We’re in a new era of molecular quality control – ISO 15189 will soon be mandatory for molecular laboratories.
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Here’s what ISO 15189 means for your team
Competitive advantage
ISO 15189 is an accreditation that signifies competent, impartial, and accurate functioning of a medical laboratory. To achieve compliance, laboratories must pass accreditation agency assessments, but above what will soon be required, ISO 15189 accreditation signals a distinct advantage over labs that haven’t yet made the leap.
Operational advantages
ISO 15189 recommends independent third-party controls to be considered wherever possible. This will save time and money by removing the requirement to prove the validity and relevance of controls used when it’s time to be audited.
A strong quality control data management software is also essential to facilitate compliance under ISO 15189.
Even in areas where compliance is not yet required, having ISO 15189 accreditation is an international token of quality, integrity, confidence, and aptitude, providing a distinct advantage over other laboratories that haven’t yet taken this step.
What auditors look for
Focus your efforts on the accreditation pillars:
- Traceability across all stages of the production process
- Proof of training and employee competence
- Proof of quality assurance performance method
Your path to compliance
The big changes to implement:
- Back-up for the examinations process as part of a degraded procedure
- Establish an initial method verification file
- Prove continuous monitoring of method performance using internal and external quality controls
- Regular reviews of non-conformity – demonstrating pattern analysis to establish improvement
- Internal audits to ensure compliance
Accreditation opens the door
Meeting ISO 15189 criteria isn’t straightforward, nor should it be, given improved patient results is the end goal for any molecular lab team. This makes choosing the right compliance partner key.
And while many are still making do with in-house or in-kit quality controls, by staying in-step with the regulatory revolution that’s already on its way, this is your opportunity to enhance your lab’s performance, reputation, and future prospects.
How can Bio-Rad help?
As a market leader with over 70 years of performance providing cutting edge, reliable, innovative healthcare products, we are well equipped to help your laboratory reach its full potential, reduce the risk of patient harm, and achieve ISO 15189 accreditation.
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