A Quality Management System is a set of business processes which are implemented to help an

organization deliver products which consistently achieve customer satisfaction. An effective

system for managing quality translates an organization's purpose and goals into policies and
resources which help every member of the organization adopt standard operating procedures
(SOPs). The use of management frameworks to ensure consistent quality isn’t a new concept, but
the purpose of quality systems has evolved slightly in recent years.

The widespread use of the phrase "Quality Management System" and the commonly used
acronym of "QMS" can be traced to British Management Consultant Ken Croucher, who created
a model for Total Quality Management (TQM) in tech organizations. Croucher’s model was
informed by best practices for quality management in manufacturing organizations in the 20th
century, including the earliest applications of statistical sampling methods to ensure consistency.
Early models for TQM focused on an interdisciplinary approach to reducing waste, such as
avoidable labor costs.

Process efficiency isn’t the only benefit of Quality Management Systems today. Organizations

use QMS frameworks to guide continuous improvement efforts and adopt data for evidence-
based decision making. Organizations in highly regulated industries seek certification with
globally recognized standards such as ISO 9001 to improve quality through transparency,
documentation, and systemic approaches to improvement. The adoption of Quality Management
Software typically supports modern QMS.

Adopting a QMS can support compliance, profitability, and the development of a quality-driven
culture. While there are numerous QMS standards, the best-known systems for total quality
management all represent a comprehensive framework for the quality-driven organization.

9 Core Elements of a Quality Management System

Quality has been defined as "the degree to which something meets or exceeds the expectations of
its consumers." The precise definition of quality can vary between industries and organizations.
The processes and measurements used for quality assurance at a small manufacturing
organization are entirely different from the checks and balances necessary for quality control in
highly regulated industries such as pharma or medical devices.

Quality is a dynamic concept which is ultimately defined by customer expectations and

satisfaction. QMS are designed to provide a framework for organizations to create and maintain
customer relationships by understanding the customer’s preferences and needs. Customer
satisfaction is achieved with QMS through the alignment of people, process, and technology
throughout the product lifecycle.

One of the world’s most broadly adopted QMS, ISO 9001:2015, includes a series of quality
principles which are frequently reflected in other QMS standards:

1. Customer focus
2. Leadership
 3. Engagement of people
4. Process approach
5. Continuous improvement
6. Evidence-based decision making
7. Relationship management

Organizations must adopt an interdisciplinary series of quality controls to achieve these

principles. The nine core elements of a QMS should include quality objectives, a quality manual,
organizational responsibilities, data management, and other practices.

1. Quality Objectives
The creation of quality objectives is a common requirement of QMS standards, including ISO
9001. These objectives are designed to encourage organizations to define strategic goals and a
purpose for the QMS. Objectives translate an organization’s vision into practice by creating a
link between customer requirements and specific, measurable, and attainable goals. Well-written
objectives lend purpose to a QMS initiative and establish a customer-centric culture in an
organization.

A pharmaceutical startup in the research phase may have identified a customer need for
affordable therapeutics to treat a common skin condition. Since the product is being developed,
the organization may create a quality policy with a stated goal "To develop a safe, effective
treatment for eczema patients which is available at a lower cost than alternatives."

Quality objectives for this organization could include:

 To obtain total compliance with staff training requirements and raise average
assessment scores from 90% to 95%.
 To successfully implement a QMS software within three months and eliminate
paper and spreadsheet-based record keeping methods within six months.
 To achieve a successful initial synthesis of the drug and complete all necessary
processes for FDA initial review within 12 months.

Quality objectives should provide a clear vision for every member of the organization to
understand the company's purpose and the value of a QMS. The objectives should provide a clear
metric for measuring progress against strategic goals, including the timeline for achievement and
a measurable parameter of improvement.
2. Quality Manual
A quality manual is defined as the first documentation of a QMS. It states the motivation for
adopting a QMS framework and the role of quality within the organization. ISO 9000
requirements for a quality manual prescribe that this document should:

 Describe the scope of the QMS

 Detail the requirements of the QMS standard or framework
 List any elements of the QMS which are excluded from the implementation
 Reference specific quality procedures used within the organization
 Provide visual documentation of critical processes via flowchart
 Explain the organization’s quality policies and objectives

3. Organizational Structure and Responsibilities

A QMS should include a clear and updated model of the organization's structure and
responsibilities of all individuals within the organization. Documentation of structure and
responsibilities should include visual guides such as flowcharts and clear documentation.

Within the context of a QMS, the organization is broadly defined inWorld Health
Organization guidance as both people and structure. For a life sciences company in the early
phases of the product development lifecycle, initial efforts to identify organizational components
may reveal a list similar to the following:

 Personnel
 Equipment
 Information Systems
 Tools for Assessment
  Facilities
 Purchasing & Inventory
 Process Controls
 Documents & Records

Documenting organizational structure should address the entire product lifecycle using
techniques such as flowcharts which depict the “path of workflow.” Defining responsibilities
requires an organizational chart with clearly defined roles which can be linked to standard
operating procedures (SOPs). 

