Approach to Quality Management System


Thus, in order for a quality management system to be built, operated, maintained and continuously improved, the organization needs to establish and carry out the following activities:

Activities related to: Leadership Responsibilities

The management of the QMS is the responsibility of the “top management” (head of the agency, head of the enterprise). The top management must recognize customer requirements when planning strategies and commit to meeting these requirements in accordance with the law and the responsibilities of the work.

Top management must determine the quality policy and to achieve this policy must determine the quality objectives and at the same time plan the measures to be taken to achieve those objectives.

Top management shall ensure clear internal communication of the effectiveness of the QMS and shall periodically review the system to ensure its continuing suitability and effectiveness.

Activities related to: resource management

This section specifies the human and physical resources required to carry out the process. Personnel must be competent to perform the tasks assigned to them and the necessary infrastructure and working environment must be in place to ensure that customer requirements are met.

Activities related to: production and provision of products/services:

Includes the processes necessary to create a product or provide a service. This is the activity of transforming the input of the process into an output with added value. For example: For the Department of Natural Resources and Environment, that process could be the process of transforming information received from the application for land use rights into a land use rights certificate after reviewing the application containing sufficient information to meet legal requirements, for a public hospital organization, the input is patients, the output is patients who are examined and cured, etc.

Activities related to: measurement, analysis and improvement

This is the work of measuring, evaluating to be able to monitor and analyze to provide information about how the system is operating to meet customer requirements through testing, monitoring processes, and customer feedback.


(including external and internal customers, stakeholders, etc.), system assessment. Synthesizing and analyzing errors in the system, implementation process and product/service delivery results will provide valuable information as a basis for implementing necessary improvements.

Thus, a quality management system can be viewed as a series of interlinked processes that produce outputs consistent with defined quality objectives.

With the above mentioned constituent elements and operations, the QMS has the following basic characteristics:

Focus on controlling and improving processes.

Focus on prevention, do it right the first time and continuously improve.

Is an open, flexible system, continuously improving to meet the fluctuations of the business environment and customer requirements.

Applicable to all types of organizations, regardless of size, type, ownership, production or service.

Use technical tools to control/monitor as well as prevent in collecting, analyzing/processing information and making decisions.

The requirements of the quality system are usually the most general so that they can be applied to all types of organizations, without mentioning the implementation method, which depends entirely on the organization, especially the leadership level. Each organization has a different QMS within the framework of general QMS principles.

It should be noted that the requirements of the QMS are different from the requirements for the product. It only supplements but does not replace the requirements for the product.

Integrability: The QMS can be integrated with different parts of the organization's QMS into an integrated system using common elements.

d) The role of quality management system

The pressure of ensuring the progress of providing products and services according to legal requirements and agreements, while at the same time wanting to avoid risks and insecurity, and minimizing unnecessary troubles requires organizations to apply a quality management system fully and seriously.

It can be said that a quality system will be applied with the desire to:


- Bring a systematic approach to all processes from design, implementation, service delivery, to the final stage of the service;

- Prevent errors from the beginning instead of relying on inspection and review measures from relevant parties;

- All administrative procedures are transparent and clear for relevant subjects to use, apply and control;

- Minimize abuse by related parties, while raising awareness and responsibility of employees towards customer service;

- Provide objective evidence that specified requirements for quality have been met.

1.2.6. Approach to quality management system

When studying the formation and development of quality management, we see that this process is divided into many stages and associated with different quality management system models. However, scholars agree that the development process of quality management goes from simple to complete, from quality inspection to control, assurance, quality management and towards perfect operation. According to the summary of quality management researchers, there are currently three main approaches to the application of quality management systems.

a) Quality management system model based on standards

The most popular standard-based management system model today is the ISO 9000 international standard set, first issued by the International Organization for Standardization (ISO) in 1987, which has been revised three times to date, the current version being ISO 9001:2008 (issued on December 15, 2008). This set of standards includes many standards, including four main standards: 1) ISO 9001:2008: standard on quality management systems - requirements (equivalent Vietnamese standard is TCVN ISO 9001:2008); 2) ISO 9000:2005 - standard on quality management systems - Fundamentals and Vocabulary (equivalent Vietnamese standard is TCVN ISO 9000:2007); 3) ISO 9004:2009 - Standard on guidelines to ensure sustainable and successful development of organizations; 4) ISO 19011:2002 - Standard for guidance on auditing quality and/or environmental management systems (Vietnamese standard)


equivalent to TCVN ISO 19011:2003).

This is a set of standards that sets out the requirements for a quality management system for an organization. The quality management system standard only supplements and does not replace the requirements for products. This standard can be applied to all types of organizations, regardless of size and form of ownership. This standard can be used by internal and external organizations, including certification organizations, to assess the ability to meet customer requirements, statutory and regulatory requirements applicable to the product as well as the organization's own requirements. The requirements of the quality management system set out in ISO 9001:2008 are specified based on the quality management principles stated in TCVN ISO 9000:2005 and TCVN ISO 9004:2009.

Building a quality management model based on international standards helps organizations ensure stable supply of products/services and aim to satisfy customers and stakeholders, through building and controlling work processes in a reasonable, legal and effective manner. The standard directs organizations to focus on preventing errors and doing it right the first time through standardizing working methods, defining responsibilities, authorities, and capacity requirements for all job positions and providing sufficient and timely resources needed to complete the work. Setting quality goals and continuous improvement are also among the main requirements of this standard.

