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GUIDELINES FOR THE
IMPLEMENTATION OF
A QUALITY MANAGEMENT
SYSTEM (QMS), ACCORDING TO
THE ISO 9001:2008 STANDARD, TO
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
1.-
INTRODUCTION
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 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 suppliers 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 branche specific situations / Internal and external reasons for implementing a QMS
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
2.-
GENERAL
2.1 THE SENSE OF THE WORD “QUALITY”
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 user’s need, and through the precise determination of the requirements, 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 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 repairing activities 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 “inherent means 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 www.smallcitycommerce.eu
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 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 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 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 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, 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 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
After the First World War Between 1935 and 1945 In the 50’s In the 60’s www.smallcitycommerce.eu
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 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
In the 70’-80’s
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 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 QUALITY 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 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 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” – 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
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 www.smallcitycommerce.eu
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 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 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
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
Customer satisfaction and Continual improvement The principles of CS and CI
2.5 THE ISO 9000:2008 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 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 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)
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.
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 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 definition
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) www.smallcitycommerce.eu
Table 3.1 Recent development in SME perception in EU
Enterprise category Medium-sized
enterprise Small 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 hidden giants
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
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
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
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 9000 (1994 + 2000versions) 561 747 70,2% ISO 9001:2000 167 210 29,8% www.smallcitycommerce.eu
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 organization conducted its business until now. Please notice that all enterprises already have a form of management system and possibly already fulfill some of the standard’s 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
implementation in a SMEs
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 management principles, the standard builds on, namely:
Principle 1 Customer focus Principle 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 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,
The eight management principles of ISO 9001:2008
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
tools and attitudes of company’s 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 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.
The two main management areas
www.smallcitycommerce.eu CUSTOMER
CONTINUAL IMPROVEMENT of
system, processes, resources
USING FACTS information, data, knowledge CHANGES MANAGEMENT KNO WLEDGE MANAGEMENT S U P P L I E R R E L A T I O N S E N V I R O N M E N T S A F E T Y R I S K S M A R K E T I N G F I N A N C E H U M A N R E S O U R C E S processes-resources-conditions leadership and management commitment attitudes ability of managers, employees 6 7 5 2 2-3 1-8 1-8 4 4 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
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)
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 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)
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 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.
The specifics of medium sized enterprises related to ISO implementation The specifics of micro and small enterprises related to ISO
implementation
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,
requires good definition of responsibilities/authorities
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
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 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
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 Cumulated responsibilities www.smallcitycommerce.eu
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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 fulfill a 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 be excluded.
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
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
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4. Quality Management System
4.1 General
requirements Quality management system has to be established, documented, implemented, maintained and continually improved in accordance with requirements of ISO 9001:2008. If an organization will claim or imply conformity to 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
requirements
Documented statements of quality policy and quality objectives. Three-level documentation (quality manual, regulations, work instructions).
High number of users = high number of copies, partial documentation centres, voluminous system documentation, usually electronic version (intranet), hypertext links, links to related documents, forms etc.
Documents and records have to be controlled.
Documented statements of quality policy and quality objectives
Two-level documentation (Quality manual and work instructions). Obligatory regulations broadly discussed in the Quality manual Low number of users = low number of copies, one documentation centre.
Form more simple, e.g. Quality manual in form of one file folder with all related documents including example forms used for records etc. Documents and records have to be controlled.
Quality policy is the basic unifying document declaring the needs of the enterprise and its customers; it should include a long-term vision Quality objectives have to set up concrete milestones on the way to fulfill the vision Quality manual – by SMEs the most suitable way to describe the interaction between processes of the QMS may be the graphical one; in some cases process cards or hyperlinks in electronic documents may be advised.
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
commitment Management usually consists of several responsible employees – (managing director, directors specialists). The company’s owner may stay outside QMS (stock corporation).
Owners as managing directors directly control the company. A specific case is a
one-owner-company, where the management is executed directly by the owner, who does not need a “management meeting” to make strategic decisions.
By SMEs this field is quite often left out. But even in their case, the management has to specify its vision and long-term intentions related to the business subject, own optimal product and its presentation on the market. The intention of an 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 company’s orientation is own marketing. Customer’s needs are to be understood as market potential – having identified it prevents wrong decisions regarding future
Information for company’s future orientation mostly won due to membership in associations, internet etc.
Both managers and employees of SMEs usually are more directly motivated to lead the company towards prosperity and thus to satisfy old and to attract new customers.
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 to the purpose of the organization and includes a long-term vision. It should include the
commitment to comply with requirements and continually improve the QMS. The quality policy provides a framework for establishing and reviewing quality objectives.
All employees should be aware of the declared quality policy of the organization.
Even in the case of SMEs, the management has to specify its vision and long-term intentions related to the business subject, own optimal product and its presentation on the market. The intention of a 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
of development expenses. Factual production plan
Establishing measurable quality objectives consistent with quality policy.
