ISO Meets PI

ISO MEETS
PROCESS
IMPROVEMENT
The Next Level of Evolution for the Healthcare Quality System
By:
Maurice C. Spann, CLSSBB,
Johnette C. Davis, MSN, RN

© 2016 MAURICE C SPANN & JOHNETTE C. DAVIS
ALL RIGHTS RESERVED
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Table of Contents
Introduction ................................................................................................................................................2
What is ISO?................................................................................................................................................2
ISO is a Foundational Model, Helping Organizations Achieve Excellence.......................................2
ISO in Healthcare .......................................................................................................................................3
What is Process Improvement (PI)? ........................................................................................................4
ISO Meets PI................................................................................................................................................5
The Healthcare Improvement Model......................................................................................................5
Top of the House – Tier I: .........................................................................................................................5
System Quality and Safety Team – Tier II: .............................................................................................6
Executive Level – Tier III: .........................................................................................................................6
Management Level – Tier IV: ...................................................................................................................7
The Foundation – Tier V: ..........................................................................................................................7
The Flywheel and Gear – The Integration of ISO and PI: ....................................................................8
Conclusion ..................................................................................................................................................9
™ Healthcare Improvement Model:......................................................................................................10
Reference Materials:.................................................................................................................................11

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Introduction
The Healthcare Improvement Model is a framework to help a healthcare system
strategically improve its processes, policies and procedures. Through the adoption of
this model, the system continuously improves the way it cares for its patients, while
positively impacting its bottom line. The Healthcare Improvement Model also allows
ISO (International Organization for Standardization) and PI (Process Improvement) to
integrate into a platform that promotes continuous improvement within a healthcare
organization. The model starts at the system level and permeates through the
individual hospitals and or its affiliates within the healthcare system.
What is ISO?
In 1946, a group of 65 delegates from 25 countries discussed the future of International
Standardization. By 1947, ISO was formed, employing 67 technical committees to focus
on specific subjects. Now, ISO includes 163 members with a total of 21,000 standards,
covering almost all aspects of business, healthcare, and technology. Out of the 21,000
standards published, more than 1,300 focus on health care issues.
ISO published its first standard for the healthcare sector on September 20, 2001. By 2013,
health care reached 9% of the monetary value of all finished goods and services
produced globally. 1
The ISO 9001 Standards employs the process approach, which
incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. 2
Implementing ISO allows the healthcare system to ensure patients receive the highest
level of quality care.
ISO is a Foundational Model, Helping Organizations Achieve Excellence
ISO isn’t an award of excellence. It is a set of requirements to provide guidance to an
organization seeking to implement a high-performing, quality management system. In
health care, ISO promotes the adoption of a process approach when developing,
implementing and improving patient care. Often compared to an award, such as
Baldrige Criteria for Performance Excellence or Shingo Prize for Operational Excellence,
ISO is a framework for excellence in quality.
Baldrige is a national award given to U.S. organizations occupying the business,
education, nonprofit and health care sectors.3 The purpose of this award is to promote
the importance of performance excellence with the intent to increase competitiveness
1
The ISO Story – www.iso.org
2
ISO 9001 Fifth edition -2015-09-15
3
Baldrige FAQs – www.nist.gov

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within consumer markets. Organizations that receive the Baldrige award exemplify the
following characteristics:
 Quality management system;
 Continuous improvement; and
 Demonstrate effectiveness and efficiency in resource utilization, process and
system optimization.
The Shingo Prize is a global award created to drive excellence through the application
of universally accepted principles.4 These principles encompass operational excellence,
alignment of management systems and the application of improvement techniques
across the entire enterprise. The award focuses on organizational transformation
creating a culture that thrive on continuous improvement at all levels. The Shingo Prize
considers the four below dimensions when assessing an organization.
 Cultural Enabler: Make it possible for employees within the organization to
engage in the transformation journey, progress in their understanding and
ultimately build a culture of operational excellence.
 Continuous Process Improvement – begin by clearly defining value based on
the customer requirements. Based on the customers’ expectations, systems are
designed to meet their needs. Every employee understands and owns their part
of the process and diligently seek ways to improve it.
 Enterprise Alignment – execution is the most valuable tool when it comes to
organizational transformation. To succeed in this transformation, it is imperative
for organizations to develop management systems that align behaviors and
work with principles and direction that are simple, comprehensible, actionable,
and standardized.
 Results – driven by value and seek ways to improve quality, cost, delivery,
safety, and morale. Widespread involvement is essential for continuous
improvement. Every employee responsible for the expected results are consider
equal owners of the process.
Both Baldrige and Shingo focus on strong customer performance, workforce
effectiveness and future growth potential for the organization. ISO is the vehicle used to
help organizations obtain either designation of choice.
ISO in Healthcare
ISO provides a clear direction of what needs to take place to achieve operational
excellence. It is imperative for healthcare organizations to understand and deploy a
4
www.shingoprize.org/model

