What is ISO 9001 Quality Management System?

Businesses have to keep up with the rapidly changing environmental conditions and increasing globalization and competition in today's world in order to maintain their assets and to realize their visions. This change is of course reflected in the organizational structures of the enterprises. In today's business world, the quality phenomenon has a strategic effect on the competitive issues of enterprises. However, on the other hand, enterprises need a number of tools in order to establish and establish the quality concept in their organizations. One of these tools is Quality Management System.

Today, a large number of businesses operate in the sectors that produce products and services, and there are many alternatives that consumers can choose. Consumers are more conscious than before, and purchasing power is increasing. In addition, when the demand is flexible in these sectors, the bargaining power of the consumer is increasing. Therefore, businesses must work more customer-oriented.

The ISO 1987 Quality Management System, first published by the International Organization for Standardization (ISO) in 9001, has created an important opportunity for enterprises aiming to meet consumer needs and demands in a high quality manner. This system aims at continuous improvement in all processes of the products and services offered by the enterprises until it reaches the consumers. All processes of enterprises are recorded, all processes are monitored, control systems of enterprises are developing, in case of any problems, where and how the problem originates easily and necessary corrective and preventive actions are implemented. However, the goods and services produced are of high quality and customer satisfaction is ensured.

The enterprises are certified by the certification bodies in accordance with their objectives and the enterprises benefit from ISO 9001 Quality Management System in line with their objectives. Moreover, having the ISO 9001 Quality Management System Certificate in our country is one of the most important requirements of the Public Procurement Law in 2005.

However, some enterprises that establish the Quality Management System see this as a necessity rather than benefiting from the benefits of this system, and thus cannot reflect on their activities and consequently they appear as the owner of ISO 9001 Certificate by keeping management practices separate from their activities. In spite of this, a large majority, especially enterprises in the manufacturing sector, apply this system effectively.

ISO 9001 Quality Management System certification studies were initiated by the Turkish Standards Institute (TSE). However, the number of institutions providing certification services has increased over time. They are also subject to the TS ISO / IEC 17021 standard (Conformity assessment - requirements for organizations providing inspection and certification of management systems). The accreditation of the certification bodies is carried out by the Turkish Accreditation Agency (TÜRKAK). However, there are also accredited certification bodies in accreditation organizations operating in foreign countries.

Scope of ISO 9001 Quality Management System

Regardless of which sector they operate, all businesses interact with their environment. It cannot be said that these enterprises create their own assets and conditions on their own. In order to maintain their assets, not only do they have to adhere to their own regulations, they must also pay attention to their relationship with their environment. Self-determined processes are determined according to information from the environment.

Therefore, the behavior of enterprises is under pressure from environmental factors, consumer demands and other enterprises. An active business must, on the one hand, have to respond to the demands of its environment and work in harmony with its environment. It is not possible for an enterprise to have all kinds of resources in its production activities. Therefore, they have to demand some resources from their environment.

Before the 1970 years began, keeping the revenues at the top level was the first goal. However, starting from 1970, enterprises started to abandon this point of view. Today, in addition to the behaviors and motivations of managers and employees, the social and cultural structure of the society has started to be effective. It is the result of the development of the ISO 9001 standard and the development of such a development. With the start of the first applications, the enterprises have ISO 9001 certificate, which means that these enterprises produce in accordance with European standards. In a sense, this document gives legitimacy to enterprises. For example, companies that have ISO 9001 certificates in terms of enterprises participating in a tender are one step ahead of enterprises that do not have this certificate.

For this reason, some businesses want to have this certificate in order to gain legitimacy rather than their gains such as competitiveness or efficiency. As a matter of fact, thanks to this document, companies are adapting to innovations, being close to economic and technological developments and developing the social structure of the company. In the long run, businesses are more fortunate to follow and catch up with the technological advantages, and at the same time they form their own values, principles and principles, quality policies and mission and vision within the company.

The ISO 9001 standard provides enterprises with the opportunity to accelerate the institutionalization process of the enterprises, to comply with the legal regulations, to follow the changes in technology and to realize the changes in the market in a timely manner. On the other hand, technological developments, legal regulations and market forces push the enterprises to new searches. Large firms want their suppliers to have ISO 9001 certification, which creates a significant market power.

