QMS - ISO9000 and TQM Flashcards
What does ‘Total’ refer to in Total Quality Management?
Made up of whole.
What is the definition of ‘Quality’ in Total Quality Management?
Degree of excellence a product or service provides.
What does ‘Management’ mean in the context of Total Quality Management?
Act, art or manner of planning, controlling, directing.
What is the primary focus of Total Quality Management (TQM)?
Systematic approach emphasizing continuous improvement, customer satisfaction, and process optimization.
What is the goal of TQM?
DO THE RIGHT THINGS RIGHT THE FIRST TIME, EVERY TIME.
List the two main objectives of TQM.
- Total client satisfaction through quality products and services
- Continuous improvements to processes, systems, people, suppliers, partners, products, and services.
What are the three aspects of TQM?
- Counting
- Customers
- Culture.
What does ‘Quality Control’ primarily focus on?
Inspecting and identifying defects in products.
What is the purpose of ‘Quality Assurance’?
Ensures processes are in place to prevent defects.
What was the contribution of Frederick W. Taylor to quality management?
Authored Principles of Scientific Management in 1911.
Who introduced the concept of ‘quality circles’?
Dr. K. Ishikawa.
What is the significance of the Pareto principle in TQM?
Highlights the most significant factors in a data set based on the 80/20 rule.
True or False: Employee involvement is a core principle of TQM.
True.
Fill in the blank: TQM emphasizes managing and improving _______ to achieve desired results efficiently.
organizational processes.
What are key benefits of implementing TQM?
- Improved product and service quality
- Increased customer satisfaction and loyalty
- Enhanced operational efficiency and reduced waste
- Higher employee morale and engagement
- Stronger market competitiveness
- Compliance with industry standards and regulations.
What are common challenges faced in implementing TQM?
RHDN
- Resistance to change
- High initial costs for training and process development
- Difficulty in maintaining consistency across departments
- Need for a cultural shift towards quality-driven thinking.
What is the role of effective communication in TQM?
Essential for fostering a culture of quality.
What is a Flow Chart in TQM?
Maps out processes to identify bottlenecks or inefficiencies.
What does a Control Chart do?
Monitors process performance over time to ensure stability and predictability.
What is the purpose of a Check Sheet?
Collects data in real-time for quick analysis and action.
What does the ‘DO’ phase in TQM implementation involve?
Develop detailed action plan and implement it systematically.
What is meant by ‘Fact-Based Decision Making’ in TQM?
Decisions should be based on data analysis rather than assumptions.
What is the significance of customer feedback mechanisms in TQM?
Collect and analyze customer input for continuous enhancement.
What does TQM aim to achieve for organizations?
Sustained success and competitive advantage.
A set of international standards for quality
management systems (QMS) developed by the International Organization for Standardization
(ISO)
ISO 9000
- Provides guidelines and principles for ensuring
product and service quality
ISO 9000
Why is ISO 9000 important?
-Helps organizations meet customer
expectations and regulatory requirements
-Improves efficiency, consistency, and customer
satisfaction
When was ISO 9000 introduced?
1987
Where did ISO 9000 developed/originate?
military and manufacturing sectors
The 1994 revision of ISO 9000 entailed what?
Introduction of preventive actions but remained compliance-driven.
The 2000 revision of the ISO 9000 entailed what?
Shift to process management
The 2008 Revision of the ISO 9000 entailed what?
focus on clarifications and consistency
The 2015 Revision of the ISO 9000 entailed what?
Integration of risk-based thinking, leadership emphasis, and continuous improvement
ISO 9000 SERIES OF STANDARDS
– Defines key principles, terms, and concepts of
quality management systems (QMS); serves as the
foundation for the series.
ISO 9000:2015
ISO 9000 SERIES OF STANDARDS
– The main standard, setting specific
requirements for certification; focuses on customer
satisfaction, process improvement, risk management, and
leadership.
ISO 9001:2015
ISO 9000 SERIES OF STANDARDS
-Guides organizations beyond compliance,
emphasizing long-term performance, sustainability, and
continuous improvement.
ISO 9004:2018
ISO 9000 SERIES OF STANDARDS
– Provides auditing guidelines for evaluating
quality systems and identifying areas for improvement.
ISO 19011:2018
The Most widely used standard in the ISO 9000 series
Follows PDCA Cycle
ISO 9001
Key Focus Areas of ISO 9001
- Leadership Commitment
-Process Approach
-Evidence-Based Decision- Making
- Risk-Based Thinking
Ensuring top management is actively involved in quality management
Leadership Commitment
Identifying and managing risks to prevent issues before they arise.
Risk-Based Thinking
Managing activities as interrelated processes for efficiency and
consistency.
Process Approach
Using data and analysis to guide decisions and improvements.
Evidence-Based Decision-Making
What are the 7 Quality Management Principles?
