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TQM Lecture Notes Unit 5

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0% found this document useful (0 votes)
48 views

TQM Lecture Notes Unit 5

Uploaded by

samyaravind53
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 37
No 5 No
Topic Introduction-Benefits of ISO Registration
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Explain the benefits of ISO registration for organizational
LO1 Understand (K2)
efficiency and customer satisfaction.
Compare and contrast the impact of ISO registration on
LO2 Understand (K2)
different aspects of business performance.
Introduction to ISO Registration
1. Overview of ISO: The International Organization for Standardization (ISO) is an
independent, non-governmental international organization that develops and publishes
standards. ISO standards cover a broad range of industries and sectors, providing frameworks
and guidelines to ensure quality, safety, efficiency, and interoperability.
2. What is ISO Registration? ISO registration refers to the process of a company or
organization obtaining certification from a recognized certification body to demonstrate
compliance with specific ISO standards. The certification indicates that the organization’s
management systems, processes, and practices meet the requirements outlined by the ISO
standard.
3. Common ISO Standards:
 ISO 9001: Quality Management Systems
 ISO 14001: Environmental Management Systems
 ISO 45001: Occupational Health and Safety Management Systems
 ISO 27001: Information Security Management Systems
4. The Certification Process:
 Preparation: Understand the requirements of the relevant ISO standard and assess
current practices.
 Implementation: Develop and implement processes and procedures to meet the ISO
standard requirements.
 Internal Audit: Conduct internal audits to ensure compliance and identify areas for
improvement.

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GE3752 Total Quality Management

 Certification Audit: A third-party auditor reviews the organization's processes and


practices to ensure they meet the standard.
 Certification: Upon successful audit, the organization is awarded ISO certification.
 Surveillance: Regular audits are conducted to ensure ongoing compliance.
Benefits of ISO Registration
1. Improved Quality Management:
 Consistency: ISO standards provide a structured approach to quality management,
ensuring consistent product or service quality.
 Customer Satisfaction: By adhering to ISO standards, organizations can improve their
processes, leading to increased customer satisfaction.
2. Enhanced Operational Efficiency:
 Streamlined Processes: ISO registration helps in streamlining processes and reducing
inefficiencies.
 Cost Reduction: Improved processes can lead to cost savings by minimizing waste and
optimizing resource use.
3. Market Advantage:
 Competitive Edge: ISO certification can enhance an organization's credibility and
reputation, providing a competitive advantage in the market.
 Market Access: Some industries or clients may require ISO certification as a
prerequisite for business.
4. Regulatory Compliance:
 Legal Requirements: ISO standards often help organizations meet legal and regulatory
requirements, reducing the risk of non-compliance.
5. Risk Management:
 Identifying Risks: ISO standards encourage organizations to identify and manage risks
systematically.
 Mitigation: Implementing ISO standards can help mitigate potential risks and improve
overall business resilience.
6. Employee Engagement:
 Motivation: ISO registration can boost employee morale by providing clear processes
and standards.
 Training and Development: Employees receive training and development
opportunities, improving their skills and job satisfaction.

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GE3752 Total Quality Management

7. Continual Improvement:
 Benchmarking: ISO standards promote a culture of continuous improvement by
encouraging regular reviews and updates to processes.
 Feedback: Organizations can use feedback from audits and customer reviews to make
ongoing improvements.
8. Customer Trust and Satisfaction:
 Quality Assurance: ISO certification reassures customers that the organization meets
high standards of quality and reliability.
 Customer Loyalty: Improved quality and service can lead to higher customer loyalty
and repeat business.
9. International Recognition:
 Global Standards: ISO certification is recognized internationally, facilitating global
trade and collaboration.
 Consistency Across Borders: Organizations with ISO certification can ensure
consistent quality and practices across different locations.
Assessment questions to the lecture
Bloom’s
Qn No Question Answer Knowledge
Level
1 What is the main purpose of ISO registration? B Remembering
A) To enhance marketing strategies
B) To demonstrate compliance with ISO standards
C) To improve employee satisfaction
D) To reduce operational costs
2 Which ISO standard is specifically focused on quality D Remembering
management systems?
A) ISO 27001
B) ISO 45001
C) ISO 14001
D) ISO 9001
3 Which benefit of ISO registration is related to reducing B Remembering
operational inefficiencies?
A) Improved Customer Satisfaction

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GE3752 Total Quality Management

B) Enhanced Operational Efficiency


C) Increased Market Access
D) Better Risk Management
4 How does ISO certification impact international trade? B Remembering
A) It complicates international trade agreements.
B) It provides global recognition and facilitates trade.
C) It restricts access to international markets.
D) It requires additional documentation for trade.

