The following content is offered to our readers as a short list of important concepts, principles and definitions that can help in building a more complete understanding how to build and operate a Quality Management System to achieve organizational goals and needs. These have been adapted from ISO 9000 and Iso 9001. The full text is available in these documents.
Fundamental Concepts of Quality Management
Quality
An organization focused on quality promotes a culture that results in the behavior, attitudes, activities and processes that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties.
The quality of an organization’s products and services is determined by the ability to satisfy customers and the intended and unintended impact on relevant interested parties.
The quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer.
Quality Management System (QMS)
A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results.
The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties.
The QMS enables top management to optimize the use of resources considering the long and short term consequences of their decision.
A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services.
Context of the Organization
Understanding the context of the organization is a process. This process determines factors which influence the organization’s purpose, objectives and sustainability. It considers internal factors such as values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments.
Examples of the ways in which an organization’s purpose can be expressed include its vision, mission, policies and objectives.
Interested Parties
The concept of interested parties extends beyond a focus solely on the customer. It is important to consider all relevant interested parties.
Part of the process for understanding the context of the organization is to identify its interested parties. The relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met. Organizations define what results are necessary to deliver to those relevant interested parties to reduce that risk.
Organizations attract, capture and retain the support of the relevant interested parties they depend upon for their services.
Quality Management Principles
Customer Focus
The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
Sustained success is achieved when an organization attracts and retains the confidence of customers and other relevant interested parties. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to the sustained success of the organization.
Key benefits may include increased customer value, satisfaction and loyalty.
Leadership
Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.
Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.
Key benefits may include increased effectiveness and efficiency in meeting the organization’s quality objectives, better coordination of the organization’s processes and improved communication between levels and functions of the organization.
Engagement of People
Competent, empowered and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value.
In order to manage an organization effectively and efficiently, it is important to respect and involve all people at all levels. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving the organization’s quality objectives.
Key benefits may include improved understanding of the organization’s quality objectives by people in the organization and increased motivation to achieve them, enhanced involvement of people in improvement activities and enhanced personal development, initiatives and creativity.
Process Approach
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
The QMS consists of interrelated processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance.
Key benefits may include enhanced ability to focus effort on key processes and opportunities for improvement, consistent and predictable outcomes through a system of aligned processes and optimized performance through an effective process management, efficient use of resources and reduced cross-functional barriers.
Improvement
Successful organizations have an ongoing focus on improvement.
Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.
Key benefits may include improved process performance, organizational capability and customer satisfaction, enhanced focus on root cause determination, followed by preventative and corrective actions and an enhanced ability to anticipate and react to internal and external risks and opportunities.
Evidence-based decision making
Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
Decision-making can be a complex process and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decision making.
Key benefits may include improved decision-making processes, improved assessment of process performance and ability to achieve quality objectives, and improved operational effectiveness and efficiency.
Relationship Management
For sustained success, organizations manage their relationships with relevant interested parties, such as providers.
Relevant interested parties influence the performance of an organization. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. Relationship management with its provider and partner networks is of particular importance.
Key benefits may include enhanced performance of the organization and its relevant interested parties through responding to the opportunities and constraints related to each interested party, common understanding of objectives and values of each interested party and a well-managed supply chain that provides a stable flow of products and services.
Key Terms and Definitions
Shall:
The word Shall in Quality Management Standard has been used in many places. We all know that in the English language the word Shall is used when an activity must be performed, therefore whenever you see word Shall, you must do what the Quality Management Standard demands if you desire certification to the Quality Management Standard. A popular exercise is to identify the places in the standard where “Shall” is used, and then address what follows that word. Some logical methods for “Engineering” the procedures needed to address the requirement can be derived from the “Shall” word, and will be offered soon in these blogs, articles and white papers.
Should:
Indicates a course of action or recommendation that results in a “best practice” that all well-managed quality management systems follow. It is not a specified requirement that an organization is required to adhere to but may be indicated as a logical and necessary course of action or “best practice”.
May:
Indicates a permission to follow the guideline.
Can:
Indicates a possibility or a capability.
Notes:
Suggestions followed by this word are not mandatory. These notes in the Quality Management Standard are provided for the convenience of the user. The notes are just an advisement or suggestion.
Process:
This is the combination of activities and resources like equipment, personnel. Process is set of interrelated or interacting actives which transforms inputs into outputs.
- a) Inputs to a process are generally outputs of other processes.
- b) Processes in an organization are generally planned and carried out under controlled conditions to add value.
- c) A process where the conformity of the resulting product cannot be readily or economically verified is frequently referred to as a “Special Process”.
Product:
Product is a result of a process (set of interrelated or interacting actives which transforms inputs into outputs). A good way to define a product is that it is what the organization offers to its customers, usually for a price. For the vast majority of organizations, product is what the customer is paying you for.
There are four generic product categories, as follows:
1) Services (e.g.: Transport, Call Center)
2) Software (e.g.: Computer Program, Dictionary)
3) Hardware (e.g.: Engine Mechanical Part)
4) Processed Materials (e.g.: Lubricant)
As you can tell, most organizations sell products that cover more than one category of product.
It can have a combination of tangible and intangible attributes (benefits, features, functions, uses) that a seller offers a buyer for purchase. For example, a seller of a toothbrush not only offers the physical product but also the idea that the consumer will be improving the health of their teeth.
Conformity:
A product is conforming when it fulfills specified requirements.
Non-Conformity:
When the product does not fulfill specified requirements.
Contract:
This is an agreement to supply a product or service. This agreement may be verbal, electronic, written or transmitted by any means. An “order” or “agreement” are common examples of a contract.
Supplier:
Organization or person that provides a product or services. Producer, Distributor, Retailer or Vendor of a product, or provider of a service or information.
1) A supplier can be internal or external to the organization.
2) In contractual situation, a supplier is sometimes called “contractor”.
Quality
quality degree to which a set of inherent characteristics of an object fulfills requirements .
Risk
Risk is the effect of uncertainty or a deviation from the expected.
Efficiency
The relationship between the result achieved and the resources used.
Effectiveness
The extent to which planned activities are realized and planned results are achieved.
Objective Evidence
Data supporting the existence or verity of something.
Verification
confirmation, through the provision of objective evidence that specified requirements have been achieved.
Validation
Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
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