Ensure ISO 15189 compliance by using PinpointBPS®

by Glenda Mary Davison
N.Dip (Medical Technology), BSc (Hons), MSc, PhD

As someone who works in diagnostics, you are probably well aware that ISO 15189 is a rigorous standard that requires significant commitment from laboratory management. By aligning your performance improvement efforts with compliance measures, PinpointBPS can be a powerful aid that supports ISO 15189 within laboratories.

Medical laboratories must maintain a standard that meets the needs of the healthcare professionals who are required to diagnose and manage the care of patients. The aim of accreditation and the drafting of international standards such as ISO 15189 is to ensure that these standards are adhered to.

PinpointBPS is a powerful aid to ISO 15189
— Glenda Mary Davison; N.Dip (Medical Technology), BSc (Hons), MSc, PhD

The International Organization for Standardization (ISO) drafted ISO 15189 specifically to address the requirements of medical laboratories. The standard addresses a myriad processes within the laboratory, including patient preparation and identification, sample collection, transport, storage, analysis of samples, validation, interpretation and reporting. 

The ISO 15189 guidelines also ensure that there are laboratory systems and processes to identify areas where improvement is required, and to put action plans in place that will prevent potential errors. These systems should ultimately lead to a cost effective and reliable service. A laboratory’s management is responsible for the design, implementation, monitoring and improvement of these processes, with the goal of maintaining the quality management system


Monitoring and maintaining quality standards and support lab staff using PinpointBPS.

PinpointBPS is a performance improvement solution for laboratories with the ultimate goal of helping laboratories to be more innovative through certainty in decision-making. It implements a culture of performance within a laboratory by means of key principles, tools and knowledge transfer, which can assist laboratory professionals to reach the goals set by ISO 15189.

In addition, it provides a means to ensure quality and efficiency, through the in-depth mapping of all the operational laboratory processes which are often located in different departments and locations. This unique property of the PinpointBPS programme allows staff to study, evaluate and ultimately manage and improve all processes.


It's ideal to have your performance improvement efforts contribute to your ISO15189 compliance - and vice versa

PinpointBPS® supports lab staff to ensure that complex decisions are made with certainty, that they will have a positive impact on the entire service of the laboratory, and that the quality system is effectively monitored and maintained.

From the purchase of new equipment, to the addition of new laboratory tests, to the scope of accreditation, laboratory managers must often make complex decisions in order to continually improve the laboratory system.

What’s more, in order to be compliant with ISO 15189, all equipment and new procedures must be validated - not only for accuracy of the results, but also for the impact on the quality and efficiency of the entire service.

PinpointBPS empowers labs to evaluate the impact of decisions before they are implemented, and provides a means to quantify in advance what the impact of a decision would be on the entire system. The methodology and its tools can analyze and optimize the laboratory in a model space and set future benchmarks. Expert engineers then work with the laboratory on an ongoing basis in order to achieve their goals.

PinpointBPS therefore evaluates the whole laboratory system and can effectively be utilized as a methodology for continuous improvement.


Performance audits made easier

A system like PinpointBPS can also be used to monitor improvement year on year.

In order to prevent non-conformances from occurring, ISO 15189 requires that all processes be audited annually by the laboratory. PinpointBPS® accumulates data on processes and turn-around times, using detailed process maps which can be easily interpreted by auditing staff.

Any potential or previous sources of error can be identified, communicated to staff and corrected. The program monitors performance over time and can therefore become a valuable tool in both the auditing and annual review of the laboratory. The creation of detailed maps also allows management to interrogate other aspects of the quality system such as the environment, accommodation and staffing. These aspects may lead to further improvements such as the relocation of departments or the better utilization of skilled staff.

PinpointBPS is a powerful aid to ISO 15189 and a tool that ensures ongoing improvement.

PinpointBPS does not aim to replace the skill and ability of laboratory professionals to write standard operating procedures, policies and maintain the daily quality processes required for accreditation. Instead, if applied correctly, PinpointBPS supports lab staff to ensure that complex decisions are made with certainty, that they will have a positive impact on the entire service of the laboratory, and that the quality system is effectively monitored and maintained.

In conclusion PinpointBPS® is a powerful aid and tool that can ensure that the entire laboratory system continues to improve.


About the author

Glenda Mary Davison (PhD) is a Senior Lecturer at Cape Peninsula University of Technology. She has extensive experience in ISO 15189 auditing and compliance. She is the external moderator for the national examinations of medical laboratory technologists and scientists and serves as an assessor for the South African National Accreditation System (SANAS).

The author has no affiliation with PinpointBPS.

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