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 Explain the significance of ISO 9001 in quality 2 CO5 Understanding
management systems.
2 List two benefits of ISO registration related to 2 CO5 Understanding
customer trust and operational efficiency.
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

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GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 38
No 5 No
Topic ISO 9000 Series of Standards
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Describe the key principles and requirements of the ISO 9000
LO1 Understand (K2)
series of standards.
Compare and contrast the ISO 9000 series with other quality
LO2 Understand (K2)
management standards.
Introduction to ISO 9000 Series
The ISO 9000 series of standards is a family of quality management standards designed to help
organizations ensure that they meet the needs of customers and other stakeholders while
complying with statutory and regulatory requirements related to a product or service. The
standards are published by the International Organization for Standardization (ISO), a
worldwide federation of national standards bodies.
The ISO 9000 series is based on seven quality management principles that provide a framework
for improving organizational performance. These principles are:
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-Based Decision Making
7. Relationship Management
Evolution and History of ISO 9000 Series
The ISO 9000 series was first published in 1987 and has undergone several revisions, with the
most recent versions being:
 ISO 9000:2015 - Quality management systems — Fundamentals and vocabulary
 ISO 9001:2015 - Quality management systems — Requirements
 ISO 9004:2018 - Quality management — Quality of an organization — Guidance to
achieve sustained success
 ISO 19011:2018 - Guidelines for auditing management systems

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GE3752 Total Quality Management

These standards provide guidance on quality management principles, define the terminology,
establish requirements for a Quality Management System (QMS), and outline best practices
for auditing.
Key Standards in the ISO 9000 Series
1. ISO 9000:2015 - Fundamentals and Vocabulary:
o This standard describes the fundamental concepts and principles of quality
management which form the basis for the ISO 9000 family of standards. It also
defines terms used in the series, helping to ensure a common understanding
among stakeholders.
2. ISO 9001:2015 - Quality Management System Requirements:
o ISO 9001 is the most well-known and widely used standard in the ISO 9000
series. It sets out the criteria for a Quality Management System (QMS) and is
the only standard in the family that can be certified. Organizations that
implement ISO 9001 must demonstrate their ability to consistently provide
products and services that meet customer and regulatory requirements and focus
on continuous improvement.
3. ISO 9004:2018 - Quality of an Organization - Guidance to Achieve Sustained
Success:
o This standard provides guidance to organizations on how to achieve sustained
success through a quality management approach. It is based on the quality
management principles described in ISO 9000 and focuses on managing for the
long term, considering the needs and expectations of all interested parties.
4. ISO 19011:2018 - Guidelines for Auditing Management Systems:
o This standard provides guidance on auditing management systems, including
the principles of auditing, managing an audit program, and conducting quality
management system audits as well as environmental management system
audits.
Benefits of Implementing the ISO 9000 Series
1. Improved Customer Satisfaction:
o By ensuring that organizations provide products and services that consistently
meet customer requirements, the ISO 9001 standard helps increase customer
satisfaction.
2. Enhanced Process Integration:

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GE3752 Total Quality Management

o The process approach of ISO 9001 integrates and aligns processes to achieve
better consistency and quality, leading to more efficient use of resources and
enhanced business performance.
3. Increased Market Opportunities:
o ISO 9001 certification is recognized worldwide and can improve an
organization's reputation and open doors to new markets.
4. Evidence-Based Decision Making:
o ISO 9001 promotes decision-making based on data and evidence, reducing risks
and improving efficiency.
5. Continuous Improvement:
o The standard encourages a culture of continuous improvement, which can lead
to better performance and sustainability over time.
6. Better Supplier Relationships:
o ISO 9001 encourages relationship management with suppliers, which can lead
to more effective partnerships and supply chain management.
ISO 9001:2015 - Key Requirements
ISO 9001:2015 specifies requirements for a QMS and is applicable to any organization,
regardless of size or industry. Some key requirements include:
1. Context of the Organization:
o Understanding the organization and its context, and determining the scope of
the QMS.
2. Leadership:
o Top management must demonstrate leadership and commitment to the QMS,
establish a quality policy, and assign relevant responsibilities and authorities.
3. Planning:
o Address risks and opportunities, define quality objectives, and plan for changes.
4. Support:
o Manage resources, competence, awareness, communication, and documented
information.
5. Operation:
o Plan, implement, and control processes required to meet quality requirements.
6. Performance Evaluation:
o Monitor, measure, analyze, and evaluate QMS performance, and conduct
internal audits and management reviews.

