Guidebook for Qms

8/2/2019 Guidebook for Qms

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www.smallcitycommerce.eu

GUIDELINES FOR THE

IMPLEMENTATION OF

A QUALITY MANAGEMENTSYSTEM (QMS), ACCORDING TO

THE ISO 9001:2008 STANDARD, TO

SMALL COMMERCIAL FIRMS


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INDEX

1.- I NTRODUCTI ON 3

1.1CONTEXT 3

2.- GENERAL 5

2.1THESENSEOFTHEWORDQUALITY 5

2.2THEDEVELOPMENTPHASESOFQUALITY:CULTURE,PRINCIPLESAND

METHODS 6

2.3QUALITYMANAGEMENTSYSTEM 8

2.4WHYTHEIMPLEMENTATIONOFAQUALITYMANAGEMENTSYSTEM? 92.5THEISO9000:2008STANDARD 9

3.- APPLI CATI ON OF THE STANDARD I SO 90 01 I N SMALL

COMMERCI AL FI RMS 11

3.1.SME 11

3.1.1 EU definition 11

3.1.2. The hidden giants 12

3.2IMPLEMENTINGTHEISOSTANDARD 15

3.2.1 What should ISO (not) be about 15

3.2.2 Management principles 15

3.2 .3 ISO in comm ercial SMEs - some character istics having impact18

3.2.4 Realization of ISO requirements and differences between SMEsand Large Enterpr ises 19

4 .- STEPS TO I MPLEMENT A QMS 29

4.1STEPSTODECIDE 29

4.1.1 Decision to implement a QMS 29

4.1.2 First planning of resources 29

4.1.3 Ext ernal consultant s 30

4.2FIRSTSELFASSESSMENT 31

4.3DETAILEDIMPLEMENTATIONPLAN 32



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1 .- I NTRODUCTI ON

1 .1 CONTEXT

During the last decades enterprises made an effort to achieve quality as a measure to

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 total enterprises power in Europe, have complained that implementing the ISO

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 todifferentiate 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 proceduresthat 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 theirsuppliers and their subcontractors certification at ISO-9001 and application of

quality processes, while in certain sectors, such as the paramedical sector the

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

The achievement of quality

The power of SMEs in

Europe

Consideration of branchespecific situations / Internal

and external reasons for

implementing a QMS



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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

to adapt the general requirements of ISO-9001 to their own case; but, in general,those tools do not address the specific needs of small enterprises.

The lack of educational

material and tools for SMEs



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2 .- GENERAL

2 .1 THE SENSE OF THE W ORD QUALI TY

The word "Quality", being an abstract concept, can have many different definitions, such

as "essential and distinguishable attribute of someone or something " or "feature defining

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

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 users need, and through the precise determination of the requirements,

its fulfilment. This acceptation underlining the adequacy to usage (Quality as value)

focuses on users 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 anddetermining his/her satisfaction. In this sense, the meaning of quality is oriented

to profit. The goal of a better quality is to enhance customer satisfaction, and

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 repairingactivities which usually bring to market shares loss, customer discontent and so

on. In this sense the word quality is oriented to costs reduction and better

quality means lower costs.

Finally, ISO 9000:2008 defines the word quality as: "degree to which a set of inherent

characteristics fulfils requirements.

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 inherentmeans existing in something, especially as a permanent characteristic.

The many different

definitions of word

quality

Quality as feature

Quality as value

Quality means

higher costs

Quality means

lower costs

The ISO 9000:2008

definition



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2 .2 THE DEVELOPMENT PHASES OF QUALI TY: CULTURE,

PRI NCI PLES AND M ETHODS

The origin of the problems related to Quality can be associated to the beginning oftrade 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 betweenquantity and quality, the former considered as belonging to production, the latter to the

product final testing. Quantity is the main goal while quality is considered as one of many

possible factors for success. Sometimes the buyer himself follows the production or salesprocess 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

order to guarantee the conformity of the product/ service, merchandise to the project

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 50s the approach to Quality is greatly modified and gradually the idea is spread thatno business activity can be totally separated from the other ones. Consequentially,

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 doesnt control theentire structure yet: however, the trend extends Quality control concepts to the

organization and planning phases.

