INSIGHT REPORT

BEYOND
COMPLIANCE:
Build a Center of
Operational Excellence
(OpEx) on ISO 9001:2015
Contents
Introduction..................................................................... 1

ISO 9001:2015 Principles and Practices......................... 2

The Anatomy of ISO 9001:2015 Failures......................... 4

Moving Beyond Compliance........................................... 5

From Compliance to Excellence: A Cultural Shift...... 6

True Executive Commitment: Clear,
Consistent, and Daily............................................... 7
An Organizational Backbone: Process
Clarity and Strategic Alignment............................... 7
A Single Source of Truth.......................................... 8
Integrating Risk-Based Thinking.............................. 8
Link Excellence to Financial Impacts....................... 8

Structures for Success.................................................... 9

The Bottom Line.............................................................. 11

References...................................................................... 11

About the Authors........................................................... 12

About Intelex................................................................... 12

Disclaimer
This material provided by Intelex is for informational purposes only. The material may include notification of regulatory activity, regulatory explanation and
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Introduction
If your organization is ISO 9001 certified (or on its way), but you still feel like you’re
struggling to satisfy customers, deliver products and services on time, and consistently
achieve your goals and objectives—you’re not alone. While some organizations report
reduced costs and improved quality and productivity from their ISO 9001
implementations, others have reported inconsistent or disappointing results on all
scales. These can include increased costs, lower morale, added bureaucracy, and even
business failure.

Although the number one reason for pursuing ISO 9001 certification is to
become an authorized supplier for key customers, there are other reasons
that companies establish a quality management system (QMS).
Documenting processes, understanding how they generate business
value, and keeping records of those processes in action increases
visibility throughout the organization. This helps front line workers,
supervisors, and executives make better decisions more quickly and more often.

Compliance, however, only indicates that minimum requirements of the standard are
met. True excellence, in contrast, requires aiming far beyond these goalposts. An
organization can comply with the standard without being officially certified by third party
auditors but cannot be certified without demonstrating compliance. While management
system standards provide a framework for organizing and coordinating aspects of the
business, they are not a panacea. Like agile and lean, unless the core values of the
practices are internalized, the entire system can be at risk.

To ensure continuous flow of value and to consistently delight customers, the goals you
set for your organization should far exceed the minimum requirements of a management
system standard. Fortunately, ISO 9001:2015 provides a solid foundation for achieving
organizational excellence. In contrast with earlier revisions, this one takes a more
strategic perspective on the business and can be used to help everyone in the
organization develop quality-minded habits and practices.

Ultimately, it is the people in an organization who make quality systems work. This Insight
Report will show you how to begin the culture change that will transform your QMS into a
foundation for organizational excellence and support continual improvement to reap the
benefits of improved efficiency and visibility.

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ISO 9001:2015 Principles and Practices
Many of the management philosophies that have been widely used since the 1980s share
the same core principles. Whether you’re implementing Total Quality Management (TQM),
Toyota Production System (TPS), Lean, Six Sigma (as a management philosophy), the
Baldrige Excellence Framework (BEF) or the European Foundation for Quality Management
(EFQM) to systematically improve all areas of operations, you will rely on first principles that
guide day-to-day work as well as strategic initiatives.

For ISO 9001, these principles are:

• customer focus
• leadership involvement
• process orientation
• continual improvement
• employee engagement
• data-driven decision making, and
• systematic risk management.

Examples of ISO 9001 practices that can help organizations realize these principles
include the following:
• Establishing, monitoring, communicating, updating, and planning to achieve quality
objectives (Clause 6.2.1).
• Managing resources, including people, infrastructure, environment, monitoring and
measurement resources, and organizational knowledge (Clause 7.1).
• Determining, assessing, developing, and continually improving workforce competency
(Clause 7.2).
• Document management and control (Clause 7.5.1).
• Planning, determining, controlling, and reviewing operations processes (Clause 8.1).
• Controlling nonconforming outputs (Clause 8.7).
• Determining monitoring and measurement needs and retaining evidence of results
(Clause 9.1).
• Organizing, scheduling, and managing the actions that arise from management
reviews (Clause 9.3).
• Determining and selecting opportunities for improvement, including corrective (CAR/
CAPA) and preventive actions (Clause 10).

