ISO 15190

ISO 15190:2020 outlines the safety requirements specifically designed for medical laboratories, focusing on a comprehensive approach to risk prevention, hazard control, and accident mitigation. This international standard supports laboratories in fostering a culture of safety, aligning with global best practices for medical environments. Quality Asia Certification enables organizations to obtain ISO 15190 certification through a streamlined, compliance-driven audit process.

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What is ISO 15190?

ISO 15190:2020 – Medical laboratories — Requirements for safety, is an internationally recognized standard published by the International Organization for Standardization (ISO). It sets guidelines for implementing safety protocols in medical laboratories, including physical infrastructure, chemical handling, biological hazard management, fire safety, emergency preparedness, and staff training. The certification demonstrates that a laboratory upholds stringent health and safety measures, safeguarding employees, patients, and the public.

Why is ISO 15190 important?

Medical laboratories are often exposed to high-risk conditions—infectious agents, chemical substances, and sensitive diagnostic tools. ISO 15190:2020 is essential for mitigating these risks through structured safety systems. It also complements other standards such as ISO 15189 (Medical Laboratory Quality and Competence), ensuring that safety and quality go hand in hand.

Opting for ISO 15190 certification helps laboratories:

  1. Build trust with stakeholders and regulators.
  2. Ensure compliance with health and safety regulations.
  3. Improve incident response mechanisms.
  4. Foster a safe working environment for staff and technicians.


What are the benefits of ISO 15190?

  1. Establishes a formal safety management system tailored for medical laboratories.
  2. Enhances emergency preparedness through structured planning and simulations.
  3. Reduces liability by identifying and mitigating health and safety risks.
  4. Improves staff awareness, morale, and retention through safe working conditions.
  5. Strengthens compliance with national and international health regulations.
  6. Facilitates integration with other ISO standards for a unified quality and safety approach.

What kind of businesses can benefit from ISO 15190?

Getting ISO 15190:2020 certified offers measurable business advantages:

  1. ✅ Improved Risk Management: Minimizes the likelihood of workplace accidents and liabilities.
  2. ✅ Regulatory Compliance: Meets safety requirements imposed by government health agencies and accreditation bodies.
  3. ✅ Competitive Advantage: Enhances your reputation among hospitals, clinics, research institutions, and public health bodies.
  4. ✅ Operational Continuity: Ensures uninterrupted operations by preventing hazardous disruptions.
  5. ✅ Global Recognition: Validates your commitment to international safety standards, boosting global partnerships.
  6. ✅ Enhanced Employee Safety Culture: Leads to lower absenteeism and higher productivity.
  7. ✅ Client Confidence: Builds trust with clients who prioritize safety and regulatory conformity.


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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