IMPLEMENTATION OF ISO 9001 STANDARD IN EDUCATION

The economy has already met with various endeavours and concepts to build an effective quality management system. From the historical point of view, the most important ones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) and

international standards pertaining to ISO 9000 (1987) family. The implementation of this last standard grows continuously, either in Europe or in the world. In the period from 2001 to 2003, there was a slight stagnation, which was the consequence of the organisations having to adapt to the requests of ISO 9001:2000 edition of the standard. Croatia also actively participates in this trend, which show that at the end of 2004, organisations were certified, of which 970 of them were from Croatia.

The economy has already met with various endeavours and concepts to build aneffective quality management system. From the historical point of view, the most importantones are Deming Prize (1950), followed by Malcom Baldrige National Award (1987) andinternational standards pertaining to ISO 9000 (1987) family. The implementation of thislast standard grows continuously, either in Europe or in the world, as shown in the picture1. In the period from 2001 to 2003, there was a slight stagnation, which was theconsequence of the organisations having to adapt to the requests of ISO 9001:2008 editionof the standard. Croatia also actively participates in this trend, as illustrated by figures fromthe table 2, which show that at the end of 2004, 670,399 organisations were certified, ofwhich 970 of them were from Croatia.

The implementation of the stated standard in educational activities took a somewhat slower pace. Trends in Croatia do not completely follow the World ones . The 2002 and 2003 stagnation, which, as already mentioned, was mainly caused by transfer from one issue of the standard to the next one, had no particular impact to Croatia, partially because the data for Croatia includes standards from both the previous and the new issue of the ISO 9001 standard.

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Aligning At ISO 9001 Standard Requirements

In conformity with the explanations of international series of standards elaborated in the 2008 year, the

implementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be done

in every kind of organization, indifferent of its field of activity , size or number of personnel. This means that

SMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to their

limited resources. The success of this action depends on more elements, mainly, the following ones:

· Strong commitment and decision of top management;

· Adopting an organization structure accordingly both with business plan of SME, and with the

requirements and guides of standards from quality management field, too.

This means that SME (sector in continuously development in Romania starting from 1990) can align to

these requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources.

The success of this demarche depends on several elements, mainly, the following:

· The decision and the strong commitment of the top management ;

· Adopting an organizational structure according to the business plan of SMEs, but also with the

requirements and the directions of the norm/standards in the quality management field.

· Accurate planning of the implementation project of a quality management system

· Allocation of the m a t erial, financial and human resources necessary for developing and

maintaining of the system;

· Suitable training of the personnel of the organization for the documentation and implementation of the system, but also for its supervising;

· Maintaining of an efficient communication and collaboration with business partners, first, with the

suppliers and the clients of SMEs, but also with other interested parts, including their own

personnel;

And one more remark: the success of a quality management system in a SME depends on endowment degree and on technological level of the equipments and working and controlling installation of the processes.

In conformity with the explanations of international series of standards elaborated in the 2000 year, theimplementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be donein every kind of organization, indifferent of its field of activity , size or number of personnel. This means thatSMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to theirlimited resources. The success of this action depends on more elements, mainly, the following ones:· Strong commitment and decision of top management;· Adopting an organization structure accordingly both with business plan of SME, and with therequirements and guides of standards from quality management field, too.This means that SME (sector in continuously development in Romania starting from 1990) can align tothese requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources. Thesuccess of this demarche depends on several elements, mainly, the following:· The decision and the strong commitment of the top management ;· Adopting an organizational structure according to the business plan of SMEs, but also with therequirements and the directions of the norm/standards in the quality management field.· Accurate planning of the implementation project of a quality management system· Allocation of the m a t erial, financial and human resources necessary for developing andmaintaining of the system;· Suitable training of the personnel of the organization for the documentation and implementation ofthe system, but also for its supervising;· Maintaining of an efficient communication and collaboration with business partners, first, with thesuppliers and the clients of SMEs, but also with other interested parts, including their ownpersonnel;And one more remark: the success of a quality management system in a SME depends on endowmentdegree and on technological level of the equipments and working and controlling installation of the processes.

A transparent quality management system, well conceived and applied, with adequate trained and motivated personnel, will be efficient and if technological level of endowments (working, supervising, measuring and monitoring equipments of the processes and product, working environment and infrastructure) will be comparable with the level of endowment of the top firms in the same activity area, as of the organization we refer to.

