What is ISO 15190?

ISO 15190:2020 outlines comprehensive safety management guidelines specifically tailored for medical laboratories. It focuses on risk assessment, hazard identification, training, emergency preparedness, infection control, and safe handling of clinical materials. The standard is applicable to both large hospital-based laboratories and small diagnostic labs, ensuring a universally adoptable framework for laboratory safety.

Key elements covered include:

  1. Safe work practices and engineering controls
  2. Use and maintenance of personal protective equipment (PPE)
  3. Waste disposal and spill management
  4. Biosafety level classification and containment
  5. Training and competence of laboratory personnel


Why is ISO 15190 important?

With the rising threats of biohazards, antimicrobial resistance, and pandemic-level outbreaks, laboratories are under increasing pressure to improve internal safety standards. ISO 15190:2020 ensures your medical laboratory complies with national and international safety guidelines, supports staff protection, and enhances operational credibility.

Whether you're preparing for accreditation (e.g., NABL, CAP, or WHO) or strengthening your internal risk management systems, adopting ISO 15190:2020 helps:

  1. Improve regulatory compliance
  2. Create a culture of safety and accountability
  3. Meet global expectations in lab safety practices
  4. Minimize operational downtime due to safety incidents


What are the benefits of ISO 15190?

Implementing ISO 15190:2020 offers several significant advantages for medical laboratories, pathology centers, and diagnostic testing facilities:

  1. Enhanced Laboratory Safety: Promotes proactive safety measures, reducing accidents, infections, and chemical exposures.
  2. Regulatory Preparedness: Aligns with local health regulations and global accreditation standards.
  3. Reduced Legal Risks: Demonstrates a documented and audited approach to safety, reducing liability in case of incidents.
  4. Efficient Waste Management: Provides structured guidelines for handling and disposing of biohazardous waste.
  5. Improved Staff Morale and Retention: A safer workplace boosts staff confidence, satisfaction, and long-term retention.
  6. Risk-Based Approach: Supports dynamic risk assessments and incident prevention planning.


What kind of businesses can benefit from ISO 15190?

Adopting ISO 15190:2020 isn't just about compliance—it's a strategic move that adds tangible value to your laboratory operations. Key business benefits include:

Strengthens Brand Trust: Positions your lab as safety-focused and globally aligned.

Attracts International Clients & Partnerships: Safety-certified labs are more likely to be chosen by hospitals, pharma companies, and research organizations.

Reduces Costs from Accidents & Downtime: Prevents costly disruptions and legal fines through better safety planning.

Streamlines Accreditation Processes: Simplifies documentation and preparedness for inspections and audits.

Demonstrates Proactive Leadership: Showcases your organization's commitment to quality, safety, and excellence.


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