Integrating Lean Thinking Into ISO 9001 - A First Guideline

International Journal of Lean Six Sigma
Integrating lean thinking into ISO 9001: a first guideline

Andrea Chiarini,
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IJLSS
2,2 Integrating lean thinking into
ISO 9001: a first guideline
Andrea Chiarini
96 Chiarini & Associates, Bologna, Italy
Abstract
Purpose – The purpose of this paper is to define a guideline for integrating ISO 9001 and lean
thinking. It seeks to cross-reference the guideline presented with ISO 9001 requirements and to
integrate parts of the standard text with lean principles and tools.
Design/methodology/approach – Over the past nine years, a group of consultants has been
collecting data and information from 107 manufacturing companies around Europe. The companies
have been chosen from different European countries and they are of different sizes. All the companies
are ISO 9001 certified and at a “mature” stage of lean implementation.
Findings – It is found that in general, lean thinking implementation affects documentation such as
quality manual, procedures and work instructions. Furthermore, tools and principles such as value
stream mapping, lean metrics, 5S and takt time are the most used inside the 107 companies. Jidoka and
total productive maintenance are those that have been more formalised into ISO 9001 documents.
Practical implications – Practitioners and consultants could use the guideline for future lean
thinking application within a quality management system, especially analysing the impact on
documentation (e.g. quality manual, procedures and work instructions). Furthermore, practitioners
and academics could use parts of the presented guideline in order to discuss and propose new ways for
integrating lean thinking and ISO 9001.
Originality/value – This is one of the first attempts to understand the impacts of lean thinking on
ISO 9001 and propose a guideline for their integration. The results of the paper propose many aspects
to investigate.
Keywords ISO 9000 series, Lean series production, Thinking styles, Europe
Paper type General review
Introduction
Since the late 1980s, several organisations in the fields of manufacturing and service
have been implementing a quality management system in compliance with International
Organization for Standardization (ISO) 9001 standard (ISO, 2008b). ISO 9001 is a
standard dedicated to a quality management system and the ISO issued the first release
in 1987. ISO 9001 can be certified and registered by an independent certification body
(ISO, 2009). Many of the manufacturing organisations that have reached ISO 9001
certification have implemented lean thinking as well, thus the improvement projects
based on lean principles and tools should also be dealing with ISO 9001 processes.
Both lean thinking and ISO 9001 quality systems are well known and there is an
extensive body of literature, especially concerning lean tools and principles. What is less
known is the impact of lean thinking on ISO 9001 requirements and documentation such
International Journal of Lean Six as quality manuals, procedures and work instructions. This paper aims to assess the
Sigma impact of lean thinking on ISO 9001 requirements and proposes a guideline for the
Vol. 2 No. 2, 2011
pp. 96-117 integration of the two systems. The guideline is based on the results of research
q Emerald Group Publishing Limited conducted since 2001 with 107 European manufacturing companies in different sectors.
2040-4166
DOI 10.1108/20401461111135000 In addition to the correlations between lean thinking and ISO 9001, the results of the
research show which formalised lean tools and principles are most used by the Integrating
companies analysed. lean thinking
Introduction to lean thinking
Since the 1970s, competition has been increasing on factors such as zero defects,
on-time delivery, price and relevant customisation (Piercy and Morgan, 1997). This
scenario is the opposite of the so-called “mass production”, a term coined within Ford
97
in the 1930s (Shingo, 1988), in which there was a huge demand for products and
services that are manufactured with low-cost resources and with poor personalisation
and quality.
The opposite and new scenario is what Ohno, ex-Toyota Production Manager,
invented and called the “Toyota production system”. Toyota has been focusing its
efforts on reducing wastes within their manufacturing processes and increasing
value added inside all the flow from suppliers to customers. Ohno (1988a, b)
identified seven types of manufacturing waste in order to improve processes and
“speed the flow”:
(1) overproduction;
(2) inventory;
(3) extra processing steps;
(4) motion;
(5) defects;
(6) waiting; and
(7) transportation.
Since the 1970s, the Toyota production system has been implemented in a large
number of companies around the world (Flynn et al., 1999), and in the West it is better
known as “lean production” or “lean thinking”.
The term lean production was first used by Krafcik (1988) and it was drawn from
the famous book titled The Machine that Changed the World: The Story of Lean
Production (Womack et al., 1990). This book chronicles the movement of automobile
manufacturing from mass production to lean production and shows how Toyota
invented a better way to do things by using very low inventory and by moving
decision making to production workers (Liker, 2004).
These principles were analysed in more detail in the book Lean Thinking (Womack
and Jones, 1996), and the focus was moved from the efficiency of production to the
effectiveness of applying the principles to the organisation as a whole, including its
strategies (Hines et al., 2004). Since 1996, the term lean thinking has become as famous
as lean production especially in Western industry where, sometimes, people simply use
just the term “lean”.
Although it is not the main purpose of this paper to take account of lean principles
and tools, the following paragraphs introduce them and their goals to aid readers’
understanding. Lean has many tools and principles; the paper explains the most used
inside the 107 companies of the research. Pavnaskar et al. (2003) wrote a paper
dedicated to a complete classification of lean tools and matching them with their
associated type of waste.
IJLSS Hoshin Kanri and planning
2,2 Lean thinking has to be linked to strategic objectives. Senior management usually
deploys strategic objectives in the processes using particular systems such as balanced
scorecard (Kaplan and Norton, 1996) and Hoshin Kanri (Witcher and Butterworth,
2002). Balanced scorecard is the classic deployment approach invented at Harvard
Business School in the 1990s by Kaplan and Norton (1992), whereas Hoshin Kanri is a
98 pure Japanese system. This latter was developed in the 1960s at Bridgestone Japan and
then theorised for the first time by Miyaji (1969 quoted by Kondo, 1998). Through
particular matrixes structured in four quadrants, strategies are typically first deployed
in tactics or action plans, then in processes and lastly in results ( Jackson, 2006;
Cudney, 2009).
Value stream mapping

