Frequently Asked Questions about ISO 15189 Software

ISO standards now trickle to thousands with limitless options and plenty of certifications to choose from. It can be hard to identify a suitable standard for your business. That said, what does ISO 15189 software measure, and is it important?

What is ISO 15189?

ISO 15189 software is specific for use in medical laboratories and the quality management systems used in the lab. It is an exceptional standard and set of rules for organizations and businesses. The initial version of this standard was made in 2003 and revised in 2007 and 2012. The latest edition is currently under review, meaning there will be a new standard sooner than later.

What is the difference between ISO 15189 and other quality standards?

ISO 9000 is the blanket standard for quality management systems. While this standard applies perfectly to the rest of the people in the industry, ISO 15189 is specific to medical laboratories alone. The framework gives a quality management system close to ISO 9001 but has added specifics concerning technical competence in a medical lab setting. It bases its quality assurance approach on Deming TQM, with specifications on technical competence in the lab.

What does ISO 15189 involve?

The technical aspects of the ISO 15189 software apply to the environmental conditions, lab equipment, personnel, accommodation, reagents, and consumables. It also includes pre-examination and examination processes, quality testing, and post-examination results. It also covers the release of results and laboratory information management.

Should you Invest in ISO 15189 software?

Every ISO standard, including ISO 15189 software, is worth the input and support from your staff members, as the benefits are unmatched. In laboratory and health care, this standard gives a platform where you can display the reliability of your organization and the services it offers.

ISO standards have taken years of testing and adjusting to only pick the best practices in the industry. By incorporating them into your organization, you will rank higher and be perceived at a different level of professionalism.