Guidebook For Qms PDF

GUIDELINES FOR THE
IMPLEMENTATION OF
A QUALITY MANAGEMENT
SYSTEM (QMS), ACCORDING TO
THE ISO 9001:2008 STANDARD, TO
SMALL COMMERCIAL FIRMS
www.smallcitycommerce.eu
2
INDEX
1.- INTRODUCTION 3
1.1 CONTEXT 3
2.- GENERAL 5
2.1 THE SENSE OF THE WORD “QUALITY” 5
2.2 THE DEVELOPMENT PHASES OF QUALITY: CULTURE, PRINCIPLES AND
METHODS 6
2.3 QUALITY MANAGEMENT SYSTEM 8
2.4 WHY THE IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM? 9
2.5 THE ISO 9000:2008 STANDARD 9
3.- APPLICATION OF THE STANDARD ISO 9001 IN SMALL
COMMERCIAL FIRMS 11
3.1. SME 11
3.1.1 EU definition 11
3.1.2. The hidden giants 12
3.2 IMPLEMENTING THE ISO STANDARD 15
3.2.1 What should ISO (not) be about 15
3.2.2 Management principles 15
3.2.3 ISO in commercial SMEs - some characteristics having impact 18
3.2.4 Realization of ISO requirements and differences between SMEs
and Large Enterprises 19
4.- STEPS TO IMPLEMENT A QMS 29
4.1 STEPS TO DECIDE 29
4.1.1 Decision to implement a QMS 29
4.1.2 First planning of resources 29
4.1.3 External consultants 30
4.2 FIRST SELF ASSESSMENT 31
4.3 DETAILED IMPLEMENTATION PLAN 32
3
1.- INTRODUCTION
1.1 CONTEXT
During the last decades enterprises made an effort to achieve quality as a measure to The achievement of quality
increase their competitiveness. This quality goal was usually achieved by trial and
error, costing, to enterprises, a great deal in terms of time and money, not to
mention the effect on clients, in the cases of error. To organise the procedure of
obtaining and maintaining quality, a series of international standards were created in
the form of ISO model. This way the improvement of quality could be obtained
through standard procedures already tried and tested in many other enterprises. The
whole procedure very often includes re-engineering of the company and, in every
case, training of the personnel. The revision of the standard in 2008 version imposes
more obligations.
Yet SMEs, including commercial ones, which represent an important percentage of The power of SMEs in
the total enterprises power in Europe, have complained that implementing the ISO Europe
9000 was expensive, as it required additional staff and paperwork. They also
complained that its demands were irrelevant to SMEs operational dimensions.
Companies are facing new challenges due to the more dynamic economic situation and the
economic crisis. Markets appear and vanish within short periods of time and customers
show growing expectations about the quality of delivered goods or services, after sales
services etc. Production in law-wage countries (e.g. Chinese shops), creates unfair
competition and the only way for commercial firms to remain competitive is to
differentiate as far as quality is concerned. Furthermore, nowadays it gets all the more
important to develop and sustain strong supply chains based on processes and procedures
that insure mutual trust. For a small commercial company, an undoubted advantage of
such a procedure is not only a support function for the systematic way of managing quality
relevant issues within their own organisation but also the knowledge that a supplier who
fulfils the criteria of an accepted Quality Management System (QMS) – i.e. the
organisation is certified to such a standard - stands for high quality commercial services.
The supplier selection process was massively supported by the emerging certification
activities and in some areas it has even become a minimum criterion for it.
Large companies, especially, were the first to begin getting certified to ISO 9000
standards whereas more and more small and medium sized enterprises have decided
to choose this way within the last few years.
Therefore a lot of commercial enterprises, even small ones, require from their Consideration of branche
suppliers and their subcontractors certification at ISO-9001 and application of specific situations / Internal
quality processes, while in certain sectors, such as the paramedical sector the and external reasons for
implementing a QMS
certification is imposed by the national legislation. Furthermore clients are
becoming active participants in requiring certified products and providers.
Criteria, if for implementing a QMS, can be subdivided mainly into two different
groups: internal aspects e.g. internal quality improvements like better handling of
orders, better stock inventory system or cost savings and external aspects e.g. lower
reclamation rate, better image, differentiation via long term quality strategy.
Another reason for implementing a QMS is that it can be required by the customer
(but it must not be the only reason!).
Educational programs and educational materials are then necessary. The majority of
them address large enterprises and there is a lack of educational material and tools
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specially designed for small enterprises with practical guidelines that can help on
the implementation of ISO-9000 without bureaucratic procedures. Moreover, even
if the requirements of ISO-9001 are single, their way of application varies between
the enterprises with different objectives, sectors and methods of operation.
Some professional organizations have already proposed guidelines to explain how The lack of educational
to adapt the general requirements of ISO-9001 to their own case; but, in general, material and tools for SMEs
those tools do not address the specific needs of small enterprises.
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2.- GENERAL
2.1 THE SENSE OF THE WORD “QUALITY”

The many different
The word "Quality", being an abstract concept, can have many different definitions, such
definitions of word
as "essential and distinguishable attribute of someone or something " or "feature defining
“quality”
the individual nature of something"; these are just some of the many definitions of the
entry "Quality" that one can find in the dictionary.
A traditional meaning - but nowadays quite old fashioned - is "conformity to specific Quality as feature
requirements". This acceptation matches the concept of quality directly to the features of
the product/service itself (Quality as feature), emphasizing its fulfilment. In this sense,
the quality implies that the requirements of the production or services e.g. sales process are
clearly specified and entirely respected, without any guarantee that these requirements will
respond to customer expectations, who is not necessarily taken into consideration.
On the contrary, the current concept of “quality” of any product/service implies the skills
to understand the user’s need, and through the precise determination of the requirements,
Quality as value
its fulfilment. This acceptation –underlining “the adequacy to usage” (Quality as value)
focuses on user’s needs.
With the acceptation of Quality as “value”, many definitions of the word “quality” have
been elaborated, and two of these are particularly important:
1. “Quality” intended as the features of the products meeting customer needs and
determining his/her satisfaction. In this sense, the meaning of quality is oriented Quality means
to profit. The goal of a better quality is to enhance customer satisfaction, and “higher costs”
finally, to increase the profit. As increasing or improving quality involves money
investments, or in other words an increase on costs. In this sense, Quality means
“higher costs”.
2. “Quality” intended as absence of flaws and errors which require repairing
activities which usually bring to market shares loss, customer discontent and so Quality means
on. In this sense the word “quality” is oriented to costs reduction and better “lower costs”
quality means “lower costs”.
Finally, ISO 9000:2008 defines the word “quality” as: "degree to which a set of inherent The ISO 9000:2008
characteristics fulfils requirements”. definition
It must be specified that (explanatory notes in the regulations):
- "the term quality can be used with adjectives such as poor, good or excellent; while the
term “inherent means existing in something, especially as a permanent characteristic”.
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2.2 THE DEVELOPMENT PHASES OF QUALITY: CULTURE,

PRINCIPLES AND METHODS
The origin of the problems related to Quality can be associated to the beginning of
“trade” activities. It is a very old concept, strictly related to the establishment of the
market itself with its main characters: the buyer-user and the seller-producer. In time, the
meaning of “quality” has undergone different relevant evolutions, which have often
changed its common meaning.
Let us concentrate on the main acceptations of “quality” developed during the 20th
century.
 In the years preceding the First World War there was a strong difference between
“quantity” and “quality”, the former considered as belonging to production, the latter to the After the First
product final testing. Quantity is the main goal while quality is considered as one of many World War
possible factors for success. Sometimes the buyer himself follows the production or sales
process and performs the final tests.
 Between 1935 and 1945 the so-called Quality Control activities (QC) are generated.
They are the set of actions which permits to point out and measure the product
features, comparing them to formerly specified parameters. In these years the
perspective changes, but the idea to intervene in the production/ service process in Between 1935 and
order to guarantee the conformity of the product/ service, merchandise to the project 1945
itself, remains unchanged; actually, the production/service is deeply analysed and
checking phases are included to guarantee the quality of the final product. Servicing
companies are still not included in this Quality management method, because the
“service” is not considered a measurable and valuable result.
 In the 50’s the approach to Quality is greatly modified and gradually the idea is spread that
no business activity can be totally separated from the other ones. Consequentially, In the 50’s
successful results can be obtained only thanks to the integration and coordination of the
many different company departments. In these years the Total Quality (TQM) approach is
born in the USA. The QC is still bound to each single activity and it doesn’t control the
entire structure yet: however, the trend extends Quality control concepts to the
organization and planning phases.
 In the 60’s the concept of Quality is newly modified and systematically operates on
both production/service process and product/service itself, the so-called Quality
Guarantee (QG). QG is a management system which considers the integration of
several activities, whose strong connections contribute to determine the quality of the In the 60’s
product itself. Activities such as action planning, staff training, records filing and
management, adjustment actions, etc.
The most relevant innovations of the Quality Guarantee method, compared to the
older approaches, are:
- integrated approach to Quality management, considered as part of the system,

controlled by the entire organization, and most of all by the management;
- immediate applicability to services;
- attention to planning and activity recording;
- widening of planning and testing concepts, from production/service provision to
designing.
The difference between Quality Guarantee and Quality Total Management systems is
based on their different approaches: the former is static, the latter is dynamic.
The Total Quality system puts Quality at the very first place among the business
values and its goal is to improve its relationship with its customers.
The active orientation to Quality implies the introduction of innovative attitudes and
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differs from traditional approaches in three points:
1. improvement of quality as a continuing process;