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When implemented properly, ISO 9001 practices are cross-functional and
establish discipline, promote alignment and communication, and provide a
common language to communicate a commitment to quality to external
organizations. But many organizations fall easily into a trap: installing practices to
“check the box” for compliance without carefully considering how those practices
advance or impede overall quality objectives.

For example, consider a company that rigorously manages documents. They have
a process for creation, for routing and approval, and for making updates. But
without policies that explain what documents should be controlled, who they
should be shared with, and why they should be created in the first place, an
organization may be inadvertently creating additional bureaucracy, increasing
costs, and increasing confusion.

The ISO 9001:2015 revision, in fact, has minimal documentation requirements.

This encourages companies to focus on the processes that enable quality, rather
than the laborious processes that create documentation:

“Just as every document should have a purpose, every training, audit,

and data collection initiative should have a purpose. A company should
never write a document, conduct an audit or training, or collect data
unless there is a clear objective. Audits should be done only on
processes that are not performing, have new people, or are high risk.
Don’t audit for the sake of auditing. Never write a document for the sake
of writing a document, either; write only what is required and what makes
processes simpler. Remember to identify the process and its purpose.
There is no reason why any company can’t choose to work smarter
rather than harder.”—Kelly (2018)

The quality management system should serve the company, making it easier
to communicate internally and externally, drive value, and satisfy customers
with high quality products and services. But too often, the QMS holds the
company hostage because too little time is spent asking why practices have
been implemented.

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The Anatomy of ISO 9001:2015 Failures
Companies can be ISO 9001 certified and still go out of business. How is this possible?
In short, having systematic processes, following them, and continuously improving them
doesn’t matter if those processes fail to deliver clear, quick, and constant value to your
customers.

In cases where ISO 9001 fails (that is, the company may be certified but fails to meet its
business goals), practices typically overwhelm principles. A practice is carried out
regardless of whether the underlying reasons for having that practice are satisfied. This
can lead to a QMS that’s bloated, with unnecessary forms and processes that must be
followed to remain compliant—but don’t actually help move the business forward.

“Most quality programs fail because organizations don’t understand the

difference [between] managing quality and managing for quality. Managing for
quality is the concept that the organization business processes are designed,
maintained and improved to incorporate proper quality principles and
practices. So, quality and customer satisfaction become the natural result of
running the organization’s business processes.”—Sidney Vianna, Quality
Executive, DNV GL

When adopting ISO 9001, it is important to reflect

on why you are adopting each practice, and what Business
you want to accomplish as a result. For example,
Quality Processes
Processes
Clause 7.5.1 documentation requirements don’t Superimposed on
Implement Quality
prescribe that you create uniformly formatted, the Business
Requirements
metadata-rich, laboriously produced word-
processed files—although that’s how many FIGURE 1
organizations interpret it. The clause does require that certain kinds of information be
available, maintained, or retained. But it’s up to the organization to decide the best way to
capture and share this information.

When organizations use ISO

9001:2015 or any other
management system as a checklist
rather than a tool for deep and
reflective self-study, the value of
the approach is depleted. To avoid
failure, keep your QMS simple and
strategic! When ISO 9001 becomes
invisible—with requirements
embedded into business processes
instead of overlaid on them, and
process owners who are
responsible for quality instead of
quality personnel who have to
“police” process owners—you
will have a better foundation
for success.

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Moving Beyond Compliance
What does it mean to “move beyond compliance” and towards excellence? Shaw (2012)
provides a practical example from environmental management. Instead of just assessing
direct greenhouse gas (GHG) emissions, she asks, why not go deeper—and map the
entire product lifecycle, maybe even to the subsystem level? This way, an organization
can gain insights from leading indicators—metrics that describe conditions that lead to
emissions. By understanding the system at this level, actions can be taken to prevent and
control emissions rather than just monitoring them.

