ISO 9001:2015 vs.

Six Sigma:
A comparison

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Table of Contents

Introduction ...........................................................................................................................................3
Understanding the basics of ISO 9001:2015 and Six Sigma .....................................................................3
Main differences between ISO 9001:2015 and Six Sigma .......................................................................4
Process approach in ISO 9001:2015 and Six Sigma .................................................................................6
Mapping of the ISO 9001:2015 clauses with the DMAIC roadmap phases..............................................8
ISO 9001:2015 & Six Sigma linkages .......................................................................................................9
Combining ISO 9001:2015 with Six Sigma ...............................................................................................11
Useful resources ...................................................................................................................................11
References............................................................................................................................................12
About the author..................................................................................................................................12

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Introduction
Many companies today are seeking to differentiate themselves in an increasingly global market,
improving the quality of their products or services. But what is the best way to reach this “quality
improvement”? Among the most recognized and proven options are ISO 9001, an international standard,
and the initiative named Six Sigma. In this white paper, we will compare both options and evaluate how
their combination can bring benefits for businesses.

Understanding the basics of ISO 9001:2015

and Six Sigma
ISO 9001 is an internationally recognized standard for creating, implementing, and maintaining Quality
Management Systems (QMS). The last review of the standard was conducted in 2015 and published by
ISO (the International Organization for Standardization), so it is referred to as ISO 9001:2015. According
to the International Organization for Standardization, more than 1 million organizations have been
certified to ISO 9001 in more than 170 countries.

Any organization – regardless of its size, sector, or industry – can use ISO 9001 to create a quality system
that will ensure not only customer satisfaction, but continual improvement as well. In addition, many
companies require their suppliers to be certified in ISO 9001, so it can also be seen by the company as an
opportunity to open to new marketplaces.

Customer focus, top management involvement, a process approach, and continual improvement are the
main quality principles found in ISO 9001.

Six Sigma was developed by Motorola in the late 1980s when they were having trouble meeting the
quality targets for their products. Since then, Six Sigma has become one of the most widely used
methodologies for improvement and has been broadly implemented in all kinds of industries and sectors.

This initiative is carried out firstly, by identifying the causes of variation in organizations and secondly, by
eliminating those causes. Six Sigma methodology is used in many organizations that seek to reach a
systematic, highly disciplined, profit-driven, and structured framework within all business operations. The
initiative uses specific tools, methods, analysis, techniques, statistical tests, and templates to achieve the
continual improvement of the processes within the organization. Also, it requires a strong leadership
commitment that will ensure its implementation success, as well as the existence of a role structure
known as a “belt system,” which has different levels of responsibilities, competence, and qualifications.

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Main differences between ISO 9001:2015
and Six Sigma
While ISO 9001:2015 is a set of requirements used for the development of a Quality Management System,
Six Sigma is only a series of tools and methods applied to enhance the different processes of an
organization. In other words, ISO 9001:2015 doesn´t prescribe any tools or techniques to use in the
implementation, and Six Sigma doesn´t have those standardized requirements that are recognized at an
international level.

Below you can find a table showing the main differences between ISO 9001:2015 and Six Sigma.

COMPARISON ISO 9001:2015 SIX SIGMA

Framework Continual improvement
Purpose Demonstrate ability to consistently
provide products and services that
meet customer and applicable
statutory and regulatory
requirements. Demonstrate ability
to enhance customer satisfaction
through the effective application of
the system.
Intent Achieve certification or
contractual agreements
Scope States the requirements for the
implementation of a Quality
Management System.
Leadership Top management must
demonstrate leadership and
commitment with respect to the
Quality Management System and
customer focus.
Improvement Method PDCA (plan-do-check-act) cycle
Techniques/Tools There are no determined or
specific tools to be used by
organizations.
Continual improvement and
profitability
Improve products and services, and
processes associated that increase
the value delivered to customers,
seeking to reach sustainable
business growth and enhance
profits.
Maximize performance and increase
profits
Seeks to enhance the organization’s
performance through different
methodologies, tools, strategies, and
metrics.
Top management plays a key role at
every stage, because Six Sigma is
considered a management strategy
that focuses on increasing margins.
DMAIC (continual improvement) or a
DFSS (new designs or design
changes) roadmap
Large selection of tools for use.