2. improvement through fixed policies and goals;
3. education of the whole organization to Quality as a rule.
 In the 70’-80’s the concept of Quality is also extended to servicing companies. In

“Quality in Services” we can distinguish two different approaches. The traditional In the 70’-80’s
approach is based on the identification of customer needs and expectations and the
subsequent product design, the activation of Quality process (in terms of mistake
reductions), control planning and its improvement.
The other approach - the so-called “staff-oriented” approach - asserts that a quality
program should be based on a change of culture, values, attitudes of the whole
personnel; its most important points are basically staff management and customer
feedback.
The starting point is the identification of the “product”, this meaning the service, offered by a
commercial company and its features -in comparison with any manufactured product - such
as:
- the service does not exist before purchasing;

- the service cannot be stocked;
- production and consumption happens in the same time;
- the customer is involved in the production phase;
- the service cannot be touched;
- mobility of the service supply system.
The attention paid to services helps to change the perspective when facing problems
regarding quality: the organization starts considering not only the “product” or selling
service, but also all management and technical activities implied in the selling service, that
is the business process.
The process includes all the activities oriented to a final result, performed by different
business units. Each of them adds a new value to the service, directly proportional to its
integration skills and ability to work for targets.
Managing for processes means highly supervising all the connections among different
activities, identifying customer needs aiming to his/her satisfaction, and exploiting
business outputs as the common target.
Whoever is responsible for Quality starts investing in the “Quality System” concept,
i.e. running the business aiming for Quality. The structure of a Quality system can be
summarized as:
1. definition of the business and its goals

2. assignment of tasks and responsibilities
3. identification of means and staff
4. implementation and management of operative modalities through monitoring and
checking
According to Quality policy, the business is more and more oriented towards customer
satisfaction and his/her needs become the organization target, at the lower
organizational costs.
Creating Quality means providing “internal quality” and “external quality”.

“External quality” refers to the customer relationship modalities, and above all, the
awareness of his/her needs, attitudes, expectations, how carefully his/her request is
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considered, how much care is given to the communication process (welcome, service
and farewell), problem solving skills, and easiness in anticipating – if needed – his/her
needs and wishes, offering services not explicitly requested. “External quality” also
means the establishment of good relationships with suppliers, media, etc. as the
corporate image contributes, in large measure, to the perception and determination of
“external quality”.
“Internal quality” refers to all that is related to worker’s satisfaction and parameters
such as: shifts, information circulation, time management, accomplished tasks
feedback, and so on. Therefore, quality can be defined as conformity of the “service” to
internal and external customer satisfaction.
The 1990-2009 period is characterized by the increasing demand of “social quality”

aiming to consumers, citizens and user’s satisfaction. The main goal is now the The 1990-2009
improvement of life quality, and all companies develop more integrated systems to manage period
quality, environment and safety. In this contest is set the SA 8000 standard (Social
Accountability). The origin and development of this first standard on social responsibility
is a world-wide recognized reference point. Its main goal is to eliminate unfair and cruel
work conditions in all kind of business.
2.3 QUALITY MANAGEMENT SYSTEM

The “quality management system” is a wide concept and it can be defined as a systemic Definition
set of management procedures used to monitor, check and improve the organization
operative and financial performances, aiming to offer the best service at lower costs.
The management procedures constituting the “quality management system” include some
activity subsets, respectively indicated as: “Quality assurance”, “Quality control” and
“Quality improvement”.
“Quality assurance” (QA) activities aim to guarantee that all changes in the process
Quality assurance
are clearly identified and valuated. It also guarantees that all product/service
specifications - necessary to satisfy both customer and product/service producer’s
requirements - are clearly fixed.
“Quality control” (QC) is a process – also known as “quality statistical control” – Quality control
which permits to valuate the performance of the current commercial company’s
processes, individuating and performing the actions necessary to eliminate undesired
performances. Thanks to this process QI standards can be fully respected. The
activities to correct irregular products can be or not be included in QC environment.
“Quality improvement” is a systematic and continuing activity, which involves all Quality
business processes, aiming at high performances. improvement
Anyway, a “quality management system” must be based on policies aiming to reach high
quality goals. Actually, all business actions reflect the management policy on fields such
as finance, product/service typology, social problems, personnel safety and so on.
Finally, a “quality management system” must be accompanied by a good “quality

technology system”: technologies able to obtain, monitor, control and improve the quality
of the commercial service itself.
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2.4 WHY THE IMPLEMENTATION OF A QUALITY MANAGEMENT

SYSTEM?
The creation of a quality management system can help the commercial company to enhance
customer satisfaction as well as of the other interested parties. Moreover, a well implemented
quality management system provides the business with the structure to activate continual
improvement actions.
The increasing of customer satisfaction (CS) - as well as of the other interested parties Customer
involved in the provision of commercial services - and the activation of continual satisfaction and
improvement (CI) are strictly linked to each other. Actually, considering the continuously Continual
changing customer needs and expectations, as well as competition and technical progress, the improvement
continual improvement of sold products and selling processes is an essential condition to remain
in the market.
The increasing of people’s satisfaction and the activation of continual improvement can be
obtained only if the commercial company considers some important principles, such as:
Principle 1 Customer focus
Principle 2 Leadership The principles of
Principle 3 Involvement of people CS and CI
Principle 4 Process approach
Principle 5 System approach to management
Principle 6 Continual improvement
Principle 7 Factual approach to decision making
Principle 8 Mutually beneficial supplier approach
2.5 THE ISO 9000:2008 STANDARD

ISO 9000 is a set of international standards published for the first time in 1987 by Geneva
The origin of the
International Organization for Standardization (ISO). Firms can use these standards to
ISO 9000
individuate requirements necessary to maintain an efficient quality management system.
For example, the standards indicate the requirements needed for the right calibration of
measurement and testing equipment (e.g. of scales and weights) or to maintain an adequate
registration system.
The ISO 9000 standards are the result of an international agreement of “good management
practice”, in order to guarantee products/services in line with customer quality
expectations, through processes, management and control.
ISO 9000 standards is a set of guidelines and requirements to implement and maintain a
quality management system, applicable to any kind of public or private organization,
regardless of its activity and size.
The ISO 9000 includes three main documents:
 ISO 9000:2005, Quality management systems – Fundamentals and vocabulary.
The ISO 9000
 ISO 9001:2008, Quality management systems – Requirements. series
 ISO 9004:2000- under revision, Quality management systems – Guidelines for
performance improvements.
As the set of ISO 9000 - 2000 edition and up- includes only one model for quality
management system (ISO 9001), the organization intending to implement a quality
management system should determine which items of the standard they want to use for
management actions and should develop its own system with those requirements. The
organization can get an exclusion from the implementation of some clauses of the 7th
paragraph of the standard, if not applicable due to the nature of the company. Design and
development must be controlled and documented if applied by the company.
The current ISO 9001:2008 edition being active from February 2009 on and the The current ISO
undergoing revision of ISO 9004 introduce minor only changes to the previous edition. 9000 edition (2008)
The main ones have to do with:
10
 Rephrasing to improve consistency between the ISO 9000 series standards and
those of ISO 22000 and ISO 14000.
 Adding the concept of business environment and risk
 Better definition of the control over outsourced processes
 Upgrading statutory and regulatory requirements
 Including the goal of managing the work environment needed to achieve
conformity to requirements, this meaning physical, environmental and other
factors
 Definition of personal data as a key example of type of customer property that
have to be protected.
 Information systems as a key example of the type of support services that may
impact conformity to product requirements, as an example of calibration
(verification and configuration))
 Making explicit reference to post delivery activities such as warranty provisions,
maintenance services and supplementary services such as recycling of final
disposal
A third – independent – part, the certification body certifies the conformity of the quality
management system according to ISO 9001 standards. The certification will show the
business processes area, which the certification has been requested for, as well as any other
management actions foreseen in ISO 9001 regulations not considered by the organization
under certification.
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3.- APPLICATION OF THE STANDARD ISO 9001 IN SMALL