Businesses want to be sustainable, efficient and efficient. Moreover, these demands are in a very strong competitive environment. Competition is experienced globally as well as in the country. In any case, consumers want to get the best quality goods and services. In addition, enterprises want to produce the products and services they produce at the lowest cost and gain much profit. The competition faced at this point depends on many factors. Competition takes place between potential competitors and between existing competitors. On the one hand, supplier companies have a certain bargaining power. ISO 9001 Quality Management System standard is a very important building block which directly affects the competitiveness of enterprises in such a complex competitive environment. However, what is important here is to establish this system in the enterprise and not to have a certificate but to develop it by integrating it with other systems and to achieve the expected benefits.

What is Quality and What is Quality Management?

Quality is one of the factors that provide a significant competitive advantage in enterprises but there is not a single definition. Because there are many different sectors producing goods and services and many different companies operating in these sectors, there are many different characteristics of consumers who need goods and services produced. As a result, the expectations from these goods or services vary and the conception of conformity to the needs of the consumers varies from person to person. For this reason, quality can be defined as the level of fitness for products and services. This conformity means compliance with the standards, method of use and customer demands and expectations.

Product characteristics are evaluated differently depending on whether the product is a product or a service. Performance, reliability, durability, simplicity of use, service facilities, aesthetics, service production accuracy, timeliness, completeness, proximity, customer expectations and the knowledge and experience of the customer stand out. For this reason, the perfection of the products for goods and service sectors also has a different meaning. In the production of goods, it is important to ensure that the goods produced are error free throughout the life of the product, to be delivered flawlessly and to complete the processes without error in all stages of production. In the production of services, it is important to ensure that the service is given without errors, after the service given, and to be perfect in production processes.

Quality Management System is of great importance for the enterprises. Because companies have to identify and realize their ability to design, manufacture, market and sell their goods or services in a way that will compete at the international level, whether they are in a serious competition or whether they will trade with foreign countries or not. In other words, the basic policy of the enterprise must be the quality of the activity strategy. With the establishment of an effective Quality Management System infrastructure, the reputation of the company will increase and trust will be established by consumers.

With the tendencies of the enterprises in this way, the achievements to be obtained are as follows:

• As a result of activities, waste, waste and scrap rates will decrease
• There will be fewer cuts in production and a higher production speed will be achieved
• Employees will be supported by appropriate tools and equipment
• Employees will be provided to operate in accordance with their documented business processes, thus increasing productivity in the business
• Time, labor and monetary costs will be reduced
• As the basic approach to quality systems, work will be done at once and correctly
• Weighted design studies to gain superiority in the structure of goods and services
• Customer losses will be minimized
• Number of customers, sales figures and operating profit will be increased by providing customer satisfaction
• To meet new customer demands, all employees of the company will be willing to change and will be flexible to innovations.
• Jobs will be completed quickly, accurately and on time with specified processes and control points
• Employee satisfaction and high motivation will be ensured to ensure that employees are satisfied, as well as customer satisfaction.
• In order to avoid problems in production activities, solutions will be determined before more problems arise

In order to reach the mentioned results, it is necessary to establish ISO 9001 Quality Management System in the enterprise, to be willing to implement and to apply correctly.

How is the Quality Management System managed?

It should not be forgotten that the way to success in quality systems lies in the management and sustainability of quality. As far as this happens, the company will see its benefits.

Today, it has reached such a point that on the one hand, customer demands and expectations are increasing and technological developments are experienced rapidly. Within global economies, businesses are now trading and wanting to be recognized around the world. Issues such as increased competition and the cost of poor quality now force the efficient management of quality. The basis of this management system is continuous change and development. The ISO 9001 system is a set of standards that create, develop and maintain quality and uses a number of tools and techniques for this purpose. It requires a planned and systematic study. Therefore, it is important for everyone to adopt and believe in the quality management approach from the top managers to the bottom employees.

Total Quality Management and Quality Management System

Today, consumers not only meet their needs in product demands but also demand that their needs be met in a quality manner. Therefore, businesses must make quality production. In order to gain an advantageous position in the fight against the competitors, the enterprises use different methods. Total Quality Management and ISO 9001 are the cornerstones of quality management. The basis of these is the design and development work and the higher quality of the goods and services produced.

Companies all over the world who implement Total Quality Management use this system both as a method to increase their earnings and as a means of legitimacy. In our country, political, economic and social changes started to be experienced especially in the years with 1980. While only a few large holdings dominated the market, the number of small and medium-sized enterprises started to increase with these changes. This was due to the encouragement of entrepreneurship, institutionalization efforts and support for the establishment of new enterprises. Meanwhile, the purchasing power of people has been increased. This situation has created a competitive environment and competition has started not only among large enterprises, but also among small, medium and large-scale enterprises.

