ISO 9001 Quality Management System (QMS)

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

ISO 9001 the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems.

When people use the word “Quality,” it’s usually as a synonym for “good.” Many brands tout their products as “high quality” or “superior quality” in just this way without really defining what the characteristics of “Quality” are, and we’re more likely to see it in marketing material than in integral business process or policy documents.

A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

Quality management is the act of overseeing all activities and tasks that must be accomplished to maintain a desired level of excellence.

This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. It is also referred to as total quality management (TQM).

In general, quality management focuses on long-term goals through the implementation of short-term initiatives.

While some use the term “QMS” to describe the ISO 9001 standard or the group of documents detailing the QMS, it actually refers to the entirety of the system. The documents only serve to describe the system.

Quality is about much more than describing a product or service as “good.” Quality Management professionals see Quality as the following:

  • Satisfying a set of explicitly or implicitly defined inherent characteristics.
  • Providing products or service features that customer’s need.

These features lead to customer satisfaction and exceeding customer expectations, which, in turn, lead to increased revenue for the producer.

  • Ensuring Quality

by adding features that customers want while ensuring consistency and reliability with every iteration has a cost, but the cost of not embracing Quality is much higher, including lost market share, missed opportunities, brand damage, and recalls due to design and manufacturing flaws.

  • Designing features that are free from deficiencies and errors.

Products or services that are deficient and don’t work as they should require rework or, if they make it to the marketplace, lead to costly recalls and customer dissatisfaction, all of which costs an organization money, time, and brand integrity.

  • Ensuring ongoing continuous improvement (CI)

To address the root causes of defects that are inherent in processes, tools, and designs and that have a significant impact.

By addressing the root causes through CI rather than the symptoms, organizations can reduce the Cost of Quality, increase efficiency, sustain a Culture of Quality, minimize rework activities on the shop floor and in the back office, reduce scrap, and ultimately have fewer recall events. Revenue and overall market share then increase as a result of improved product quality, higher levels of customer satisfaction, and increased market share.

Those who work in Quality often refer to the Quality Management System (QMS).

The QMS is not a machine or an application, but is the underlying Quality process architecture on which the organization sits. The term “QMS” includes all the people, processes, stakeholders, and technologies that are involved in an organization’s Culture of Quality, as well as the key business objectives that make up its goals.

Quality is both a perspective and an approach to increasing customer satisfaction, reducing cycle time and costs, and eliminating errors and rework using a set of defined tools such as Root Cause Analysis, Pareto Analysis, etc.

The International Organization for Standardization (ISO) defines “Quality” as “the degree to which a set of inherent characteristics fulfills a need or expectation that is stated, generally implied or obligatory.

Quality is not a program or a discipline. It doesn’t end when you have achieved a particular goal. Quality needs to live in the organization as the Culture of Quality in which every person experiences and understands the need for dedication to its values. Quality is a continuous race to improvement with no finish line.

At a more general level, Quality is about doing the right thing for your customers, your employees, your stakeholders, your business, and the environment in which we all operate. From the level of the individual employee all the way up to the level of our planet, Quality is about maximizing productivity and delighting customers while protecting our people and our resources from the harm that results from shoddy processes and careless oversight. Quality is an approach that should be the goal of every organization from business and manufacturing to healthcare, government, and not-for-profits.

Understanding Quality Management

At its core, TQM is a business philosophy that champions the idea that the long-term success of a company comes from customer satisfaction and loyalty. TQM requires that all stakeholders in a business work together to improve processes, products, services and the culture of the company itself.

Benefits of quality management systems

Implementing a quality management system affects every aspect of an organization’s performance. Benefits of a documented quality management system include:

  • Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business?
  • Meeting the organization’s requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit?

These benefits offer additional advantages, including:

  • Defining, improving, and controlling processes.
  • Reducing waste.
  • Preventing mistakes.
  • Lowering costs.
  • Facilitating and identifying training opportunities.
  • Engaging staff.
  • Setting organization-wide direction.
  • Communicating a readiness to produce consistent results.

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