2. What is a QMS?
The short answer:
Say what you do (documentation)
Do what you say (implementation)
Prove what you do (records)
Review and improve (continuous improvement)
3. QMS Definitions
A Quality Management System is:
System for managing the quality of an organization
Includes everything in the organization that relates to quality:
◦ Products and services
◦ Processes
◦ Operations
◦ Customer Satisfaction
4. QMS Description
As required by ISO 9000:
The Quality System is well documented, implemented, understood,
maintained and continually improved
Emphasis is placed on problem prevention rather than inspection
Quality planning is required
The PROCESS APPROACH to management is encouraged
5. What makes it so special?
Process Approach to management
Integration of processes into a System/ Interrelation of all activities
Continual Improvement at all levels
Communication among all employees and management that leads
to full utilization of everyone’s talents.
6. DEFINITION
“A desired result is achieved more efficiently when activities and
related resources are managed as a process.”
PROCESS – collection of interrelated activities that transform
inputs into outputs
7. DEFINITION
“Identifying, understanding, and managing interrelated processes as a
system contributes to the organization’s effectiveness and efficiency
in achieving its objective.”
SYSTEM – a collection of interrelated processes with a common
set of objectives and outputs.
8. DEFINITIONS
PROCESS CHAMPION – member of top management who
has interest in promoting the control and improvement of a
specific process.
PROCESS OWNER – the head of one of the key functions
involved in the actual operation of the process and is
responsible for ensuring that the process is understood,
documented, implemented, controlled, and improved.
9. DEFINITIONS
VERIFICATION – the confirmation that specified
requirements have been met
VALIDATION – confirmation through the provision of
objective evidence that the requirements for a specific
intended use or application have been fulfilled.
10. ISO 9000 QM System
Continuous Improvement of the QMS
Customers
Resource
Manageme
nt
Measurement,
Analysis and
Improvement
Management
Responsibility
Product
Realization
PRODUCT
OUTPUT
Requirements
INPUT
Customer
s
Satisfaction
11. Quality Management Style
Focus on the entire system
Customer is main concern
Communication at all levels
Continuous Improvement
Responsibility assigned
12. Why Implement a QMS?
Ensure Customer Satisfaction
Improve Quality System
Enhance Control of Resources
Improve Suppliers Performance
13. ISO 9000 Elements
• SCOPE covers why the standard is used
• APPLICATION states that the standard is generic and there can
be exclusions from section 7
• TERMS AND DEFINITIONS reference ISO 9000 and 9001
vocabulary
• General Requirements (Documentation requirements covered in
earlier training)
• Management Responsibility
15. General ( Documentation)
Covered in “Creating and Documenting a Quality Management
System”
Managers and supervisors most likely would write or participate in
writing documents:
◦ procedures
◦ forms
◦ work instructions
Managers and supervisors provide oversight of record creation,
preservation, and retention
17. Resource Management
(Human, Infrastructure and Environment)
Provision of Resources
Human Resources
◦ General
◦ Competence, Awareness, and Training
Infrastructure
Work Environment
18. Product Realization
Planning
Customer-Related Processes
Design and Development
Purchasing
Production and Service Provision
Control of Monitoring and Measuring Devices
19. Measurement, Analysis and Improvement
General
Monitoring and Measurement
Control of Nonconforming Product
Analysis of Data
Improvement
21. What are ISO 9000 Principles?
Fundamental beliefs that form the foundation of the ISO
requirements
Lead to quality excellence by following them
Are based on practical application
Can be applied at any level of the quality pyramid
◦ Quality Control (QC)
◦ Quality Management (QM)
◦ Total Quality Management (TQM)
22. ISO 9000 Principles
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually beneficial supplier relationship
23. ISO 9000 Principles
(1) Customer Focus
QC -- understand and meet basic requirements; little or no
knowledge of customer perceptions
QM – better understanding of overall requirements; customer
satisfaction tracked
TQM – customer information collected systematically
throughout the company; knowledge of customer perception;
ability to offer preferred products
24. (2) Leadership
QC – management provides resources sufficient for quality
control
QM – management establishes policy, objectives and
environment to control processes that ensure quality
TQM – managers provide personal examples that create
customer satisfaction; quality is a strategic issue
25. (3) Involvement of people
QC – people must create and operate basic process; does
not draw on full talents
QM – processes defined and personnel qualified; employees
contribute to improvement
TQM – employees fully engaged & entirely involved; high
level of communication between leaders and employees
26. (4) Process Approach
QC – inspection and testing are common; controlled
processes provide feedback
QM – movement from control of only process outputs to
control of the process itself ; additional processes such as
management review, corrective actions, etc.
TQM – optimizes resources, continually improves, uses
process measures
27. (5) System Approach to Management
QC – inspection and control systems work together but not
integrated with the rest of the organization
QM – moved to integrate the process for creating the product with
verification of the final product; focus on customer satisfaction
TQM – fully understands the interaction among the processes;
continually improves
28. (6) Continual Improvement
QC – focus on improvements to ensure that the customer does
not receive defective products
QM – focus on improving the effectiveness and efficiency of
the QMS; mature corrective/preventive loop
TQM – focus on efficiently meeting customer needs through
the QMS; leaders involved in improvement process
29. (7) Factual Approach to Decision Making
QC – uses data to distinguish nonconformities; statistical data
ensure requirements are met; little use of data to measure
trends
QM – facts and data used to make decisions regarding the
QMS; focus on improvement
TQM – analysis used to improve market position; information
gathered from all members of the organization
30. (8)Mutually Beneficial Supplier Relationship
QC – some validation of the suppliers product
QM – processes to define and document, review and evaluate; well
developed and defined validation process
TQM – focus changes with established strategic alliances or
partnerships; mutual commitment to customer satisfaction; focus on
continual improvement becomes common
