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Terms relating to management in QMS

We shall try to define and understand some of the terms used in quality management system. The standard ISO 9000:2005 is the basis on which the terms are defined.

2) Terms relating to Management:

Terms relating to Management has following defination:

2.1) System

ISO 9000 definition:
“set of interrelated or interacting elements”
Explanation:

System Approch
System Approach

A system is a set of elements that are interrelated  or interact with one another. An organization will have multiple process in their organization. There is a relationship between these processes. Output of one process can be input to another process  or can be control for another process. The integration of the processes and their interaction can be termed as system. When managers use a systems approach, it means that they  treat the interrelated processes that make up an organization as an integrated system and then they use this system to achieve  its objectives.  Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives

2.2) Management System

ISO 9000 definition:

“System to establish policy and objectives and to achieve those objectives”
NOTE: A management system of an organization can include different management systems, such as a quality management system, a financial management system or an environmental management system.

Explanation:

Management system means what the organization does to manage its processes, or activities in order that its products or services meet the organization’s objectives, such as satisfying the customer’s quality requirements, complying to regulations, or meeting environmental objectives.  To be really efficient and effective, the organization can manage its way of doing things by systematizing it. Nothing important is left out.  Everyone is clear about who is responsible for doing what, when, how, why and where.In a single organization there can be many management systems such as Quality management system, Environment management system, Health and safety management system etc. Only policies and objective will differ for different management system.  Management system standards provide the organization with an international, state-of-the-art model to follow.

2.3) Quality Management System

ISO 9000 definition:
“Management system  to direct and control an organization  with regard to quality”
Explanation:

A quality management system (QMS) is a collection of business processes focused on achieving your quality policy and quality objectives — i.e. what your customer wants and needs. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. A quality management system is a set of interrelated or interacting elements that organizations use to direct and control how quality policies are implemented and quality objectives are achieved. A process-based QMS uses a process approach to manage  and control how its quality policy is implemented and quality objectives are achieved. A process-based QMS is a network  of many interrelated and interconnected processes (elements). Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of  such input-output relationships. These process interactions  create a single process-based QMS.

Elements of a Quality Management System are

  1. Quality Policy
  2. Quality Objectives
  3. Quality Manual
  4. Organizational structure and Responsibilities
  5. Data Management
  6. Processes – including purchasing
  7. Resources – including natural resources and human capital
  8. Product Quality leading to Customer satisfaction
  9. Continuous Improvement including Corrective and preventive action
  10. Maintenance
  11. Sustainability – including efficient resource use and responsible environmental operations
  12. Transparency and independence audit
  13. Engineering Change Control

2.4)  Quality Policy

ISO 9000 definition:

“Overall intentions and direction of an organization related to quality as formally expressed by top management”
NOTE 1:  Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives.
NOTE 2: The Eight  Quality management principles  can form a basis for  the establishment of a quality policy.

Explanation:

Quality policy is a document jointly developed by management  to express the quality objectives of the organization, the acceptable level of quality and the duties of specific departments to ensure quality. An organization’s quality policy defines top management’s commitment to quality. A quality policy statement should  describe an organization’s general quality orientation and clarify its basic intentions.Quality policies should be used to generate quality objectives and should serve as a general framework for action. Quality policies can be based on the ISO 9000 Quality Management Principles and should be consistent with the organization’s  other policies.Section 5.3 of the ISO 9001 standard requires a written, well defined quality policy that is communicated and understood within an organization.

 2.5)  Quality Objective

ISO 9000 definition:

“Something sought, or aimed for, related to quality”
NOTE 1 Quality objectives are generally based on the organization’s quality policy.
NOTE 2 Quality objectifies are generally specified for relevant functions and levels in the organization

Explanation:

A quality objective is a quality oriented goal. A quality objective is something you aim for or try to achieve.Quality objectives are generally based on or derived from an organization’s quality policy and must be consistent with it. They are usually formulated at all relevant levels within the organization and for all relevant functions. The organization should develop measurable quality objectives, consistent with the quality policy of the organization. Internal and external auditors review quality objectives at each audit to see if they are being met. For planning of the quality management system, it is necessary to establish measurable quality objectives.

2.6)  Management

ISO 9000 definition:

“Coordinated activities to direct and control an organization”
NOTE: In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority and 
responsibility for the conduct and control of an organization. When “management” is used in this sense, it should always be used with some form of qualifier to avoid confusion with the concept “management” defined above. For example,“management shall.. .” is deprecated whereas “top management  shall.. .“ is acceptable.

Explanation:

The term management refers to all the activities that are used to coordinate, direct, and control an organization. In this context, the term management does not refer to people. It refers to activities. ISO 9000 uses the term top management to refer to people.

2.7) Top Management

ISO 9000 definition:

“Person or group of people who directs and controls an organization  at the highest level.”

Explanation:

When ISO 9001 uses the term top management it is referring to a person or a group of people at the highest level within an organization. It refers to the people who coordinate, direct, and control organizations.

2.8) Quality Management

ISO 9000 definition:

“Coordinated activities to direct and control an organization  with regard to quality.”
NOTE:  Direction and control with regard to quality generally includes establishment of the quality policy and quality objectives , quality planning , quality control , quality assurance and quality improvement.