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 COMPARISON ISO 9001:2015
Responsibilities Responsibilities and authorities
for relevant roles within the
Quality Management System must
be assigned, communicated, and
understood within the
organization. Top management
must define the structure,
hierarchy, and lines of reporting.
Competence Establish the competency
requirements (appropriate
education, training, skills, and
experience) of the people doing
the work under the organization´s
control (including contract / agency
workers and any personnel
undertaking outsourced work) that
affects the performance and
effectiveness of the management
system.
Financial Benefits Implementation of the standard
brings many benefits, such as
financial benefits; however, these
usually are not measured.
SIX SIGMA
Includes specific functions and
responsibilities that need to be
assigned, i.e.: Champion, Sponsor,
Process Owner, Master Black Belt,
Black Belt, and Green Belt.
Sets a belt infrastructure (Black Belt,
Green Belt, Yellow Belt) with
different qualification requirements
(including education, training, skills,
etc.) to carry out the methodology at
distinct levels of the organization.
Great savings have been quantified
by organizations after conducting
this methodology.

Documentation
Major Limitations
Some mandatory documented
information is required to be
maintained (documents) and
retained (records).
There are no financial
requirements related to increasing
the organization´s profits.
The initiative does not prescribe any
mandatory documentation.
Availability of a considerable
amount of data to carry out some
methods and tools. In addition,
there are some statistical
assumptions that are not justified
very well.
Although the initiative is very good
for competing on cost, improving
margins, improving physical
productivity, and improving
efficiency, it is bad for competition
based on service / customization or
innovation / design.

Table 1: Main differences between ISO 9001:2015 and Six Sigma

For more information, see: ISO 9001 vs. Six Sigma: How they compare and how they are different.

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Process approach in ISO 9001:2015 and
Six Sigma
Both ISO 9001:2015 and Six Sigma use a process approach when applying their different requirements
and methodologies, which is based on a cycle of continual improvement.

In ISO 9001, the PDCA (Plan-Do-Check-Act) cycle is used. This approach is not one of the standard
requirements, but it is promoted by ISO 9001. The cycle is a dynamic process approach that consists of
planning, implementing, controlling, and continual improvement of company processes. It can be applied
to every process, from management review to product realization, and the organization can decide to
apply this cycle to the main process, to smaller processes, or to a group of processes.

Requirements contained in the different clauses of ISO 9001:2015 can be linked to each phase of the
PDCA cycle, as shown in Figure 1.

• Context of the • Support (7)

organization (4) • Operations (8)
• Leadership (5)
• Planning (6)

PLAN DO

ACT CHECK
•Improvement •Performance
(10) evaluation (9)

Figure 1: PDCA process approach and related clauses in ISO 9001:2015

For more information, see Plan-Do-Check-Act in the ISO 9001 standard.

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Six Sigma uses two different methodological approaches, both of which are based on the PDCA cycle:

 The DMAIC (define-measure-analyze-improve-control) roadmap seeks to improve the processes

by minimizing the variability of the most important inputs of that process.
 The DFSS (design for Six Sigma) approach is used to design a new process, or to redesign or re-
engineer it. It is not utilized for improving a process that already exists. The most common
roadmaps used to perform a DFSS project are the acronyms identify-design-optimize-validate
(IDOV) and define-measure-analyze-design-verify (DMADV).

The following figure explains every phase of the DMAIC roadmap:

• Understand customer requirements and expectations for products/services.

• Define the boundaries of the process under investigation.
DEFINE • Map the process flow of the process to be improved.

• Determine a plan for data collection of the core business process involved.
• Use several sources of data collection to identify defects and metrics.
MEASURE • Compare with customer satisfaction outcomes to determine deficiencies.

• Understand gaps between current performance and your performance

objectives.
• Establish a hierarchy for potential opportunities to improve.
ANALYSE • Determine sources of variation.

