What is ISO 15189?

The ISO 15189 standard is a set of requirements for quality management specific to medical laboratories. The common components of the standard include document control, internal audits, occurrence management, and risk management. Compliance with ISO 15189 improves the overall quality of a laboratory’s services and products, which directly affects the quality of health care.

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Who is ISO 15189 Designed For?

ISO 15189 was first published in 2003. It was revised in 2007 and again in 2012. The standard establishes a stringent set of quality management requirements specifically for laboratories at every level of the health care system. Some of the standard’s objectives for lab operations include ensuring the quality and traceability of patients’ information, maintaining the safety and integrity of lab materials, monitoring the facility’s environmental conditions, and supporting public health decision-making.

ISO 15189 Standards

Documentation: Effective quality management includes maintaining comprehensive and accurate documentation of all laboratory processes. Ensuring the completeness and integrity of documentation means every document should be reviewed, signed, and dated annually or when any changes are made.

Training: Compliance with ISO 15189 requires that all laboratory staff are properly trained and qualified for the work they perform. The facility’s quality management system should include a training program that helps establish training needs, keeps employee training records current and accurate, and alerts specified personnel of any nonconformances.

Quality Assessment: All operational procedures should be systematically reviewed by laboratory management at intervals defined in the quality management system policy. This helps identify deficiencies and opportunities for improvement.

Internal Audit: To verify that laboratory operations maintain compliance to the ISO 15189:2012 requirements, delegated staff should conduct internal audits at regular intervals. Staff members can be trained to complete audit procedures using a predefined ISO 15189 checklist.

Corrective and Preventive Action (CAPA): Procedures for CAPA should include an investigative process to determine the underlying cause or causes of a nonconformance. Issues should be escalated to CAPA according to the magnitude of the problem and potential for risk.

Supplier Management: Laboratory facilities should have documented policies and procedures for supplier qualification and monitoring, competitive bidding, and quality checking of supplies received. This involves maintaining a list of approved suppliers and up-to-date records of supplier evaluations.

The Value of ISO 15189 Compliance

ISO 15189 provides guidelines for establishing an effective quality management system. Following the guidelines leads to the assurance of accurate test results, a significant reduction in errors, and the increased confidence of patients, clinicians, and external stakeholders in the value of your laboratory testing.

In a laboratory environment, safety rules must be established to reduce risks to staff, customers, and visitors. Developing a quality management system based on the ISO 15189 standard helps laboratories achieve the highest level of safety, consistency, and performance.

The Role of ISO 15189 in the ISO Family

ISO 15189 is becoming a widely accepted standard used for accreditation of clinical laboratory competence. Prior to this standard, laboratories relied on ISO 17025 for verification of their laboratory’s quality performance. However, many of the requirements were irrelevant to a laboratory operation. The following are the key aspects of ISO 15189:

  • Published as the first harmonized clinical practice standard.
  • The primary objective is to enable laboratories to improve their quality management processes and operational efficiency in order to achieve client satisfaction.
  • Considered a practical complement to the quality management requirements of ISO 9001.
  • Created specifically for the unique requirements of clinical laboratory practice, whereas ISO 9001 is applicable to all organizations, regardless of type, size, or product.
  • Provides an important template for effective quality management of a laboratory and its staff.

MasterControl Automates Quality Processes for ISO 15189 Compliance

The MasterControl Quality Excellence™ solution automates all clinical laboratory quality management processes and tasks, making it easier to achieve ISO 15189 compliance. The applications are fully integrated to more effectively manage document control, change control, training management, audits, CAPA, supplier management, deviations, and more.

QMS Provider for the FDA

MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries. Since 2009, the U.S. Food and Drug Administration (FDA) has been using a variety of MasterControl’s Quality Excellence™ solutions to improve the quality processes of the Office of Regulatory Affairs (ORA) and the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).