Mission Possible: ISO Certification


ISE Magazine Volume : 50 Number: 5
By Casey Bedgood

The significance of accreditation and ISO certification

Accreditation is the financial lifeline for healthcare organizations, as the Centers for Medicare and Medicaid Services (CMS) requires accreditation to reimburse healthcare organizations for the services and care provided to patients and other customers. For many healthcare organizations across the country, CMS funding represents the majority of reimbursement dollars received each year. Minus such funding, many healthcare organizations would become insolvent, and others would have a difficult time maintaining long-term market relevancy as a healthcare institution.

To become accredited, a healthcare organization selects an accrediting body such as DNV GL or The Joint Commission. Accrediting bodies must be recognized and permitted by CMS to administer accreditation standards that adhere to CMS guidelines. The accrediting body conducts periodic (yearly for DNV GL) on-site assessments to make sure the healthcare institution meets minimum regulatory guidelines for patient safety, physical environment, medication management and many other CMS requirements. During these on-site surveys, the accrediting body cites healthcare institutions for nonconformities (NCs), or findings of deficiencies that the healthcare institutions must correct, in a short time, to comply with CMS standards. If nonconformities are not corrected properly, the healthcare institution may lose its accreditation, which, of course, risks losing CMS reimbursement.

The ISO healthcare culture offers many benefits to the organization, customer and employees. The organization benefits because ISO standards help it provide cheaper, faster and higher-quality services to customers, which in turn contributes to growth, partnerships, enhanced revenue streams and longterm relevancy. Customers benefit because an ISO-certified organization continuously improves services and care by fostering a continuous improvement culture that strives for high performance, yielding reliable processes that meet and even exceed customer requirements. Healthcare employees benefit because ISO-certified organizations have high performance, which leads to enhanced job security, better working environments, higher pay and reward mechanisms that encourage and require staff to improve their work environments continuously, which in turn improves the customer experience. Overall, ISO certification is a win for all interested parties.

The journey

Navicent Health’s ISO journey began with a 15-week deadline prior to the forthcoming DNV-ISO survey, and the core team chose a three-phase implementation process over the 15-week period to achieve certification. Phase 1 focused on gap analysis and macro-strategic planning, Phase 2 centered on micro-DNV-ISO regulatory content-related action items and Phase 3 was to coordinate the first two phases and focus on final preparation and systemwide communication before the survey.

The starting point of Phase 1 was the creation of a simple gap analysis, including a strengths, weaknesses, opportunities and threats (SWOT) analysis for both the accreditation team and health system. The purpose of conducting a SWOT for both the team and health system was to identify and leverage the strengths of the team members and organization to compensate for internal weaknesses. The end goal was to “divide and conquer” by assigning team members and leaders to initiatives that played well with their respective strengths. Since the team’s skill sets were so diverse, all weaknesses were covered by the strengths that other members contributed.

The communication plan was simple and included visuals such as ISO employee badges outlining the basic principles, ISO flyers attached to all departmental communication boards used for cascade with front-line staff and screen savers as well as other internal electronic publications showcasing ISO principles. Moreover, voice-of-the-customer sessions were held to gain insight on burning issues that were used during the journey’s design, planning and implementation phases. The secret to success was keeping the road map information simple and visually interesting, which allowed the team to showcase the burning issues in red (excessively behind goal), yellow (close to goal, but work needed) or green (meeting goal) on a regular basis to system leaders for support and timely correction.

In tandem with the ISO road map, the team created a master action item list (Gantt chart) with more than 200 action items that were successfully accomplished over the 15-week time period. Action items, such as creating 6,500 employee ISO badges, conducting 750 vendor contract evaluations, accounting for nearly 7,000 documents and training hundreds of leaders in ISO principles, were managed by the core team and delegated to specific leaders throughout the organization as needed.

The team used the simple red, yellow and green method for identifying and designating specific actions as completed (green), fast approaching (yellow) and missed deadline (red). This action item list was imperative to keeping the organization on track with completing milestones and preparing for a successful survey, as the team either created or put eyes and hands on nearly 20,000 items in preparation for the survey. The red and yellow items were escalated to senior executives (strategic business unit ISO champions) to expedite immediate resolution and completion with their respective leaders and business units. Both the road map and action item list were constantly socialized to all system leaders regularly for status updates and to garner support for correcting outstanding items.

