2.0 Quality Systems PDF
2.0 Quality Systems PDF
Quality Systems
Introduction to Quality Systems
• A quality management system (QMS) is a
formalized system that documents processes,
procedures, and responsibilities for achieving
quality policies and objectives.
• It helps coordinate and direct an organization’s
activities to meet customer and regulatory
requirements and improve its effectiveness and
efficiency on a continuous basis.
Introduction to Quality Systems
• ISO 9001:2015, the international standard specifying
requirements for quality management systems, is the
most outstanding approach to QMS.
QMS serve many purposes, including:
• Improving processes
• Reducing waste
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction
Introduction to Quality
Systems
• Best practices for controlling product and process
outcomes were established and documented and
turned into standard practices for quality
management systems.
• The American response to the quality revolution in
Japan gave birth to the concept of total quality
management (TQM)
• In the late 20th century, independent
organizations began producing standards to assist
in the creation and implementation of QMS
Benefits of QMS
Implementing a quality management system affects
every aspect of an organization's performance.
Two benefits to the design and implementation of
documented QMS include:
• Meeting the customer’s requirements:
• Helps to give confidence in the organization, in turn leading
to more customers, more sales, and more repeat business
• Meeting the organization's requirements:
• 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
Elements of a QMS
General elements that all systems have in common:
Basic Steps:
1. Design
2. Build
3. Deploy
4. Control
5. Measure
6. Review
7. 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 that the needs of the organization and the
needs of its customers are a driving force behind
the systems development.
Deploy
• Deployment gives better results when each process
down into sub processes, and educating staff on
documentation, 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.
• This can 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
Continuous Improvement
Quality and Productivity
• One impediment to achieving high quality has
been the misconception of some managers that
there is an inverse relation between productivity
and quality.
Continuous Improvement
With this tool you can review a quality problem and its
possible cause.
When two variables are strongly related you will observe the
form of a line