Annual plan in financial indicators, cash-flow depending on development expenses, main activity often controlled by operative plan. Establishing measurable quality objectives consistent with quality policy.
Planning is an integral part of any enterprise management. In the case of SMEs, however, some of the plans (e. g. investment plan, training plan etc.) might be understood only as a framework and may be controlled operatively according to actual cash-flow development.
5.5 Responsibility, authority, communication
Branched organizational structure, easier defining of authorities and responsibilities, executive and control functions.
Management representative is usually a member of top management, can be helped in QMS administrative tasks by an
employee.
Sophisticated means of communication (e.g. intranet)
Simple organizational structure, often cumulated functions. When distributing responsibilities and authorities, specifics of the SME and
characteristics of individual managers have to be taken into account.
Management representative for QMS usually has other cumulated functions.
Elementary communication means (e.g. joint management and sales meetings)
Appointing a member of management responsible for the QMS is essential. It has to be a strong leader provided with authority to coordinate the whole system. While there is usually a new position established in large enterprises, in micro enterprises the task is often taken over by one of the managing directors or, in most cases, by the owner
him/herself.
5.6 Management
review Complex report on given period as input for management review. Review during a management meeting, documented in minutes, formulated remarks and actions resulting from the evaluation. New challenges for Quality objectives or continual improvement program.
Complex report on given period as input for management review.
Documented owner’s standpoint to the report (by companies, where the influence of management meeting members on the owner is only advisory), including specification of actions if necessary. Review of quality objectives.
Management review means a recapitulation of the whole QMS in regular periods (annual, biannual). Unlike other system requirements, applied by SMEs already before the implementation of QMS, it is not common in SMEs to execute management review in an extent requested by the standard. In the context of strategic management such a standstill and recapitulation is very useful. The standard requires decisions to be made based on 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
resources Detailed financial plan and exact calculation of development expenses. Planned resources respecting the cash-flow oscillation in the course of the year. Even an SME should determine resources needed to 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.
6.2 Human resources Human resources department/section with divided personnel and educational activities. Map of company’s qualification structure, specification of work positions, personal development plans.
Evaluation of employees through interview. Annual training plan.
Evaluation of training quality and effectiveness.
Cumulated personnel work and training management.
Map of company’s qualification structure, specification of work positions.
Annual training plan. Training evaluation.
Good personnel development work can be done even in an SME. It is necessary to evaluate the performance and reserves of every employee and to plan the use of it in a broader context, in new fields or at least by conserving the actual state. Employees, however, have to feel that they are followed and evaluated and that the company counts on them. The most suitable form of applying the requirement is a simple evaluation of ability and planning personal development of every single employee (regular detecting of training needs, 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.
Infrastructure development planning based on long-term strategic plans, making use of different investment studies and scenarios. Annual maintenance plan.
Rather simple infrastructure.
Infrastructure development realized under conditions of more simple decision making processes (owner makes short-term decisions based on actual resources).
Annual maintenance plan.
SMEs often develop their infrastructure more dynamically than large enterprises. Continual
detecting of the means needed to ensure conformity of the merchandise involves technology, measuring devices, information system, car park, conveyors systems, communication technologies, work tools for 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 work environment needed to achieve
conformity to product requirements. Besides control of compliance to obligatory requirements of related laws and standards (according to subsector and field of activity) additional surveys are carried out on the impact of work environment on the quality of the provision of goods.
The organization determines and manages the work environment needed to achieve conformity to regulatory and statutory requirements, including the management of the work environment.
As an SME: do not forget to fulfill requirements of related laws and standards, as well as obligatory revision of state authorities!
The ISO9001:2008 edition pays special attention to the management of the work environment needed in order to achieve conformity to sales requirements.
7. Product realization
7.1 Planning and
product realization Main activity (production or service provision) usually planned in an annual or quarterly detailed factual plan. Planning quality, detecting risks.
Products/services as well as
production/service processes have to meet requirements defined by laws and superior standards.
If the sales process cannot be long-term factual planned (company satisfies direct demand of individual customers), than a planning in e.g. financial indicators is necessary.
Merchandise as well as sales processes have to meet requirements defined by laws and superior standards.
Even in an SME it is useful to set requirements for the merchandise. Consequently, there should be records providing evidence that the realization process and the merchandise meet set requirements.
7.2 Customer-related
processes During the decision process regarding order acceptance all managers influencing the Review of order acceptance has always to be documented (at least simplified), even if the Records on order acceptance review make part of controlled documentation.
order have to make their comments. The standpoint has to be documented (recommended - in information system). Negotiations with customer specifying the contract are documented.
owner decides.
7.3 Design and
development The company usually disposes of own capacity for product or services/processes development, in the case of commercial firms sales development.
Cases appear, that companies ensure development mainly utilizing co-operating experts. This demands proper documentation reflecting requirements of clause 7.3. of the standard.