So, adopting a quality management system based on the requirements of the ISO 9001 standard is a strategic decision of the top management of an organization, much more for the management of SME that first of all has to analyse very well all the necessary resources, to put in balance both the necessary costs of the implementation and sustaining in function of a quality management system and the benefits brought, then to decide advisedly. Developing a quality management system gives both direct benefits and a contribution at the cost and risk management, being important not only for organization but also for the satisfaction of its clients and other interested parts.

The decision of designing and implementation of a quality management system in SME is influenced by proposed objectives, by the demand of the market, by products and services offered, as well as by objectives tendency of developing and the continuously improving of the performances of the processes of any organization.

A quality management system contains two essential elements. First, the most critical, refers to human resources and the other necessary resources for constant delivery of the adequate products and services to the client. Second refers to the existence of “documented quality management system” that is, usually, defined by documented policies, objectives, plans, processes, procedures and fabrication standards. The documented quality management system has to reflect the planning and carrying on the activities, made by SME. Both for the audit reported to the ISO 9001 standard’s requirements but also for improving activities, will need to generate adequate registrations to document the effective performance and to demonstrate the concordance.

Top management of SME has to be aware that the implementation of a quality management system according to this standard has to be approached as a project, to which are assigned resources and which has to be managed by a defined schedule.

First step is represented by defining the objectives of the schedule with an accent on those that will bring benefits for SME. For each objective must be defined the way in which will be measured his achievement, as well as the reference level. Schedule must also establish:

· An identification, documentation and continue improving system of SME’s processes;

· Stages that must be carried out for achieving the objectives regarding to the quality of the product and for long-term improving of a quality management system of SME;

After establishing the objectives, the next decision of the top management of SME refers to the type of approaching that will appeal to [3].

There are two ways of approaching:

a) to design the whole quality management system and then to be implemented;

b) to evaluate the processes and to appeal to improving techniques to build the system step by step, starting from existing elements.

The advantage of designing the whole quality management system is represented by obtaining a distinct structure, the main disadvantage being the tendency of a theoretical approach, separated from the realities and practices of SMEs. The performances of the personnel can also suffer because of the necessity to apply simultaneous a great number of new procedures.

The essential advantage of step by step approach is that if through evaluation of processes are determined both the adequate practices and the less acceptable, the efforts can be focused on those areas that ensure a maximum benefit. This approach has the disadvantage of the tendency to achieve a quality management system that is not so well structured and so is more difficult to understand and to apply by the personnel of SME.

The optimum approach represents a combination of the two variants. So, initially it is good to be established a general structure of the quality management system and then to be established frame models for documentation of the processes. Implementation activities will have in view identification and solving the problems and then the improving key processes of SME.

Indifferent the approaching way, top management of SME can decide if the conceiving and implementation project of the quality management system will be carried out through internal forces, or will be carried out external appealing to a specialised advising. In case they appeal to an advising firm, must exist an abiding collaboration between the two firm and a well tuned up contract to which will be affixed a plain schedule, with responsibilities and achievement terms.

Designing and implementation project of the quality management system cannot ensure solving all the problems. Changing the culture of an organization takes time and patience. Project must be accomplished through a well defined series of phases, with well established terms and with objectives that can be reached.

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Active Implication Of The Implementation Of Quality Management System

Successful implementation of a quality management system is conditioned by implication of the top management of SME. ISO 9001 gives a special importance of the commitment of the top management obviously defining its role in the quality management system. It is underlined the promoting the leadership principle in practice as a base for operational the others principles of the quality management system.

The commitment and active implication of the top management are essential for developing, implementation and maintaining an efficient and efficacy quality system management, having as a final purpose ensuring an increasing clients’ satisfaction.

To achieve such a desideratum, top management must consider the following actions:

· defining the visions, policies and strategic objectives of SME;

· direct participation of the management to improving projects;

· obtaining the feedback regarding efficiency and efficacy of the processes of making the products;

· developing an environment that encourages the involving of the personnel;

· ensuring the necessary resources for achieving the objectives.

Top management defines the methods of the performances of SME to determine the stage of achievement the objectives.

These methods must allow the evaluation:

· financial performances of SME;

· performances of the processes of SME;

· client’s satisfaction, personnel’s and other interested parts’ satisfaction;

· other success factors identified by management.

Information that results from such evaluations are used as incoming elements for the analysis done by management for continue improving of the quality management system, that must ensure the base for improving

the performances of SME.

