ISO 15189: Everything you need to know about accreditation for your laboratory

To date, more than 60 countries have adopted ISO 15189 as the official governing standard for laboratory quality.  In addition to a ISO 15189 standards and guidelines manual, there are various training courses and online knowledge bases that can help your laboratory achieve accreditation.PinpointBPS provides performance improvement tools that can make ISO 15189 compliance easie

"PinpointBPS is a powerful aid to ISO 15189"

Glenda Mary DavisonN.Dip (Medical Technology), BSc (Hons), MSc, PhD

 

ISO 15189 is all about maintaining — and improving — quality in your laboratory.

The standards and guidelines prescribe ways in which you should ensure quality. It mainly boils down to six key areas:

 

Laboratory Management

 Ensuring leadership and management structures that enables quality in your lab

Ensuring leadership and management structures that enables quality in your lab

Error and Improvement

 Monitoring errors and ensuring the right measures are in place to detect, correct and prevent errors

Monitoring errors and ensuring the right measures are in place to detect, correct and prevent errors

Technical Quality

 Ensuring quality in pre-examination, examination and post-examination

Ensuring quality in pre-examination, examination and post-examination

 

ISO 15189 focuses primarily on quality. PinpointBPS can help you by aligning your performance improvement efforts with your quality improvement efforts.

 

Physical Lab

 Looking after sample security and general safety

Looking after sample security and general safety

Customer

 Understanding patients and their families, as well as public health and the community

Understanding patients and their families, as well as public health and the community

Laboratory Staff

 Having the correct job descriptions, training schedules and review plans in place

Having the correct job descriptions, training schedules and review plans in place

 

A brief history of ISO 15189

ISO 15189 has its roots in laboratory automation and continues to be adopted by countries as a laboratory standard to assist with quality control.

  • 1980s Medical laboratories become more sophisticated with the introduction of automated analysis equipment, otherwise known as analysers.
  • By 1994 Automated equipment was becoming more readily available and affordable to laboratories, effectively changing the way analysis was conducted.
  • In 2003 The first publication of ISO 15189 is released after an ongoing discussion with medical laboratories on the need for a new standard that recognises the impact of laboratory automation
  • Today ISO 15189 is recognised in over 70 countries
 

“PinpointBPS is very impressive. It provides a strong evidence base to drive our improvements.”

- Neil Callow,

Finance Director at NHS Empath
United Kingdom