COMMERCIAL FIRMS
The aim of this chapter is firstly to introduce briefly the SME phenomenon and its
Objective of
specifics and secondly to outline how these specifics affect the implementation of quality
chapter 3
management system in a small commercial firm.
3.1. SME
Micro, small and medium-sized enterprises (SMEs) are socially and economically
important, they represent 99 % of all enterprises in the EU and provide around 65 1 million
jobs. Besides that, they are an essential source for entrepreneurial spirit and innovation.
Since SMEs play a key role in the economies, the term SME is a frequently used one.
However, there is not one single definition used by all. On the contrary: the criteria for a
small and medium-sized enterprise can vary not only between different European
countries, but even within one country, depending for example on the field of activity of
the enterprise. Selective approach to SMEs (different criteria for being considered a SME
depending on field of activity) can for example be applied as one of criteria for obtaining
entrepreneurship support in various aid programs.
3.1.1 EU definition
To introduce one definition, we have chosen the SME definition of EU, used apart The
from statistical purposes also to handle this economic phenomenon with respect to EU definition
support schemes (especially state aid, Structural Funds and the Research and
Development Framework Programme). In addition, the European definition gives us
the opportunity to demonstrate, that the content of the term SME also undergoes
changes in time.
Since 1996 the following European description of a SME was used based on
Recommendation 96/280/EC:
to the group of SMEs count all enterprises with less than 250 employees, with the
balance sum lower than 27 mil. EUR/year or the turnover per year max. 40 mil. EUR.
At the same time the independency requirement has to be fulfilled (not 25% or more of
capital or votes may be owned by one enterprise or a group of enterprises, not
matching with the SME definition).
Since the economic development has been considered as relevant for the position of
SMEs, the criteria have been revised and a new definition published by
Recommendation 2003/361/EC in May 2003, applied since the 1 January 2005. 2
While the headcount requirement remains the same, there are changes regarding the
turnover and balance sheet sums:
1
Compare (http://europa.eu.int/comm/enterprise/enterprise_policy/sme_definition/index_en.htm)
12
Table 3.1 Recent development in SME perception in EU
Enterprise category Medium-sized Small Micro

enterprise enterprise enterprise
‘96-‘04 ’05- ‘96-‘04 ’05- ‘96-‘04 ’05-
Headcount < 250 < 250 < 50 < 50 < 10 < 10
Turnover max. (mil. EUR) 40 50 7 10 - 2
Balance sheet total (mil. 27 43 5 10 - 2

EUR)
According to EC, the main aim of the increase of the financial ceilings is to avoid
penalizing enterprises that invest. While the increase is significant in percentage
terms, it should not affect the number of SMEs on the market. From an economic
point of view, it is neutral since it takes account of subsequent price and productivity
increases while maintaining the staff ceilings.
3.1.2. The hidden giants
As stated in the introduction to this chapter, SMEs play a key role in our economy. SMEs – hidden
Sometimes they are even called the hidden giants or the real giants of the European giants
economy, since large enterprises form only 1 % of the total number of enterprises.
More than that, 93 % of all enterprises are micro enterprises (0-9 employees) 3 .
medium-sized
0,8%
small
large
6,0%
0,2%
micro
93,0%
Figure 3.1 European enterprises by size

(Source: SMEs in focus. Observatory of European SMEs 2002; EC, 2002)
Two thirds of all jobs (private non-primary sector) are in SMEs, split up roughly
2
On 6 May 2003 the Commission adopted a new Recommendation 2003/361/EC regarding its SME definition (replacing
Recommendation 96/280/EC). For more information please see:
http://europa.eu.int/comm/enterprise/enterprise_policy/sme_definition/index_en.htm.
3
SMEs in focus. Observatory of European SMEs 2002, European Communities, 2002
4
idem
13
equally between micro enterprises, small and medium sized. The size-class
distribution of employment, however, differs, between countries. Very important is
also, that SMEs create - unlike large enterprises - a net increase of job opportunities.
The strong position of SMEs, especially micro enterprises can be considered specific
for Europe: an average European enterprise employs 6 people, while a Japanese 10
and an American 19 people. Therefore SMEs account only for 33 % of employment in
Japan and 46 % in USA whereas in EU for 66 %. 4
Europe’s private sector jobs are in:

Employment by firm size
ISO certification
When linking the important market position of SMEs in Europe to the

importance of ISO implementation three figures might be interesting:
 world total of ISO 9000 certificates which shows a constant increase,
14
Figure 3.2 Issued ISO 9000 certificates, world total

(Source: http://www.iso.org/iso/survey2007.pdf)
 distribution of issued certificates among world regions, which proves the

strong emphasis laid on ISO certification in European countries,
Figure 3.3 Distribution of issued certificates among world regions (2007)

(Source: http://www.iso.org/iso/survey2007.pdf)
 number of certificates issued to the revised standard ISO 9001:2000 (which

replaces the 1994 versions of ISO 9001, ISO 9002 and ISO 9003), which more than
tripled in 2002 in comparison to 2001 and represented nearly 30 % of the overall
ISO 9000 total at the end of 2002
ISO
9001:2000
167 210
29,8%
ISO 9000
(1994 +
2000versions)
561 747
70,2%
15
Figure 3.4 Share of certificates of conformity to ISO 9001:2000 on ISO 9000 total
(2002) (Source: http://www.iso.ch/iso/en/iso9000-14000/pdf/survey12thcycle.pdf)
Even if the extent of this manual does not allow us to go deeper in on the issue, the
high share of Europe in issued ISO certificates together with the overwhelming
majority of European enterprises being SMEs and the high acceptance of the new
standard let us expect a high potential of QMS implementation according to ISO
9001:2000 in SMEs in Europe.
3.2 IMPLEMENTING THE ISO STANDARD
3.2.1 What should ISO (not) be about
Depending on the size of the enterprise, the implemented quality management system
should not draw up something that would be totally different from how the The “sense” of
organization conducted its business until now. Please notice that all enterprises QMS
already have a form of management system and possibly already fulfill some of the implementation
standard’s requirements, even if they have not, as yet, necessarily defined and in a SMEs
documented how they do it. The aim of the ISO standard is definitely not to impose a
totally new management system or to force the owner to change existing management
activities.
On the contrary, implementing a quality management system according to ISO 9000+
should be understood as a strategic mean to control the business, monitor what is
going on and which areas should be focused on. All requirements of the standard
should be applied with insight and commitment. The quality management system
should, to a maximal extent, implement modes already existing in the enterprise and in
addition proved, known and used by employees. Only then can the enterprise fully
benefit from implementation of the quality management system – it can improve
internal processes and serve as a tool for excellent market performance.
3.2.2 Management principles
In an SME as well as in a large commercial enterprise the company management consists

of several mutually dependant factors, such as management of human resources, supplier -
purchaser relationship, financial management, marketing, sales and after sales
management, safety management, environmental management etc.
The ISO 9001:2008 standard covers in different clauses the whole management diversity
outlined above. Before implementing the standard even in small and medium-sized
commercial enterprises the management should first of all get acquainted with the eight
The eight
management principles, the standard builds on, namely:
management
Principle 1 Customer focus
principles of ISO
Principle 2 Leadership
9001:2008
Principle 3 Involvement of people
Principle 4 Process approach
Principle 5 System approach to management
Principle 6 Continual improvement
Principle 7 Factual approach to decision making
Principle 8 Mutually beneficial supplier approach
Despite the fact, that these eight principles are not explicitly mentioned in the ISO
9001:2008 standard, they provide a framework for implementation of good
management practice. To make you aware of that, we have linked the principles with
different fields of management activities, discussed in individual clauses of the
standard. It regards e.g.:
 ensuring resources for human resources development, development and
maintenance of infrastructure and improvement of the work environment,
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effective involvement of employees in processes (principle 2 and 3),