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high performing Quality Management System (QMS) such as ISO. The definition of a
high performing quality management system is a collection of processes that
consistently meet patient requirements while augmenting patient and family
satisfaction. In order for a health care system to implement a high performing quality
management system, a structured safety and quality team must be identified and
commissioned at the system level.
Furthermore, ISO has requirements that deal with systems, processes, procedures, and
policies, within the healthcare organization. Employing these requirements allows the
hospital to standardize and deliver quality care. From a quality management system
perspective, the hospital is able to identify key performance indicators to measure the
effectiveness of patient care. By executing internal audits, the high performing quality
management system is able to identify nonconformities or broken processes using key
performance indicators as its process control mechanism.
What is Process Improvement (PI)?
Process Improvement is the continuous and ongoing effort to achieve measurable
improvements exploiting an efficient and effective technique. PI uses performance,
accountability, outcomes and other indicators of quality to improve efficiency and
effectiveness of an organization. It is a scientific methodology for leaders to address,
resolve and eliminate complex issues driving negative quality performance.
PI provides tools for staff to develop and implement corrective/preventive action plans
used to resolve and prevent nonconformities. As failures occur within processes,
process improvement tools help define and understand the root cause of the failures.
The most commonly used PI tools are DMAIC and PDCA cycle. Many organizations
use these two methods to instill controls and continuous improvement of processes,
products, and services.
For example, a large healthcare system pursued its ISO certification; it discovered there
were nonconformities that must be addressed prior to obtaining its certification. After
further investigation, the administration launched a system-wide task force trained in
quality and process improvement to resolve the nonconformities. The team needed to
use the appropriate PI tools to identify the root cause, create a future state process, test
the process and standardize. Practicing PI helped standardize, reduce and eliminate
future similar nonconformities and obtain their ISO certification without further delay.

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ISO Meets PI
ISO creates the foundation to develop a structure to provide resources and support
through inputs and outputs of a robust quality management system. PI is the tool used
to reduce or eliminate the potential failures within the quality management system.
When PI and ISO are integrated, hospitals should expect to produce the following
results:
 Significant decrease in the number of patients harmed;
 Increase in patient and employee satisfaction;
 Reduced administrative cost;
 Standardization of processes and documentation;
 System uniformity and optimization;
 Continuous improvement;
 Quality improvement projects to produce positive impacts on revenue.
The Healthcare Improvement Model
The Healthcare Improvement Model was created
to visualize the integration of ISO and PI. The
model uses a five-tier approach to infuse
continuous improvement at all levels of the
system. As the model shifts from tier to tier, the
requirements and responsibilities for PI intensifies.
This places the burden of responsibility for
sustained improvement and financial growth at
the local as well as the system level.
The Healthcare Improvement Model continues to rotate feedback throughout the
system. This ensures that everyone understands the main objectives created to promote
patient safety first, followed by continued financial growth.
Top of the House – Tier I:
At the system level, executive leaders set the vision and quality objectives for the entire
health care system. The quality objectives are tracked through a balanced scorecard or
similar tracking tool at the system level. The metrics are determined by national best
practices, benchmarks and health care analytics. At the system level, transparency is
vital to improving the health care organization. The health care system’s vision and
objectives filter throughout the entire healthcare model thereby creating a culture of
continuous improvement.

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System Quality and Safety Team – Tier II:
To achieve cultural transformation with sustainability, the system must create and
leverage a quality and safety team to develop, guide, control and execute a high
performing quality management system. Along with this robust QMS, a strategic
approach must be developed for how the system is audited with proper protocol for
resolving nonconformities. Tier II develops the PI strategy, facilitates training and
coach local level executives and PI resources.
The PI strategy dictates training requirements, certifications, project development and
execution as well as sets parameters for project success. Through PI education, the team
is able to dispatch future subject matter experts to manage projects at the system and
local level. While PI isn’t new to health care, integrating ISO and PI is a fairly new
approach. A team of experts will be needed to manage its implementation and success.
Having a systematic approach to improving and sustaining quality requires a high
performing quality management system.
To continually execute the standards of this robust system requires tools that can
identify and resolve root causes to all nonconformities. This is where ISO and PI are
amalgamated to produce system optimization and process sustainability. At the Tier II
level, the system quality and safety team ensures all services provided to our patients
are safe and reliable.
To achieve this goal with excellence, metrics and tools must be in place to continually
audit the process and effectiveness of the staff. In addition to resolving nonconformities,
the integration of ISO and PI gives the system quality and safety team the ability to
predict and solidify financial gains for the system.
Executive Level – Tier III:
The executive level tier III is responsible for the top leadership of the local hospitals
within the health care system. The role of the executive level is to assess, prioritize and
delegate quality improvement projects including a strategic plan.
Data is reviewed from across the organization and top leadership provides resources,
promotes improvement and establishes accountability for the effectiveness of the
quality management system. In addition, they are required to perform a management
review of all the nonconformities, identify risk and opportunities to ensure safe delivery
of quality care. The executive level will be the liaison between tier IV and tier II. There
should also be some form of local quality and safety support personnel to assist in
meeting the system’s quality objectives. The executive level will consider all financial
ramifications to determine what PI projects will best improve and sustain the overall
quality management system (ISO). Through these efforts, the executive level

