Case Study

Accreditation of medical laboratories and empowering small and medium enterprises (SMEs) in Iran

Summary

Introduction: Accreditation of medical laboratories is critical for ensuring high-quality healthcare services. In Iran, this role is fulfilled by the Iranian Association of Clinical Laboratory Doctors (IACLD Accreditation Body).

Role of SMEs: Some medical laboratories in Iran are categorized as Small and Medium Enterprises (SMEs). They provide essential services, such as disease diagnosis, cost-effective healthcare, preventive measures, and data for medical research.

Strengths of SMEs: SMEs contribute significantly to public health, enhance trust through accreditation, and gain opportunities for global market integration.

Challenges for SMEs: Financial constraints, limited infrastructure, and a shortage of skilled personnel are among the key barriers. Additionally, navigating regulatory changes and competing internationally pose difficulties.

IACLD’s Supportive Approach: IACLD has introduced a phased accreditation process to empower SMEs, including training, assessments, and some facilities, ensuring a gradual and manageable pathway toward accreditation.

Conclusion: Accreditation boosts the capabilities and recognition of SMEs, enabling them to contribute more effectively to public health and to access international networks. A tailored, supportive process for SMEs is crucial for maximizing their potential.

Background

In the realm of healthcare, medical laboratories play a pivotal role by providing accurate diagnostic services essential for disease prevention, management, and treatment. In Iran, there are thousands of medical laboratories, ranging from small privately-owned facilities to larger hospital-affiliated institutions. Some of these laboratories qualify as Small and Medium Enterprises (SMEs) due to their size, limited staff, and scope of operations.

The importance of accreditation stems from its ability to ensure the quality, reliability, and standardization of laboratory practices. Globally, the ISO 15189 standard provides a framework for medical laboratories to demonstrate their competence and commitment to quality. Accredited laboratories gain trust among patients and healthcare providers while also being recognized in international networks.

In Iran, the Iranian Association of Clinical Laboratory Doctors (IACLD) is the authorized accreditation body (AB) to accredit medical laboratories in compliance with ISO 15189. IACLD holds membership in international organisations like ILAC and APAC and has signed the MRA agreements, ensuring international recognition for accredited laboratories.

SMEs in this sector face unique challenges, including limited financial resources, inadequate infrastructure, and insufficient expertise in accreditation processes. Despite these challenges, empowering SMEs through accreditation is a crucial strategy to improve public health outcomes, enhance their market position, and integrate them into global healthcare networks.

The IACLD has developed a phased approach to support SMEs, enabling them to gradually achieve accreditation by addressing these barriers and fostering their growth. This approach aligns with global practices and aims to enhance the quality of diagnostic services in Iran while ensuring compliance with international standards.

Strategy 

To empower SMEs in the medical laboratory sector and support their accreditation under ISO 15189, the following strategic approach has been outlined:

• Developing a Phased Accreditation Process
• Enhancing Accessibility to Accreditation
• Building Capacity
• Strengthening Infrastructure
• Promoting Collaboration and Networking
• Continuous Improvement and Monitoring
• Advocacy for Policy and Regulatory Support

Results

Improved Diagnostic Quality: Accredited medical laboratories demonstrate consistent compliance with ISO 15189, ensuring higher quality and reliability in test results. This directly contributes to accurate disease diagnosis and patient safety.

Increased Participation in Global Networks: Through accreditation under the guidance of IACLD, many SMEs gain recognition in international networks such as ILAC and APAC, enhancing their reputation and ability to compete on a global scale.

Enhanced Public Trust: The accreditation of laboratories builds confidence among patients, healthcare providers, and regulatory bodies, reinforcing the perception of reliability in medical testing services.

Capacity Building and Skill Development: Training programs and technical support for SMEs result in a more skilled workforce capable of maintaining international standards in laboratory operations.

Sustainability of SMEs: Accreditation facilitates access to financial incentives, partnerships, and growth opportunities, ensuring the survival and expansion of SMEs in a competitive market.

Impact

Strengthened Healthcare System: The availability of reliable medical laboratories across the country enhances public health infrastructure and improves access to quality healthcare in rural and urban areas alike.

Economic Growth: SMEs contribute to local economies by creating jobs and fostering innovation in the medical field. Accreditation ensures their sustainability and productivity.

Global Recognition for Iran’s Laboratories: By integrating accredited SMEs into international frameworks, Iran strengthens its presence in global medical accreditation networks, showcasing its commitment to quality healthcare services.

Encouragement of Innovation: Accreditation fosters a culture of continuous improvement and innovation, enabling laboratories to adopt new technologies and methodologies.

Enhanced Collaboration: Accredited laboratories are better positioned to participate in cross-border research, collaborations, and public health initiatives, promoting shared learning and innovation.

Conclusion: The empowerment and accreditation of SMEs in Iran’s medical laboratory sector result in a cascade of positive outcomes. By ensuring the quality of diagnostic services, bolstering SMEs’ capacity, and facilitating integration into global frameworks, this approach not only benefits individual laboratories but also contributes to broader public health and economic objectives.

Contact

IACLD Accreditation Body: Iranian Association of Clinical Laboratory Doctors
Email: ab@iacld.ir , shadi.edris@iacld.ir
Website: https://ab.iacld.com/