QMS - ISO9000 and TQM Flashcards

1
Q

What does ‘Total’ refer to in Total Quality Management?

A

Made up of whole.

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2
Q

What is the definition of ‘Quality’ in Total Quality Management?

A

Degree of excellence a product or service provides.

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3
Q

What does ‘Management’ mean in the context of Total Quality Management?

A

Act, art or manner of planning, controlling, directing.

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4
Q

What is the primary focus of Total Quality Management (TQM)?

A

Systematic approach emphasizing continuous improvement, customer satisfaction, and process optimization.

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5
Q

What is the goal of TQM?

A

DO THE RIGHT THINGS RIGHT THE FIRST TIME, EVERY TIME.

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6
Q

List the two main objectives of TQM.

A
  • Total client satisfaction through quality products and services
  • Continuous improvements to processes, systems, people, suppliers, partners, products, and services.
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7
Q

What are the three aspects of TQM?

A
  • Counting
  • Customers
  • Culture.
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8
Q

What does ‘Quality Control’ primarily focus on?

A

Inspecting and identifying defects in products.

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9
Q

What is the purpose of ‘Quality Assurance’?

A

Ensures processes are in place to prevent defects.

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10
Q

What was the contribution of Frederick W. Taylor to quality management?

A

Authored Principles of Scientific Management in 1911.

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11
Q

Who introduced the concept of ‘quality circles’?

A

Dr. K. Ishikawa.

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12
Q

What is the significance of the Pareto principle in TQM?

A

Highlights the most significant factors in a data set based on the 80/20 rule.

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13
Q

True or False: Employee involvement is a core principle of TQM.

A

True.

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14
Q

Fill in the blank: TQM emphasizes managing and improving _______ to achieve desired results efficiently.

A

organizational processes.

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15
Q

What are key benefits of implementing TQM?

A
  • 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.
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16
Q

What are common challenges faced in implementing TQM?
RHDN

A
  • 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.
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17
Q

What is the role of effective communication in TQM?

A

Essential for fostering a culture of quality.

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18
Q

What is a Flow Chart in TQM?

A

Maps out processes to identify bottlenecks or inefficiencies.

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19
Q

What does a Control Chart do?

A

Monitors process performance over time to ensure stability and predictability.

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20
Q

What is the purpose of a Check Sheet?

A

Collects data in real-time for quick analysis and action.

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21
Q

What does the ‘DO’ phase in TQM implementation involve?

A

Develop detailed action plan and implement it systematically.

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22
Q

What is meant by ‘Fact-Based Decision Making’ in TQM?

A

Decisions should be based on data analysis rather than assumptions.

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23
Q

What is the significance of customer feedback mechanisms in TQM?

A

Collect and analyze customer input for continuous enhancement.

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24
Q

What does TQM aim to achieve for organizations?

A

Sustained success and competitive advantage.

