ISO 15189
Unlock ISO 15189 compliance, the essential standard for medical labs wanting to demonstrate their commitment to quality.
Simplified ISO 15189 compliance
ISO 15189 standardizes the quality requirements for medical laboratories and assesses their competence. Compliance with the standard allows labs to demonstrate high quality at every stage with patient safety at the core, gaining an internationally recognized seal of approval.
- Easily demonstrate compliance
- Harmonize lab processes
- Identify areas for improvement
Continual improvement
Go beyond simple compliance with ISO 15189 and into making quality improvements to drive a range of KPIs. With the right software, it is easy to identify areas to make meaningful change, so your medical lab runs as efficiently as possible. Save time, money, and deliver better patient outcomes.
- Improve patient outcomes
- Make data-led decisions
- Drive efficiency
Meeting the requirements of ISO 15189
Compliance with ISO 15189 includes many rigorous demands. The best way to unlock and simplify compliance is to use powerful, tried-and-tested quality management software. Ideagen Quality Management offers a trusted solution for managing ISO 15189 compliance worldwide.
Meeting the requirements of ISO 15189
Meeting the requirements of ISO 15189 |
Ideagen Quality Management solution |
|---|---|
| Processes for ensuring quality must be clearly documented and available at the point of need for all interested parties, including auditors. | Robust document control is central to Ideagen Quality Management. Documents can be stored and tracked centrally and pulled up at a moment’s notice. |
| Labs must identify, understand, and manage key risks in their medical lab, in particular any risks that may impact patient safety. | Non-conformance management is made simple with Ideagen Quality Management, and a 360-degree view of risks can be created and visualized with the software. |
| Labs must be able to demonstrate that they are identifying areas for continual improvement to deliver a better service and improved patient outcomes. | Reporting and analysis functionality within Ideagen Quality Management makes the identification of trends and key areas for process improvement easy. |
| The lab must be able to demonstrate that all personnel have the appropriate training and competency to deliver services of a high standard. | Ideagen Quality Management has a user-friendly module for tracking and managing training and competency of staff. Training is assigned automatically for convenience. |
ISO 15189 FAQs
Is ISO 15189 a requirement for medical labs?
While ISO 15189 isn’t a strict requirement for medical labs, it would be an understatement to say it’s highly recommended.
As a globally recognized signifier of quality, there is no better way to secure your reputation as a trusted medical lab that prioritizes the health and wellbeing of the public.
How difficult is it to attain ISO 15189 accreditation?
Attaining certification shouldn’t be a difficult process, since accreditation bodies make the process as straightforward as possible.
However, being prepared to meet the demands of the accreditation body can be difficult if your quality management system isn’t of a high standard.
Is QMS software necessary to ensure compliance?
While quality management software isn’t strictly necessary to have an ISO 15189 compliant quality management system, it is much more difficult to attain and maintain compliance without at least a basic electronic QMS system.
Ideagen Quality Management is an example of a QMS trusted across the globe for compliance.
Who provides ISO 15189 certification?
In the UK, UKAS are the main accreditor. For the USA, CAP (College of American Pathologists) are the primary accreditation body.
Global bodies exist, such as the International Accreditation Service (IAS), and many more organizations are eligible to grant accreditation in countries around the world.
How does ISO 15189 differ from similar standards, like ISO 9001 and ISO/IEC 17025?
The key detail of ISO 15189 is that it applies specifically to medical laboratories.
ISO 9001 sets out the criteria for a quality management system in any type of organization, and ISO/IEC 17025 sets out requirements for testing and calibration labs (not necessarily medical labs).
Does ISO 15189 override local regulations and requirements?
Being ISO 15189 certified doesn’t mean you won’t have to meet the demands of regulatory bodies on a national or regional level.
However, it is unlikely that you won’t comply with local regulations governing quality, or at worst only minor adjustments to your ISO 15189 processes will be required.