In this way, top management can demonstrate its commitment through:

· understanding the necessities and present expectations and client’s perspective;

· promoting policies and objectives for increasing the awareness and implication of the personnel in SME;

· adopting the principle of continue improving as a base principle for the processes of SME.

· Rigorous planning of all processes of SME and to operate the changes;

· ensuring an adequate background to satisfy the requirements of the interested parts.

Top management has to involve directly in identification the processes of fabrication the products because these are directly tied by SME’s success. Also, a special attention must be paid on identification of those reliance processes that affects either the efficacy and efficiency of the processes of fabrication of the products of SME, or the necessities and expectations of the interested parts.

The management of SMEs should ensure that the processes are carried out as an efficacious and efficient net. For this it should be analyzed and got at its best the interaction of all processes. In this purpose it must consider the following aspects:

· ensuring the sequence and interaction between processes are in that way designed so they allow getting the desired results;

· ensuring that incoming and outgoing elements are obvious defined and are kept under control;

· monitoring the incoming and outgoing elements to check if the processes are correlated and carried out efficacious and efficient;

· identification and administrate the risks and to turn to account the opportunities of improving

performances;

· doing the analysis of the information for continuously improving of the processes;

· designating the responsible of the processes;

· ensuring that every process is managed so that it allows the achievement of the established objectives;

· defining the necessities and expectations of the interested parts.

Top management can present proves regarding its commitment for developing and implementation of the quality management system as well as for continuously improving of its efficacy through:

· communication of the importance of satisfaction of the clients’ requirements in SME, as well as legal requirements;

· defining the policy and objectives regarding the quality;

· managing the analysis of the quality management system;

· ensuring the necessary resources for the achievement of the objectives.

One of the main tasks that top management has to accomplish refers to defining the policy in the quality field. There is no form of standard presentation, but the policy must be in such way formulated so it ensure:

· getting client’s satisfaction as a main goal;

· clarifying the way in which it is ensured the quality of the products and services of SME;

· explicit commitment of the management regarding continue improving of the quality;

· assuming by the management the responsibility regarding the achievement of the objectives regarding quality.

Policy will be implemented through the objectives regarding the quality, that should be measurable. The more participation of the top management is more direct and more visible, the more the necessary period will be shorter for establishing and implementation of the quality system management, on one hand because of the availability of the resources and on the other hand because of a less bureaucratic approach that top management of SME has in this case.

When it is decided the implementation of a quality management system or it is approved an improving schedule of this, it is vital to exist an obvious understanding of the estimated duration and necessary resources from the management. Often, the initiatives regarding the quality management system fail because of this commitment is missing, especially from the top management.

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Why do organizations implement ISO 9000 systems?

More often than not, organizations get ISO 9000 because certain customers force them or encourage them to. In many market sectors—electronics, pulp and paper, telecommunications, automobile manufacturing, defense—major customers have mandated ISO 9000 registration to their key suppliers. Similarly, some overseas regulatory bodies mandate ISO 9000 for the makers of qualitysensitive products (such as medical devices).

Many of these major customers impose ISO 9000 systems in place of, or in addition to, specific quality programs, requirements, specifications, and so on that have been in place for many years. The ISO 9000 Standard becomes a key part of the relationship between the customer and its suppliers.

ISO 9000 is not, however, meant to replace customer-specific requirements in any market segment. Rather, ISO 9000 is meant to be a floor: a basic set of generic requirements. They are generic enough to apply to virtually all supplier/customer relationships anywhere in the world. It matters not the size of the supplier, the location of the customer, or the nationalities involved.

In some industrial segments, formalized standards have been created, adding to the generic ISO 9000 requirements additional clauses that are industry specific. Examples include:

_ Automotive (QS-9000).

_ Aerospace (AS-9000).

_ Telecommunications (TL-9000).

To the extent that ISO 9000 replaces customer-specific quality programs and supporting audit/oversight activities, it can relieve both customers and suppliers of a great deal of redundancy, duplication, and waste of resources. The fundamental requirements are understood, agreed to, and (usually) confirmed by objective third-party audit. This gives customers confidence in the integrity and effectiveness of their supplier’s basic quality practices. The customer and supplier can then invest their energies and resources in agreeing to and working on the specific requirements unique to their relationship.