Value stream mapping (VSM) is the first tool used to see within the processes. Material
flows and information flows that control the material are mapped by VSM. This visual
representation boosts the process of lean implementation by helping to identify the
value-adding and non-value adding activities (Rother and Shook, 1998).
VSM comprises two maps: the current state and the future state map. VSM uses
standardized symbols for mapping the process and follows the entire flow of a product,
service or product family from the suppliers to the customers.
Lean office
Wastes are not found just in the production processes. The seven wastes principle can
also be applied to administration, support, marketing and other office processes. These
latter are normally mapped and improved after applying lean tools in the shop floor
(Huls, 2005). Applying lean to the office processes is different from production because
within the office there are transactions instead of products, sometimes these are not
easily visible (Subramoniam et al., 2009). For instance, the wastes could be a backlog of
electronic orders, long approval processes, documents waiting to be signed and so on
(Keyte and Locher, 2004).
Lean metrics
The results of waste reduction are measured by efficiency and effectiveness indicators.
Lean has many indicators; among the most important metrics are lead-time, on-time
delivery, overall equipment effectiveness (OEE), process cycle efficiency, process cycle
time, work in process (WIP), throughput rate (Montgomery, 2010) and many others.
Through Hoshin Kanri, strategic objectives are usually linked to lean key performance
indicators. Indicators should be measured and managed inside the processes
day-by-day or even day-by-the hour (Maskell and Baggaley, 2004).
Push and pull systems

Push and pull are completely different ways of manufacturing. Push is based on
forecasts of sales and thus the organisation manufactures pushing the products into
the warehouses (make to stock). Pull, the opposite, is when production is launched and
pulled only by orders (make to order). Pull is the typical system used in mass
production (Spearman and Zazanis, 1992) where the product demand is stable and
predictable, few products are personalised and the warehouse cost is not high.
Kaizen event Integrating
Continuous improvement is the English translation of the Japanese term Kaizen, a lean thinking
principle made known by Masaaki’s (1986) book Kaizen. The Kaizen event is a quick
and full-immersion event for solving a problem or reducing waste; it takes from two to
five days and it is carried out by personnel at all levels (Mika, 2006) using the tools and
principles described in the next paragraphs.
99
Visual control and management
Workers and managers have to control and visualize immediately the waste at the
shop floor. This means that all the shop-floor indicators and problems have to be
controlled and managed by the means of displays, signals, horns and other systems in
real time (Mann, 2005). For instance, defects, inventories and takt time (see next
paragraph) should be well identified.
Takt time
Takt time is a German term that derives from the Produktionstak system applied at
Focke-Wulff aircraft works in Germany (Holweg, 2006). In brief, it is the rhythm of the
sales or frequency at which the customer needs the product. It affects all the processes
from sales to the suppliers (Swank, 2003), because it sets the rhythm at which the
product and its components should be made. A faster production could introduce
inventories and a slower production could delay the delivery.
5S
The 5S are five precise steps for setting in order and having an area cleaned up.
A messy workplace, desk or manufacturing area makes it hard to find things, easier to
get distracted, and can introduce accidents, mistakes and lower productivity
(Pavnaskar et al., 2003). The five steps are: sort, sort needed and unneeded items; set in
order, arrange things in their proper place; shine, clean up the workplace; standardize,
standardize the first three S’s method; and sustain, make 5S a part of your duty. 5S is
one of the most visual lean tools.
One-piece-flow
The shortening of product/service life cycles and the increasing demands for
customisation make it difficult to produce the products on traditional production lines
structured for relevant quantities (Miltenburg, 2001). Using one-piece-flow, traditional
lines are replaced by a U-shaped cell in which there is every activity and all equipment
useful for the product/service. Cells can be dedicated either to a single product, when it
has high volumes, or to several products through a mixed-model concept. When using
the one-piece-flow tool, it becomes fundamental to change quickly from one
part-number product to the next.
SMED – quick changeover

