ISO 9000 Standards Document Control System

The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

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.

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.

Organizations preparing to implement a QMS For ISO 9001

For organizations that are in the process of implementing a QMS, and wish to meet the requirements ofISO 9001:2008, the following comments may be useful.
For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:
- Identifying the processes necessary for the effective implementation of the quality management system
- understanding the interactions between these processes.
- documenting the processes to the extent necessary to assure their effective operation and control. (It may be
appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)
These processes include the management, resource, product realization and measurement processes that are relevant
to the effective operation of the QMS.
Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.

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Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

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INTEGRATING THE NATURAL STEP ELEMENTS INTO ENVIRONMENTAL MANAGEMENT SYSTEMS

In 1988, Dr. Karl-Henrik Robert began the process of developing the principles and objectives that have become known as The Natural Step.

Robert convened a group of over 100 Swedish scientists and asked them to develop a vision for a sustainable society based on the scientific principles. The Natural Step framework (Robert, 1991) was the result of this effort and is becoming widely recognized.

In this framework, there are four underlying principles or conditions and four guiding objectives.

These system conditions are:

Nature should not be subject to systematically increasing concentrations of substances extracted from the Earth’s crust;

Nature should not be subject to increasing concentrations of substances produced by society;

Nature should not be subject to systematically increasing degradation by physical means; and

People should not be subject to conditions that systematically undermine their capacity to meet their needs.

These conditions can be converted to four objectives that are more easily understood:

Eliminate our community’s contribution to fossil fuel dependency and to the wasteful use of scarce metals and minerals;

Eliminate our community’s contribution to dependency upon persistent chemicals and the wasteful use of synthetic substances;

Eliminate our community’s contribution to encroachment upon nature; and Meet human needs fairly and efficiently.

To apply The Natural Step, Boisvert et al. (1999) recommend an A-B-C-D approach: Awareness, Baseline Analysis, Compelling Vision, and Down to Action. Kent County chose to align its program with The Natural Step because of its simplicity and scientific basis.

An environmental management system (EMS) is a set of processes and practices that enable an organization to reduce the environmental impacts from its operations and increase efficiency. It helps the organization to systematically manage its environmental “footprint.” Alternatively, according to the ISO definition (ISO, 2004) an EMS is “a part of an organization’s management system used to develop and implement its environmental policy and manage its environmental aspects.” It is built upon the concept of continuous improvement and follows a four element Plan-Do-Check-Act cycle. The EMS is an evolving process and is consistently modified to accommodate new information, changing circumstances and changes in organization priorities.

The critical components of each of the four elements are:

Planning, includes identifying environmental aspects and establishing goals [Plan];

Implementing, includes training and operational controls [Do];

Checking, includes monitoring and corrective action [Check]; and

Reviewing, includes progress reviews and acting to make needed changes to the EMS [Act].

There are a variety of reasons that an organization may develop and implement an EMS. The reasons are many and varied and often depend upon the type of organization. A business with international offices has different reasons than a public agency to develop and implement an EMS. Table 1 provides a list of the most common of these reasons.

Some disadvantages to developing and implementing an EMS relate to the costs associated with development of the program and include:

An investment of internal resources, including staff/employee time;

Costs for training of personnel;

Costs associated with hiring consulting assistance, if needed; and

Costs for technical resources to analyze environmental impacts and improvement options, if needed.

Critical factors that assure the success of any management system include:

Commitment from senior management;

Designated staff including a Core team to act as a cheerleader and a representative trained in the program;

Involvement of all employees in the covered fenceline;

Dedicated resources;

A link to the overall strategic planning of the organization;

Sufficient time to develop and implement the program;

Proper follow through on the checking and acting components; and

A willingness to make the cultural shift required for the program to succeed.

The ISO 14001 guidance lists 17 elements, shown in Table 2, as the foundation of an EMS.

Several documents and publications cover the various elements of an EMS in detail. One of these is the US EPA publication “Achieving Environmental Excellence: An Environmental Management Systems (EMS) Handbook for Wastewater Utilities,”

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Iso 9001 And 14001 Certification

ISO stands for International standard organisationwhich is an non-governmental body. This body was developed in Switzerland in 1945, right after World War II. The reason behind the development of ISO is to create international standards for industrial and commercial products within a business. ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability – and at an economical cost. Receiving certification by the ISO means that a business has agreed to uphold certain standards and practices in its day-to-day operations. These standards are of particular importance when it comes to industries and commercial interests that may have a significant environmental impact through the discharge of waste of by-products. ISO standards are an internationally recognised set of benchmarks for any association that enable you to create as well as maintain a structured management system with a clearly defined set of processes.

ISO 9001 is known across the world as the standard for high quality business operations and management whereas ISO 14001 for environmental management. Both big and small companies prefer going by ISO 9001 and ISO 14001 standards because of its versatility and efficiency. Today, over 875,000 companies are ISO certified. The ISO 9001and 14001 standard is designed to be implemented in various business procedures necessary for the creation and quality control of a given product or service that a company offers. A solid monitoring and control system is incorporated, making sure that a company provides consistent, high-quality production outputs that always satisfy customer demands. ISO 9001and 14001 can be implemented in any process, regardless of the location of the company or department facility.

Having ISO 9001 Certification is an indication that a company or business firm is committed to providing customers with high quality products and services. It also shows that a company is willing to do what it takes to achieve better production efficiency. For environmental management system ISO 14001 helps you to identify the key impacts that you have on the environment, important legislation and then set about controlling as well as improving these impacts. These are the two traits all customers and organizations look for when choosing a company to do business with. An ISO 9001 certificate also shows that it has a solid and excellent Quality Management System that is capable of passing the rigors of independent and external auditing. By enhancing a company’s image in the customer’s eyes, an ISO 9001 certified business firm has a competitive advantage over other businesses in the same industry.

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