Originating directly from the quality assurance standards of the US Department of Defense and becoming an international standard over the past 20 years, the ISO 9000 standard set has been applied by many organizations and businesses around the world and has become the national standard of many countries. According to the survey results of 12/2008 by ISO, the number of organizations applying and evaluating certification of conformity to ISO 9000 standards is nearly 1 million organizations and in Vietnam, it is nearly 4,000 organizations and businesses (see table below for details).



Table 1.1: Number of organizations that have applied ISO 9001 in the world

(Source: ISO survey report December 2008)

Table 1.2: 10 countries with the largest number of organizations applying ISO 9001

Water

2004

2005

2006

2007

2008


Table 1.3: Number of organizations that have applied ISO 9001 in Vietnam from 2004-2008

(Source: ISO survey report December 2008)

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Approach to Quality Management System

b) Non-standard quality management system model

The application of the ISO 9000 quality management system has brought many benefits to the applying organization in standardizing operations and stabilizing the quality of products and services provided. In particular, the assessment and certification of conformity to standards carried out by certification organizations is an independent and objective assessment that provides evidence of the organization's implementation of quality commitments.

Besides the advantages of the QMS according to the above mentioned standards, the approach according to this model also reveals limitations. Because the standards apply to


All organizations should require only general, general, not specific, causing confusion and difficulty in applying in specific types of organizations. The standard only sets out the requirements to be met but does not guide how to meet them, so the specific response is up to the organization to consider and implement. This leads to the situation where many organizations only focus on meeting the minimum requirements with the goal of having a certificate without paying attention to investment and improving operations, and especially the fact that the system is not improved after certification, leading to the quality management system being just a formality, not promoting the effectiveness and efficiency of the system. This will be analyzed specifically in chapter 2 of this thesis.

The non-standard quality management system (QMS) model is based on quality management principles, initiated, applied and formed by the world's leading corporations with different names such as: Total Quality Management model in Japanese style (TQM-Total Quality Management); Toyota Production Management model (TPS - Toyota Production System); American defect reduction model (6 Sigma) initiated by Motorola... to perfect business operation models (Business Excellence) of the US, Japan, Singapore... different from the standard-based QMS model, these models do not have certification assessment activities, do not have certificates. This model is based on the philosophy of continuous improvement and the pursuit of perfection. The models use different tools and techniques but all aim to minimize waste, errors and improve customer and employee satisfaction.

Successful implementation of a non-standard QMS requires a long-term, continuous effort from everyone in the organization. It requires the organization to create a quality culture.

c) Integrated management system model

The integrated management system model is the simultaneous application of multiple management models based on standards and non-standards. This integration helps the organization to meet many different requirements at the same time, reducing time and costs.


system construction costs. This is a trend that many organizations are currently applying. This integration can be the integration of management standards together such as: ISO 90001

+ ISO 14001+ OSHAS 18000/ISO 26000 or ISO 9001 + application of information management software (edocment, e office) + non-standard management systems such as: TQM, Lean, KM and quality improvement tools.

1.2.7. The process of implementing quality management system in hospitals

Building a quality management system in a hospital can be carried out in the following steps:

after:


Step 1: Leadership commitment

The first step in building and implementing a quality system

is to see its significance in maintaining and developing the organization. Organizational leaders need to orient the activities of the quality system, determine the goals and scope of application to support their management activities to bring practical benefits to the organization. Many organizations, they first conduct training on quality management awareness and implementation methods for the board of directors and all key staff, then organize study tours to learn about successfully applied models at home and abroad to gain consensus and support from management levels when implementing the quality management system.

Strong commitment from the leadership is a prerequisite to ensure the sustainable development, application, maintenance and improvement of the quality management system in the organization. Because in essence, the decision to apply a quality management system according to a standard or non-standard model is also a strategic decision of the organization, it is a process of changing the mindset, way of thinking and working of all members in the organization about quality. It requires a persistent effort, long-term dedication, and continuity of everyone in the organization to achieve a "quality culture" and customer satisfaction, not just a certificate or a trophy.

Step 2: Establish a steering committee on quality management

Building, applying and improving the QMS is a long-term process, including:


many stages, so the organization needs to build an organizational structure to ensure the effectiveness and efficiency of the QMS. The steering committee includes the village chief and members, the secretariat/standing steering committee group. The head of the steering committee is usually the highest leader of the organization, the deputy head of the steering committee is usually a member of the leadership and the representative of the leadership in terms of quality, and the members of the steering committee are heads of units within the scope of application of the QMS.

The Steering Committee on Quality Management is responsible for selecting a quality management model; determining the scope of application of the Quality Management System; and directing the construction, application, maintenance and improvement of the Quality Management System.

It is necessary to appoint a quality representative of the leadership, responsible to the leadership for quality activities. Assisting the steering committee is a secretariat/standing steering committee whose task is to coordinate the activities of the QMS.

Usually, organizations that do not have experience in building a QMS often invite experienced consultants/consulting organizations to advise and guide them in building a QMS.

Step 3: Assess the current status of the organization's quality management activities

This is the step of assessing the current status of the organization's quality management activities to compare with the requirements and determine the level of compliance. The results of the assessment will be the basis for developing a plan to implement the QMS. Identify the resources needed to build the QMS, such as: people, facilities, improving working conditions, etc.

Step 4: Design and build a quality management system

This is the most difficult and arduous process in implementing the QMS. This process focuses on the basic contents including: building a quality policy; building quality objectives at appropriate levels in the organization; determining a plan to implement the objectives, resources and measures to achieve the objectives; clarifying the functions and tasks of each unit, responsibilities and authorities, and capacity requirements of each job position; reviewing all processes in the system for standardization and improvement; establishing a system of quality control and inspection points in the processes; building a suitable quality management document system (usually including the following objectives).

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