Quick changeover, also known in the manufacturing field as single minute exchange of
die (SMED), is a particular tool that avoids dead times and reduces the setup operations;
it was developed for the first time inside Toyota by Shigeo Shingo in 1955 (Shingo,
1983). The reduction in setup times means that workers can change part-numbers that
go over the machine more frequently and consequently reduce WIP inventories.
IJLSS Jidoka – autonomation
2,2 Jidoka is an automatic system that checks machine or product characteristics and stops
production in the case of nonconformity. It does not require worker control (Sobek et al.,
2008). Jidoka has the same principle of Poka-Yoke or mistake proofing tools for
avoiding, not necessarily in an automatic way, human errors on the processes to reduce
defects (Fisher, 1999).
100
Kanban
Kanban consists of two Japanese words: kan that means visual, and ban that means
card or board; it was introduced for the first time by Ohno in 1956 in Toyota (Holweg,
2006). Kanban works like supermarket shelves: in a supermarket the customer can get
what is needed at the time needed in the amount needed. The supermarket only stocks
what it can sell and the customers only take what they need because future supply is
assured. In the same way, a production line or cell has “supermarket shelves” in which
there is the right quantity of products that has to be worked. The rate of this
replenishment is controlled by a Kanban card system that gives permission to
produce to the cell or line to assure supply (Sugimori et al., 1977). In this way, Kanban
levels off the flow reducing the WIP and introducing the so-called just-in-time
(Rees et al., 1989).
Total productive maintenance

Total productive maintenance (TPM) is a fundamental pillar of lean, a mandatory
system for introducing preventive maintenance of the machines, equipment and
raising the awareness of the workers about self-maintenance (Rizzo, 2008). Nakajima
(1988) wrote an interesting book in which TPM is presented as the combination of two
parts: the preventive maintenance and the total involvement of workers. The first part,
based on a statistical approach, derived from US engineering research, whereas the
second is the typical Japanese approach. TPM, when well applied, reduces machine
down-time, as well as product defects.
Asaichi – market morning – A3 report

Masaaki (1997) explained how workers and engineers have to solve problems as soon
as possible directly in the Gemba ( Japanese translation of manufacturing floor). The
Asaichi morning market is the Japanese market where fish, fruits and vegetables are
prepared and sold in the early morning when they are fresh. In the same way, every
morning a team controls and reviews the “fresh” nonconformities of the last day using
a quick problem-solving method registered and displayed in an A3 report.
The ISO 9001 model

Before debating the correlations between lean thinking and ISO 9001, it is important to
understand the ISO 9001 model as well.
The ISO 9001 model has four main processes that along with the “quality
management system” represent the five most important ISO 9001 requirements:
(1) quality management system;
(2) management responsibility;
(3) management of the resources;
(4) product realisation; and Integrating
(5) measurement, analysis and improvement. lean thinking
The four main processes follow the famous plan-do-check-act (PDCA) methodology
(ISO, 2008a). Table I summarises the links between PDCA stages, ISO 9001, and the
lean tools and principles used in the 107 companies analysed in this research.
According to ISO 9000 (2005), any activity, or set of activities, that uses resources to 101
transform inputs to outputs can be considered a process. For a company to effectively
implement a quality management system, it needs to identify and manage various
processes and their interactions. The output of one process is an input to another process.
Nowadays, hundreds of thousands of organisations have obtained ISO 9001

