’s transition to ISO 15189:2022 is complete, attention has shifted from understanding the new requirements to demonstrating that they are effectively implemented in everyday laboratory practice. So where are laboratories still getting stuck, and what can they do about it?

For many medical laboratories, achieving accreditation to ISO 15189 is not the greatest challenge. Maintaining a management system that consistently supports quality patient care, satisfies accreditation requirements, and remains practical to operate is often where laboratories become stuck.

When we first wrote about this subject, ISO 15189:2022 was relatively new. The transition is over. Now that the transition is complete, what has changed, and what problems are still showing up?

The more interesting question: how well is ISO 15189:2022 actually working inside medical labs? Laboratories have invested considerable effort in updating documentation, revising procedures, and implementing new requirements. Yet during assessments, many of the same issues continue to emerge.

Interestingly, these issues are rarely the result of poor technical capability. More often, they arise because laboratories become focused on individual clauses of the standard rather than how their management system works as a whole.

Based on our experience working with medical laboratories, here are some of the areas where laboratories most commonly encounter difficulties and practical ways to move forward.

What Are the Common ISO 15189 Accreditation Challenges?

1. Management Reviews Become Reporting Exercises

Management review is intended to be much more than an annual meeting to satisfy the standard. And the timing of your lab’s management review doesn’t have to coincide with a looming assessment. Sometimes, it’s a race to get it done in time for the NATA assessment. But it doesn’t have to be this way.

Effective management reviews should answer important questions such as:

• Is our quality system achieving its objectives?
• Are patient needs continuing to be met?
• Where are our greatest risks?
• What opportunities exist for improvement?

Unfortunately, many reviews become a collection of reports rather than meaningful discussions that lead to decisions and action.

 

As for the timing of your management review, NATA requires this to be done at least once per year. Consider if your lab does any annual business planning and incorporating the management review activity as a part of that. After all, the point of management review is to tell managers how the lab is working and how effective its systems are in meeting referrer and patient needs.

Practical Tip

Focus on the decisions made during management review, not simply the information presented. Assessors are interested in seeing how leadership uses the review process to drive continual improvement.

 

2. You Have a Risk Register, But Is Anyone Actually Using It?

Most laboratories now have risk registers. Sometimes, they are used as a shiny document that gets brought out just for an assessment. But that’s not what the requirements for managing risks are aimed at.

The greater challenge is demonstrating that risk-based thinking influences day-to-day decisions.

Examples of when a review of risks should be considered include:

• introducing new equipment
• changing methods
• staffing decisions
• supplier changes
• responding to quality control trends

Risk management should become part of normal laboratory thinking rather than an isolated exercise completed once each year. It needn’t be complicated and should b e a part of the lab’s change management processes.

 

3. Point-of-Care Testing (POCT) Continues to Challenge Many Organisations

POCT often operates across multiple departments, making governance more complex than traditional laboratory testing.

There are several challenges we see in labs. These include clearly defining responsibilities; establishing and ongoing monitoring of staff competency; equipment management; quality control; and oversight of decentralised testing.

Successful laboratories treat POCT as an extension of the laboratory quality system rather than a separate activity.

 

 

4. Demonstrating Impartiality

Most laboratories understand the concept of impartiality. Demonstrating it can be more difficult.

Assessors may look for evidence that laboratories have considered situations where impartiality could be compromised and have appropriate processes to manage those risks.

Those risks to impartiality can come from lab staff knowing the patient or referrer, through to risks to management from ownership and governance structures.

Think about this scenario. It actually happened……

A young scientist is on the pregnancy test profile in the lab and happens to see that one of the patients is an old friend from school. It’s confronting to see that the question of pregnancy is a real one in the case of a peer aged less than 20. Is it OK for the scientist to do the test? Should anyone be told about this situation? Nobody had provided any instructions to staff about what to do in these situations.

Impartiality is often less about creating additional documentation and more about demonstrating awareness and appropriate governance.

 

5. Confidentiality Extends Beyond Patient Results

Confidentiality under ISO 15189 is broader than protecting patient information.

 

 

 

Laboratories should also consider:

• electronic information systems
• access permissions
• contractor access
• remote working arrangements
• information shared with external providers

In Australia, there are regulations about where servers containing health data can be housed and these regulations require data to only be on servers located in Australia. As laboratory technology evolves, including with AI capabilities, confidentiality arrangements in the lab should evolve with it.

 

6. Patient-Centred Thinking Isn’t Always Visible

One of the strengths of ISO 15189 is its emphasis on patient care.

Sometimes laboratories become so focused on compliance activities that the patient perspective becomes less visible within the management system. This is especially the case because there are limited, if any, interactions with patients by laboratory staff.

Questions worth asking include:

• How do our processes support patient outcomes?
• Does this improvement make the service better for patients?
• Are our quality objectives aligned with patient needs?

Keeping the patient at the centre of decision-making often helps laboratories prioritise improvement activities.