In the 60s the concept of Quality is newly modified and systematically operates onboth production/service process and product/service itself, the so-called Quality

Guarantee (QG). QG is a management system which considers the integration ofseveral activities, whose strong connections contribute to determine the quality of the

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 todesigning.

The difference between Quality Guarantee and Quality Total Managementsystems 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

After the First

World War

Between 1935 and

1945

In the 50s

In the 60s



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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 70-80s the concept of Quality is also extended to servicing companies. InQuality in Services we can distinguish two different approaches. The traditional

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 - suchas:

- 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 besummarized as:

1. definition of the business and its goals2. assignment of tasks and responsibilities3. identification of means and staff4. 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

In the 70-80s



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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 thecorporate image contributes, in large measure, to the perception and determination of

external quality.

Internal quality refers to all that is related to workers 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 users satisfaction. The main goal is now the

improvement of life quality, and all companies develop more integrated systems to manage

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.

The 1990-2009

period

2 .3 QUALI TY MANAGEMENT SYSTEM

The quality management system is a wide concept and it can be defined as a systemic

set of management procedures used to monitor, check and improve the organizationoperative 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 andQuality improvement.

Quality assurance (QA) activities aim to guarantee that all changes in the process

are clearly identified and valuated. It also guarantees that all product/service

specifications - necessary to satisfy both customer and product/service producers

requirements - are clearly fixed.

Quality control (QC) is a process also known as quality statistical control

which permits to valuate the performance of the current commercial companys

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

business processes, aiming at high performances.

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.

Definition

Quality assurance

Quality control

Quality

improvement



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2 .4 W HY THE I MPLEMENTATI ON OF A QUALI TY MANAGEMENT

SYSTEM?

The creation of a quality management system can help the commercial company to enhancecustomer 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

involved in the provision of commercial services - and the activation of continual

improvement (CI) are strictly linked to each other. Actually, considering the continuously

changing customer needs and expectations, as well as competition and technical progress, the

continual improvement of sold products and selling processes is an essential condition to remain

in the market.

The increasing of peoples 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

Principle 3 Involvement of people

Principle 4 Process approachPrinciple 5 System approach to management

Principle 6 Continual improvement

Principle 7 Factual approach to decision making

Principle 8 Mutually beneficial supplier approach

Customer

satisfaction and

Continual

improvement

The principles of

CS and CI

2.5 THE I SO 900 0:2 00 8 STANDARD

ISO 9000 is a set of international standards published for the first time in 1987 by Geneva

International Organization for Standardization (ISO). Firms can use these standards to

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.

ISO 9001:2008, Quality management systems Requirements.

ISO 9004:2000- under revision, Quality management systems Guidelines forperformance improvements.

As the set of ISO 9000 - 2000 edition and up- includes only one model for qualitymanagement 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

undergoing revision of ISO 9004 introduce minor only changes to the previous edition.

The main ones have to do with:

The origin of the

ISO 9000

The ISO 9000

series

The current ISO

9000 edition (2008)



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Rephrasing to improve consistency between the ISO 9000 series standards andthose 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 achieveconformity to requirements, this meaning physical, environmental and other

factors

Definition of personal data as a key example of type of customer property thathave to be protected.

Information systems as a key example of the type of support services that mayimpact 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 .- APPLI CATI ON OFTHESTANDARD I SO 9 0 0 1 I N SMALL

COMM ERCI AL FI RMS

The aim of this chapter is firstly to introduce briefly the SME phenomenon and its

specifics and secondly to outline how these specifics affect the implementation of quality

management system in a small commercial firm.

Objective of

chapter 3

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 651 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 de f in i t i on

To introduce one definition, we have chosen the SME definition of EU, used apart

from statistical purposes also to handle this economic phenomenon with respect to

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:

The

EU definition

1 Compare (http://europa.eu.int/comm/enterprise/enterprise_policy/sme_definition/index_en.htm)



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Table 3.1 Recent development in SME perception in EU

Enterprise category Medium-sized

enterpriseSmall

enterprise

Micro

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.