certification and the most common benefits of implementing an ISO 9001 quality
system include:
.
Standardization, and repeatability of processes; this is important, for example, at
the end of all the Kaizen events, so that standardization of results is achieved.
.
Improvement of customer satisfaction.
.
Reduction of costs of poor quality, including most of the seven lean wastes.
Both practitioners and academics need a guideline in order to better implement and
analyse lean principles and tools inside the ISO 9001 requirements.
Literature review
Literature concerning the link between ISO 9001 processes and lean thinking is limited.
Lantelme and Formoso (1999) were the first to analyse the application of lean production
and how ISO 9001 can affect performance measurement. Bamber et al. (2000) discussed
the possibility of integration between some particular tools of lean thinking, such as 5S
and TPM, and ISO 9001 – ISO 14001 management systems. The conclusions bring new
perspectives on how to integrate all the management systems mentioned, but there is not
a precise correlation between ISO 9001 requirements and Lean tools. Bendell (2006)
reviewed and compared different management systems such as total quality
management, european foundation for quality management prize, ISO 9001, lean
thinking and Six Sigma; the differences, and the how and why of implementing the
management systems are compared in particular. More recently, Micklewright (2010)
PDCA
stage ISO 9001 explanationa Lean tool/principle
Plan Establish the objectives and processes necessary to deliver Hoshin Kanri
results in accordance with customer requirements and the
organization’s policies
Do Implement the processes Kaizen events and all the tools
Check Monitor and measure processes and product against Lean metrics, visual control
policies, objectives and requirements for the product and and management
report the results Table I.
Act Take actions to continually improve process performance Hoshin Kanri, Kaizen events Link between PDCA,
ISO 9001 and lean
Note: aFrom Clause 0.2 – ISO 9001:2008 tools/principles
IJLSS wrote a book the title of which is emblematic, Lean ISO 9001, showing in an original way
how, with the use of 5S tools, documentation can be brought under control. The second
2,2 chapter is dedicated to explaining how to “lean out” the documentation system; in
addition, in the third chapter, the book discusses the integration between lean and ISO
9001. Unfortunately, the book does not present a strict correspondence between lean
tools and principles and ISO 9001 clauses. Furthermore, just a few lean tools and
102 principles are taken into account, in particular 5S, A3 report and training within the
industry. This latter seems to be a new slogan even if quite foregone. The book presents,
in any case, an interesting assessment guide for quality management systems
considered “matures” and integrated with lean thinking.
The ISO web site does not provide standards about lean thinking. The only
standard that is linked to lean principles and tools is ISO/TS 16949 (ISO and
International Action Task Force, 2009). This standard is the application of ISO 9001 to
automotive production; the lean tools directly or indirectly mentioned within the scope
of increasing efficiency are 5S, TPM, Kanban, quick-change over and Poka-Yoke.
The standard is, however, dedicated to the automotive sector and the links with lean
tools are not detailed.
As a result of the literature review, it can be claimed that there is no model or
guideline for the manufacturing sector to precisely integrate lean principles and tools
within ISO 9001 requirements.
Research methodology
This research has been led in an inductive way in order to generate theory using
multiple case studies (Bryman, 1988). Over the past nine years, a group of consultants
has been collecting data and information from 107 manufacturing companies around
Europe.
It is impossible to know exactly how many companies are implementing both ISO
9001 and lean thinking, so one of the first limits of the research is the sampling process.
The sample selects a subset of the population and this subset should represent the
population from which it is drawn but the total amount of the population is not known
(ISO 9001 and lean companies). However, it has been assumed that 107 companies is a
sample large enough to make the sampling process reliable. The sample has a small
bias because the companies have been chosen from different European countries and
they are of different sizes (from 30 to 5,000 employees). All the companies are at a
“mature” stage of lean implementation: they have been implementing lean thinking for
at least three years and lean is not a trial, but a complete management system. Table II
shows how the sample has been stratified.
During the nine years covering the research period, the leading researcher has been
collecting data and information through a participant observation approach (Jorgensen,
1989). The researcher has not interfered with the companies or their managers. Data and
information from the processes were collected using a checklist that shows the
correlation between ISO 9001 requirements and lean principles and tools.
Findings: lean thinking and ISO 9001

A typical ISO 9001 quality system is implemented through:
.
a quality manual (in cross reference with the ISO 9001 requirements);
.
a quality policy;
Integrating
Size of the company (employees) Count
30-50 11 lean thinking
51-100 14
101-200 18
201-300 23
301-500 16
501-1,000 15 103
1001-2,000 8
Over 2,000 2
Total amount 107
Country
Bulgaria 3
France 15
Germany 24
Italy 23
The Netherlands 2
Poland 7
Romania 6
Slovakia 2
Spain 18
UK 7 Table II.
Total amount 107 Data stratification
.
procedures that describe the main processes; and
.
work instructions or other operative documents.
In general, lean thinking implementation affects the documentation above. In two out
of 107 companies (less than 2 per cent), lean principles and tools do not have any link to
ISO 9001 documentation. It seems that the reasons for this are grounded in the division
between who is responsible for managing the management systems. The quality
manager is not as involved as production managers in lean thinking and consequently
lean processes are not documented and formalised.
Summarizing the results: VSM, lean metrics, 5S and takt time are the most used lean
principles or tools, and 5S, Jidoka and TPM are those that have been more formalised
into ISO 9001 documents.
Table III shows the percentage of companies that use a specific lean principle or
tool, and the percentage of those who have formalised and documented them when
applied. Formalisation means that the tools or principle is managed by the means of a
procedure or a work instruction.
Hoshin Kanri and lean office are not as implemented as the other principles or tools,
in the instance of Hoshin Kanri this is because companies usually prefer planning and
deployment systems such as balanced scorecard (Kaplan and Norton, 1996) or other
similar systems. Lean office seems to be a topic that is not as well known as other
manufacturing tools; companies believe that the majority of waste occurs in production
processes in which therefore they concentrate their efforts (Bicheno, 2004). All the
companies have introduced lean metrics. The most important key performance
indicators used by the organisations are:
IJLSS
Percentage of companies that Percentage of companies that
2,2 Lean principle or tool use the principle/tool formalise and document it
Hoshin Kanri and planning 13 5