Compliance requires measuring and reporting emissions and making sure they fall within
acceptable limits. Going beyond compliance means understanding why those emissions
are what you measured, how they might be more carefully controlled, who might be in a
position to do so, and setting up the appropriate processes and controls to become more
mindful about emissions on an organizational scale.

Moving beyond compliance means looking at business processes and quality

requirements holistically. For example, consider what happens when you shift from a
compliance-oriented view of a Corrective Action/Corrective and Preventive Action (CAR/
CAPA) process to an excellence-oriented view, as shown in Figure 2:

Compliance-Focused Corrective Excellence-Oriented Corrective

Actions (CAR/CAPA)
• Implement software to help you
log and track CAPAs.
• Deploy it uniformly across sites,
facilities, and functional areas.
• Keep track of how many CAPAs
are launched and time to
resolution.
• Launch continuous improvement
efforts/kaizen events if time to
resolve exceeds thresholds or
targets.
Actions (CAR/CAPA)
• Understand where CAPAs originate,
and why: customer complaints,
nonconformances, internal or third
party audits, management reviews,
and/or other sources.
• Implement software to help you log
and track CAPAs and CAPA sources;
keep track of linkages to ensure
traceability.
• Examine trends and root causes to
proactively address the underlying
issues that produce the most CAPAs.

FIGURE 2

By adopting systems thinking, it is easier to find and address the

root causes of issues that lead to customer dissatisfaction and
internal inefficiency.

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From Compliance to Excellence: A Cultural Shift
Maintaining compliance and becoming ISO 9001 certified isn’t a painful process when an
organization’s leaders are committed to excellence. These are some of the ways that a
compliance-focused environment differs from an excellence-oriented one:

Compliance Excellence

To achieve understanding, facilitate

Why To achieve or maintain certification by a required date.
Beg for support; convince people to participate in risk
assessments, nonconformance triage, complaint
How
handling, and cross-functional communication to enable
smoother operations.
communication, improve visibility, and catalyze
collaborative continuous improvement.
Trust individuals to carry out their roles according
to shared values and principles; quality becomes
a habit, embedded in business processes to the
point where systems like ISO 9001 become
invisible, and doing the right things the right ways
becomes second nature.

Whenever required to support the internal and third party In regular and predictable cycles; daily;
When
audit schedule. continuously.

Who Quality manager; quality department. Everyone in the organization.

Consistent, meaningful executive support; strong

organizational backbone of cross-functional
Executive support or dictate; enough documentation
Requires processes that are documented in meaningful,
and records to satisfy third party auditors.
useful ways (e.g. videos) and supported and
followed.
Leading indicators: results from preventive
Lagging indicators: number of nonconformances, time to
maintenance, employee engagement, safety
resolve nonconformances, number of complaints, time
Metrics engagement, audit completion rates, open
to resolve complaints, number of corrective actions, time
corrective actions, recurring corrective actions,
to resolve, etc.
results from quality training, etc.
People spend hundreds of hours preparing for audits;
Always ready for audit, and always confident that
lack of confidence that certification will be obtained due
Audits audit results will reveal meaningful opportunities
to open challenges and issues; pervasive fear and worry.
for improvement. Auditors are welcome helpers.
Auditors are a necessary evil.

FIGURE 3

To move beyond compliance, your organization will need the following:

• True executive commitment—actions, not just words.
• An organizational backbone—not just courage, but structures for success.
• A single source of truth—meaningful knowledge management.
• A risk-based focus—adopt systems thinking to anticipate priorities.
• A link between excellence and financial impacts—make quality
financially meaningful.

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The following sections explain each of these concepts and how to make
them actionable.

True Executive Commitment: Clear, Consistent,

and Daily
Some organizations think “top management support” means that the
executive team and senior leaders are in favor of getting ISO 9001
certification. Posting the quality policy on the walls of your office (and on
your web site) and reciting slogans at all-hands meetings surely lets the
workforce know you are committed to quality, right?