EUR)

27 43 5 10 - 2

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 h idden g ian t s

As stated in the introduction to this chapter, SMEs play a key role in our economy.

Sometimes they are even called the hidden giants or the real giants of the European

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

.

micro

93,0%

large

0,2%

small

6,0%

medium-sized

0,8%

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

SMEs hidden

giants

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



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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 inJapan and 46 % in USA whereas in EU for 66 %. 4

Europes private sector jobs are in:

Employment by firm size

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,

ISO certification



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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 thestrong emphasis laid on ISO certification in European countries,

Figure 3.3Distribution 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 (whichreplaces 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 9000

(1994 +

2000versions)

561 747

70,2%

ISO

9001:2000

167 210

29,8%

http://www.iso.org/iso/survey2007.pdfhttp://www.iso.org/iso/survey2007.pdf


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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, thehigh 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 ISO9001:2000 in SMEs in Europe.

3.2 I MPLEMENTI NG THE I SO STANDARD

3 .2 .1 Wh a t shou ld I SO ( no t ) be abou t

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

organization conducted its business until now. Please notice that all enterprises

already have a form of management system and possibly already fulfill some of thestandards requirements, even if they have not, as yet, necessarily defined and

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.

The sense of

QMS

implementationin a SMEs

3 .2 .2 Managem en t p r i nc ip l es

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

management principles, the standard builds on, namely:Principle 1 Customer focusPrinciple 2 Leadership

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 makingPrinciple 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 andmaintenance of infrastructure and improvement of the work environment,

The eightmanagement

principles of ISO

9001:2008



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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 lowermanagement (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 commercialservices the ISO 9001 methodology ensures an adequate level of documentation

of relevant selling and control procedures and instructions, compliance withoperational 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 customers requirements (principle 1); the level of customers

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 aneffective 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 executingchanges 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, implementingtools and attitudes of companys management (principle 4 and 5, further 1, 6, 7

and 8),

2. human resources management implementing tools in order to form attitudes

systematically, to increase work ability and to create an environment supportingeffective 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.

The two main

management areas



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CUSTOMER

CONTINUAL IMPROVEMENTof

system, processes, resources

USING FACTS

information, data, knowledge

CHANGESMANAGEMENT

KNOWLEDGEMANAGEMENT

SUPPLIER

RELATIONS

ENVIR

ONMENT

SAF

ETY

RISKS

MARK

ETING

FINAN

CE

HUMAN

RESOURCES

processes-resources-conditions

leadership andmanagement

commitment

attitudes

ability ofmanagers,employees

6 7

5

2

2-3

1-8

1-8

44

8

1

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


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3.2 .3 I SO in com m erc ia l SMEs - some charac te r i s t i cs

hav ing im pact

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)

When implementing a QMS each member of the commercial company must be aware

of the importance of this step and must be motivated to contribute. Because of their

smaller size, it is less difficult for the quality manager of a medium-sized enterprise to

involve everyone than it is in large enterprises.

Furthermore, compared to large enterprises medium-sized enterprises may have a

more plain organizational structure, run a lower number of processes liable to QMSand can manage with simpler communication tools. This might lead to a significantreduction 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 companys 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 knoweach other and rumor is very easily spread.

Micro and small enterprises (up to 50 employees)

This is model for most commercial small city firms. The obvious advantage of micro

and small enterprises is that they are quite often family-related businesses with a

director at the head, who usually is the owner as well. Consequently, he/she is directly

motivated to lead the company towards prosperity, to satisfy old and to attract new

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 proceduresand 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 reductionof system documentation. On the other hand, the unavoidable accumulation of

functions requires multi skilled employees together with a well-advised definition ofauthorities and responsibilities, not forgetting a focus on communication, its content

and the way of documenting it.

