Standard ISO-15189

The ISO 15189 standard specifies the quality process requirements for the medical laboratories. It aims to manage all the practices and activities of the medical laboratories. ISO 15189 standard is essential for the control and the treatment follow-up, but also to supervise the professionals’ activities, as for the medical biologist.

norme-iso-15189-laboratoire

 

ISO-15189 standard history for the medical laboratories

 

The ISO 15189 standard is based upon the ISO 9001 and the ISO/IEC 17025 standards for the medical laboratories and essay offices. It has been published by the ISO following the HPST law (Hospital Patient Health and Territory) dated July, 21st 2009.

Nowadays, each medical laboratory must have begun an ISO 15189 accreditation process.

According to the reform of the medical biology dated May 30th, 2013, a schedule provides a gradual integration of the ISO 15189 standard regarding some of the activities of the laboratory, up to 100% in 2020.

However, each new medical laboratory created has to be accredited ISO 15189 from its opening.

In France, medical laboratories has to ask for the COFRAC to be accredited.

 

ISO-15189 : a two-part standard

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements.

  •  The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party.
  • The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories’ examination results shall have traceability of measurements and implement uncertainty of measurement.

Nanotrack and ISO-15189

In the management of the quality process for medical laboratories, pre analytical phase is the source of numerous mistakes due to control and measure of samples transport conditions.

During transportation, biological samples have to be kept at precise temperature levels:

  • -20° for frozen samples,
  • +2°C à +8°C for refrigerated samples,
  • +15°C à +25°C for ambient samples.

The one in charge of the round has to check these temperatures and to bring the proof of this control with a temperature recording.

The Nanotrack recorder tube is a simple way to solve this issue. Closely placed with the samples, it measures the temperature felt by the samples inside the transport boxes and gives its result at the end of the round:

– Green LED : ISO-15189 standard rise, samples have been transported in good temperature conditions.

– Orange LED : the samples have undergone little temperature variation.

– Red LED : warning, biological samples were exposed to critical temperature variations.

 

The Nanotrack meets the different needs of medical laboratories :

 

Each of these Nanotrack, are available in three different versions of warning signal activation. It means that the Nanotrack must records continuously an overtaking threshold during a specified duration.

  • 15 min
  • 30 min
  • 60 min