 ensuring credible information, so that management can define the basic long-
term orientation of the company – quality policy,
 setting concrete short-term measurable tasks – annual quality objectives for lower
management (coming out of principles 1, 2 and 3),
 concluding commercially and technically clear contracts with suppliers and
customers (principles 1 and 4),
 ensuring economically convenient, high-quality inputs for the main activity
(principle 8),
 controlling own activity – concerning main processes of providing commercial
services the ISO 9001 methodology ensures an adequate level of documentation
of relevant selling and control procedures and instructions, compliance with
operational practice, proper way to handle controlled documentation,
identification and retrospective traceability (principle 4),
 ensuring outputs of main processes, thus commercial services of such a quality,
that meet customer’s requirements (principle 1); the level of customer’s
satisfaction is proved by gathering and evaluating information (by conducting
customer satisfaction surveys, customer data on delivered product quality, user
opinion surveys, lost business analysis, compliments, warranty claims, dealer
reports etc.) and by implementing measures, resulting from the evaluation
(principles 4 a 7),
 development of continual improvement program, being at the same time an
effective management tool and a means to activate employees; it includes
internal quality controls and transparent, consequent corrective and preventive
actions (principle 6).
The principles of process and system approach (4 and 5) illustrate two aspects: firstly
the importance of links between single processes and secondly the importance of links
between processes, resources (financial, qualified employees, infrastructure, work
environment, information) and conditions (framework outlined through requirements
of interested parties).
At the same time active participation of the organization is required while executing
changes and improving the knowledge level of employees, both being pre-requisites
for continual improvement (principle 6). Decisions are based on facts – results of tests
and analyses (principle 7). Other key factors - attitudes, motivation and competence of
employees are more or less included in all eight principles.
Summarizing, the eight principles for quality management outlined above can be
divided into two main management areas:
1. process management - applying process and system principles, implementing The two main
tools and attitudes of company’s management (principle 4 and 5, further 1, 6, 7 management areas
and 8),
2. human resources management – implementing tools in order to form attitudes
systematically, to increase work ability and to create an environment supporting
effective and efficient functioning of human factor (principle 2 and 3, but also 1,
6 and 7).
While providing management in both these fields, the new ISO 9001:2008 standard
stresses evidential care for compliance with superior laws and standards, related not
only to the goods sold but also for example with health and safety norms etc.
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CUSTOMER
4
4
2
S H
U E F U processes-resources-
P N M I M conditions
V S A N
P A 2-3
I A R A
L N
8 R F K N
I leadership and
O E E C
E R management
N T T E
R E
M Y I S 1-8
E N commitment
R O
N R G
E U
T I
L R attitudes
S
A C
K ability of
T E 1-8
S managers,
I S
O employees
N
S
CHANGES KNO WLEDGE

MANAGEMENT MANAGEMENT
6 7
CONTINUAL IMPROVEMENT USING FACTS

of
system, processes, resources information, data, knowledge
Figure 3.5 QM processes according to the eight ISO 9000 principles: 1 Customer focus, 2 Leadership, 3
Involvement of people, 4 Process approach, 5 System approach to management, 6 Continual improvement, 7 Factual
approach to decision making, 8 Mutually beneficial supplier approach
18
3.2.3 ISO in commercial SMEs - some characteristics

having impact
Even if there is a single ISO 9001:2008 standard and so is the set of requirements on
quality management system, there are some differences in the character of SMEs and
large enterprises having influence on the implementation. Some of the differences
bring about an easier start for SMEs, generally they ask for special attention. Within
the group of SMEs micro and small enterprises, which constitute the vast majority of
commercial firms in small cities, have an even more specific position. Therefore the
two groups will be dealt with separately.
Medium-sized enterprises (50 to 250 employees)
The specifics of
When implementing a QMS each member of the commercial company must be aware medium sized
of the importance of this step and must be motivated to contribute. Because of their enterprises related
smaller size, it is less difficult for the quality manager of a medium-sized enterprise to to ISO
involve everyone than it is in large enterprises. implementation
Furthermore, compared to large enterprises medium-sized enterprises may have a
more plain organizational structure, run a lower number of processes liable to QMS
and can manage with simpler communication tools. This might lead to a significant
reduction of system documentation. On the other hand, the number of employees and
the level of complexity of the enterprise usually result (different than in micro and
small enterprises) in an - at least partly - documented system of conducting business,
so that there is a certain base to build on when working out the quality documentation.
Another specific, resulting from the company’s character is a usually emphasized
customer focus. Since market potential of medium sized enterprises is limited
compared to the possibilities of large enterprises or chains, they can be considered
rather dependent on certain customers (big, important, regionally present), but in some
aspects also strong supplier-dependent. Therefore these enterprises mostly care for
good supplier – purchaser relationship. This characteristic is all the more important for
medium sized commercial companies operating in small cities, where people know
each other and rumor is very easily spread.
Micro and small enterprises (up to 50 employees) The specifics of
This is model for most commercial small city firms. The obvious advantage of micro micro and small
and small enterprises is that they are quite often family-related businesses with a enterprises related
director at the head, who usually is the owner as well. Consequently, he/she is directly to ISO
motivated to lead the company towards prosperity, to satisfy old and to attract new implementation
customers. The customer focus is in general additionally strengthened since micro and
small enterprises operate usually in regional markets and are in contact with an often
limited number of customers and suppliers. A consequent care for good supplier –
purchaser relationship is thus a precondition to survive.
The informality of the management brings a further advantage: the director/owner
gives oral indications on who does what and how and thus gives constant guidance,
checks and controls the quality of the service, the others follow the instructions. The
small size and informal management make it easier to motivate everybody within the
company for the QMS.
In general, all enterprises have an established way or system of conducting business.
As explained above, in micro and small enterprises informality is quite effective;
however, it is rarely documented. In connection with lack of documented procedures
and processes the quality documentation usually has to be worked out from scratch.
Micro and small enterprises have a very plain organizational structure and can
manage with few, simple communication tools. This results in a significant reduction
of system documentation. On the other hand, the unavoidable accumulation of
functions requires multi skilled employees together with a well-advised definition of
authorities and responsibilities, not forgetting a focus on communication, its content
and the way of documenting it.
19
Another difference between micro and small enterprises on one hand and medium
sized enterprises and on the other can consist (but not necessarily) in the number of
management processes, where all management effectiveness requirements are
consequently applied, including stated measurable indicators helping to follow the
effectiveness trends.
3.2.4 Realization of ISO requirements and differences between SMEs

and Large Enterprises
In the previous chapter some characteristic aspects have been appointed, having
impact on ISO implementation in SMEs. Please find here an overview of areas which
are considered specific, enriched by the findings resulting from the Correspondence
table, enclosed further on in this chapter.
First of all some specifics of the ISO implementation result directly from the very
nature of SMEs, such as the character of:
 management - informal, directly motivated, plain organizational structure, SMEs vs. large
requires good definition of responsibilities/authorities enterprises
 personnel - few, multi skilled, cumulated functions, not responsible exclusively
for QMS
 documentation - lack of documented procedures
 communication - simple form and tools
 supplier-purchaser relations, customer focus - more depending on certain
subjects, regionally limited
 processes – lower number, structure rather simple
Further, from the correspondence table some additional trends emerge as significant
for the implementation of individual clauses and specific requirements in SMEs. To
summarize the most obvious ones:
Group vs. individual
Group vs.
Where in a large enterprise a management meeting and group decision is needed, in an individual
SME the responsibility often lays with the owner/managing director - clauses 5.1
Management responsibilities and 5.6 Management review mirror clearly this aspect.
Long-term vs. short-term
Long-term vs.
Dealing clauses 5.4 Planning, 6.1 Provision of resources, 6.3 Infrastructure, 7.1
short-term
Planning etc. there has been stated a strong emphasis on short-term planning by SMEs
respecting the cash-flow development. This can be partly explained by the dependence
on individual orders.
Shifting outside Shifting outside
While in a large enterprise some activities and inputs are provided internally, in the
case of a SME they are substituted by activities/inputs delivered from outside.
Consider e.g. clause 7.4 Purchasing where input control tests are often replaced by
output control results and certificates from supplier. Similar by 7.3 Design and
development carried out by customer or 7.5 Service provision often is based on
customer’s documentation. Last but not least, sometimes 8.2.2 internal audits cannot
be provided by trained employees – internal auditors, because of their low number and
thus possible conflict of interests. The ISO 9001:2008 has special provision as far as
outsourcing and the control of outsourcing processes are concerned.
Cumulated responsibilities
Cumulated
Where in a large enterprise selected employees are appointed and trained to carry
responsibilities
responsibility for a certain activity, in SMEs this task has often to be executed by
somebody with other cumulated functions – consider e.g. 7.6. Control of monitoring
20
and measuring devices with responsibility for compliance of the devices with laws on
metrology automatically lying with the managing director when there is no other
management member appointed. The extent of the accumulation depends on the
company itself.
Flexible extent
Another thing about ISO 9001:2008 standard is, that it enables the enterprise to fulfill
a requirement “in an adequate way” (to a certain extent). This approach means that Flexible extent
e.g. by 4.2 Documentation requirements the complexity of quality documentation will
be lower in SMEs as well as its quantity, that extent and amount of information
gathered in the frame 8.2.1 Customers satisfaction will differ in SMEs and large
enterprises or that in the frame of 8.5 Improvement there might not be a separate
Continual improvement program but concrete tasks resulting from periodic evaluation
based on quality objectives.
Alternatively, it has to be stressed that the ISO 9001:2008 standard will not “forgive“
the SME anything simply because “it is small“. Exceptions in the sense of letting out
are possible only by requirements, discussed in clause 7. Product realization. And
even then possible exceptions are available to all kinds of enterprises (not depending
on size), the eligibility of every exception has, however, to be justified. Hereby a
simple rule can be applied: no requirements affecting quality of the service may be
excluded.
Correspondence table
The requirements of the ISO 9001:2008 standard are defined in clauses 4 till 8. In this
The differences
chapter and in the previous one (3.2.3 ISO in SMEs - some characteristics having
between SMEs and
impact) we have outlined some differences between SMEs and large enterprises,
large enterprises
which can affect the implementation of the quality management system. The table
related to the ISO
below links these differences together with the requirements of the standard (clauses
requirements
4-8) and gives you an easy to use overview of those requirements, which may require
a particular approach when implementing the standard in a SME. The correspondence
table is drawn up according to clauses and requirements of the ISO 9001:2008
standard.
21
Table 3.2 The ISO related differences between SMEs and large enterprises in a nutshell
ISO 9001:2008 standard – Correspondence table
Clause Large enterprise SME Comments
4. Quality Management System