The specifics of

medium sized

enterprises related

to ISOimplementation

The specifics of

micro and smallenterprises related

to ISO

implementation



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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 theeffectiveness trends.

3.2 .4 Rea l i za t ion o f I SO requ i rem ents and d i f f e rences be tw een SMEsand Large Ent erpr i ses

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,requires good definition of responsibilities/authorities

personnel - few, multi skilled, cumulated functions, not responsible exclusivelyfor QMS

documentation - lack of documented procedures

communication - simple form and tools

supplier-purchaser relations, customer focus - more depending on certainsubjects, regionally limited

processes lower number, structure rather simple

Further, from the correspondence table some additional trends emerge as significantfor the implementation of individual clauses and specific requirements in SMEs. To

summarize the most obvious ones:

Group vs. individual

Where in a large enterprise a management meeting and group decision is needed, in an

SME the responsibility often lays with the owner/managing director - clauses 5.1

Management responsibilities and 5.6 Management review mirror clearly this aspect.

SMEs vs. large

enterprises

Group vs.

individual

Long-term vs. short-term

Dealing clauses 5.4 Planning, 6.1 Provision of resources, 6.3 Infrastructure, 7.1

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

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

customers 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 asoutsourcing and the control of outsourcing processes are concerned.

Cumulated responsibilities

Where in a large enterprise selected employees are appointed and trained to carry

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

Long-term vs.

short-term

Shifting outside

Cumulatedresponsibilities



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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 fulfilla requirement in an adequate way (to a certain extent). This approach means that

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 beexcluded.

Flexible extent

Correspondence table

The requirements of the ISO 9001:2008 standard are defined in clauses 4 till 8. In this

chapter and in the previous one (3.2.3 ISO in SMEs - some characteristics having

impact) we have outlined some differences between SMEs and large enterprises,

which can affect the implementation of the quality management system. The table

below links these differences together with the requirements of the standard (clauses

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.

The differences

between SMEs and

large enterprises

related to the ISO

requirements


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on fandeve

8.5 Improvement The company usually has a separatedocument to deal with improvement, theContinual improvement program. It expands

on declared quality objectives specifyingminor important tasks.

Annual quality objectives include usually alsominor concrete tasks ensuring development of theenterprise. Thanks to a frequent actualization and

completion in the course of the year an up-to-datestate and effectiveness is guaranteed.

OveQMper

8.5.2 Corrective action The corrective action control system guarantees in both, a large enterprise as well as a SME, thatsuggestions for preventing insufficiencies will be evaluated, a procedure for a corrective actionwill be established and executed and result of the action controlled.

Evecon

8.5.3 Preventive action The preventive action control system guarantees in both, a large enterprise as well as a SME,that suggestions for preventing insufficiencies will be evaluated, a procedure for a preventiveaction will be established and executed and result of the action controlled.

Evecon


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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, accomplishedresults and authorized validation of the sales prior to delivery or

implementation. The use of planning tools or organizations 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.


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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 inthe future, cause conformities such as customer complaints or deficiencies in

merchandise.



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4 .- STEPSTO I MPLEMENT A QMS

4 .1 STEPS TO DECI DE

Every decision making process in a company is accompanied by a more or less detailed

research of data or at least discussion of experience and personal opinion of business

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.

Some preparation

work is necessary

4.1 .1 Decis ion to im p lem ent a QMS

If a company wants to decide if it should implement a QMS it has to take a lot ofdifferent facts into consideration, which could be worked out in an internal

management meeting. Main players in this meeting are the general manager who has

to decide from a more strategic viewpoint, and the existing quality representative

(quality manager), if there is such, who should be aware of more QMS details

(necessary resources, costs, etc.) and its business impact. The marketing/salesmanager 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 stronglyconnected 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 worthwhileinvestment 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 outsourcingduring the implementation process, which means the scope of consultant involvement.