To some, ISO 9000 sounds like a mandatory, gun-to-your-head, my-way-or-the-highway program. For many suppliers, it is exactly that (“get ISO 9000 or get lost”). For many others, it is perceived that way:

“They’re trying to tell us how to run our businesses.”

But the goal of ISO 9000 is not to strengthen customers’ control over how their suppliers run their businesses. The goal is to give customers confidence in the ability of suppliers to meet their needs, resulting in satisfied customers, and growing and prosperous suppliers.

Admittedly, implementing ISO 9000 does not guarantee this. Like most things, what you get out of it depends on what you put into it. You can implement a compliant ISO 9000 system that is all cost and no benefit and it’s even possible to pass registration audit this way. This happens, usually, when the supplier’s approach is to try to:

_ Squeak by.

_ Do just enough to get registered.

_ Get this thing done without changing how we work.

But suppliers who implement ISO 9000 fully—to the spirit, as well as the letter—can and do achieve real benefits.

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What Is ISO 9000 Registration?

Registration is documented and objective evidence that an organization’s quality system meets the requirements of ISO 9000. Certification is a term often used interchangeably with registration. In the context of ISO 9000, they mean the same thing. Registration is the technically correct term for verification of compliance to standards of quality systems. Certification usually applies to verification of the quality of products (as opposed to quality systems).

Registration is carried out by independent companies called registrars. These companies are:

_ Wholly independent.

_ Accredited by a recognized international accreditation body.

_ Selected, and paid, by you.

Registration can cover:

_ The sole location of a single-location organization.

_ Multiple locations of a multilocation organization.

_ Only certain parts of a multilocation organization (under certain conditions).

_ Separate locations under separate certificates. (This is a more costly approach.)

The registration body audits your quality system against the requirements of ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances. Major noncompliances must be closed out prior to official registration.

When this has been done, the registration body:

Lists the organization’s name in its book of registered companies— in effect, registers the organization in its book.

Issues a certificate to the registered organization. This registration includes:

— Identity of the organization.

— Location(s) covered by the registration.

— A list of products/services supplied by the registered locations.

— Revision date of the Standard.

— Registration effective dates.

— Name and location of registrar.

Most registrars limit registrations to three years. After that, you must renew your registration by undergoing another complete systems audit. Some registrars do not use the renewal approach. They simply keep checking the system via surveillance audits. Whichever the scheme, the organization, to keep registration, must undergo a surveillance assessment every so often. Six months is the typical interval. Some registrars offer annual surveillance schemes (not recommended except for firms with exceptionally well-implemented quality management systems). Surveillance assessments are scheduled events (there is no such thing as a “surprise” surveillance audit). Only part of the quality system is checked at each surveillance. Usually, the registrar does not disclose what part will be assessed until the day of the assessment, although some registrars will tell you everything up front.

The entire quality system is usually checked via surveillance audits over the course of three years. There is no way to “fail” a surveillance assessment, just as there is no way to “fail” a registration audit except by refusing to implement corrective action required by the registrar. Normally, registrars allow adequate time, but corrective actions must be done in a timely and agreed upon manner to keep registration.

One final note: As mentioned, each registrar publishes a list of the firms it has registered to ISO 9000. A comprehensive list of ISO 9000 registered firms is available from Irwin Professional Publishing (703-591-9008).

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Process Approach In ISO 9001 Standards

The process approach was introduced into ISO 9001 with the year 2000 version of the standards.

Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.

2.4. Verify the process and its activities against its planned objectives
3. Implementation and measurement of the process
4. Analysis of the process
5. Corrective action and improvement of the process Implementation
This document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.
In addition to the guidance documents, ISO maintains a web site with “official interpretations” of

approach was introduced into ISO 9001 with the year 2000 version of the standards.
Prior versions used an element approach. The document Guidance on the concept and use of the process approach for managementsystems describes to process approach and offers an implementation paradigm.
1. Identification of processes of the organization
1.1. Define the purpose of the organization
1.2. Define the policies and objectives of the organization
1.3. Determine the processes in the organization
1.4. Determine the sequence of the processes
1.5. Define process ownership
1.6. Define process documentation
2. Planning of a process
2.1. Define the activities within the process
2.2. Define the monitoring and measurement requirements
2.3. Define the resources needed

ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.
Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.
Auditing Practices
The ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance(ISO/TC 176) and the International Accreditation Forum (IAF).
The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.
The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

ISO 9001 Standards & ISO 14001 Standards

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.