4.1 General Quality management system has to be established, documented, implemented, maintained and If an organization will claim or imply conformity to
requirements continually improved in accordance with requirements of ISO 9001:2008. ISO 9001:2008, then it may not exclude from its
QMS requirements that do not meet the criteria
stated in clause 1.2 Application of the standard.
4.2 Documentation Documented statements of quality policy and Documented statements of quality policy and Quality policy is the basic unifying document
requirements quality objectives. Three-level quality objectives declaring the needs of the enterprise and its
documentation (quality manual, regulations, Two-level documentation (Quality manual and customers; it should include a long-term vision
work instructions). work instructions). Obligatory regulations Quality objectives have to set up concrete
High number of users = high number of broadly discussed in the Quality manual milestones on the way to fulfill the vision
copies, partial documentation centres, Low number of users = low number of copies, Quality manual – by SMEs the most suitable way
voluminous system documentation, usually one documentation centre. to describe the interaction between processes of the
electronic version (intranet), hypertext links, Form more simple, e.g. Quality manual in form QMS may be the graphical one; in some cases
links to related documents, forms etc. of one file folder with all related documents process cards or hyperlinks in electronic documents
including example forms used for records etc. may be advised.
Documents and records have to be Documents and records have to be controlled.
controlled. The ISO 9001:2008 edition previews that a single
document may include the requirements for one or
more procedures.
5. Management responsibility
5.1 Management Management usually consists of several Owners as managing directors directly control the By SMEs this field is quite often left out. But even
commitment responsible employees – (managing director, company. A specific case is a one-owner- in their case, the management has to specify its
directors specialists). The company’s owner company, where the management is executed vision and long-term intentions related to the
may stay outside QMS (stock corporation). directly by the owner, who does not need a business subject, own optimal product and its
“management meeting” to make strategic presentation on the market. The intention of an
decisions. SME can be for example to become partner of a
certain client, e.g. a hotel chain or to be authorized
partner (dealer or service provider) in the case of
commerce
The management shows personal involvement and
activity while improving the QMS and stimulating
continual improvement through internal message
about the importance of meeting customer’s
requirements and requirements imposed by related
superior laws and standards.
5.2 Customer focus Usually, information source for the Information for company’s future orientation Both managers and employees of SMEs usually are
company’s orientation is own marketing. mostly won due to membership in associations, more directly motivated to lead the company
Customer’s needs are to be understood as internet etc. towards prosperity and thus to satisfy old and to
market potential – having identified it attract new customers.
prevents wrong decisions regarding future
22
orientation. Own marketing limited, possibly due to relative

high costs. In small commercial firms, however,
the use of windows and the adoption of clever,
law cost ways for marketing is often.
5.3 Quality policy Basic unifying document declaring the results desired by the enterprise. It should be appropriate Even in the case of SMEs, the management has to
to the purpose of the organization and includes a long-term vision. It should include the specify its vision and long-term intentions related
commitment to comply with requirements and continually improve the QMS. The quality policy to the business subject, own optimal product and its
provides a framework for establishing and reviewing quality objectives. presentation on the market. The intention of a
All employees should be aware of the declared quality policy of the organization. commercial SME can be e.g. to provide customers
with individualized orders, according to their
specifications delivered on time.
5.4 Planning Detailed financial plan and exact calculation Annual plan in financial indicators, cash-flow Planning is an integral part of any enterprise
of development expenses. depending on development expenses, main management. In the case of SMEs, however, some
Factual production plan activity often controlled by operative plan. of the plans (e. g. investment plan, training plan
Establishing measurable quality objectives etc.) might be understood only as a framework and
Establishing measurable quality objectives may be controlled operatively according to actual
consistent with quality policy. consistent with quality policy.
cash-flow development.
5.5 Responsibility, Branched organizational structure, easier Simple organizational structure, often cumulated Appointing a member of management responsible
authority, defining of authorities and responsibilities, functions. When distributing responsibilities and for the QMS is essential. It has to be a strong leader
communication executive and control functions. authorities, specifics of the SME and provided with authority to coordinate the whole
Management representative is usually a characteristics of individual managers have to be system. While there is usually a new position
member of top management, can be helped taken into account. established in large enterprises, in micro enterprises
in QMS administrative tasks by an Management representative for QMS usually has the task is often taken over by one of the managing
employee. other cumulated functions. directors or, in most cases, by the owner
him/herself.
Sophisticated means of communication (e.g. Elementary communication means (e.g. joint
intranet) management and sales meetings)
5.6 Management Complex report on given period as input for Complex report on given period as input for Management review means a recapitulation of the
review management review. management review. whole QMS in regular periods (annual, biannual).
Documented owner’s standpoint to the report (by Unlike other system requirements, applied by
Review during a management meeting, companies, where the influence of management SMEs already before the implementation of QMS,
documented in minutes, formulated remarks meeting members on the owner is only advisory), it is not common in SMEs to execute management
and actions resulting from the evaluation. including specification of actions if necessary. review in an extent requested by the standard. In
the context of strategic management such a
Review of quality objectives. standstill and recapitulation is very useful. The
New challenges for Quality objectives or standard requires decisions to be made based on
continual improvement program. facts, not opinions. In the context of management
review original intentions, objectives and resulting
tasks can be modified.
6. Resource management
6.1 Provision of Detailed financial plan and exact calculation of Planned resources respecting the cash-flow Even an SME should determine resources needed to
resources development expenses. oscillation in the course of the year. implement and maintain the QMS and to meet quality
objectives and should specify how the resources will
be provided. In the case of SME, distribution of
resources during the year might be controlled
operatively according to cash-flow development.
23
6.2 Human resources Human resources department/section with Cumulated personnel work and training Good personnel development work can be done even
divided personnel and educational activities. management. in an SME. It is necessary to evaluate the performance
Map of company’s qualification structure, and reserves of every employee and to plan the use of
Map of company’s qualification structure, it in a broader context, in new fields or at least by
specification of work positions, personal specification of work positions.
conserving the actual state. Employees, however, have
development plans. to feel that they are followed and evaluated and that
Evaluation of employees through interview. the company counts on them. The most suitable form
Annual training plan. of applying the requirement is a simple evaluation of
Annual training plan.
Training evaluation. ability and planning personal development of every
Evaluation of training quality and single employee (regular detecting of training needs,
effectiveness. training plans, evaluation). Use of experience and
ability of employees is typical for SMEs-service
providers such as commercial firms, where the quality
of the service often depends on skills and experience
of single employees, e.g. salespaersons.
6.3 Infrastructure Demanding, large infrastructure. Rather simple infrastructure. SMEs often develop their infrastructure more
dynamically than large enterprises. Continual
Infrastructure development planning based on Infrastructure development realized under detecting of the means needed to ensure conformity of
long-term strategic plans, making use of conditions of more simple decision making the merchandise involves technology, measuring
different investment studies and scenarios. processes (owner makes short-term decisions based devices, information system, car park, conveyors
on actual resources). systems, communication technologies, work tools for
Annual maintenance plan.
Annual maintenance plan. employees. It is to be recommended to improve the
infrastructure development plan in relation to quality
objectives.
6.4 Work environment The organization determines and manages the The organization determines and manages the work As an SME: do not forget to fulfill requirements of
work environment needed to achieve environment needed to achieve conformity to related laws and standards, as well as obligatory
conformity to product requirements. regulatory and statutory requirements, including the revision of state authorities!
Besides control of compliance to obligatory management of the work environment.
requirements of related laws and standards The ISO9001:2008 edition pays special attention to
(according to subsector and field of activity) the management of the work environment needed in
additional surveys are carried out on the impact order to achieve conformity to sales requirements.
of work environment on the quality of the
provision of goods.
7. Product realization
7.1 Planning and Main activity (production or service If the sales process cannot be long-term factual Even in an SME it is useful to set requirements for
product realization provision) usually planned in an annual or planned (company satisfies direct demand of the merchandise. Consequently, there should be
quarterly detailed factual plan. Planning individual customers), than a planning in e.g. records providing evidence that the realization
quality, detecting risks. financial indicators is necessary. process and the merchandise meet set requirements.
Merchandise as well as sales processes have to
Products/services as well as meet requirements defined by laws and superior
production/service processes have to meet standards.
requirements defined by laws and superior
standards.
7.2 Customer-related During the decision process regarding order Review of order acceptance has always to be Records on order acceptance review make part of
processes acceptance all managers influencing the documented (at least simplified), even if the controlled documentation.
24
order have to make their comments. The owner decides.