Phase 2 of Navicent Health’s ISO journey began with a heavy focus on content. The core team created an ISO content binder for each of its three hospitals and support areas that explained how the organization complied with each of the ISO 9001:2015 quality management system requirements. As the road map portrayed the high-level organizational plan leadership used to understand and cascade the ISO core elements to their respective leaders and staff, the content binder served as the detailed manuscript talking points for conversations with the surveyors during the survey. Once actionable content items were catalogued, the team conducted regular systemwide audits for compliance to ISO standards that spawned corrections to nonconformities. Constant content-related status updates were socialized throughout the organization to leadership, support services and patient-facing areas as the organization transitioned into Phase 3 of implementation.

Phase 3 of the ISO journey focused mainly on final preparation, ensuring that all three hospitals and support areas were on target with tollgates, tying up loose ends and continued socialization of the core principles of ISO throughout the system of care as the survey deadline approached. As Phase 3 concluded, the DNV surveyors arrived and completed a successful survey and ISO transition for Medical Center Navicent Health in October 2017. Within a few weeks, DNV surveyors completed the DNV surveys and ISO transitions for both Rehab Hospital Navicent Health and Medical Center Peach County Navicent Health the first week of November 2017.

Strategy and planning: Post-survey focus

To function as a highly reliable ISO organization, sustainability strategy and planning efforts do not start or stop after the successful survey.

During Phase 2, several weeks before the survey occurred, the core team began thinking about the strategy, planning and executable action items that would move the organization to a continuous state of organizational improvement aimed at meeting customer requirements even after the survey. The focus areas of these planning sessions included accreditation, quality, operations and clinical functions throughout the enterprise. In order to meet and exceed customer requirements, leadership, support services and customer-facing areas must be actively engaged with a common focus to create a synergistic environment. The main goal was to foster an environment of continuous organizational improvement by focusing on continuous operations improvement and process improvement, which would allow leaders, staff and clinicians to identify and address risks and opportunities proactively.

The ideal result of these efforts is to create a culture of accountability, continuously achieving and sustaining results long-term and controlling those changes to ensure customers receive the right care at the right time.


Navicent Health successfully became ISO 9001:2015 certified with only a 15-week preparation timeframe by focusing on leadership, support services and patient-facing environments. The team accomplished this by leveraging top leaders, internal process experts (Six Sigma black belts) and experienced accreditation leaders with distinguished track records of successful surveys.

Becoming ISO certified is only the beginning of a long journey toward high reliability by continuously improving the organization to serve patients better. The team realized early on that meeting and exceeding customer requirements directly correlates to having highly reliable processes that can be consistently repeated in all customer-facing environments.

Here is an overview of the lessons learned:

  • Begin the road map or journey to ISO 9001 early and include as much pre-planning as possible. The ideal plan would allot for at least two years of planning, implementation and fine-tuning before the initial ISO survey. Planning should include all entities of the health system and voice of the customer.
  • Establish a good process and follow it. The core team learned early on that to meet deadlines and tollgates appropriately, a well-thought-out process was needed, and constant communication to leadership was crucial in staying on track.
  • Create a small core team of seasoned healthcare employees well-versed in accreditation and process improvement ranging from the C-suite to nonleadership staff to drive the ISO road map initiatives throughout the organization. The more diversified the team’s skill sets and experience levels, the easier it will be to cover implementation weaknesses with team strengths. At all costs, make every effort to avoid groupthink.
  • Don’t forget the continuous communication plan consisting of incoming and outgoing communication channels. The team learned that at least weekly communication among team members and leaders was crucial in achieving implementation tollgates, driving change throughout the organization and becoming ISO-certified. Never forget to include voice of the customer, as those closest to the process will play a pivotal role in sustaining long-term change. If in doubt about the communication plan, overcommunicate and include all leaders, support services and front-line staff as often as possible.
  • Always focus on continuous improvement of the process, organization, communications, adherence to ISO principles, ensuring internal and external customer requirements are measured, met and exceeded.
  • Leverage top leadership during the ISO journey. It is not only one of the ISO seven core element requirements, but top leadership engagement, participation and support of ISO principles is crucial in attaining a favorable survey and becoming certified.
  • Begin post-survey planning and strategy sessions long before the survey occurs. High reliability and high performance require continuous long-term efforts that should not begin and/or end once the successful survey is complete.