These developments eventually increased the interest of enterprises in Total Quality Management. In addition to increasing consumer demand, the efforts of enterprises to increase product quality and control costs have been effective.

On the other hand, the fact that enterprises follow foreign countries closely together with globalization has made the implementation of Total Quality Management mandatory. The perception of the companies that follow this method is strong in global competition. However, despite all these developments, the adoption of Total Quality Management in our country is not based on voluntarism. Rather, it has been accepted as a means of gaining legitimacy. Nevertheless, it is accepted by some enterprises that the system will create superiority in competition, respond to customer expectations and reduce costs.

In our country, the Association of Turkish Industrialists and Businessmen in the adoption and widespread use of Total Quality Management (TUSIAD) and Turkey Quality Association (REMOVE) has been a powerful influence.

Quality Management System is an important tool and element of Total Quality Management. ISO 9001 Quality Management System standard improves the efficiency of enterprises while reducing unnecessary and value-added activities.

The ISO 9000 standards were first designed to determine military standards during World War II. Upon successful results, these standards were adapted to civil life and 1979 standard was published in 5750 by British Standards Institute. This standard sets the basis for the ISO 9001 standard which is in force today. ISO 9000 standards are applicable in all sectors.

In general, the ISO 9001 standard and Total Quality Management are mixed together. There are the following main differences:

• Total Quality Management mainly focuses on customer satisfaction and focuses on the development of quality in the enterprise.
• ISO 9001 Quality Management System focuses on trade and focuses on increasing and facilitating trade.

Both approaches actually complement each other. For this reason, it is recommended to establish and implement the ISO 9001 Quality Management System, which is a larger system than Total Quality Management, in order to achieve competitive advantage and to establish and implement quality systems for this purpose. ISO 9000 series standards make a significant contribution to quality improvement in enterprises.

As it is known, Total Quality Management has eight basic principles. All of these principles are included in the ISO 9001 Quality Management System. These principles are:

1. Customer orientation: Businesses must strive to understand and meet the needs of their customers today and in the future.
2. Leadership: Leaders in the enterprise must create a unity of purpose and management.
3. Employee participation: Employees are the foundation of the business and must participate in the system and use their skills for business benefit.
4. Process approach: Businesses must document and implement processes related to their activities.
5. System approach in management: Businesses must define and manage close to one another business processes within a system.
6. Continuous improvement: The objective of the enterprises should be the continuous improvement of performance.
7. Realistic decisions: The data should be analyzed by appropriate methods to ensure that the decisions are correct and effective.
8. Mutual benefits of relationships with suppliers: Businesses and supplier companies are interdependent and mutual benefits in relations should be considered.

ISO 9001: 2015 Quality Management System Standard

ISO 9001 standard has been changed since its first publication. The most recent arrangement was carried out in 2015. The previous arrangements were made in 2008. In fact, a radical change in the revision can not be said much. The revision made in 2015 had significant structural changes.

The basic structure of the ISO 9001 standard was as follows:

1. Scope
2. Sampling
3. Term and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product Grip
8. Measurement, analysis and improvement

The basic structure of the 2015 standard with 9001 revision is as follows:

1. Scope
2. Sampling
3. Term and definitions
4. Organization content
5. leadership
6. Planning
7. Supporting
8. Operation
9. Performance evaluation
10. Enhance on

With these new regulations, the structure of the standard has become more generalized and has become easily applicable by the service sector. While only the term ad product ve was used, the term ken goods and services da is now in the new structure.

With the 2015 revision, a risk based thinking perspective has been introduced for the companies implementing the ISO 9001 standard and the integration of existing business processes with the quality management processes is aimed. In addition, some flexibility has been recognized in the documentation conditions. The concept of risk based thinking in the standard has replaced the Standard preventive activity kavram item in the previous structure.

ISO 9001: A three-year transition period is also required for enterprises implementing the 2008 standard. During this time, the enterprises will harmonize their quality systems with the ISO 9001: 2015 standard. Inspection audits will be carried out by the certification bodies for the enterprises that have completed these works and ISO 9001: 2015 certificate will be given to them if appropriate. The documents of the enterprises that do not complete these works and do not make the necessary arrangements will be voided after 15 September 2018 date. The enterprises that will receive the first document will be subject to the ISO 9001: 2015 standard.

