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ISO 15189 overview

ISO 15189 is an international standard which specifies requirements for competence and quality that is specific to medical laboratories. Medical laboratory services are fundamental to patient care and, as a result, must be ready to fulfil the demands of all patients and the medical staff liable for their patients’ care. Gaining and maintaining ISO 15189 accreditation shows that your medical laboratory values the quality of the service it provides – from examination requests to processing clinical samples and producing reports, to name a few. Using a holistic approach, this standard provides a comprehensive framework for managing all the services required within a medical laboratory correctly and efficiently. 

ISO 15189 Benefits

Medical laboratories are responsible for gaining and providing accurate medical results for their patients and clinical staff. These are a few of the many benefits ISO 15189 accreditation offers medical laboratories. 

Work with An Expert

For some companies, it might be tempting to read the standard and attempt to implement these processes without receiving any expert guidance. However, this is typically not enough to implement an efficient, long-term management system. A literal interpretation of this standard may easily create an overly bureaucratic management system, yielding the opposite results of what would otherwise be achieved. Instead of a structured system based on the smart analysis of data, you could end up with an overly complicated and inefficient system.  

Instead, hiring an expert consultancy with years of experience is the best way to effectively meet your ISO standards. Make sure to choose an expert you trust, to provide you with a grounded approach that will simplify your life, rather than over-complicate it.  

Accreditation Body

When looking to get ISO accreditation, a company can only work with that country’s accreditation body. It is important to make sure that your accreditation body is fully accredited, as only these entities are truly qualified to provide ISO accreditation. In Malta, NAB (National Accreditation Board) is the only accreditation body authorised to provide ISO 15189 accreditation. 

ISO 15189 Accreditation

Fund YOUR JOURNEY TO ISO accreditation

As a Malta Enterprise approved advisor, Luke can help his clients reap the full benefits of currently available funding. Applicable to any business based in Malta, the Government of Malta’s current funding schemes have never been better. The precise amount depending on your company’s size and ownership structure. 

For more information, simply get in touch for a free consultation session! Luke will help you to make the most of the best available funding incentives applicable to your business.

Fund YOUR JOURNEY TO ISO accreditation

Luke’s approval as a Malta Enterprise approved advisor means that his clients can reap the full benefits of currently available funding schemes. Find out whether you are eligible for funding by getting in touch with Luke!

Funding Opportunities

For medical laboratories, getting ISO 15189 certification is a crucial milestone. Recognizing the importance of working towards this standard, there are various funding opportunities to be found in Malta. These include:  

  • 50% Tax Credits  
  • cash grants by Malta Enterprise, JobsPlus, & other entities. 

ISO 15189: A Closer Look

Why is it Needed and What Does It Cover?

Published in March 2012, the ISO 15189:2012 Medical Laboratories Quality Management System remains the most recent and up-to-date version of this standard. Using a high-level system that allows it to be easily implemented alongside other ISO management systems, this standard follows the same ‘Plan-Do-Check-Act’ model which defines all of the revised ISO standards. The following shows a brief overview of the topics the ISO 15189 covers: 

  • Contextualising the Organisation’s MLMS and defining its overarching scope. 
  • Establishing MLMS leadership and worker roles 
  • Planning to manage MLMS risks and opportunities 
  • Offer support through suitable communication and documentation. 
  • Operational planning  
  • Performance evaluation 
  • Opportunities for corrective action 

Achieving ISO 15189

What Does This Say About Your Organisation?

Although achieving ISO 15189 accreditation is not a legal requirement, owning this accreditation says a lot about what type of medical laboratory you are running. Adhering to this ISO standard boasts inherent benefits but it also sends the right message to you clients, investors and competitors. Getting ISO 15189 accreditation proves that your laboratory: 

  • Values the quality of the medical services it provides its patients and clinical staff. 
  • Is compliant with medical laboratory statutes and requirements. 
  • Understands the business related benefits of having management systems in place. 
  • Is an industry leader which operates at a level of excellence by implementing the most up-to-date management standards. 
GDP and MDR malta

Achieve mdr & gdp compliance


When gaining ISO certification, your business is also be better equipped to pass regulatory audits for compliance.

Companies within the medical supply chain are naturally under legal scrutiny. Not only is it good practice to follow well-structured quality management systems but companies are lawfully required to comply with Medical Device Regulations (MDR) and Good Distribution Practice (GDP). 

Using his years of ISO and compliance experience, Luke makes sure that your company follows ISO standards and consequently, is compliant with legal regulations.

Follow the links to learn more about the importance of Medical Device Regulations (MDR) compliance and Good Distribution Practice (GDP) compliance.

Frequently Asked Questions

Medical laboratories are responsible for gaining and providing accurate medical results for their patients and clinical staff.  Laboratories accredited with ISO 15189 are officially identified as being competent, therefore making them trustworthy for all stakeholders.

Your ISO 15189 accreditation will need to be renewed after a period of three years. To maintain your certification, an assessment must be conducted once a year and re-accreditation is issued every three years to ensure that your medical laboratory management systems continue to operate within the ISO 15189 required standards. 

Yes, like other ISO standards that are concerned with different types of management systems - including ISO 9001 and ISO 14001 - the ISO 15189 uses a high-level structure. This indicates that the ISO 15189 may be effortlessly integrated within any existing ISO management system. 

The amount of time it takes your company to earn your certification all depends on the size and complexity of your business. Luke will help you to make this process as swift and efficient as possible for your convenience.

Whilst organisations can attempt to optimise their medical laboratory management systems without accreditation, ISO 15189 provides a structured approach which is sustainable and internationally trusted. 

Therefore, although it is not necessary, this is a recommended tried-and-tested means of achieving efficient medical laboratory management. 

Any laboratory which conducts medical testing may apply for accreditation. 

In Malta, only the National Accreditation Board (NAB) can provide accreditation.

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