But true executive commitment happens moment by moment, in the

words leaders use during meetings, in the data-driven decisions they
make on a weekly and monthly basis, and in the financial decisions that
shape budgets. If your organization’s quality and continuous
improvement managers have trouble getting or keeping a budget,
genuine executive commitment is not in place. If senior leaders show up
to Management Review meetings unprepared and disengaged and are
simply putting in the face time so they can quickly “get back to real
work”—genuine executive commitment is not in place.

Even if they are not directly involved in the day-to-day management of

quality, executives and senior leaders must adopt a “Quality Mindset”—
and embed quality consciousness into their leadership approach. They
must understand why all the sections and clauses matter, and the impact
that addressing each clause can have on operations. Quality is not an
add-on, but a lens through which all business processes—including
strategic management—should be examined.

An Organizational Backbone: Process Clarity and

Strategic Alignment
A system of policies, procedures, and guidelines to coordinate people,
processes, and technologies provides navigational memory for everyone
in your organization. An organizational backbone consists of digital
systems supported by systematic, repeatable processes, and is one of
the critical support structures for companies undergoing digital
transformation. (Roth et al., 2019; Radziwill, 2020) In addition to clear,
consistent executive commitment, this backbone requires the following:
• A framework for translating strategic objectives into action plans.
• Clear roles, responsibilities, and accountability.
• Standard work/descriptions of work processes.
• Value stream maps to support continuous flow of value in production.
• Workforce capability and capacity development.
• Framework for continuous organizational learning.
• Effective communication channels between customers, suppliers,
collaborators, workforce, and leaders.

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Lacking solid processes or having processes that are out of date or not aligned with
reality will hold your organization back. But an accurate and consistent frame of reference
will strengthen all processes, projects, and initiatives. (Radziwill & Simmons, 2020)

A Single Source of Truth

Effective knowledge management is just as important as the documented processes that
people rely on every day to do their jobs. Data-driven decisions are no good, after all,
when the data supporting them is of questionable quality. Establishing systems of record
can help to reduce the ambiguity introduced by too many data repositories. How do you
know if data should be in a system of record? Hurst (2019) recommends the following
guidelines:
• The data is used to run a mission-critical business process.
• It is proprietary or high value.
• Many employees interact with it daily or weekly.
• It is needed for important business decisions.
• It captures knowledge that the business needs even if the
employee leaves.
• It is enhanced and improved over time.

When people consult divergent sources of information to solve

critical business problems, they are only guaranteed one thing:
confusion. A “single source of truth” (which does not have to be a single
repository) should be created and treated as a core asset. Knowledge
management, particularly for core business processes, is essential to shift from
compliance to excellence.

Integrating Risk-Based Thinking

As quality cost models demonstrate, issues cost more the longer it takes to detect
them—and when nonconformances aren’t detected, the potential for customer
dissatisfaction, recalls, warranty claims, and loss of reputation increases dramatically.
Risk-based thinking, which was introduced as a requirement in ISO 9001:2015, can
highlight areas where organizations should focus to systematically reduce the likelihood
of problems.

Risk assessments draw out nonconformances, customer complaints, and other

challenges that haven’t happened yet. (Jaine, 2019) By taking an anticipatory approach,
companies can be proactive about how they study and continually improve their business
processes. In complex organizations (or when time or budget is limited), risk assessment
can be focused on mission-critical departments and business processes.

Link Excellence to Financial Impacts

Finally, for optimal impact, encourage business process owners to consider the financial
ramifications of all processes. For example, can you describe the benefit that resolving a
nonconformance brings (or similarly, describe the costs of not addressing it)? Can you
characterize issues in terms of lost revenue or abbreviated financial growth? Management

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will always care about activities that impact the bottom line, and nonconforming products
or processes can be costly. Although true executive commitment should already be in
place, speaking to your most senior leaders in the language of finance can engage them
more directly with the pursuit of cross-functional excellence.

