QMS

A quality management system (QMS) is a set of policies, processes and procedures required for planning
and execution (production/development/service) in the core business area of an organization. (i.e. areas
that can impact the organization's ability to meet customer requirements.)

A quality management system (QMS) is a collection of business processes focused on consistently

meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's
purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and
aspirations, policies, processes, documented information and resources needed to implement and
maintain it.

Early quality management systems emphasized predictable outcomes of an industrial product

production line, using simple statistics and random sampling. By the 20th century, labor inputs were
typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and
dynamics, especially the early signaling of problems via a continuous improvement cycle. In the 21st
century, QMS has tended to converge with sustainability and transparency initiatives, as both investor
and customer satisfaction and perceived quality is increasingly tied to these factors. Of QMS regimes, the
ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit
regime applies to both, and deals with quality and sustainability and their integration.

A quality management system (QMS) is 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.

Quality management systems serve many purposes, including:

 Improving processes

 Reducing waste

 Lowering costs

 Facilitating and identifying training opportunities

 Engaging staff

 Setting organization-wide direction

Requirements of QMS

Although any quality management system should be created to address an organization’s unique
needs, there are some general elements all systems have in common, including:

 The organization’s quality policy and quality objectives

 Quality manual

 Procedures, instructions, and records

1. Data management

2. Internal processes

3. Customer satisfaction from product quality

4. Improvement opportunities

5. Quality analysis

Each element of a quality management system serves a purpose toward the overall goals of
meeting the customers’ and organization’s requirements. Ensuring each of the elements of a
QMS is present ensures proper execution and function of the QMS.

Establishing and implementing a QMS

Establishing a quality management system helps organizations run effectively. Before
establishing a quality management system, the organization must identify and manage various
connected, multi-functional processes to ensure customer satisfaction is always the target
achieved.

There are many things to consider when establishing a QMS for your organization. Of great
importance is ensuring it is a strategic choice influenced by the 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:

 Design

 Build

 Deploy

 Control
  Measure

 Review

 Improve

Design and build

The design and build portions serve to develop the structure of a QMS, its processes, and plans
for implementation. Senior management must oversee this portion to ensure the needs of the
organization and the needs of its customers are a driving force behind the systems development.

Deploy

Deployment is best served in a granular fashion via breaking each process down into sub-
processes, and educating staff on documentation, education, training tools, and metrics.
Company intranets are increasingly being used to assist in the deployment of quality
management systems.

Control and measure

Control and measurement are two areas of establishing a QMS that are largely accomplished
through routine, systematic audits of the quality management system. The specifics vary greatly
from organization to organization depending on size, potential risk, and environmental impact.

Review and improve

Review and improvement deal with how the results of an audit are handled. The goals are to
determine the effectiveness and efficiency of each process toward its objectives, to communicate
these findings to the employees, and to develop new best practices and processes based on the
data collected during the audit.