standpoint has to be documented
(recommended - in information system).
Negotiations with customer specifying the
contract are documented.
7.3 Design and The company usually disposes of own Cases appear, that companies ensure By SMEs the development of the sales often
development capacity for product or services/processes development mainly utilizing co-operating happens by the customer, which can be qualified as
development, in the case of commercial experts. This demands proper documentation not fulfilling of the requirement and may be even
firms sales development. reflecting requirements of clause 7.3. of the reason for exclusion.
standard.
7.4 Purchasing List of suppliers for a limited period derives Evaluation of suppliers for a limited period and Even by SMEs evaluation of suppliers forms an
by running companies from repeated documenting of the list of approved suppliers has important input for preventive actions and
evaluation. Members of sales and technical to be done even if a strong accumulation of negotiations with partners. In the organization a
control department should be involved in the information and responsibilities exists. permanent drive for evaluation has to be evident.
evaluation. Acquiring output control results and certificates
from the supplier can replace the input control
The company has an own test room, where tests.
input control of purchased material is
executed and its release into production/sales
approved.
It is used to execute customer audits by

supplier.
7.5 Production and Sales or providing services is usually Providing sales often carried out according to If there is no after sales service provided, there may
service provision operated according to own documentation documentation or procedures delivered by the be a co-operation with a service provider assigned
and procedures. Processes being verified. customer. Documentation verified and released instead. This co-operation has to be exactly
All material in productionor any before use. Processes verified. specified (especially quality requirements).
merchandise sold is properly signed, After sales service directly provided by the
marking enables backward tracing of all company does not always exist.
relevant information.
Procedures for providing service of own
products exist, service realization
documented.
7.6 Control of In the frame of QMS laws on metrology If there is no management member appointed as Even if calibration of measuring devices is carried
monitoring and usually count as superior standard. Member responsible for compliance with laws on out externally, in the company there has to be kept
measuring devices of metrology department participates in metrology, then this responsibility lies documentation that meets requirements of clause.
management. automatically on the managing director of the 7.6 of the standard.
Calibration of measuring devices often company.
provided internally. If the company uses to Calibration of measuring devices is usually
do calibration of measuring devices itself, provided by an external competent center.
calibration procedures have to be defined.
25
8. Measurement, analysis and improvement

8.1. General The organization shall plan and implement
processes needed to demonstrate conformity
of the merchandise and the sales process,
ensure conformity of the QMS and its
continually improvement.
Used methods should be defined, including
statistical methods (if applied).
8.2 Monitoring and measurement
8.2.1 Customer Besides top management also members of Relevant information on customer’s satisfaction Even in SMEs the collected information on
satisfaction other departments have the possibility to can usually be collected only by management customer’s satisfaction should be documented in
obtain information on customer’s satisfaction members or by the owner. Structure of the written form even in case of a strong accumulation
directly from customers, e.g. members of the information needed (checklist) and strategy of its of information by one person.
marketing or service department. Collected acquisition have to be worked out beforehand.
information is processed, selected, and based Obtained information is evaluated, necessary
on evaluation necessary actions are defined. actions defined.
8.2.2 Internal audit Internal audit plan guarantees that all External auditors can be accepted for carrying out Even if the audit is ensured by external auditors,
departments and all clauses of the standard internal audits only if - because of a low number the audit procedure has to be described and
will be checked up in the course of current of employees - own auditors cannot ensure documented According to requirements of clause
year. internal audits without facing conflict of interests. 8.2.2 of the standard.
There is a team of own auditors ensuring the Audit plan for one year worked out in advance,
realization of internal audits. Members of compliance with requirements of the standard as
this team are regularly retrained, their work well as extent and content of audits are monitored
evaluated. thoroughly.
Summary of through internal audits acquired Audit findings have to be reflected and if
information forms an essential part of the necessary the QMS improved.
management review report.
8.2.3 Monitoring and All management and sales activities are, to an adequate extent, monitored and evaluated. By SMEs the number of processes liable to
measurement of monitoring and measurement will be considerably
processes lower than by large enterprises.
8.2.4 Monitoring and Control between individual operations as Control between individual operations and Thanks to the controls nonconformities can be
measurement of well as output control is carried out by sometimes also output control carried out by detected.
product professional inspectors, members of sales persons in form of self-test. In that case,
independent technical control department. sales persons are extra trained for control activity
All types of controls are specified in and based on training they are entrusted with
controlling and testing procedures. control.
Control documents archived as quality Evidence of conformity/authorization of release
records. should be documented.
8.3 Control of Nonconforming merchandise must be separated and protected from (even unintended) use, Even by SMEs, monitoring and analysis of
nonconforming assessed and handled in one of the by the standard accepted ways. nonconformities is one of the inputs to be
product considered for decision on a corrective/preventive
action.
8.4 Analysis of data Adequate analyses are a non-excludable instrument for decision making and management. The standard requires decisions to be made based
26
on facts, not opinions. Monitoring of sales process

and analysis of acquired data is thus unavoidable
even by SMEs (in appropriate extent).
8.5 Improvement The company usually has a separate Annual quality objectives include usually also Overview of actions undertaken to improve the
document to deal with improvement, the minor concrete tasks ensuring development of the QMS forms a part of the complex report on given
Continual improvement program. It expands enterprise. Thanks to a frequent actualization and period (being input for management review).
on declared quality objectives specifying completion in the course of the year an up-to-date
minor important tasks. state and effectiveness is guaranteed.
8.5.2 Corrective action The corrective action control system guarantees in both, a large enterprise as well as a SME, that Every corrective action has to be proportional to
suggestions for preventing insufficiencies will be evaluated, a procedure for a corrective action consequences of nonconformity stated.
will be established and executed and result of the action controlled.
8.5.3 Preventive action The preventive action control system guarantees in both, a large enterprise as well as a SME, Every preventive action has to be proportional to
that suggestions for preventing insufficiencies will be evaluated, a procedure for a preventive consequences of possible nonconformity.
action will be established and executed and result of the action controlled.
\
Table 3.3 Records required by ISO 9001:2008
Clause Record required