CLEPIER
-Customer Focus
-Leadership
-Engagement of People
-Process Approach
-Improvement
-Evidence-based Decision Making
-Relationship Management
7 QUALITY MANAGEMENT PRINCIPLES
Meet and exceed customer expectations
Customer Focus
7 QUALITY MANAGEMENT PRINCIPLES
Provide purpose, direction, and engagement
Leadership
7 QUALITY MANAGEMENT PRINCIPLES
Recognition, empowerment, and enhancement of skills and knowledge
Engagement of People
7 QUALITY MANAGEMENT PRINCIPLES
Understand processes to optimize performance
Process Approach
7 QUALITY MANAGEMENT PRINCIPLES
To maintain current performance and to create new opportunities
Improvement
7 QUALITY MANAGEMENT PRINCIPLES
Manage relationship with interested parties to optimize performance
Relationship Management
Benefits of ISO 9000
ICOCM
Improved Quality
Customer Satisfaction
Operational Efficiency
Compliance with Regulatory & Legal Requirements
Market Competitiveness
BENEFITS OF ISO 9000
Helps businesses identify inefficiencies and improve production
methods.
Improved Quality
BENEFITS OF ISO 9000
With a well-defined Quality Management System (QMS), businesses can meet or exceed customer expectations.
Builds trust and loyalty, as customers are more likely to return if they
receive consistent, high-quality service.
Customer Satisfaction
BENEFITS OF ISO 9000
Encourages a process-driven approach, meaning businesses optimize their workflows to eliminate unnecessary steps and reduce costs.
Operational Efficiency
BENEFITS OF ISO 9000
Helps businesses stay compliant with government regulations, industry
laws, and safety protocols.
Avoids penalties, lawsuits, or product recalls due to poor quality or safety
violations.
Compliance with Regulatory & Legal Requirements
BENEFITS OF ISO 9000
Having an ISO 9000-based QMS helps organizations differentiate
themselves by demonstrating commitment to quality.
Market Competitiveness
Steps to Achieve ISO 9001 Certification:
GPIICC
- Gap Analysis
- Planning & Documentation
- Implementation
- Internal Audit
- Certification Audit
- Continuous Improvement
assess current process vs ISO 9001
requirements
Gap Analysis
The organization reviews its existing processes, policies, and
procedures to determine where they align with ISO 9001
standards and where changes are needed.
Gap Analysis
The company creates or updates its Quality Management
System (QMS) to align with ISO 9001.
Includes documentation like process workflows, quality
control procedures, and employee responsibilities.
Planning and Documentation
Employees are trained on ISO 9001 principles and how to
follow the new quality management procedures.
Implementation
An internal team or hired auditors review the company’s QMS
to ensure it meets ISO 9001 standards.
Internal Audit
An independent ISO-accredited certification body (such as
SGS, TÜV, or BSI) conducts an official audit.
Certification Audit
Companies conduct annual audits and quality assessments
to ensure compliance and efficiency
Continuous Improvement
CHALLENGES IN IMPLEMENTING
ISO 9000
HRTCLD
High Implementation Costs
Resistant to Change
Time-Consuming Process
Complex Documentation
Lack of Management Commitment
Difficulties in Maintaining Certification
Core Principles of TQM
CEPISCFE
Customer Focus
Employee Involvement
Process Approach
Integrated System
Strategic & Systematic Approach
Continuous Improvement
Fact-Based Decision Making
Effective Communication
Understanding and meeting
customer needs is
paramount.
Customer Focus
TQM emphasizes managing and
improving organizational processes
to achieve desired results efficiently.
Process Approach
All employees are encouraged
to participate in quality
improvement initiatives.
Employee Involvement
An effective TQM system integrates all
organizational functions, ensuring that all departments work towards common quality goals.
Integrated System
Quality management should align with
the organization’s strategic objectives,
ensuring that quality initiatives support
overall business goals.
Strategic and Systematic Approach
Decisions should be based on data analysis rather than assumptions
Fact-Based Decision Making
Organizations must strive for ongoing
improvements through incremental changes and innovative solutions.
Continuous Improvement
Open communication
channels are essential for fostering a culture of quality.
Effective Communication
Implementation of TQM
Establish a Quality Policy
Set Quality Objectives
Employee Training and Engagement
Process Standardization and Documentation
Use of Quality Tools and Techniques
Monitoring and Evaluation
Customer Feedback Mechanisms
Implementing TQM can be divided into
four categories:
Plan-Do-Check-Act
Define and analyze a
problem and identify
the root cause.
Plan
Devise a solution.
Develop detailed
action.
Plan and implement it
systematically.
Do
Confirm outcomes
against plan.
Identify deviation and
issues.
Check
Standardize solution.
Review and define next
issues.
Act
7 Tools of TQM
FCHSPCC
Flow Chart
Check Sheet
Histogram
Scatter Diagram
Pareto Diagram
Control Chart
Cause-and-Effect Diagram
Maps out processes to
identify bottlenecks or
inefficiencies.
Flow Chart (Process Diagram)
Collects data in real-
time for quick analysis
and action.
Check Sheet
Visualizes the frequency distribution of data to identify
patterns and variations.
Histogram
Highlights the most significant factors in a data set based on the
Pareto principle (80/20 rule).
Pareto Diagram
Shows the relationship between two variables.
Scatter Diagram
Monitors process performance over time to ensure stability and
predictability.
Control Chart
Identifies potential root causes of problems by categorizing them into
different areas.
Cause & Effect Diagram
(Fishbone/Ishikawa Diagram)
