The vital link between quality management systems and diagnostics development

November 20, 2023 by Deborah Oroszlan

The biggest secret to successful local manufacturing is something the global health community doesn’t consider enough.

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Quality management systems are essential for ensuring the quality and reliability of diagnostic products. Photo: Revital Healthcare.

Diagnostics are essential for identifying diseases, planning treatments, and monitoring patients. However, access to diagnostics in low- and middle-income countries (LMICs) is often very limited, leading to delayed diagnoses and incorrect treatments, contributing to drug resistance, and ultimately exacerbating the burden of disease.

Local manufacturers can play a pivotal role in improving access to quality-assured medical tests and ensuring a stable supply of essential devices in underserved areas. However, many local manufacturers lack the resources and capacity to implement a robust quality management system (QMS), which is essential for ensuring the quality and reliability of their products.

PATH recently developed a local diagnostics company dashboard, showcasing more than 150 diagnostic developers, manufacturers, and distributors in Africa. However, of the 70 diagnostic manufacturing companies in the region, only 33, or less than 50 percent, reported standard quality assurance certifications. Filling this gap with QMS is essential to enable local manufacturers to meet the global quality standards required for centralized procurement and broader market reach.

What is a QMS?

A QMS is a systematic approach to managing the quality of products and services. It encompasses all aspects of the product life cycle, from design and development to manufacturing, testing, and distribution. A well-implemented QMS helps an organization to ensure that its products consistently meet customer requirements and regulatory standards.

Key benefits of a QMS

  • Consistency and reliability: A well-implemented QMS ensures that diagnostics are appropriately designed to be fit for purpose and manufactured consistently, reducing the likelihood of errors or inconsistencies in test results. This is critical in low-resource settings where every diagnostic test must be accurate and reliable to facilitate proper patient management.
  • Compliance with international standards: Manufacturers operating under a QMS typically adhere to globally accepted quality standards, such as ISO 13485 for medical devices. This compliance not only enhances product quality but also facilitates international trade, allowing these countries to participate in the global diagnostics market.
  • Regulatory approval: Most countries have national regulatory authorities that oversee the quality and safety of medical devices, including diagnostics. A strong QMS streamlines the process of regulatory approval, ensuring that products meet the necessary standards and can be marketed and used with confidence.
  • Cost-effective production: An effective QMS can identify areas for process improvement, making manufacturing more efficient and cost-effective. This is of paramount importance in resource-constrained settings.
  • Sustainability: Implementing a QMS fosters a culture of continuous improvement, which leads to more sustainable manufacturing practices. This is crucial in low- and middle-income countries where resources are often scarce.

Everyone benefits when quality management systems are implemented. Manufacturers can reduce nonconformance, improve product quality, and expand their market reach. Test procurers gain confidence in their diagnostic purchases, helping to assure the value of their investment. End users encounter fewer problems with tests they are performing, helping to increase confidence in testing and test results, and patients benefit from uninterrupted access to quality diagnostics.

How does PATH support local manufacturers to implement and strengthen their QMSs?

PATH Diagnostics collaborates with partners and stakeholders to support local manufacturers in LMICs to implement and strengthen their QMSs. This includes:

  • Capacity building: PATH Diagnostics provides training and technical assistance to help manufacturers understand the requirements of QMS standards and to develop and implement a QMS tailored to their specific needs.
  • Networking and partnerships: PATH Diagnostics facilitates networking and partnerships between local manufacturers and stakeholders, such as decision-makers, test procurers, and end users.

By establishing a robust QMS early in the product development process, manufacturers can improve the quality and reliability of diagnostics, compliance with international standards, regulatory approval, cost-effective production, and sustainability. All of which are critical to ensuring a consistent, dependable, long-term supply of crucial, high-quality, sustainable diagnostic products in LMICs.

For further details on our work to support QMS implementation email us below