 

7. Personnel Authorisations Need Ongoing Attention

Staff competency does not end with initial training. In fact, this area is one of the most common areas for non-conformances, as highlighted by NATA.

Assessors commonly review many documents such as training records, competency assessments, authorisations, records of ongoing monitoring and evidence of continuing competence and continuing education and professional development.

Personnel records should clearly demonstrate who is authorised to perform specific activities and how that competence has been maintained.

 

 

8. Equipment, Calibration and Metrological Traceability Still Creates Unnecessary Findings

Equipment, Calibration and Metrological Traceability remain one of the more technical underpinnings of ISO 15189.

Calibrating and maintaining equipment is a BIG area of continued non-conformance.

The best advice is to plan a system that works. You could look at our previous article Keeping NATA happy about Calibrations for ideas.

Laboratories sometimes concentrate on obtaining calibration certificates without considering whether traceability has been appropriately established throughout the measurement process.

You can periodically do a “health check”, asking simple questions like:

• What equipment does the method require?
• Do we have that equipment?
• Is it critical to the performance of the test or calibration?
• Does it need to be calibrated?
• What is the required traceability?
• Where are the calibration records and what is the calibration traceable to?

Another tip is to not only have a robust system to alert you to calibrations falling due, but also ensure you consider delays with calibration providers in factoring in the pre-calibration alert period. It’s a good idea to be in touch with the calibration providers well before to determine their lead times.

If you want to be sure that you’re on top of those pesky traceability requirements, check out our Complete Guide to Traceability.

The important question is not simply whether calibration has occurred, but whether confidence in measurement results can be demonstrated.

 

9. Technical Records

This is a big one. This area is all about the ‘paperwork’ traceability of your results. Your activities must have records that are detailed enough to replicate the exact process that produced them. Who did what, when and how?

“If you couldn’t reconstruct what happened from the record alone, you may have a problem.”

This means that you will need to consistently record all relevant factors relating to your testing. Plus, you’ll need to retain all the original records and any amendments.

Common problems include insufficient audit trails, missing original observations or calculations, failure to identify who performed activities, and poorly controlled amendments.

 

The Common Thread

The laboratories that struggle are not necessarily lacking technical expertise. Often the difficulty lies in connecting the requirements, people, records and technical processes into a management system that actually works. Although these topics appear quite different, they often share the same underlying issue.

Lab people become busy addressing individual requirements instead of viewing the quality management system as an integrated whole.

The strongest laboratories rarely have the most complicated systems. Instead, they have systems where:

• processes support one another
• staff understand their responsibilities
• quality activities are embedded into everyday work
• improvement is continuous rather than reactive

When this happens, accreditation becomes far less stressful because the management system reflects how the laboratory genuinely operates.

 

Supporting Assessment Readiness

It’s all too easy to get caught in the spiral of preparing for an upcoming assessment. But, preparing for a NATA assessment is not about perfect documentation or anticipating every possible question.  It is about demonstrating that the laboratory understands its own systems and can consistently deliver technically valid, patient-focused services.

When assessors see engaged leadership, competent staff, practical risk management, meaningful management review, and well-implemented quality processes, they gain confidence that the laboratory is effectively managing its activities. That confidence is ultimately what accreditation is designed to recognise.

 

What Comes Next

Many of the issues discussed in this article also apply to testing and calibration laboratories.

In the next article in our Assessment Readiness Series, we explore why laboratories continue to receive the same recurring nonconformances and what can be done to break the cycle of repeated findings.

Frequently Asked Questions

What is ISO 15189?

ISO 15189 is the international standard that specifies requirements for quality and competence in medical laboratories. It focuses on both technical competence and the quality management systems needed to support reliable patient care.

 

Why do medical laboratories struggle with ISO 15189?

Many laboratories have strong technical expertise but find it challenging to embed requirements such as risk management, management review, impartiality and patient-centred thinking into everyday operations.

 

What are the most common findings during ISO 15189 assessments?

While findings vary between laboratories, common areas include incomplete competency records, ineffective management reviews, weak implementation of risk management, point-of-care testing governance and metrological traceability.

 

Is ISO 15189 only about documentation?

No. Documentation is important, but assessors are equally interested in how well the documented processes are understood, implemented and maintained in practice.

 

How can laboratories prepare more effectively for an ISO 15189 assessment?

The most successful laboratories prepare continuously rather than immediately before an assessment. Regular internal audits, meaningful management reviews, ongoing competency monitoring and practical implementation of the quality system all contribute to assessment readiness.

 

Moving Forward

ISO 15189 is not intended to create more paperwork. Its purpose is to support confidence in the services medical laboratories provide and, ultimately, in the care patients receive.

By focusing on practical implementation rather than clause-by-clause compliance, laboratories can move beyond simply maintaining accreditation and develop systems that genuinely support quality, competence and continual improvement.