• Create solutions and test them utilizing technology and discipline.

• Develop a sustainable implementation plan for the improvements.
IMPROVE • Implement planned solutions and monitor their outcomes.

• Ensure that sustainability criteria are fulfilled (i.e., training, communication,

development of new procedures, etc.).
• Extend the knowledge to other adequate parts of the organization.
CONTROL • Check the project for new improvements.

Figure 2: DMAIC Phases description (adapted from Graeme Knowles (2011) “Six Sigma”)

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Mapping of the ISO 9001:2015 clauses
with the DMAIC roadmap phases
Therefore, we can confirm that both systems, ISO 9001 and Six Sigma, use a similar approach: a cycle for
continual improvement. Whenever those improvements are conducted, this approach allows the
organization to make any necessary corrections or consolidate the change made.

Below you can learn how each phase of the DMAIC roadmap in Six Sigma aligns to each phase of the PDCA
cycle in ISO 9001:

DEFINE

MEASURE PLAN

ANALYSE

DO
IMPROVE
CHECK

CONTROL ACT

Figure 3: Relationship between DMAIC roadmap phases and PDCA phases

(adapted from Graeme Knowles (2011) “Six Sigma”)

The “Plan” phase in the PDCA cycle of ISO 9001, which corresponds to Clause 4 (Context of the
organization), Clause 5 (Leadership), and Clause 6 (Planning), is aligned with the phases of defining,
measuring, and analyzing in the DMAIC roadmap.
The “Do” phase, which includes Clause 7 (Support) and Clause 8 (Operations), and the “Check” phase,
which covers Clause 9 (Performance evaluation) in the PDCA cycle used in ISO 9001, are linked to the
phase of improving in the DMAIC roadmap.
The “Act” phase, which corresponds to Clause 10 (Improvement) in the PDCA cycle is related to the phase
of controlling in the DMAIC roadmap.

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ISO 9001:2015 & Six Sigma linkages
The table below presents every clause of ISO 9001:2015, and linkages to the tools, techniques,
and approaches used in Six Sigma to cover the same scope.
ISO 9001:2015
Scope Tools/techniques/approach
clause number
4. Context of the 4.1 Understanding the SWOT analysis (strengths,
organization Organization and its Context weaknesses, opportunities,
4.2 Understanding the Needs threats)
and Expectations of PEST analysis (Political, Economic,
Interested Parties Social, and Technological)
4.3 Determining the Scope of Stakeholder Analysis Business
the Quality Management Case
System VoC analysis (Voice of the
4.4 Quality Management Customer)
System and its Processes VoB analysis (Voice of the
Business)
5. Leadership 5.1 Leadership and Organizational architecture: top
Commitment management, Sponsors,
5.2 Policy Champions, Process Owners (PO),
5.3 Organizational Roles, Master Black Belt, Black Belt,
Responsibilities, and Green Belt, Yellow Belt, etc.
Authorities
6. Planning 6.1 Actions to Address Risks Failure Mode and Effects Analysis
and Opportunities (FMEA)
6.2 Quality Objectives and Fault Tree Analysis (FTA)
Planning to Achieve Them Quality Function Deployment
6.3 Planning of Changes (QFD)
Benchmarking
Hoshin Kanri X Matrix
Change Acceleration Process (CAP)
7. Support 7. 1. Resources Competency mapping
7.1.2 People Belt selection
7.1.3 Infrastructure Tollgate review
7.1.4 Environment for the Visual Controls
operation of processes Visual Displays
7.1.5 Monitoring and Project documentation
measuring resources KPI deployment
7.1.6 Organizational Knowledge management
knowledge Reward and recognition
7.2 Competence Suggestion schemes
7.3 Awareness Quality circles
7.4 Communication
7.5 Documented Information