4. Data Management
Data is at the core of modern approaches to total quality management. Data quality and
availability are critical to the success of a QMS framework to drive continuous improvement and
preventative quality control activities. Organizations with ineffective data management practices
can experience inconsistent product quality, operating inefficiencies, compliance risks, poor
customer satisfaction, and low profitability.

An organization must be able to provide meaningful data evidence of effective quality controls.
Data management systems should support continuous improvement efforts and corrective actions
by defining the types of data that are gathered by the organization and third-party sources. The
policy for data management should address data types, sources, collection methods,
responsibilities, storage, disposal, and analysis.

The types of data required to demonstrate effective QMS performance can vary significantly
between organizations. However, at a minimum it should include the following sources:

 Customer Satisfaction
 Supplier Performance
 Product and Process Monitoring
 Non-Conformances
  Trends
 Preventative or Corrective Action

5. Processes
QMS are inherently process-driven approaches to quality control and assurance. Standards for
quality management require organizations to identify and define all organizational processes
which use any resource to transform inputs into outputs. Virtually every responsibility in the
organization can be tied to a process, including purchasing.

Initial efforts to define processes should create a high-level picture of how processes serve the
organization and intersect with resources such as employees, machines, or technology. After
identifying processes, organizations can begin to define standards and success metrics:

 Identify organizational processes

 Define process standards
 Establish methods for measuring success
 Document a standardized approach to ensuring quality output
 Drive continual improvement

6. Customer Satisfaction with Product Quality

A core component of QMS is the requirement for organizations to monitor customer satisfaction
to determine if quality objectives are achieved. Some standards do not prescribe specific methods
for measuring customer satisfaction since the definition of product quality and available data can
vary significantly between organizations.

A first step to establishing monitoring systems for customer satisfaction should be the definition
of appropriate methods for measuring customer attitudes and complaints. This could include:

 Satisfaction Surveys
 Complaints Procedures
 Analytical Applications to measure satisfaction trends
 Management Review of customer satisfaction

7. Continuous Improvement
Continuous improvement and adaptation are necessary for organizations to drive benefits with
the QMS and maintain customer satisfaction. QMS dictate that continual improvement is an
organization-wide responsibility. However, ISO 9001 is clear that leadership should play a core
role in implementing a quality-driven culture. Clause 5.1.1 states "top management shall
demonstrate leadership and commitment with respect to the quality management system by
taking accountability for effectiveness."

Designing organizational processes to meet QMS standards for continuous improvement requires
clear documentation of controls across the organization. Improvement documentation should
encompass, at a minimum:

 Quality Planning Procedures

 Compliance Requirements
 Safety Design
 Risk-based Thinking
 Corrective Action (CAPA)
 Gradual and Breakthrough Improvement
 Innovation
 Assessment of the QMS

8. Quality Instruments
The control and calibration of tools used to measure quality are integral to the success of a QMS.
If machines or equipment are used to validate products or processes, this equipment must be
carefully controlled and calibrated according to industry standards. Depending on the instrument,
this could involve periodic calibrations or calibration before every measurement.

The QMS system design within an organization should dictate a clear policy for the maintenance
of quality instruments based on nationally or internationally recognized standards for each piece
of quality equipment.

This documentation should address:

 Intervals for instrument calibration

 Recognized Standards for instrument calibration
 Manufacturer Instructions for adjustment
 Procedures for identifying and documenting calibration
 Controls against tampering or adjustment post-calibration
 Methods to protect instruments and equipment from damage

In addition to these requirements, the QMS should address effective documentation of

calibration results, including procedures for maintaining complete records of activities and
calibration results.
9. Document Control
The definition of a document in a quality-driven organization is broad, according to ISO. It
includes all records of:

 Communications
 Evidence
 QMS Conformity
 Knowledge Sharing

QMS dictate standards for the types of documentation which are necessary to support quality
management at a minimum, which may not be reflective of all the documents needed for
accurate quality control. This generally includes quality objectives, a quality manual, procedures,
process documentation, and records keeping. Document management systems must contain all
evidence necessary to prove QMS performance objectively.

Effective records-keeping is crucial to the success of the QMS, the ability to obtain certification
with QMS standards, and for regulatory compliance. During QMS design, organizations should
create specific definitions of records within the organization and policies for document creation,
retention, and editing. While QMS standards do not typically prescribe a method for document
management, being able to capture and retain all supporting evidence is generally best
accomplished with Quality Management Systems software.

Are You Quality-Driven?

Quality Management Systems are not designed to provide a prescriptive checklist for TQM
which can be seamlessly applied to companies in highly regulated industries. Instead, QMS are
intended to serve as a framework which guides the organization in achieving quality objectives,
continuous improvement, and customer satisfaction by including the nine core elements such as
objectives, document management processes, and data management policies.

The most successful QMS implementations balance simplicity and customization. A QMS needs
to be purpose-built to fit an organization's objectives, industry, and compliance requirements to
have a meaningful impact on culture. Simultaneously, every customization to the QMS should
provide clear value without needless complexity. The right QMS design is a mixture of
flexibility and standardization. Organizations need enough standardization to produce consistent
results and enough flexibility for continuous improvement to create a quality-driven culture.