5.6.1 Records from management reviews
Example: Table of minutes, memo or equivalent document presenting the
results and actions made in a management review.
6.2.2 (e) Records of education, training skills and experience
Example: An Excel-table including information of employees´ education and
work history, training during current employment, specific skills etc. => All in
one database; easier to predict future training needs. Alternative records are
copies of curriculum vitae, certificates and attendance sheets from training.
7.1 (d) Evidence that the realization processes and resulting sales fulfil requirements
Example: Usually these are normal delivery documents, such as work orders
or equivalent documents.
7.2.2 Results of the review of requirements related to the sales and actions arising
from the review
Example: The record of the review can be e.g. a signature on a quotation or an
order-entry into a computerized system. The idea is to check if all customer
requirements can be met by checking e.g. material or merchandise availability and
delivery time.
7.3.2 Design and development (inputs for R & D, review and verification of results
against the input requirements, validation prior to delivery or implementation)
Example: A memo, drawing or equivalent document to present all needed
information, including sales parameters, possible amendments, accomplished
results and authorized validation of the sales prior to delivery or
implementation. The use of planning tools or organization’s own models of
conducting design and development is advisable.
7.4.1 Results of supplier evaluations and any necessary actions arising from the
evaluations
Example: This can be discussed during internal auditing and be reported in the
table of minutes.
7.5.2 (d) Demonstration of the validation of processes where the resulting output cannot
be verified by subsequent monitoring or measurement
Example: A document showing acceptance of tolerances and parameters.
7.5.3 Record of the identification of the merchandise, where traceability is a
requirement
Example: Usually a work order includes information for traceability.
7.5.4 Reports on customer property that is lost, damaged or otherwise found to be

unsuitable for use. ISO 9001:2008 previews that customer data are also
considered as customer property and have to be protected.
Example: The use of internal complaint form.
28
7.6 a) Records on calibration and verification (basis for calibration or verification of

measuring equipment where no international or national measurement standards
exist; results)
Example: Memo of calibration.
8.2.2 Internal audit results and follow-up actions

Example: Documented audit report.
8.2.4 Indication of the person(s) authorizing release of merchandise

Example: Usually stated on a work order.
8.3 Nature of the sales process or merchandise nonconformities and any

subsequent actions taken, including concessions obtained
Example: The use of internal complaint form.
8.5.2 Results of corrective action

Example: Nonconformities are documented using an internal complaint form
or a written complaint sent by the customer. Nonconformities are discussed
and corrective actions composed (useful tools: fishbone, brainstorming).
Results are documented on table of minutes and relevant instructions and
information distributed to personnel.
8.5.3 Results of preventive action

Example: The use of different methods (such as Failure Mode and Effect
Analysis, FMEA) to detect root causes i.e. factors that can, at some point in
the future, cause conformities such as customer complaints or deficiencies in
merchandise.
29
4.- STEPS TO IMPLEMENT A QMS
4.1 STEPS TO DECIDE

Every decision making process in a company is accompanied by a more or less detailed Some preparation
research of data or at least discussion of experience and personal opinion of business work is necessary
leaders. Implementation of a quality management system, which could be quite a
challenging task especially for smaller sized companies, also needs a certain amount of
preparation and planning.
4.1.1 Decision to implement a QMS

If a company wants to decide if it should implement a QMS it has to take a lot of
different facts into consideration, which could be worked out in an internal Definition of
management meeting. Main players in this meeting are the general manager who has quality manager /
to decide from a more strategic viewpoint, and the existing quality representative First information
(quality manager), if there is such, who should be aware of more QMS details to the management
(necessary resources, costs, etc.) and its business impact. The marketing/sales level
manager may support the decision making process by daily business experience.
Some companies start their own research but most of the time the decision is made
after a deep discussion of the topic with a chances and risk analysis, which is strongly
connected with the later first planning of resources (5.1.3). In addition to that, a person
who will take the responsibility for the next steps has to be named – of course the
quality manager (QM) is the best-qualified person. If there is no quality manager
available who has the necessary knowledge about this topic, it might be a worthwhile
investment to send the management representative to an external training on QMS.
Quality managers should be able to build and improve the management system but
also bring in as well an excellent level of social competence.
Once the decision is made by the general manager as another early step the whole
management level (if the company has more than one managers and/or owners) should
be informed and committed to the QMS because full management support is a crucial
factor for a successful implementation process. Lack of information about what a
QMS stands for and which changes will occur might create misunderstandings and
restrictions against the implementation process. The management has the task to
create a positive awareness for this new quality initiative by providing the necessary
information and participative leadership.
Another important decision the management has to take is the level of outsourcing
during the implementation process, which means the scope of consultant involvement.
4.1.2 First planning of resources
Implementing a QMS could be quite a challenge for a company because the elements
of a QMS are interdependent with most of the vital parts of the organisation. For this
reason a first rough projects plan with the most important milestones and the
corresponding resources should be sketched. Many QMS implementations are divided
into phases like:
 Start-up phase: collection of information about QMS, decision making process, Rough projects
training on QM, support of consultants, benchmarking plan including
main phases and
 assessment phase: identification of actual strengths and weaknesses resources for
 system building phase: management handbook, creation of documents, implemen-tation
30
identification and description of key processes and quality relevant issues

 training phase: training of staff in all areas of the organisation
 improvement phase: first review of the system (internal audit) and improvement
activities
 auditing phase: external certification audit
Each of these phases should be roughly estimated concerning time plus money and in
addition to that clear responsibilities should be defined. During the next step – the self
assessment – this plan should be reviewed and revised.
4.1.3 External consultants
Organisations choose different ways how to implement a QMS regarding the scope of Outsourcing
external involvement. The range runs from a totally “home made” system to a factors: internal
complete outsourcing of all implementation activities. An advantage of the first case is knowledge,
that deep knowledge about the system is built up in the company whereas the danger available internal
of creating only a sub optimal QMS is higher because of the fact that a consultant will human resources,
encompass high implementation experience often in the same branch. The decision financial resources
which grade of outsourcing has to be taken is depended on certain factors. Some of the
most important are:
 Level of internal knowledge: if there is already an expert in the company, the

planning and implementation can easily be done in house. Perhaps external help
could be worthwhile during the internal audit phase. Furthermore the role of
consultants is to adjust the requirements of the standard to each company, since
the standard is quite general and “open”, so an inexperienced person could omit
things.
 Available internal human resources: some companies are so lean in their

organisational structures that it is not possible to transfer enough staff capacity to
a new implementation project and work for this reason intensively with external
consultants. Furthermore external consultants can stimulate the staff in the
implementation of the quality process.
 Financial resources: of course external consultants cost money but in most cases
the payback time of this investment is very short because of an efficient project
management system and high knowledge about how to design a QMS could save
a lot of money in the longer run. In addition to that many companies hire
consultants with high reputation and use this fact as a first marketing instrument
for their customers.
Either way the management of the company has to take care that the QMS is strictly
result oriented, which means it has to be aligned with the company’s success factors
and its strategy. QMS that are focused only on achieving the certificate are not strictly
result oriented and are often perceived as red tape and a topic, which is for the QM
department or the quality manager only.
For the two following phases, it is a great advantage to work with an external
consultant because he/she has a new and neutral look on the enterprise and on its
organization.
31
4.2 FIRST SELF ASSESSMENT
The first self assessment or horizontal assessment (some or all aspects of the ISO standard) Check lists /
has the goal to figure out which actual level of QMS maturity the organisation has and Strenghts and
where the fields of highest potentials are as every organisation that is seeking certification weaknesses
is required to: analysis / Force
 Formalize the way things are done field analysis
 Demonstrate assurance that things are done in the right way
 Monitor the effectiveness of what is done and
 Improve
For this reason using some tools could be very helpful. Beside some software products
which are provided by many different companies and are designed to help identifying
“unknown land in the ISO world”, check lists, strengths-weaknesses analysis and forced
field analysis are often used tools for the first assessment. Normally the first self-
assessment is a mixture of analysis and in the case of small companies one single
assessment workshop. The output of all these methods and tools is to measure and assess
the actual state of the organisation against the elements of the ISO standard.
Checklists are the most frequent tools, which are used in this phase and can easily be found
in ISO literature. In long lists there are detailed questions about every single element of the
ISO but for smaller sized companies a certain amount of simplification work is often
necessary because in this case the organisational structures and documentations are less
complex. The best way to conduct checklists is an individual interview with key persons of
the company.
Chapter 5:
Management
responsibility Question: Yes No Remarks
5.1.1 Does a quality policy exist? X
5.1.2 Do management reviews X There is no systematic

exist and do they include all customer satisfaction
essential aspects? analysis
5.1.3 …? X ……
Figure 5.1 Example of a first assessment checklist.
In the workshop itself the concentrated results should be presented and discussed. One of
the most common supportive tools is the so called strengths and weaknesses analysis,
whereby the areas of high ISO maturity are highlighted against the areas of extraordinary
low maturity in a kind of balance sheet.
32
Input O utput
 Definition of ISO elements Level
Levelof
Level of maturity
of maturity
maturity  Visualization of
In columns. strengths and
Elements
Elements of
of ISO
Elementsof ISO
ISO Weak
Weak Average
Average Strong
Strong
Weak Average Strong weaknesses.
 Assessment of maturity
levels of the elements.  Definition of
Processes
Processes
Processes
 Identification of critical improvement actions.
elements (low level). Continual
Continual
Continual Improvement
Improvement
Improvement
Supplier
Supplier
Supplier Development
Development
Supplier Development
Development
……..
……
……
……
……
……
……
……
Figure 5.2 Example of a strengths and weaknesses analysis