VSM 100 22
Lean office 16 3
104 Lean metrics 100 94
Pull system 100 35
Kaizen event 100 72
Takt time 100 86
5S 100 99
One-piece-flow 89 16
SMED – quick changeover 76 89
Jidoka – autonomation 92 100
Kanban 98 17
TPM 97 100
Table III. Asaichi – market morning –
Percentage of companies A3 problem solving 34 95
that use and formalise Poka-Yoke, mistake proofing 96 58
lean principles/tools Visual control and management 100 89
.
lead-time;
. OEE;
.
first time yield (FTY);
.
cost of poor quality;
.
inventory turns; and
.
safety incidents/accidents.
It can be noted that lean thinking tools not only improve the processes of quality but
also those of management safety. All the companies used VSM and some of them have
re-designed the structure of their manufacturing processes in manufacturing cells,
following the principle of one-piece-flow and group technology. Almost 22 per cent of
the companies have changed the ISO 9001 process map after VSM redesign.
All the companies through lean thinking have introduced new roles in their
organisation chart, particularly concerning the Kaizen events:
.
lean specialist or lean champion; and
. Kaizen team leader.
The Kaizen events are managed by mixed teams with the goal of reducing the seven
lean wastes (Liker and Meier, 2005). Almost all the companies’ staff has been involved
at least once in the participation of a Kaizen event because lean thinking means
involvement at every level. The Kaizen events were useful for the redesign of the
manufacturing shop floor and for the introduction of typical lean tools. The Kaizen
events bring an improvement in the processes and that improvement is subsequently
formalised in the ISO 9001 procedures and work instructions in 72 per cent of cases.
Visual control and management are largely used in all the companies, and it is a
must that indicators, data and all kind of information should be very close at hand.
Poka-Yoke and Jidoka are used in almost all the companies and because Jidoka is Integrating
strictly linked to the ISO 9001 product measures it is quite formalised. lean thinking
Tools such as Asaichi and A3 report are sometimes used (around 35 per cent) because
many companies claim that their standard ISO 9001 records for nonconformities are
suitable for the scope of this tool.
These are the general impacts of the lean principles/tools on the ISO 9001
management system. Collecting and structuring the results in cross-reference with the 105
most important ISO 9001 processes, this paper proposes a guideline for implementing
lean thinking inside a quality management system. The five most important processes
in ISO 9001 are from “quality management system” (ISO 9001, fourth paragraph) to
“measurement, analysis and improvement” (ISO 9001, eighth paragraph).
The guideline
The guideline is structured into five tables (Tables IV-VIII): one for each of the five most
important ISO 9001 requirements. Each table is divided into three columns. The first
column on the left represents the ISO 9001 requirement, using the same title and
paragraph number of the ISO document. The second column states the type of lean tool
and principle that can affect the requirement. Finally, the third column proposes how to
integrate the ISO 9001 requirement with the lean principle and/or tool. This is the core of
the guideline and represents the result of the data and information collected from the
107 companies. The criterion by which it has been written the guideline column is
the majority of the information collected. For example, 99 per cent of the companies have
documented a work instruction or document on how to manage the 5S process, therefore
in Clause 4.2 it is stated that the organisation should issue a controlled document about
5S. According to ISO guidelines, such as ISO 9004 (ISO, 2009), “should” is the preferred
term for guidelines because “shall” is used when text is directly quoted from the ISO 9001
standard. When a principle or tool is not so largely applied, the text uses “can” instead of
“should” or “shall”.
Agenda for future research