By SMEs the development of the sales often happens by the customer, which can be qualified as not fulfilling of the requirement and may be even reason for exclusion.
7.4 Purchasing List of suppliers for a limited period derives by running companies from repeated evaluation. Members of sales and technical control department should be involved in the evaluation.
The company has an own test room, where input control of purchased material is executed and its release into production/sales approved.
It is used to execute customer audits by supplier.
Evaluation of suppliers for a limited period and documenting of the list of approved suppliers has to be done even if a strong accumulation of information and responsibilities exists.
Acquiring output control results and certificates from the supplier can replace the input control tests.
Even by SMEs evaluation of suppliers forms an important input for preventive actions and negotiations with partners. In the organization a permanent drive for evaluation has to be evident.
7.5 Production and
service provision Sales or providing services is usually operated according to own documentation and procedures. Processes being verified. All material in productionor any merchandise sold is properly signed, marking enables backward tracing of all relevant information.
Procedures for providing service of own products exist, service realization documented.
Providing sales often carried out according to documentation or procedures delivered by the customer. Documentation verified and released before use. Processes verified.
After sales service directly provided by the company does not always exist.
If there is no after sales service provided, there may be a co-operation with a service provider assigned instead. This co-operation has to be exactly specified (especially quality requirements).
7.6 Control of
monitoring and measuring devices
In the frame of QMS laws on metrology usually count as superior standard. Member of metrology department participates in management.
Calibration of measuring devices often provided internally. If the company uses to do calibration of measuring devices itself, calibration procedures have to be defined.
If there is no management member appointed as responsible for compliance with laws on metrology, then this responsibility lies automatically on the managing director of the company.
Calibration of measuring devices is usually provided by an external competent center.
Even if calibration of measuring devices is carried out externally, in the company there has to be kept documentation that meets requirements of clause. 7.6 of the standard.
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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
satisfaction Besides top management also members of other departments have the possibility to obtain information on customer’s satisfaction directly from customers, e.g. members of the marketing or service department. Collected information is processed, selected, and based on evaluation necessary actions are defined.
Relevant information on customer’s satisfaction can usually be collected only by management members or by the owner. Structure of the information needed (checklist) and strategy of its acquisition have to be worked out beforehand. Obtained information is evaluated, necessary actions defined.
Even in SMEs the collected information on customer’s satisfaction should be documented in written form even in case of a strong accumulation of information by one person.
8.2.2 Internal audit Internal audit plan guarantees that all departments and all clauses of the standard will be checked up in the course of current year.
There is a team of own auditors ensuring the realization of internal audits. Members of this team are regularly retrained, their work evaluated.
Summary of through internal audits acquired information forms an essential part of the management review report.
External auditors can be accepted for carrying out internal audits only if - because of a low number of employees - own auditors cannot ensure internal audits without facing conflict of interests. Audit plan for one year worked out in advance, compliance with requirements of the standard as well as extent and content of audits are monitored thoroughly.
Audit findings have to be reflected and if necessary the QMS improved.
Even if the audit is ensured by external auditors, the audit procedure has to be described and documented According to requirements of clause 8.2.2 of the standard.
8.2.3 Monitoring and measurement of processes
All management and sales activities are, to an adequate extent, monitored and evaluated. By SMEs the number of processes liable to monitoring and measurement will be considerably lower than by large enterprises.
8.2.4 Monitoring and measurement of product
Control between individual operations as well as output control is carried out by professional inspectors, members of independent technical control department. All types of controls are specified in controlling and testing procedures. Control documents archived as quality records.
Control between individual operations and sometimes also output control carried out by sales persons in form of self-test. In that case, sales persons are extra trained for control activity and based on training they are entrusted with control.
Evidence of conformity/authorization of release should be documented.
Thanks to the controls nonconformities can be detected.
8.3 Control of
nonconforming product
Nonconforming merchandise must be separated and protected from (even unintended) use,
assessed and handled in one of the by the standard accepted ways. Even by SMEs, monitoring and analysis of nonconformities is one of the inputs to be considered for decision on a corrective/preventive action.
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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
document to deal with improvement, the Continual improvement program. It expands on declared quality objectives specifying minor important tasks.
Annual quality objectives include usually also minor concrete tasks ensuring development of the enterprise. Thanks to a frequent actualization and completion in the course of the year an up-to-date state and effectiveness is guaranteed.
Overview of actions undertaken to improve the QMS forms a part of the complex report on given period (being input for management review).
8.5.2 Corrective action The corrective 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 corrective action will be established and executed and result of the action controlled.
Every corrective action has to be proportional to consequences of nonconformity stated.
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 preventive action will be established and executed and result of the action controlled.
Every preventive action has to be proportional to consequences of possible nonconformity.
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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, 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.
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.
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 research of data or at least discussion of experience and personal opinion of business leaders. Implementation of a quality management system, wh
