By: Rick Joslin, Senior Advisor, Healthcare Strategy


As I covered in the previous installment, “Quality”, as an objective, has been a force within healthcare for a very long time. We have taken great strides to improve quality in patient care, but continue to allow other healthcare-focused efforts to remain at their effective, yet rudimentary, levels.  

Often, the main resistance to implementing ISO 9001:2015 standards within an organization comes from leadership. Implementing a qualified Quality Management Systems (QMS) will involve all aspects of the organization that interact or affect the interested parties; it’s either all or nothing. This presents, initially, a daunting perspective to leadership – though this is usually overcome once a full understanding of the process and outcome is developed.  


Leadership’s Role in a QMS  

Leadership in a QMS has responsibility for many pieces that drive and direct the overall QMS process. Consider this a main ingredient of the Plan portion of the “Plan\Do\Check\Act” process. Leadership is both organizational and QMS leadership. Senior management must focus on the organization’s ability to meet the needs and expectations of customers and other relevant interested parties. In doing this, they imbue confidence in others that they can achieve and sustain success. Senior leadership is crucial in an QMS since they are responsible for funding and removing any obstacles to the implementation (like reluctant interested parties).


Figure 1: PDCA (Plan-Do-Check-Act) Cycle
Figure 1: PDCA (Plan-Do-Check-Act) Cycle


Step 1: Determine Context  

A key first-step is to determine the organizational context (Clause 4 of ISO 9001:2015). This is a comprehensive document focusing on and defining internal and external issues that can affect the customer satisfaction and delivery of the product(s) and\or service(s) of your organization.  

This section of a QMS is where you define the scope of systems that will be included in the QMS policy, as well as management responsibilities for them. As part of this, you must define the internal environment in which you will achieve your goals and objectives. Internal context comes from:

  • The mission, vision, values, and culture of the organization
  • Contractual relationships with customers
  • Self-governance approach
  • Interested parties (entities that add value to the organization, key stakeholders in the delivery of the product\service, etc.), their needs and expectations
  • Complexity of processes and structure
  • Existing issues (good and bad) that affect the quality of the product\service you deliver
Figure 1: Interested Parties grid (sample)
Figure 1: Interested Parties grid (sample) 


You may already be doing things that convert into operational context: strategic planning, market research, benchmarking, SWOT (strengths, weaknesses, opportunities, threats), etc. Take advantage of these activities when implementing a QMS.


Figure 2: SWOT Analysis (sample)
Figure 2: SWOT Analysis (sample) 


To determine external context, leadership should consider issues arising from its technological, environmental, ethical, legal, and economic landscape. Examples of external context may include:


  • Government (local, national, industrial, international) regulations and laws  
  • Economic and market shifts
  • Competition
  • Events that may affect corporate image
  • Changes in technology, tools, etc.


Within many organizations, much of this content is in the heads of the CEO and other members of management but hasn’t been documented.  

Step 2: Determine Planning Functions of the QMS  

Once the context is complete, leadership will develop the planning functions of the QMS (Clause 5 & 6 of ISO 9001:2015). These will define:

  • Actions needed to address risks and opportunities
  • Identifying individual quality objectives and goals
  • Producing individual plans for changes needed that apply to processes, procedures, products, services, personnel, training, etc.  
  • Define how leadership will support, promote, and assure organizational members of the QMS
  • Listing inputs and outputs of QMS processes
  • Identify the sequence of activities
  • Retain a customer-focus


Be Prepared to Learn  

As you can see, implementing a QMS provides numerous opportunities to enhance the customer experience within an organization. It also exposes any issues that may detract from it, such as supply chain, staffing, training, and leadership support issues. For service departments, a QMS could expose training and equipment issues that contribute to longer turnaround times for repairs, processes that impede correction of patient-focused issues, purpose-focused detractions that prevent service staff from performing their primary roles, etc.  

The process of implementing a QMS will provide opportunities for service departments within a healthcare organization to dramatically reimagine their roles. It provides an open platform for identifying issues directly affecting the quality of the services your team provides to the organization and its customers. This also means there’s an opportunity to eliminate these issues, increase employee job satisfaction, and ultimately improve the patient experience at your organization. Beyond what we covered, the chance of rewriting and\or creating policies and procedures to support the QMS goals, implementing customer satisfaction surveys (for both internal and external customers), and continuous quality analysis all lead to a greatly improved department where the organization sees high value in your efforts, staff grow in responsibilities and capabilities, and customers receive high-quality services. All this leads to higher patient satisfaction, lower cost, and improved outlook for the healthcare organization.

To learn more about how to gain internal support for your QMS program, check out part three of this series, Support and Operation – Getting it Done.

About The Author

For more than 23 years, Rick Joslin IRCC, Senior Advisor, Healthcare Strategy at Accruent, has helped hundreds of healthcare systems navigate the ins and outs of managing service missions within their organizations. He has 35+ years in the maintenance management industry, including roles such as technician, inspector/compliance surveyor, and director. He is known for promoting continuous improvement, driving operational efficiency, increasing resource utilization, and ensuring regulatory success by identifying gaps and inefficiencies in business processes. Rick leverages LEAN thinking and Six Sigma processes to guide customers in the development of short and long-term goals. His broad knowledge of healthcare operations and regulatory requirements, coupled with an intimate knowledge of CMMS systems, allow him to assist customers in developing easily implemented solutions to unique, and changing, business needs.