Quality Management System

What Is a 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. 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.

ISO 9001:2015, the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems. 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.

  • Benefits of QMS
  • ISO 9001:2015 and other QMS standards
  • Elements and requirements of a QMS
  • Establishing and implementing a QMS
  • Industrial influence on quality and standardization
  • QMS resources

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

Elements and requirements of a QMS

Each element of a quality management system helps achieve the overall goals of meeting the customers’ and organization’s requirements. Quality management systems should address an organization’s unique needs; however, the elements all systems have in common include:

  • The organization’s quality policy and quality objectives
  • Quality manual
  • Procedures, instructions, and records
  • Data management
  • Internal processes
  • Customer satisfaction from product quality
  • Improvement opportunities
  • Quality analysis

Establishing and implementing a QMS

Before establishing a quality management system, your organization must identify and manage various connected, multi-functional processes to help ensure customer satisfaction. The QMS design should be influenced by the organization’s varying objectives, needs, and products and services provided. This structure is based largely on the plan-do-check-act (PDCA) cycle and allows for continuous improvement to both the product and the QMS. The basic steps to implementing a quality management system are as follows:



The design and build portions serve to develop the structure of a QMS



The design and build portions serve to develop the structure of a QMS, its processes, and plans for implementation



Deployment is best served in a granular fashion by breaking each process down into subprocesses and educating staff


Control and Measure

Control and measurement are two areas of establishing a QMS that are largely accomplished through routine


Review and Improve

Review and improve detail how the results of an audit are handled. The goals are to determine the effectiveness and efficiency

The Rise of Quality Management Systems

The American response to the quality revolution in Japan gave birth to the concept of total quality management (TQM), a method for quality management that emphasized not only statistics but approaches that embraced the entire organization.

In the late 20th century, independent organizations began producing standards to assist in the creation and implementation of quality management systems. It is around this time that the phrase “Total Quality Management” began to fall out of favor. Because of the multitude of unique systems that can be applied, the term “Quality Management System” or “QMS” is preferred.

At the start of the 21st century, QMS had begun to merge with the ideas of sustainability and transparency, as these themes became increasingly important to consumer satisfaction.

Cleanroom Validation Plan | Cleanroom Commisioning | Pharmaceutical Site Qualification | Cleanroom consultants |

Our Presence

Saskatchewan, CanadaFrankfurt, Germany

Toronto, CanadaNorth Carolina, USA

Indiana, USACalgary, Canada