This document discusses quality management systems (QMS) and their key principles and benefits. It outlines the main components of a QMS including customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. It emphasizes that a QMS establishes unity of purpose, improves processes and communication, enhances learning and innovation, and improves decision making and relationships with interested parties. Finally, it notes that a quality assurance system within a QMS ensures products meet safety, quality and efficacy requirements and comply with regulations.
5. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
Leaders at all levels establish unity of purpose and
direction and create conditions in which people are
engaged i achieving the organization’s quality objectives.
• Increased
effectiveness and
efficiency in
meeting the
organization’s
quality objectives.
• Better
coordination of the
organization’s
processes.
• Improved
communication
between levels and
functions of the
organization.
• Development and
improvement of the
capability of the
organization and its
people to deliver
desired results.
6. Customer Focus
Leadership
Engagement
of People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Improved
understanding of
the organization’s
quality objectives
by people in the
organization and
increased
motivation to
achieve them.
• Enhanced
involvement of
people in
improvement
activities and
attention to shared
values and culture
throughout the
organization
• Enhanced
personal
development,
initiatives and
creativity.
• Enhanced people
satisfaction and
trust and
collaboration
throughout the
organization.
8. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Improved process
performance,
organizational
capabilities and
customer satisfaction. • Enhanced focus on
root-cause
investigation and
determination,
followed by
prevention and
corrective actions.
• Enhanced ability to
anticipate and react
to internal and
external risks and
opportunities.
• Enhanced
consideration of both
incremental and
breakthrough
improvement.
• Improved
use of learning
for
improvement.
• Enhanced
drive for
innovation.
10. Customer Focus
Leadership
Engagement of
People
Process
Approach
Improvement
Evidence-Based
Decision Making
Relationship
Management
• Enhanced performance of the organization and its interested
parties through responding to the opportunities and constraints
related to each interested party.
• Common understanding of goals and values among interested
parties.
• Increased capability to create value for interested parties by
sharing resources and competence and managing quality-related
risks.
• A well-managed supply chain that provides a stable flow of
goods and services.
11. QA System should ensure:
• Starting materials, intermediate products, bulk products are controlled
• In-process controls, calibrations, and validations are carried out
• Finished products are correctly processed and checked
• Products are not sold or supplied before release by authorized persons
• Systems ensure that products are appropriately stored and distributed
Quality Management
12. QA System should ensure:
• Self-inspection and/or quality audits are done regularly
• Deviations are reported, investigated and recorded
• Changes are controlled
• Systems are followed to verify the consistency of processes and
ensuring continuous improvement
• Quality Risk Management is implemented
13. Quality Assurance
• Products must be:
– safety, quality and efficacy requirements - fit for their intended use
– comply with the requirements of the marketing authorization
• Senior management is responsible - and all staff must be committed
to achieve this.
• Relies on a comprehensively designed, documented, correctly
implemented system of QA incorporating GMP and QC.
• Relies on competent personnel, suitable and sufficient premises,
equipment and facilities.
