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Healthcare's Approach to ISO 9001 Implementation
As ISO 9001 becomes more recognized in the healthcare industry, proper implementation becomes crucial for those organizations that intend for their newly implemented ISO 9001 Quality Management System to be a performance versus a compliance based tool.
In the healthcare industry, we are fortunate and unfortunate in the same breath. We are fortunate as an industry because ISO 9001 is relatively new, and therefore we have the opportunity to learn from the implementation mistakes other industries have made. Therefore, we get to implement ISO 9001 as it was intended to truly drive performance within our hospitals and healthcare systems.
Unfortunately, we are susceptible to the same temptations other industries did 20+ years ago; the temptation to implement ISO 9001 using templates and focused only on compliance. With this approach, organizations met the requirements, but then it only became one more requirement they had to manage and it failed to drive performance. Healthcare needs to be cautious that we do not fall into the same trap that our predecessors did and keep our focus on implementing the ISO 9001 Quality Management System with a performance driven mindsetwith the overarching advantage to more easily manage accreditation and regulatory requirements.
To help us in this endeavor, there is an industry recognized Four Phased Approach to implement ISO 9001 in healthcare organizations. By following this Four Phased Approach that the healthcare industry recognizes to deliver the best results and, more importantly, results in a performance driven system that not only complies with the standard, but also produces consistent service delivery, customer (patient) satisfaction and continual improvement.
The four industry recognized phases:
- Phase 1 - Foundation and Documentation
- Phase 2 - Leadership Alignment
- Phase 3 - Organization Integration
- Phase 4 - System Validation
Foundation and Documentation
This phase educates the organization about ISO 9001. During this education, a foundation and mindset are established to understand the differences between compliance and performance. In addition, this phase details the need for the required documents (the six required procedures and the quality manual) with great clarity of the purpose and benefit of each. It also encourages the organic, ground-up creation of these documents versus the use of a template or copying another organization's policies. The template approach is the primary trap previous industries fell into.
Leadership Alignment
This phase furthers the education of ISO 9001 to top management and clarifies their role in the implementation and maintenance of their organization's ISO 9001 Quality Management System. This phase also brings into alignment all of the organization's plans, strategies, mission, vision, and values with the ISO 9001 system. It also enhances the internal communication flow throughout the organization by evaluating the committee structure of the organization to ensure the effective sharing of data, analysis, measurement and monitoring results. This phase is unique to healthcare and not recognized by other industries. It is however, essential to healthcare due to the complexities and high degree of oversight and regulations the healthcare industry must deal with on a daily basis.
Organization Integration
This phase takes a focused look at all departments throughout the organization to bring them into alignment with the newly developed policies and procedures. However, there are two recognized disciplines in healthcare that make up the vast majority of gaps in relation to the newly implemented ISO 9001 system; Calibration and Purchasing, not as departments, but as processes. While Calibration and/or Biomed have been a part of the accreditation process in the past, it is a new journey for many members of the purchasing or materials management process.
System Validation
This phase is the process of training the organization itself to validate that their ISO 9001 system is implemented with a performance mindset, maintained and managed appropriately, and continuously improving over time.
Having assisted over 160 hospitals and healthcare systems across the Country, we highly recommend following the Healthcare industry's recognized four phase approach to ISO 9001 implementation. Hospitals and healthcare industry across the Country often wonder why they struggle to comply 2-3 years after implementation of ISO 9001 and see little, to no, performance results. When asked, these organizations have chosen to follow the path of least resistance and followed a template driven implementation approach with little to no alignment of their newly formed system to the organizations existing systems, plans and strategies. This approach did get them to initially comply with the standard, however, without the in depth knowledge of how and why these policies are created and without the additional alignment from leadership, integration with the whole organization and effective validation of the system, they quickly discover that ISO 9001 has become nothing more than just another set of guidelines to manage.
On the other hand there are hospitals and healthcare systems that have chosen the correct, more challenging approach, and years later their system is maturing and they are seeing great performance based results for their organization with little thought given to whether or not they are in compliance, because by following the Four Phased Approach they undoubtedly are.
Again, if your organization has implemented or are thinking of implementing ISO 9001, we encourage you to follow the healthcare industry recognized Four Phased Approach to implementation. In doing so, we are confident that you will not only have an ISO 9001 system that is compliant, but a system that drives performance, quality and patient satisfaction throughout your entire organization.
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