Explanation:

Quality management includes all the activities that organizations  use to direct, control, and coordinate quality. These activities  include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance, and quality improvement. Quality management  means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulations applicable to those products or services. Quality management also means what the organization does to enhance customer satisfaction, and achieve continual improvement of its performance. The four tools of quality management are
a) Quality planning, b) Quality control,  c) Quality assurance  and d) Quality Improvement

2.9) Quality Planning

ISO 9000 definition:

“Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives”
NOTE Establishing quality plans can be part of quality planning.

Explanation:

Quality Planning is defined as the part of quality management focused on setting quality objectives and specifying necessary operational processes and resources to fulfill quality objectives. Quality planning involves setting quality objectives and then specifying the operational processes and resources that will  be needed to achieve those objectives. Quality planning is a  systematic process that translates quality policy into measurable objectives and requirements, and lays down a sequence of steps for realizing them within a specified time frame. A quality plan is a document that is used to specify the procedures and resources that will be needed to carry out a project, perform a process, realize a product, or manage a contract. Quality plans  also specify who will do what and when.

2.10) Quality Control

ISO 9000 definition:

“Part of quality management focused on fulfilling quality requirements”

Explanation:

Quality Control is defined as the part of quality management focused on fulfilling quality requirements.Quality control is a set of activities intended to ensure that quality requirements are actually being met. Quality Control  is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced. QC aims to identify  and correct  defects in the in-process and  finished product. Quality control, therefore, is a reactive process.Quality control activities are performed after the product is developed.  Quality control is used to verify that deliverables are of acceptable quality and that they are complete and correct. Examples of quality control activities include inspection, deliverable peer reviews and the testing process.

2.11) Quality Assurance

ISO 9000 definition:

“Part of quality management focused on providing confidence that quality requirements will be fulfilled”

Explanation:

Quality Assurance is defined as the part of quality management focused on providing confidence that quality requirements will be fulfilled.Quality assurance is a set of activities intended to establish confidence that quality requirements will be met.Quality Assurance is a set of activities for ensuring quality in the processes by which products are developed.Quality Assurance aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.The goal of Quality Assurance is to improve development and test processes so that defects do not arise when the product is being developed.Quality Assurance refers to the process used to create the deliverables, and can be performed by a manager, client, or even a third-party reviewer. Examples of quality assurance include process checklists, project audits and methodology and standards development.

2.12) Quality Improvement

ISO 9000 definition:

“Part of quality management focused on increasing the ability to fulfill quality requirements”
NOTE:The requirements can be related to any aspect such as effectiveness, efficiency or traceability. 

Explanation:

Quality Improvement is defined as the part of quality management focused on increasing the ability to fulfill requirements.Quality improvement refers to anything that enhances an organization’s ability to meet quality requirements.

2.13) continual improvement

ISO 9000 definition:

“recurring activities to increase the ability to fulfill requirements.”NOTE: The process  of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings  and audit conclusions, analysis of data, management reviews  or other means and generally leads to corrective action  or preventive action.”

Explanation:

Continual improvement is a set of recurring activities that an organization carries out in order to enhance its ability to meet requirements. Continual improvements can be achieved by  carrying out, self-assessments, management reviews, and benchmarking projects. Continual improvements can also  be realized by collecting data,analyzing information, setting objectives, and implementing corrective and preventive actions. Continuous improvement is an ongoing effort to improve products, services or processes. These efforts can seek “incremental” improvement over time or “breakthrough” improvement all at once.
Among the most widely used tools for continuous improvement is a four-step quality model—the plan-do-check-act (PDCA) cycle, also known as Deming Cycle:

  • Plan: Identify an opportunity and plan for change.
  • Do: Implement the change on a small scale.
  • Check: Use data to analyze the results of the change and determine whether it made a difference.
  • Act: If the change was successful, implement it on a wider scale and continuously assess your results. If the change did not work, begin the cycle again.

The terms continuous improvement and continual improvement are frequently used interchangeably. But some quality practitioners make the following distinction:
Continual improvement: A broader term preferred by W. Edwards Deming to refer to general processes of improvement and encompassing “discontinuous” improvements—that is, many different approaches, covering different areas.
Continuous improvement: a subset of continual improvement, with a more specific focus on linear, incremental improvement within an existing process. Some practitioners also associate continuous improvement more closely with techniques of statistical process control

2.14) Effectiveness

ISO 9000 definition:

extent to which planned activities are realized and planned results achieved

Explanation:

Effectiveness refers to the degree to which a planned effect is achieved. Planned activities are effective if these activities are realized. Similarly, planned results are effective if these results are actually achieved. An effective process is one that realizes planned activities and achieves planned results. Similarly, an effective set of characteristics or specifications is one that has the potential to realize planned activities and achieve planned results.Effectiveness is about doing the right task, completing activities and achieving goals.

2.15) Efficiency

ISO 9000 definition:

Relationship between the result achieved and the resources used

Explanation:

Efficiency is a relationship between results achieved (outputs) and resources used (inputs).Efficiency can be enhanced by achieving more with the same or fewer resources. The efficiency of a process or system can be enhanced by achieving more or getting better results (outputs) with the same or fewer resources (inputs).Efficiency is about doing things in an optimal way, for example doing it the fastest or in the least expensive way. It could be the wrong thing, but it was done optimally.

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