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 ISO 9001:2015
Scope Tools/techniques/approach
clause number
8. Operation 8.1 Operational Planning and DFSS/DMADV approach
Control Cause and effect mapping
8.2 Determination of FMEA
Requirements for Products Control plans
and Services Measurement System Analysis
8.3 Design and Development (MSA)
of Products and Services Statistical process control
8.4 Control of Externally Design of experiments (DOE)
Provided Products and
Services
8.5 Production and Service
Provision
8.6 Release of Products and
Services
8.7 Control of Non-
conforming Process Outputs,
Products and Services
9. Performance Evaluation 9.1 Monitoring, Balance score card
Measurement, Analysis and KPIs monitoring and analysis
evaluation Tollgate reviews
9.2 Internal Audit Gemba walk
9.3 Management Review Control plans
Measurement System Analysis
(MSA)
10. Improvement 10.2 Nonconformity and Kaizen
Corrective Action Kaizen event
10.3 Continual Improvement Kanban
DMAIC
PDCA
Breakthrough Improvement

Table 2: ISO 9001:2015 & Six Sigma Linkages

This table demonstrates the practicality of using several tools and methods of Six Sigma in ISO 9001:2015.
In fact, some of the tools mentioned in the table, such as the FMEA (Failure Mode and Effects Analysis)
and SWOT analysis, are widely applied by many people who ignore the existence of the Six Sigma
initiative.

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Combining ISO 9001:2015 with Six Sigma
Although ISO 9001 provides organizations with a series of requirements in order to make some progress
in certain areas, the standard doesn´t tell you how to establish your objectives, nor how to achieve the
desired progress in those areas. It is the responsibility of the organization to decide which objectives to
define and what tools will be used to reach the process improvement. Here is when you can start thinking
about applying the initiative of Six Sigma within your Quality Management System.

These days, customer needs and expectations are changing in the marketplace. Customers look for quality
products that are tailored to their expectations at affordable prices. Organizations must adapt to this
relatively new situation by creating production systems that are sustainable, but also that can be trusted.
Combining ISO 9001 and Six Sigma provides the company with the elements needed to achieve continual
improvement in a reliable and sustainable system.

Integrating ISO 9001 and Six Sigma can bring many benefits to organizations. It has been proven that their
combination helps to cut companies’ bottom-line costs, helping them to become more profitable, but
also more productive and competitive in the market.

Additionally, decision making in the Quality Management System will be enhanced when using both ISO
9001 and Six Sigma. This is because Six Sigma use analysis tools and techniques that contribute to
analyzing available data and information in a structured way.

On the other hand, implementing both systems independently can be a waste of time, because the overall
objectives of each system are the same. Benefits will be greater when aligning both systems, resulting in
important savings for the organization and significant improvements in its business management.

Useful resources
These online materials will help you with your ISO 9001:2015 implementation:

 Diagram of 4 steps in ISO 9001 risk management

 Why ISO 9001:2015 - Awareness presentation
 ISO 9001 Documentation Toolkit – full set of documents with expert support
 ISO 9001 Foundations Course – free online training that explains the basics of the standard and
the implementation steps

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References
9001 Academy

Graeme Knowles (2011) “Six Sigma”, Graeme Knowles & Ventus Publishing ApS.

Muhammad Nauman, Tahir Ali (2015) “Integration of Six Sigma and ISO 9001 Quality Management
System. Case Study: Wire Manufacturing Industry Ltd.” Master of Science in Management, Economics
and Industrial Engineering. Politecnico di Milano.

Pedro Marques, Jose Requeijo, Pedro Saraiva, Francisco Frazao-Guerreiro (2013) “Integrating Six Sigma
with ISO 9001” International Journal of Lean Six Sigma.

International Organization for Standardization (2019).

https://www.iso.org/iso-9001-quality-management.html

About the author

Iciar Gallo has more than 10 years of experience in business consulting
training and auditing, including a number of management systems such as
ISO 14001 and ISO 9001. She has worked for several international companies
and prestigious universities, leading projects in Spain, Panama, Venezuela,
England, and more recently in the USA. She has also worked as a teacher of
several courses on environmental standards and at AENOR and Advisera.
Iciar holds a MSc degree in Environmental Management and Control from
the Technical University of Madrid and is certified as an auditor of ISO 9001
and ISO 14001.

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