Because this is one of the first attempts to understand the impacts of lean thinking on
ISO 9001 and propose a guideline for their integration, there are many aspects to
investigate.
First of all, research is required to find out how many companies in Europe are
implementing both lean thinking and ISO 9001. Through a survey, in a deductive way,
some of the results of this research could be transformed into hypotheses in order to be
validated. From a sample of 107 companies, it seems that, for example, Hoshin Kanri,
Asaichi – A3 report, lean office – Makigami are not used as much as 5S, quick-change
over, TPM and VSM. Using case studies and a more qualitative approach, it would be
useful to understand the reasons (it there are) why there is less use of these tools.
Another interesting area of future research would be to understand the impacts of lean
thinking on ISO 14001 (2004) and OHSAS 18001 (2007). The first is related to the
so-called environmental management system and the second to the health and safety
management system.
Practitioners and consultants could use the guideline for future lean thinking
application within a quality management system, especially analysing the impact on
documentation (e.g. quality manual, procedures and work instructions).
2,2
106
system”
IJLSS
Table IV.
9001 requirement
“quality management
Correlation inside the ISO
ISO 9001 requirement Lean tools and principles Guideline for integration
4. Quality management system

4.1. General requirements VSM, lean office The organisation shall determine the processes needed for the quality
management system. In order to better determine the sequence and
interaction of the processes the organisation should use VSM. VSM shows
resources, information and waste inside and among processes. For
processes based more on transactional than on the physical
transformation of the product such as sales, marketing, finance, post-
delivery service, etc. Makigami or other transactional mapping can be
used. Both VSM and Makigami should be applied in the “current state”
and in the “future state” for implementing continual improvement
Lean metrics To monitor and measure the processes, the organisation should use lean
metrics
For effectiveness the important metrics are for example:
FTY
on-time delivery performance
OEE
For efficiency the important metrics are for example:
lead time
inventory turns
cost of poor quality
4.2. Documentation requirements Documents required by the quality management system shall be
controlled. The documentation shall include:
a quality policy and quality objectives
a quality manual
procedures, records
other documents such as work instruction, control plan, etc.
The organisation should document how to use the most important Lean
tools through procedures and/or work instructions.
In particular, the use of these tools should be documented:
5S for setting in order and cleaning up the workstations
quick-changeover or SMED to reduce setup times
TPM and autonomous maintenance for operators
5. Management responsibility
5.1. Management commitment Commitment to lean thinking Top management should provide evidence of its commitment to
lean thinking as well by:
communicating to the organisation the, importance of Lean
principles and tools
establishing strategic lean objectives
ensuring resources for the lean projects
5.2. Customer focus Takt time and pull system The voice of the customer should be captured in order to
understand what are the spoken and unspoken needs of the
customer (Kano et al., 1984). The so-called takt time or rhythm
of the sales should be met with the aim of enhancing customer
satisfaction, introducing a real pull system and improving on-
time delivery as well as quality
5.3. Quality policy Top management should ensure that the quality policy includes
principles of lean thinking, in particular:
efficiency
waste reduction
etc.
5.4. Planning Hoshin planning Top management should ensure strategic measurable
objectives concerning lean thinking. A deployment process
should lead the objectives to the relevant functions and levels,
including the shop floor
The deployment of the objectives can be carried out by Hoshin
planning or another tool such as balanced scorecard
(continued)
“management
Integrating
responsibility”
lean thinking
9001 requirement
Table V.
107
2,2
108
IJLSS
Table V.
5.5. Responsibility, authority and communication Visual control and management Top management shall ensure that responsibilities and
authorities are defined and communicated within the
organisation. Top management should appoint a manager as
lean champion or lean sponsor. This management
representative should report to the top management on the lean
performance and ensure the promotion of awareness of waste
reduction. The management should appoint other figures such
as Kaizen event team leader. A responsibility should be