Beside this comparison of the organisational state in relation to ISO elements, human
aspects and the organisational change process should be taken into consideration. A very
simple method to do this is the so called force field analysis (FFA). The underlying model
of the FFA states that during a change process there will always be enforcing and
constraining forces in an organisation such as the mind set of specific employees,
experience with former changes, motivational aspects, incentive systems, etc. As well as in
the strength and weaknesses analysis both kinds of forces are listed and discussed. As the
major result enforcing aspects should be supported by actions and constraining aspects
should be weakened or eliminated.
Input Output
 The goal has to be defined  Visualization of project
(e.g. efficient forces
Which
Which forces
forces are
are effecting
effecting the
the goal?
goal?
implementation process).
 Determination of
 Identification of improvement activities
reinforcing and
constraining forces
(brainstorming)
 Results in form of a balance Reinforcing Constraining

sheet aspects aspects
 Support reinforcing aspects

and eliminate constraining
aspects
Figure 5.3 Force Field Analysis

With the collected, discussed and committed knowledge of the actual ISO maturity and
change aspects, a more detailed implementation plan can be developed.
4.3 DETAILED IMPLEMENTATION PLAN

The implementation plan is strongly interrelated with all afore mentioned contents and draws a Project
general picture of what should be done and when it should be done until the certification audit has
organisation / Goal
been successfully passed and encompasses the system building phase, the training phase, the description / Early
improvement phase and the audit phase of the implementation project. planning of
trainings /
Between each of these phases milestones should be defined which are in most cases points for Definition of
management reports or workshops. For example the milestone after the system building phase quality policy
could be a completed QM handbook plus ready designed and described processes. After the
training phase all learning and training activities should be completed whereas the milestone for
the improvement phase could be a successfully passed internal audit with a timetable for the
33
elimination of minor and major nonconformities. And finally the audit phase could be completed
by the certification of the company whereas the last phase (improvement) shouldn’t find an end at
all.
Phase 1 Phase 2 Phase 3
Self Assessment System Building Improvement

Start 01/ 04
10/ 03
09/ 03 Completed Completed
first system
 Data analysis self  Generation of Q M draft  ….
 Strenghts - assessment Handbook
weaknesses  Identification of Processes
 Force field analysis  Definition of
 … Documentation
 Design of records
 Management Commitment
and responsibilities
 ….
Figure 5.4 Example of an implementation plan with milestones (no details are shown in this
graph)
Besides phases and milestones the project organisation should be clearly defined. Even in small
companies it doesn’t make sense that one single person is in charge of every activity during the
whole implementation project. For this reason it is common to create a multi layer project
organisation. This means that different employees of various departments are responsible for
smaller tasks; the quality manager or the external consultant does the coordination and the main
decisions and directives are given by a steering group which consists of management members.
As mentioned above, the steering group is only active in milestone workshops or if there are
exceptional decisions to make.
All subprojects and tasks have to have at least a very short form of goal description:
 What is to be done (if necessary in form of a detailed description)?
 Until when should it be done (check the correlation with the master plan)?
 Who should do it?
 Which resources are available (staff, money and infrastructure)?
One of the core elements of systems engineering – a widely used philosophical approach
on how to build a QMS – states that it is crucial to establish a model or system from the
top perspective and on this basis continue step by step towards more detailed levels. This
“low to high detail” dogma is as applicable in the implementation plan: start with the
master plan (phases) and develop top down until the most detailed level is reached.
Feedback and results are reported bottom up and are collected and condensed until the top
level (steering group meeting) is reached. Only under these conditions can a permanent
flow of information be guaranteed. In small commercial firms this operation is of course
simpler as there are no many levels of management.
Of course many software solutions are available to support these planning issues (e.g. MS
Project) but for small enterprises, in particular, where the knowledge of project
management tools is often not very well established it sometimes makes more sense to
sketch the plan simply on a flip chart and pin it on a wall.
The earlier training activities can be done the better for the QMS because the more
employees that are aware of the new system and are involved in the implementation
process, the easier the information will flow. Especially in the first phases as it may be
necessary to train selected employees in the basics of ISO standards and in the tools they
will have to use during the following phases (process orientation, documentation of quality
relevant issues, etc.). Training and quality education of employees is one of the most
34
important and regarding the duration of the corresponding activities, one of the most
underestimated aspects.
One of the first steps in the implementation plan is the discussion and definition of the
quality policy and quality objectives wherein the management draws a picture of strategic
quality issues. As a rule the quality policy describes how the company is aiming at
permanent improvement via the QMS, the importance of quality for every single member
of the organisation and the relationship with customers and suppliers. Of course it has to be
aligned with the company’s general strategy, it should be known and understood by all
employees and should be much more than only a lip-service by the company’s leaders.

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GUIDELINES FOR THE

2.1 THE SENSE OF THE WORD “QUALITY”

2.2 THE DEVELOPMENT PHASES OF QUALITY: CULTURE,

- integrated approach to Quality management, considered as part of the system,

differs from traditional approaches in three points:

1. improvement of quality as a continuing process;

 In the 70’-80’s the concept of Quality is also extended to servicing companies. In

- the service does not exist before purchasing;

1. definition of the business and its goals

Creating Quality means providing “internal quality” and “external quality”.

The 1990-2009 period is characterized by the increasing demand of “social quality”

2.3 QUALITY MANAGEMENT SYSTEM

Finally, a “quality management system” must be accompanied by a good “quality

2.4 WHY THE IMPLEMENTATION OF A QUALITY MANAGEMENT

2.5 THE ISO 9000:2008 STANDARD

3.- APPLICATION OF THE STANDARD ISO 9001 IN SMALL

Table 3.1 Recent development in SME perception in EU

Enterprise category Medium-sized Small Micro

‘96-‘04 ’05- ‘96-‘04 ’05- ‘96-‘04 ’05-

Headcount < 250 < 250 < 50 < 50 < 10 < 10

Turnover max. (mil. EUR) 40 50 7 10 - 2

Balance sheet total (mil. 27 43 5 10 - 2

3.1.2. The hidden giants

Figure 3.1 European enterprises by size

Europe’s private sector jobs are in:

When linking the important market position of SMEs in Europe to the

Figure 3.2 Issued ISO 9000 certificates, world total

 distribution of issued certificates among world regions, which proves the

Figure 3.3 Distribution of issued certificates among world regions (2007)

 number of certificates issued to the revised standard ISO 9001:2000 (which

3.2 IMPLEMENTING THE ISO STANDARD

3.2.1 What should ISO (not) be about

3.2.2 Management principles

In an SME as well as in a large commercial enterprise the company management consists

effective involvement of employees in processes (principle 2 and 3),

CHANGES KNO WLEDGE

CONTINUAL IMPROVEMENT USING FACTS

3.2.3 ISO in commercial SMEs - some characteristics

3.2.4 Realization of ISO requirements and differences between SMEs

Clause Large enterprise SME Comments

4. Quality Management System

orientation. Own marketing limited, possibly due to relative

order have to make their comments. The owner decides.

It is used to execute customer audits by

8. Measurement, analysis and improvement

on facts, not opinions. Monitoring of sales process

Clause Record required

7.5.4 Reports on customer property that is lost, damaged or otherwise found to be

7.6 a) Records on calibration and verification (basis for calibration or verification of

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of merchandise

8.3 Nature of the sales process or merchandise nonconformities and any

8.5.2 Results of corrective action

8.5.3 Results of preventive action

4.- STEPS TO IMPLEMENT A QMS

4.1 STEPS TO DECIDE

4.1.1 Decision to implement a QMS

4.1.2 First planning of resources

identification and description of key processes and quality relevant issues

4.1.3 External consultants

 Level of internal knowledge: if there is already an expert in the company, the

 Available internal human resources: some companies are so lean in their

4.2 FIRST SELF ASSESSMENT