Structures for Success

How can your organization tie all of those elements together in a consistent and effective
manner? Fortunately, robust OpEx frameworks are already available, including the
Baldrige Excellence Framework (BEF) and the European Foundation for Quality
Management (EFQM). BEF—an approach to strategy execution that has been continually
improved by senior leaders from all industries over three decades—asks organizations to
critically examine seven interconnected areas:
1. Leadership. Senior leaders set the tone by establishing the vision, mission, and
values, developing protocols for governance and robust communication, and creating
the conditions for success. Senior leaders model the behavior they wish to see
throughout the organization.
2. Strategy. A solid process for identifying a strategy is key, but it must be supported by
development of relevant core competencies, development and execution of action
plans, and timetables that are matched to resource availability.
3. Customer Focus. Figuring out what customers want should be a data-driven, holistic,
continuous process. Mapping customer needs to product and service offerings that
appeal to defined customer segments will influence the potential for success.
Actionable plans to engage those customers should also be included.

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4. Data and Knowledge Management. Measuring and improving performance based on
data is also critical. These criteria questions help organizations avoid “data silos” and
decision making based on incomplete information.
5. Workforce Management. Strategic objectives can’t be realized without capable,
engaged, motivated employees who have manageable workloads. A solid workforce
management plan emphasizes retention and helps the organization understand how
to adapt to changing needs.
6. Operations. Work processes are developed to establish how inputs are transformed
to outputs and provide a basis for growth and innovation. Understanding how
those work processes align with processes in the broader supply network can
also impact success.
7. Results. Processes and structures are only as good as the results they can achieve.
The final category links each of the previous categories to overall performance.

Many organizations that adopt the Baldrige Excellence Framework also implement
standards like ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018. But incorporating
an excellence model can lead to 10x performance improvements. Hertz (2019) explains
the linkages between ISO 9001:2015 in depth and outlines exactly how companies can
step up their 9001 game by incorporating these unique aspects of Baldrige:
• Ethics: Demonstrating and monitoring ethical performance; ensuring transparency.
• Governance: Achieving responsible governance through oversight of senior leaders.
• Societal Contributions: Supporting and strengthening local, regional, and
professional communities.
• Security and Cybersecurity: Attending to sensitive or privileged data, information,
systems, and processes.
• Risk: Identifying “intelligent risks” as opportunities for innovation.
• Results: Processes are only as good as the results they produce. BEF articulates a
framework for workforce, leadership and governance, as well as financial, market, and
strategy results.

The added value of using

the Baldrige Excellence
Framework in addition to
these standards is that it
encourages organizations
to think holistically. By
drawing out the
connections between
people, processes, data,
and technologies, silos
can be eliminated from
the organizational design.

FIG. 4. FROM HERTZ (2019)

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The Bottom Line
Compliance is just the beginning. To get more value out of your QMS
investment, think about ISO 9001:2015 as the foundation for a center of
excellence. Put your business processes first and work with process owners to
embed ISO 9001 requirements everywhere so that the QMS becomes invisible
to your workforce. When compliance is practiced and achieved as a natural
outcome of solid business processes, the undesired bureaucracy and overhead
of compliance (and related financial and human costs) decreases.

One way to jump start the process is to do a self-study using the Baldrige
Excellence Framework (BEF), a guidebook for operational excellence that
encourages organizations to think holistically. When companies draw out the
connections between people, processes, data, and technologies, silos can be
eliminated from the organizational design. OpEx frameworks like Baldrige help
organizations more mindfully manage change, transformation, and growth.