appointed to stop production when problems or
nonconformities arise
Top management should ensure the communication processes
regarding lean principles. This can include:
visual control and management
effectiveness of the Kaizen events
day-by-day results
internal communication about lean results
5.6. Management review Top management shall review the quality management system
at planned intervals
The input to management review should include the results of
the lean metrics (OEE, lead time, cost of poor quality, on-time
delivery performance, etc.)
The output from the management review should include
actions, decisions and plans to reduce waste, including specific
resources
6. Resource management
6.1. Provision of resources The organisation should determine and provide the resources needed:
to implement lean manufacturing and continually reduce waste;
to enhance customer satisfaction by meeting customer requirements, including on-
time delivery and takt time (rhythm of the sales)
6.2. Human resources Cross-functional training, job The organisation should:
enlargement and enrichment (1) Determine the necessary competences for personnel dedicated to lean thinking. In
particular for:
Kaizen event team leader
Lean specialists
Lean champion
(2) Provide training in order to increase the skills of personnel
Multi-skills are fundamental to obtain flexibility in the processes, in particular using
one-piece-flow system. The organisation can implement job rotation for enlarging
and enriching skills
6.3. Infrastructure VSM, spaghetti chart TPM The organisation should design plant layouts using VSM. Spaghetti chart can reduce
and autonomous maintenance all the waste due to motion, transportation, handling, etc. Layouts should facilitate
synchronous material flow
The organisation shall determine, provide and maintain the infrastructure. For the
key machines, equipments and plant the organisation should implement TPM
through:
data-gathering about the failures
statistical analysis of the failure distribution
preventive and predictive maintenance
key performance indicators such as OEE, down-time, mean time to/ between
failure, etc.
The organisation should promote autonomous maintenance for operators
6.4. Work environment 5S The organisation shall determine and manage the work environment needed to
achieve conformity to product requirements
5S should be a useful tool for maintaining a clean and tidy work environment
“resource management”
Integrating
lean thinking
9001 requirement
109
Table VI.
2,2
110
IJLSS
Table VII.
9001 requirement
“product realization”
ISO 9001 requirement Lean tools and principles Guideline to integration
7. Product realization
7.1. Planning of product realization Pull system The organisation shall plan and develop the processes needed for product
Kanban realization. The planning of the processes should avoid push systems or make
Visual control and management to stock. The processes should pulse at the takt time. Visual management and
tools such as Kanban should be used to introduce a real pull system
7.2. Customer related processes Takt time The organisation should determine:
Kanban the takt time for each part number or product
Makigami – lean office the mix of products to supply to the customers
the kind of pallet, box, container, etc. for the customer
the exact information/data within the Kanban
Marketing, sales and managing of the orders can be mapped to reduce their
lead time and increase completeness and accuracy of the transactions. Tools
of the lean office such as Makigami can be used for the scope
7.3. Design and development Variety reduction programme The organisation should use a multidisciplinary approach to design and
develop the products. Marketing, engineering, production, purchasing,
quality, etc. should review the design and development of products and
processes to reduce variety inside bill of materials. Standardization of the
components can help to reduce waste
The organisation can map and plan the design and development process (for
example using Makigami ) in order to reduce the lead time and increase
completeness and accuracy of the data. Concurrent and simultaneous
engineering should be preferred to reduce time to market
7.4. Purchasing Development of the supplier The organisation should develop a strategy to improve supplier performance.
towards lean Kanban Supplier should gradually apply lean principles and tools to reduce waste as
well. The involvement of the suppliers sometimes is not easy, thus the
organisation should involve suppliers through training and communications
concerning lean. The organisation should develop the supplier with the
purpose of the partnership
The organisation should transmit to the supplier precise scheduling of the
products
(continued)
Supplier performance should be monitored through the following indicators:

