The importance of attaining ISO 15189 accreditation


The reason a great number of medical errors occur is due, in large part, to inadequate services. Equipment not fit for purpose or general use can lead to complications, and with so much at stake, it is wise to continually reassess the standards and competence of the services you provide. In England alone, over 237 million medical errors are made every year, resulting in over 1700 deaths annually.

An ISO 15189 accreditation can help greatly reduce this figure. Meeting the International Standards (ISO) means laboratories meet the technical competence requirements to ensure they deliver the best results as safely as possible. But what is it? And why do you need it?

What is ISO 15189?

ISO 15189 is a globally recognised accreditation that can be used by medical laboratories to assess their own competence. It can also, according to its official document, be used for “confirming or recognizing the competence … by customers, regulating authorities and accreditation bodies.”

In essence, as well as ensuring the reliability of your own services, it can be used as a barometer for how your business is perceived by potential customers on things such as trustworthiness and credibility. Accreditation verifies three crucial components of a laboratory: integrity, impartiality, and capabilities.

Do I need ISO 15189 accreditation?

It is not mandatory, but if you are operating within the medical sphere, being ISO 15189 accredited is widely recommended. Think of it as being the medical equivalent of a Michelin Star restaurant versus a mediocre one.

The services you provide ought to be as dependable as possible to avoid compromising customer health, so a certificate that vouches for both the competence and quality of the instruments used to provide that service will help ensure that a) errors occur as infrequently as possible, and b) customer confidence remains unwavering.

What’s more: the accreditation will also demonstrate to stakeholders that you are committed to keeping their data safe.

How will ISO 15189 accreditation benefit me?

ISO 15189 accreditation can aid your business in a variety of different ways, both internally and externally. To name only a few, it can:

  • Increase business resilience
  • Improve team morale & staff confidence
  • Help you to qualify in the tender application process
  • Achieve preferred supplier status
  • Attract new customers and business opportunities
  • Provide you with a competitive advantage
  • Improve processes and competence
  • Improve your brand reputation
  • Improve quality
  • Create a culture of continual improvements

How it works

This is a three-stage process with stage 1 being an online application via the appropriate UKAS website.

In preparation for the stage 2 UKAS audit a gap analysis, Quality Manual and other documentation needs to be prepared.

Stage 3 is the main UKAS audit against the criteria detailed in ISO 15189.

How do I attain ISO 15189 accreditation?

Synergos Consultancy can help you to ascertain a plethora of accreditations and certifications, including this one. Better yet: we guarantee we will get you through the certification/accreditation process or we will refund 100% of all money paid to Synergos Consultancy. Sound good? Click here to get in touch with one of our experts and discuss whether or not accreditation can benefit you.

Share This Post:

Emma Allen
Emma Allen
What our clients say:
Subscribe to our newsletter

Sign up to receive updates, promotions, and sneak peaks of upcoming products. Plus 20% off your next order.

Promotion nulla vitae elit libero a pharetra augue
Subscribe to our newsletter

Sign up to receive updates, promotions, and sneak peaks of upcoming products. Plus 20% off your next order.

Promotion nulla vitae elit libero a pharetra augue