According to the newly revised ISO 9001 standard, management must consider this standard not only in relation to quality but also as a management control tool associated with the enterprise's strategy. Companies will now be able to structure their activities on the process model and use the system more effectively. The system has become more effective in terms of measuring, consolidating and continuously improving customer satisfaction.

ISO 9001 Documentation Process

After establishing and implementing the ISO 9001 standard, the companies will naturally want to have the ISO 9001 certificate. Before the start of certification work, enterprises must operate the system for at least three months. During this time, all employees will know what they are doing. In order to achieve this, each level of staff must have received the necessary training. When necessary, the enterprise may receive external support at these stages. Before the certification audits, the entity prepared the relevant documents, kept the relevant records, made internal audits and made a management review meeting. Once these requirements are completed, a certification body can now apply.

At this point, it is very important to select an accredited certification body. This accreditation is important in terms of the reliability of the certification body and the international validity of its activities.

The certification body evaluates the application request and prepares a proposal. If this offer is found to be appropriate by the entity, an agreement is signed between the two parties and the certification body initiates audit work.

The entity is subject to a two-stage audit by the certification body. The first stage is documentation studies. The appointed auditors, in particular, focus on the following points:

• Is the top management commitment taken as the first step in the enterprise that wants to have ISO 9001 certificate?

• Has the organization prepared the documents required by the ISO 9001 standard?
• Are the documents prepared or published effectively within the company?
• Are the records of activities required to be kept within the framework of these documents?
• Are inappropriate situations defined in the processes?
• Is it determined by whom?
• Is the internal audit system established?
• Are employees capable of problem solving?

If the documents prepared meet the requirements of the standard, then the certification body shall initiate a second stage audit in the enterprise. This is field supervision and the supervised auditors observe at this stage whether the documented processes are applied to the work. If the size and area of ​​activity of the enterprise creates a necessity, the first stage of the audit can also be carried out in the field. With the second stage, the documented processes are verified on-site and the system is working effectively. At this stage, it is determined whether all the processes of the enterprise interact with each other and whether they form a whole.

Certification bodies conduct audit work through checklists and guideline standards. If an improper situation is encountered during audits, this is recorded in the audit report prepared by the auditors.

The certification body makes its decision on this report. According to the results of the report, if the company decides that it deserves the document, ISO 9001: 2015 Quality Management System certificate is issued and put into operation.

The ISO 9001 certificate is valid for three years. The companies that receive the certificate have to undergo inspection once a year. However, some improper situations may be encountered during these interim inspections. The auditors shall make the necessary warnings at this stage. If these nonconformities are at an acceptable level (minor non-conformities), the entity commits to how long and how it will resolve these nonconformities. This period cannot be longer than three months. It initiates corrective actions within the system. At the next audit, it is observed that these nonconformities are eliminated and eliminated. However, if these non-conformities are not at an acceptable level (major nonconformities), then the enterprise must immediately resolve these non-conformities. Otherwise, no document is given or the given document is suspended.

Why Businesses Want to Have an ISO 9001 Certificate?

Reasons that lead businesses to obtain ISO 9001 certification may result from inside or outside the enterprise. The reasons arising within the business can be to improve the quality of products and services and to increase the efficiency and efficiency of the enterprise. Out-of-business reasons may be customer pressure, reputation concerns or competitive advantage. However, having the ISO 9001 certificate, regardless of the cause, affects the performance of the enterprises.

The ISO 9001 standard is seen as a tool for systematically addressing and improving management within the framework of the vision and mission of the enterprise. In this way, the companies apply ISO 9001 standard to increase internal audits, meet customer pressure, reduce transaction costs, maintain its presence in the sector, increase market share, improve the image of the enterprise, increase efficiency and efficiency, and compete in domestic and foreign markets.

In spite of this, enterprises also face some difficulties in the establishment and implementation of the Quality Management System. The most common difficulties are:

• Lack of participation of employees and managers
• Lack of education and awareness
• High working circulation
• Resistance to change of existing system
• Top management does not own the system
• Not having the right planning
• Not using effective measurement methods
• No quality meetings
• The importance of quality is not detected
• Lack of available documentation
• Not being able to document some activities
• Entering great expectations in a short time
• Detection of the system as a load
• Lack of decision-based decision-making approach
• Lack of communication