References
Freeman, G. (2018). Integrating Quality and Safety in Organizational Culture: A Cross-Industry Look. Intelex Insight Report. Available from
https://www.intelex.com/resources/insight-report/integrating-quality-and-safety-organizational-culture
Freeman, G. (2018). How to Leverage QMS Software to Promote a Culture of Quality. Intelex Insight Report. Available from https://www.
intelex.com/resources/insight-report/how-leverage-qms-software-promote-culture-quality
Gordon, D. K. (2005). Unintended consequences. Quality Progress, 38(7), 78.
Hertz, H. (2019, February 21). Is Good, Good Enough for You? Taking the Next Step After ISO 9001:2015. Blogrige. Available from https://
www.nist.gov/blogs/blogrige/good-good-enough-you-taking-next-step-after-iso-90012015
Hohan, A. I., Olaru, M., & Keppler, T. (2015). Integration of risk management practices in the framework of an integrated management
system environment-health and safety-information security. Calitatea, 16(1), 289295. -- INTEGRATING RISK
Hoyle, D. (2017). ISO 9000 Quality Systems Handbook - Updated for the ISO 9001: 2015 standard: Increasing the Quality of an
Organization’s Outputs. Routledge.
Hurst, H. (2019). 5 Systems of Record Every Modern Enterprise Needs. Available from https://www.workfront.com/blog/systems-of-record
Intelex (2014). Reduce the High Cost of Poor Quality: Top 5 Strategies for Managing NCRs and CAPAs. Intelex Insight Report. Available
from https://www.intelex.com/resources/whitepaper/reduce-high-cost-poor-quality-top-5-strategies-managing-ncrs-and-capas
Jaine, N. (2019, September 26). ISO 9001 and Top Management Support: What if You Don’t Have It? Intelex Community. Available from
https://community.intelex.com/explore/posts/iso-9001-and-top-management-support-what-if-you-don%E2%80%99t-have-it
Kelly, B. (2018, December 20). ISO 9001: It’s About the Records, Not the Documents. Quality Digest. Available from https://www.
qualitydigest.com/inside/standards-column/iso-9001-it-s-about-records-not-documents-122018.html
Kumar, D. A., & Balakrishnan, V. (2011). A study on ISO 9001 Quality Management System Certifications: Reasons behind the failure of
ISO certified Organizations. Global Journal of Management and Business Research, 11(9).
Radziwill, N. M. (2020). Connected, Intelligent, Automated: The Definitive Guide to Digital Transformation with Quality 4.0. ASQ Quality
Press, Milwaukee WI, 545 pp.
Radziwill, N.M. & Simmons, R. (2020, February 24). Lean Transformation Lessons for Students and Practitioners. ASQ Lean Six Sigma
Summit, Phoenix AZ.
Ross, J. W., Beath, C. M., & Mocker, M. (2019). Designed for Digital: How to Architect Your Business for Sustained Success. MIT Press.
Shaw, B. (2012, December). Guinness Anchor Berhad Brewing Sustainability Beyond Compliance. Imperial Capital Report. Available from
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Vianna, S. (2011, May 26). Why do so many ISO 9001 Implementation Programs Fail? Elsmar Cove. Available from https://elsmar.com/
elsmarqualityforum/threads/why-do-so-many-iso-9001-implementation-programs-fail.48481/

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About the AuthorS
NICOLE RADZIWILL
Nicole Radziwill is SVP Quality & Strategy at Ultranauts Inc. She is a Fellow of the American Society for
Quality (ASQ), a Certified Six Sigma Black Belt (CSSBB), a Certified Manager of Quality and Organizational
Excellence (CMQ/OE), and editor of Software Quality Professional with a PhD in Quality Systems from
Indiana State. She is one of ASQ’s Influential Voices and blogs at http://qualityandinnovation.com.

NICKY JAINE
Nicky Jaine is the Director, Quality at Intelex Technologies, ULC. She is a Continuous Improvement leader
and advocate for “quality” over “Quality.” Nicky’s articles have been published on LinkedIn and by the
Canadian Broadcasting Corporation (CBC).

About Intelex
Intelex Technologies, ULC is a global leader in environmental, health, safety and quality (EHSQ)
management software. Since 1992 its scalable, web-based platform and applications have helped
clients across all industries improve business performance, mitigate organization-wide risk, and
ensure sustained compliance with internationally accepted standards (e.g., ISO 9001, ISO 14001, ISO
45001 and OHSAS 18001) and regulatory requirements. Virgin Atlantic, Brinks, Air Liquide, Lafarge,
Volvo and over 1,300 customers in 150 countries trust Intelex to power their EHSQ initiatives. Intelex
is one of North America’s fastest-growing technology companies, recognized as a Great Place to
Work for over 7 years, recipient of Waterstone’s Most Admired Corporate Cultures award, and
Deloitte’s Best Managed Companies award. For more information, please visit www.intelex.com.

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