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disseminates the most important projects to tier IV to complete and report results back
to the executive level tier III as well as the foundation (i.e., frontline) tier V.
Management Level – Tier IV:
Most of the quality performance improvement work will take place at this level.
Managers trained in PI should execute the performance improvement projects for their
respective department or service line. The trained PI leaders will use PI tools to identify,
validate and resolve the root cause of nonconformities and other identified risk.
This level must be the voice for continuous improvement throughout the culture. This
will assure the quality management system (ISO) operates at its highest efficiency. The
management level will ensure standardized processes, policies and procedures are
implemented and effective. This level alongside tier V will constantly look for
opportunities to improve the experiences and outcomes of all patients served.
Collaboration and communication with both tier III and tier V will be the key to success.
This level is the quality champion for the health care system.
The Foundation – Tier V:
When you think about the foundation of any organization it is impossible to believe
that success is achievable without frontline employees. Frontline employees are the
foundation of every process improvement project. They are the true subject matter
experts and catalyst for change. Their support, buy-in, and ownership will be needed to
improve any process, policy, procedure or system. In order for ISO and PI to work in
unison, frontline employees must be trained and empowered to identify and resolve
nonconformities. This requires a cultural shift in behaviors, roles and responsibilities.
At this level, front-line employees will be the gate-keepers for processes, policies and
procedures. Any improvement work filtered down from tier III and tier IV must be
methodical and purposeful for this group to commit to the change. In addition, this
group must feel valued by tiers I through tier IV to guarantee sustainability and
continuous improvement. Tier V will need to receive basic PI training to support
improvement and lead small projects within their service lines.
Toyota continues to have great success because management realizes that their
employees are the key to success. Top level executives empower their teams to
consistently identify and resolve nonconformities on a daily basis. What is so awesome
about the Toyota Production System is that it is not a respecter of position. All of
Toyota’s employees have the authority to stop the flow of work to resolve any and all
nonconformities identified.

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Small scale PI is not always a project to project basis at this level of the model. It is a
continuous effort to identify nonconformities within the tier V sphere of influence. This
creates a culture that believes in completing work at the highest level of efficiency and
keeping safety first. Therefore, the health care improvement model considers frontline
employees the foundation of the model.
The Flywheel and Gear – The Integration of ISO and PI:
It is imperative to integrate ISO with the tools used to develop and execute a process
improvement initiative. It is true that both ISO
and PI can stand alone and operate in silos.
However, this will make it very difficult to drive
continuous improvement and sustainability
throughout the entire healthcare system. ISO
creates the framework through systematic
definitions and management of processes and
their interactions. 5
Process improvement provides the tools needed to
reveal root causes, create standardized processes
and resolve identified nonconformities. Both ISO
and PI require great commitment and
understanding and can yield immense high-
quality care in any health care system.
The Flywheel of the model is ISO driven and therefore provides the requirements
needed to reduce cost, create system uniformity, standardize processes and
documentation, and promote efficiency in resource
utilization.
In addition, ISO provides a framework on how to identify
nonconformities through internal audits and risked based
thinking. However, it does not provide the tools needed to
resolve the opportunities for improvement. PI is the check
and balance for the quality management system. Its main
purpose is to monitor and resolve nonconformities in the
quality management system. It uses data received from what
the model calls the gear to process and analyze root causes to process and system
failures. It then creates corrective and preventive action plans for implementation at the
local and system levels. PI is the workhorse of the two that yields the results of a high
5
ISO 2015 – Reference number ISO 9001:2015(E)

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performing quality management system. ISO and PI both drive continuous
improvement. By constantly focusing on action plans through monthly, quarterly or
even annual updates, leadership is able to track the progress at the local and system
level ongoing.
Data is the gear that drives the impact of the flywheel. It rotates and provides the
information needed for the local and system to complete risk assessments, strategic
planning and management review. All of this information is filtered back up through
the entire health care system impacting quality and financial results.
Conclusion
The integration of ISO and PI will be the catalyst to launch every health care system to
the next evolution in its pursuit of excellence in patient care. This is a continuous
improvement journey. Determination is the key factor in standardizing processes,
policies, and procedures. Once adopted, the health care system’s financial blueprint will
consistently exceed expectations. This is due to its insatiable appetite to constantly look
for ways to eliminate waste within its processes. Implementing the health care
improvement model will not only position your organization to apply for any top
quality prestigious award, it will act as a constant reminder of our promise to always do
what is best for our patients.

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Reference Materials:
 The Essential Guide to Health Care Quality by National Committee for Quality
Assurance
 The ISO Story – www.iso.org
 Baldrige FAQs – www.nist.gov
 Shingo Prize – www.shingoprize.org
 Lean Enterprise – www.lean.org
 Six Sigma – www.isixsigma.com
 Six Sigma Certification – www.iassc.org

ISO Meets PI

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