Lab Excellence: Why You Must Automate ISO 15189 Workflows with a Next-Generation Quality Software

Lab Quality Matters

The quality of medical treatment and therapy begins in the laboratory! What happens ‘under the hood’ in a lab plays a key role in the health and safety of patients and impacts medical diagnosis in 70% of the cases. Therefore, to ensure excellence in patient care – excellence in the quality of laboratory tests and processes is critical.

To enable laboratories to ensure quality and continuous improvement, they must follow the requirements of ISO 15189, a standard based on ISO 17025 and ISO 9001. This ensures the competence and quality of medical laboratories. Accreditation to this standard improves credibility and ensures the competence of the testing services they offer. 

Developed in collaboration with the medical, scientific, and clinical communities, ISO 15189 sets down the standards to be followed by diagnostic labs to demonstrate competence in the timely delivery of accurate and reliable results.

Five Key Requirements for ISO 15189 Compliance

ISO/IEC 17025 specifies the general requirements for the competence of testing and calibration laboratories. ISO 9001 pertains to the requirements of a Quality Management System. In addition to these, ISO 15189 has five specific requirements for medical laboratories. These include:

• The type of sample and testing required
• Facilitating collaboration between the staff at the laboratory responsible for conducting the tests and the referring clinicians to ensure the quality of service
• Giving recommendations based on the test results regarding diagnosis and patient care
• Collecting samples or sharing information regarding the collection procedures, sample containers, and sample volumes
• Following ethical practices

ISO 15189: Increasing Accuracy with Better Quality Processes

The tests conducted at medical laboratories help clinicians to determine the course of the treatment. Therefore, accuracy is paramount.

But, there are possibilities of errors that can result from the following:

• Poor calibration of the testing equipment/instruments
• Lack of sufficient qualified and trained staff performing the test
• Lack of a quality control process
• Errors that occur in the pre-analytical phase of the testing, externally, beyond the supervision of laboratory staff such as:

• Preparing the patient for the test
• Correct interpretation of the physician prescription
• The use of the correct preservative when collecting the specimen
• Time of specimen collection
• Transportation of the specimen to the laboratory within the prescribed time and with the right environmental controls

• In the post-analytical process, the accuracy of the result must be established beyond any doubt. Manual communication is prone to errors.

It is essential to identify and understand the weaknesses in the testing process and develop a quality control process. A process map with checklists and automation can help to improve the accuracy of the tests, ensure machines are calibrated periodically, and that the entire workflow is transparent to identify any errors for future corrections.

Key Advantages of Getting ISO 15189 Accreditation

Laboratories are becoming complex. The need to keep costs low, improve outcomes, and deliver in a timely manner without compromising on quality and patient safety. With ISO 15189 compliance, businesses can overcome some of the challenges. Some of the benefits they experience by aligning their process to ISO 15189 include:

• Risk-based Approach: Adhering to ISO 15189 recommendations enables laboratories to identify potential risks and plan and mitigate them by implementing controls.
• Enhanced Quality Management: This will help improve the Quality Management System (QMS) and enable the early identification of errors to proactively implement effective corrective measures.
• Increased Efficiency: Implementing ISO 15189 to increase efficiency and productivity by enabling medical laboratories to streamline their processes and procedures.
• Enhanced Customer Satisfaction: Laboratories can improve the quality of their services and the accuracy of their results as ISO 15180 compliance improves quality management and increases efficiency.
• Better Marketability: ISO 15189 accreditation is internationally recognized – it can improve brand reputation and marketability. It reassures patients of competence and commitment to providing quality services of global standards.

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CQ Guide: 5-Steps for ISO 15189 Accreditation

Experts say the process of getting ISO 15189 is almost akin to getting the Deming TQM recognition and requires the involvement of the entire organization.

#1 - Start with a QMS
Create and implement a QMS that aligns with ISO 15189. It should meet the unique needs of the laboratory and must be documented & accessible to all staff members.

#2 - Internal Audit of Your Operations
Auditing the laboratory to identify any gaps and rectifying them to align with the ISO 15189 standard is the second step. These changes would include delivering required trainings, improving processes or implementing new policies and procedures.

#3 - Submit ISO 15189 Application
Once the necessary changes to the QMS have been made, a duly filled application for ISO 15189 certification must be submitted to an accredited certification body with the required fees.

#4 - Undergo External Auditing
The accredited certification body will audit the laboratory upon accepting the application to assess ISO 15189 compliance. This will include a series of site visits, interviews, and document reviews.

#5 - Receive Certification
After compliance has been established, an ISO 15189 certification will be awarded to the laboratory, valid for three years. A re-certification audit will have to be conducted to renew the certification.

ComplianceQuest EQMS: Preferred Solution to Automate Quality

A risk-based approach enables laboratories to proactively identify and mitigate risks, minimize quality issues and improve patient outcomes. This requires a data-centric approach with end-to-end workflow management for better traceability and transparency.

The QMS from ComplianceQuest is designed for ISO compliance and is a natural fit in a laboratory environment. It integrates all critical functions of a laboratory, right from documentation, training, and supplier management to risk and change management. It enables laboratories to automate audit and inspection processes and empowers the management and quality teams with centralized data to have a holistic view for improved decision-making and continuous improvement of quality.

The QMS also provides CAPA and Root Cause Analysis features that help to go to the root of any quality issue and implement corrective and preventive actions. The CAPA process is vital in mitigating risks and eliminating quality issues from the laboratory.

The risk management solution also helps to assess the impact of risk and prioritize it based on frequency and severity of occurrence. This helps to ensure that the critical risks are addressed first and resource utilization is optimized. Collaboration and communication from within the system provide better visibility and also enhance compliance.

To know more about CQ EQMS and how it can improve compliance and performance of your laboratory, request a demo: https://www.compliancequest.com/lp/eqms/