Definition of

quality manager /

First information

to the management

level

4.1 .2 Fi rs t p lann ing o f 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,

training on QM, support of consultants, benchmarking

assessment phase: identification of actual strengths and weaknesses

system building phase: management handbook, creation of documents,

Rough projects

plan including

main phases and

resources for

implemen-tation



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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 Exte rna l consu l tan ts

Organisations choose different ways how to implement a QMS regarding the scope of

external involvement. The range runs from a totally home made system to a

complete outsourcing of all implementation activities. An advantage of the first case isthat deep knowledge about the system is built up in the company whereas the danger

of creating only a sub optimal QMS is higher because of the fact that a consultant will

encompass high implementation experience often in the same branch. The decision

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 companys success factors

and its strategy. QMS that are focused only on achieving the certificate are not strictlyresult 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.

Outsourcing

factors: internal

knowledge,available internal

human resources,

financial resources



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4 .2 FI RST SELF ASSESSMENT

The first self assessment or horizontal assessment (some or all aspects of the ISO standard)

has the goal to figure out which actual level of QMS maturity the organisation has and

where the fields of highest potentials are as every organisation that is seeking certificationis required to:

Formalize the way things are done

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 theISO 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

exist and do they include all

essential aspects?

X There is no systematic

customer satisfaction

analysis

5.1.3 ? X

Figure 5.1Example 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 extraordinarylow maturity in a kind of balance sheet.

Check lists /

Strenghts and

weaknesses

analysis / Force

field analysis



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OutputInput

Definition of ISO elementsIn columns.

Visualization ofstrengths andweaknesses.

Definition ofimprovement actions.

Element s of ISOElements of ISO

ProcessesProcesses

Conti nual Impr ovementConti nual Impr ovement

Supplier DevelopmentSupplier Development

..

Element s of ISOElements of ISO

Processes

Conti nual Impr ovementContinual

Improvement

Supplier DevelopmentSupplier

Development

..

Level of maturit yLevel of maturit yLevel of maturit yLevel of maturity

WeakWeak AverageAverage Str ongStr ongWeakWeak AverageAverage Str ongStrongAssessment of maturity

levels of the elements.

Identification of criticalelements (low level).

Figure 5.2 Example of a strengths and weaknesses analysis

Beside this comparison of the organisational state in relation to ISO elements, humanaspects 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 themajor result enforcing aspects should be supported by actions and constraining aspects

should be weakened or eliminated.

Output Input

The goal has to be defined(e.g. effi cient

implementat ion process). Identification of

reinforcing andconstraining forces(brainstorming)

Result s in form of a balancesheet

Visualization of projectforces

Which forces are effecting the goal?Which forces are effect ing the goal?

Support reinforcing aspectsand eliminate constrainingaspects

Determination ofimprovement activities

Constraini ngaspects

Reinforcingaspects

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 DETAI LED I MPLEMENTATI ON PLAN

The implementation plan is strongly interrelated with all afore mentioned contents and draws a

general picture of what should be done and when it should be done until the certification audit has

been successfully passed and encompasses the system building phase, the training phase, the

improvement phase and the audit phase of the implementation project.

Between each of these phases milestones should be defined which are in most cases points for

management reports or workshops. For example the milestone after the system building phase

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

Project

organisation / Goal

description / Early

planning of

trainings /

Definition ofquality policy



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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) shouldnt find an end at

all.

01/04Completed

systemdraft

Improvement

Phase 3

. Dataanalysis Strenghts-

weaknesses Force fieldanalysis

Phase 1

Self Assessment

Phase 2

Generation of QMHandbook

Identification of Processes Definition of

Documentation

Design of records Management Commitment

and responsibilities

.

System BuildingStart09/03 10/03Completed

firstself

assessment

Figure 5.4Example 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 doesnt 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 areexceptional 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. Thislow 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. MSProject) 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 implementationprocess, 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



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he implementation plan is the discussion and definition of the

important and regarding the duration of the corresponding activities, one of the most

underestimated aspects.

One of the first steps in t

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 memberof the organisation and the relationship with customers and suppliers. Of course it has to be

aligned with the companys general strategy, it should be known and understood by all

employees and should be much more than only a lip-service by the companys leaders.

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