on-time delivery performance (including incidents of premium freight)
delivered product conformity
Kanban or other system for avoiding stock in incoming should be used for
purchasing information
7.5. Production and service Visual management and control The organisation shall plan and carry out production and service provision
provision VSM under controlled conditions. Controlled conditions should include:
5S, Kanban, SMED, TPM, one- the availability of work instructions for each Lean tool such as 5S, SMED-
piece-flow quick change over, autonomous maintenance, etc.
Pull system the use of visual management and control aids in respect of takt time and
quality results;
checking day-by-day or day-by-the hour the performance of the cell/line/
process
Production should be scheduled using a pull system instead of a make to
stock system. Kanban, one-piece-flow or other systems should be
implemented to gradually reduce work in process inventory. If make to stock
is something impossible to avoid, stock rotation should be maximised
7.6. Control of monitoring and 5S, autonomous maintenance Monitoring and measuring equipment should be managed in the same way as
measuring equipment other equipment. 5S should be used for setting in order and protecting them
Operators should clean and maintain the monitoring and measuring
equipment using the principles of autonomous maintenance
Integrating
lean thinking
Table VII.
111
2,2
112
IJLSS
Table VIII.
9001 requirement
and improvement”
“measurement, analysis
8. Measurement, analysis and measurement

8.1. General Visual control and management The organisation shall plan and implement the
monitoring, measurement and analysis processes.
This shall include determination of applicable
methods. Among them, the organisation should
include visual control and management using light,
horn, display, board, coloured card, etc.
8.2.1. Customer satisfaction Takt time The organisation shall monitor customer perception
as to whether the organisation has met customer
requirements. This should include:
respect of takt time
complaints, returned products, penalties, etc.
on-time delivery performance;
cost of the product
logistic details such as packaging, pallet, box,
container, freight, etc.;
customer support
8.2.2. Internal audit 5S The organisation should audit the manufacturing
processes to determine the effectiveness of the lean
tools. In particular, through a checklist, the
organisation should audit the keeping of order and
cleanliness and application level of other lean tools
and principles
8.2.3. Monitoring and measurement of processes Lean metrics See ISO 9001 – 4.1 requirement
8.2.4. Monitoring and measurement of product Poka-Yoke, Jidoka The organisation should implement and prefer Poka-
Yoke (mistake-proof) tools rather than manual
monitoring and measurement. Jidoka or
“autonomation” can free monitoring and
measurement equipment from constant operator
attention in order to reduce waste of labour time
(continued)
8.3. Control of nonconforming product Asaichi – A3 report The organisation shall ensure that a product that
does not conform is identified and controlled to
prevent its unintended use or delivery. Actions to
eliminate the nonconformity and its causes should be
taken as soon as possible. Asaichi or A3 report can
be used as systems to quickly control and review the
nonconformity state
8.4. Analysis of data Hoshin Kanri The organisation should determine, collect and
Visual control and management analyse data to demonstrate the suitability and
effectiveness of the lean system and to evaluate
where to reduce waste
The data should be analysed at all levels, from shop
floor to top managers with the scope of achieving
targets. Quality and operational performance should
be displayed day by day and all personnel should
raise awareness about data and visual control and
management
Management should act quickly to analyse data and
develop priorities and solutions
8.5. Improvement Kaizen The organisation should continually improve the
processes and the products from top management to
workforce. Results in terms of reduction of the seven
wastes should be reached not only by “big leaps” (for
example by infrastructure investments) but also by
day-by-day efforts
All the personnel should solve problems as they arise
by using both training and learn-by-doing approach.
Kaizen events should generate rapid results through
cross-functional teams
Integrating
lean thinking
Table VIII.
113
IJLSS Furthermore, practitioners and academics could use parts of the presented guideline in
2,2 order to discuss and propose new ways for integrating lean thinking and ISO 9001.
Last but not least, an investigation about the point of view of the external ISO 9001
auditor should be carried out. In fact, some around 70 per cent of the 107 companies
reckon that external auditors do not know lean tools and principles as much as ISO
9001 requirements. It seems that when the auditors know lean thinking they use lean
114 tools and principles as findings of the ISO 9001 requirements compliance.
Conclusions
The research has shown that there was a lack of detailed guidelines for integrating ISO
9001 and lean thinking. Thus, using the results of nine years of data gathering from
107 European manufacturing companies the first guideline has been developed. The
guideline presented is cross-referenced with ISO 9001 requirements and integrates
parts of the standard text. Through careful use of the terms “shall”, “should” and “can”,
the guideline can be applied in all the manufacturing companies in which lean and ISO
9001 cohabit. The use of “should” invites an organisation to accurately reflect on the
way of integration proposed by the guideline because it is suggested by all the sampled
companies. By contrast, the use of “can” or “could” indicates suggestions derived from
some of the companies and is dependent on the kind of process and/or organisation.
According to this approach, the guideline invites users to implement and formalise
principles and tools such as lean metrics, 5S, TPM, Jidoka and Kaizen events. Hoshin
Kanri, lean office and Asaichi – A3 report are principles and tools that are less known
and implemented. Companies that integrate lean and ISO 9001 receive as a gift the
possibility of increasing efficiency (ISO, 2009), considering that ISO 9001 is more
focused on effectiveness. The reduction of wastes in the process flow is something
peculiar to lean thinking and ISO 9001 can help companies to standardize and
formalise such concepts.
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About the author

Andrea Chiarini is Managing Director of Chiarini & Associates, one of the most important Italian
consulting firms and part-time Professor at Modena and Reggio Emilia University, Italy. He
received his Master’s degree in Electronic Engineering and MBA from Bologna University, Italy.
He has also been awarded a Master of Arts in Social Science and Research Methods at Sheffield
Hallam University, UK at which he is a PhD researcher in the “TQM and Business Excellence”
sector. He is a member of American Society for Quality.
To purchase reprints of this article please e-mail: reprints@emeraldinsight.com

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Value stream mapping

Push and pull systems

SMED – quick changeover

Total productive maintenance

Asaichi – market morning – A3 report

The ISO 9001 model

Nowadays, hundreds of thousands of organisations have obtained ISO 9001

Findings: lean thinking and ISO 9001

Hoshin Kanri and planning 13 5

“measurement, analysis and improvement” (ISO 9001, eighth paragraph).

Agenda for future research

4. Quality management system

ISO 9001 requirement Lean tools and principles Guideline to integration

Supplier performance should be monitored through the following indicators:

8. Measurement, analysis and measurement

ISO 9001 requirement Lean tools and principles Guideline to integration

ISO (2008b), ISO 9001:2008. Quality Management Systems – Requirements, International

IIE Transactions, Vol. 33 No. 4, pp. 303-21.

About the author

To purchase reprints of this article please e-mail: reprints@emeraldinsight.com

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