ISO 15189:2012

Medical Laboratories- Requirements for quality and competence

What is ISO 15189?

ISO 15189 is the management standard for medical laboratories who want to demonstrate their quality and competence, thus ultimately improving patient care. The requirements include aspects of ISO 17025 and ISO 9001 and has been adopted by medical laboratories in countries around the world. ISO 15189 is a single document that can be used by medical laboratories around the world to unify efforts to improve laboratory procedures.

First introduced in 2003, the ISO 15189 standard was adopted by 23 countries around the world within a year. By 2009, 44 countries had implemented the standard and by 2013, this figure raised to over 60.

Clearly, the standard is popular and this is for a good reason. The ISO 15189 standard is very comprehensive and ensures best practices are carried out. It covers a wide range of aspects of laboratory quality including:

  • Staff

Personnel records should be kept and key data should held on file including job descriptions, educational and professional qualifications, training courses undertaken and annual appraisal forms or periodic staff reviews. In short, the management should be able to prove that their staff members are competent enough to carry out their duties and can demonstrate proficiency.

  • Management

The management should show a commitment to the development and implementation of the quality management system. A policy should be established and objectives created. A Quality Manager should be appointed and adequate resources should be made available to enable the proper conduct of pre-examination, examination and post-examination activities.

  • The physical lab

Storage space and conditions shall be provided to ensure the continuing integrity of sample materials, documents, equipment, reagents, consumables, records, results and any other items that could affect the quality of examination results.

Of course, the list above is not exhaustive and many other aspects are included. A full version of the standard can be found here.

Are you ready for ISO 15189?

Over the next few years, all UK Clinical Pathology Accredited (CPA) laboratories will have to be ISO 15189 compliant.

Your next CPA audit may already expect you to comply. By using an ISO 17025 accredited service agent such as Henderson Biomedical, your compliance with the ISO 15189 requirements dramatically increases. Here are just a few examples of how we are helping our customers to comply:

  • We are ISO 9001 and ISO 17025 accredited. (Section 4.13.a “Supplier selection and performance” of ISO 15189).
  • We have a digital library of ALL our service reports, customers’ equipment calibration certificates and the calibration certificates for our test tools. (Section 4.13.i “Instrument maintenance records” of ISO 15189).
  • We supply risk assessments and method statements and use only UKAS-calibrated test equipment. (Section “Equipment calibration” of ISO 15189).
  • Our database tracks all work on your equipment and its history is available on request, including service reports, calibration certificates and a comprehensive list  of all faults reported and how they were resolved. (Section “Equipment records” of ISO 15189).

Though ISO 15189 covers many other aspects of your laboratory, by taking advantage of one of our Service Maintenance Agreements, you have one less thing to worry about.