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25
A set of international standards for quality management systems (QMS) developed by the International Organization for Standardization (ISO)
ISO 9000
26
- Provides guidelines and principles for ensuring product and service quality
ISO 9000
27
Why is ISO 9000 important?
-Helps organizations meet customer expectations and regulatory requirements -Improves efficiency, consistency, and customer satisfaction
28
When was ISO 9000 introduced?
1987
29
Where did ISO 9000 developed/originate?
military and manufacturing sectors
30
The 1994 revision of ISO 9000 entailed what?
Introduction of preventive actions but remained compliance-driven.
31
The 2000 revision of the ISO 9000 entailed what?
Shift to process management
32
The 2008 Revision of the ISO 9000 entailed what?
focus on clarifications and consistency
33
The 2015 Revision of the ISO 9000 entailed what?
Integration of risk-based thinking, leadership emphasis, and continuous improvement
34
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
35
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
36
ISO 9000 SERIES OF STANDARDS -Guides organizations beyond compliance, emphasizing long-term performance, sustainability, and continuous improvement.
ISO 9004:2018
37
ISO 9000 SERIES OF STANDARDS – Provides auditing guidelines for evaluating quality systems and identifying areas for improvement.
ISO 19011:2018
38
The Most widely used standard in the ISO 9000 series Follows PDCA Cycle
ISO 9001
39
Key Focus Areas of ISO 9001
- Leadership Commitment -Process Approach -Evidence-Based Decision- Making - Risk-Based Thinking
40
Ensuring top management is actively involved in quality management
Leadership Commitment
41
Identifying and managing risks to prevent issues before they arise.
Risk-Based Thinking
42
Managing activities as interrelated processes for efficiency and consistency.
Process Approach
43
Using data and analysis to guide decisions and improvements.
Evidence-Based Decision-Making
44
What are the 7 Quality Management Principles? CLEPIER
-Customer Focus -Leadership -Engagement of People -Process Approach -Improvement -Evidence-based Decision Making -Relationship Management
45
7 QUALITY MANAGEMENT PRINCIPLES Meet and exceed customer expectations
Customer Focus
46
7 QUALITY MANAGEMENT PRINCIPLES Provide purpose, direction, and engagement
Leadership
47
7 QUALITY MANAGEMENT PRINCIPLES Recognition, empowerment, and enhancement of skills and knowledge
Engagement of People
48
7 QUALITY MANAGEMENT PRINCIPLES Understand processes to optimize performance
Process Approach
49
7 QUALITY MANAGEMENT PRINCIPLES To maintain current performance and to create new opportunities
Improvement
50
7 QUALITY MANAGEMENT PRINCIPLES Manage relationship with interested parties to optimize performance
Relationship Management
51
Benefits of ISO 9000 ICOCM
Improved Quality Customer Satisfaction Operational Efficiency Compliance with Regulatory & Legal Requirements Market Competitiveness
52
BENEFITS OF ISO 9000 Helps businesses identify inefficiencies and improve production methods.
Improved Quality
53
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
54
BENEFITS OF ISO 9000 Encourages a process-driven approach, meaning businesses optimize their workflows to eliminate unnecessary steps and reduce costs.
Operational Efficiency
55
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
56
BENEFITS OF ISO 9000 Having an ISO 9000-based QMS helps organizations differentiate themselves by demonstrating commitment to quality.
Market Competitiveness
57
Steps to Achieve ISO 9001 Certification: GPIICC
1. Gap Analysis 2. Planning & Documentation 3. Implementation 4. Internal Audit 5. Certification Audit 6. Continuous Improvement
58
assess current process vs ISO 9001 requirements
Gap Analysis
59
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
60
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
61
Employees are trained on ISO 9001 principles and how to follow the new quality management procedures.
Implementation
62
An internal team or hired auditors review the company’s QMS to ensure it meets ISO 9001 standards.
Internal Audit
63
An independent ISO-accredited certification body (such as SGS, TÜV, or BSI) conducts an official audit.
Certification Audit
64
Companies conduct annual audits and quality assessments to ensure compliance and efficiency
Continuous Improvement
65
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
66
Core Principles of TQM CEPISCFE
Customer Focus Employee Involvement Process Approach Integrated System Strategic & Systematic Approach Continuous Improvement Fact-Based Decision Making Effective Communication
67
Understanding and meeting customer needs is paramount.
Customer Focus
68
TQM emphasizes managing and improving organizational processes to achieve desired results efficiently.
Process Approach
69
All employees are encouraged to participate in quality improvement initiatives.
Employee Involvement
70
An effective TQM system integrates all organizational functions, ensuring that all departments work towards common quality goals.
Integrated System
71
Quality management should align with the organization's strategic objectives, ensuring that quality initiatives support overall business goals.
Strategic and Systematic Approach
72
Decisions should be based on data analysis rather than assumptions
Fact-Based Decision Making
73
Organizations must strive for ongoing improvements through incremental changes and innovative solutions.
Continuous Improvement
74
Open communication channels are essential for fostering a culture of quality.
Effective Communication
75
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
76
Implementing TQM can be divided into four categories:
Plan-Do-Check-Act
77
Define and analyze a problem and identify the root cause.
Plan
78
Devise a solution. Develop detailed action. Plan and implement it systematically.
Do
79
Confirm outcomes against plan. Identify deviation and issues.
Check
80
Standardize solution. Review and define next issues.
Act
81
7 Tools of TQM FCHSPCC
Flow Chart Check Sheet Histogram Scatter Diagram Pareto Diagram Control Chart Cause-and-Effect Diagram
82
Maps out processes to identify bottlenecks or inefficiencies.
Flow Chart (Process Diagram)
83
Collects data in real- time for quick analysis and action.
Check Sheet
84
Visualizes the frequency distribution of data to identify patterns and variations.
Histogram
85
Highlights the most significant factors in a data set based on the Pareto principle (80/20 rule).
Pareto Diagram
86
Shows the relationship between two variables.
Scatter Diagram
87
Monitors process performance over time to ensure stability and predictability.
Control Chart
88
Identifies potential root causes of problems by categorizing them into different areas.
Cause & Effect Diagram (Fishbone/Ishikawa Diagram)