Navigating the Challenges of Implementing ISO 9001 in the Healthcare Sector.
ISO 9001:2015, renowned for shaping quality management systems, isn't exclusive to product-oriented organisations. Its relevance extends to service providers, as evidenced by SouthDoc, an entity offering an out-of-hours family doctor service in Ireland. Recently certified to ISO 9001, SouthDoc faced distinctive challenges in certifying a service rather than a tangible product.
A Transition from Products to Top-quality Services
Denis Foley, Quality and Compliance Manager at SouthDoc, brought his extensive experience from the engineering and manufacturing sectors to lead the implementation of ISO 9001 in a service-oriented organisation. SouthDoc, providing urgent medical care, experienced a 5% growth last year, underscoring the need for a robust quality management system in the dynamic and pressure-laden healthcare environment.
The Decision to Implement ISO 9001
While SouthDoc had an existing system, the decision to enhance it with a structured quality management system led to Foley's involvement. The primary goal was to formalise the system, gain independent certification, and improve efficiency and patient services.
Implementing ISO 9001: A Comprehensive Approach
Foley initiated the certification process with an in-depth assessment of the organisation, creating a structured system aligned with ISO 9001 requirements. Developing a detailed strategy document and expanding the risk register were pivotal tasks. A quality awareness programme, leveraging Foley's experience in quality management education, ensured widespread understanding and involvement.
Key Milestones: Strategy, Risk Management, and Awareness
With a strategy, risk management system, and quality awareness in place, restructuring the documented management system involved input from various functions. Internal audit training, drawing from Foley's expertise, established auditors and a schedule covering all main processes. Continuous improvement became embedded in SouthDoc's culture, with patient and GP surveys, equipment calibration monitoring, and the pursuit of enhanced service quality.
ISO 9001 Certification: A Structure for Improvement
Reflecting on the benefits of ISO 9001 certification, Foley emphasises that it showcases existing effective practices while providing a structured framework for ongoing improvement. The focus remains on enhancing services for patients and making the entire system more effective.
Advice for Quality Professionals in Similar Situations
Foley's advice for quality professionals embarking on ISO 9001 implementation in diverse sectors is straightforward: adhere to the standard's requirements. Regardless of the industry, understanding and strictly following the standard's stipulations ensure the right implementation.
In conclusion, SouthDoc's successful ISO 9001 journey illustrates the adaptability of the standard to service-oriented sectors, reinforcing the pivotal role of structured quality management in healthcare.
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