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GE3752 Total Quality Management

7. Improvement:
o Identify and take action on nonconformities and implement continual
improvement processes.

Assessment questions to the lecture

Bloom’s
Qn No Question Answer Knowledge
Level
1 Which standard in the ISO 9000 series provides D Remembering
guidelines for auditing management systems?
a) ISO 9001:2015
b) ISO 9000:2015
c) ISO 9004:2018
d) ISO 19011:2018
2 What is the primary focus of ISO 9001:2015? B Remembering
a) Vocabulary and definitions for quality management
b) Requirements for a Quality Management System
c) Guidelines for environmental management
d) Sustained success of an organization
3 Which principle is NOT part of the seven quality C Remembering
management principles of ISO 9000?
a) Customer Focus
b) Leadership
c) Cost Reduction
d) Evidence-Based Decision Making
4 Which of the following is NOT a benefit of implementing C Remembering
ISO 9001:2015?
a) Improved customer satisfaction
b) Enhanced process integration
c) Increased product variety
d) Better supplier relationships

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GE3752 Total Quality Management

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 Explain the role of ISO 9004:2018 in the ISO 2 CO5 Understanding
9000 series.
2 List any three key requirements of ISO 9001:2015 2 CO5 Understanding
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

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GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 39
No 5 No
Topic Sector-Specific Standards-AS 9100
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Explain the key requirements and principles of AS 9100 for
LO1 Understand (K2)
aerospace industry standards.
Explain the effectiveness of AS 9100 in improving quality
LO2 Understand (K2)
management systems in aerospace organizations.
Introduction to AS 9100
AS 9100 is an international quality management standard specifically developed for the
aerospace industry. It integrates the requirements of ISO 9001 and adds additional requirements
that are critical for the aerospace sector. The AS 9100 standard ensures that organizations in
the aerospace industry can consistently deliver products that meet customer and regulatory
requirements while continuously improving their processes and systems.
Evolution and Background of AS 9100
AS 9100 was first released in 1999 by the Society of Automotive Engineers (SAE) and the
European Association of Aerospace Industries. The standard has undergone multiple revisions,
with the latest being AS 9100 Rev D (also known as AS 9100:2016), which aligns with ISO
9001:2015. The need for AS 9100 arose due to the highly regulated nature of the aerospace
sector, which demands stringent quality control and risk management to ensure product safety
and reliability.
Key Features and Requirements of AS 9100
AS 9100 builds upon ISO 9001 by adding specific requirements relevant to aerospace quality
management. Key features include:
1. Risk Management: The standard emphasizes risk management by requiring
organizations to identify, assess, and mitigate risks associated with aerospace products
and processes. This includes preventive action plans and risk-based thinking throughout
the entire quality management system.
2. Product Safety: AS 9100 places special emphasis on product safety by requiring
organizations to establish, implement, and maintain processes to manage product safety

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GE3752 Total Quality Management

throughout the product life cycle. This includes design, production, and post-delivery
support.
3. Counterfeit Parts Prevention: The standard includes specific requirements to prevent
the use of counterfeit or suspected unapproved parts. This ensures the authenticity of
all aerospace components and materials, thus maintaining safety and integrity.
4. Configuration Management: Aerospace products often require a high level of
configuration management. AS 9100 mandates that organizations maintain the integrity
of product configuration throughout its life cycle to ensure that each product variant
meets specific design requirements.
5. Human Factors: The standard incorporates human factors into the design,
development, and implementation of quality management systems. It recognizes that
human errors can affect product quality and safety, and it requires organizations to
establish processes to minimize these errors.
6. Documentation and Records Control: The standard emphasizes the importance of
documentation and control of records. Organizations are required to maintain accurate
records that demonstrate conformity to requirements and the effective operation of the
quality management system.
7. Supplier Management: The standard has stringent requirements for supplier selection,
monitoring, and performance evaluation. This ensures that the entire supply chain meets
the required quality standards, which is critical for aerospace products.
Benefits of AS 9100 Certification
1. Improved Product Quality and Safety: AS 9100 certification ensures that an
organization’s quality management system is optimized for aerospace product safety
and reliability.
2. Regulatory Compliance: Organizations that implement AS 9100 standards are better
equipped to meet regulatory requirements, thus avoiding legal issues and penalties.
3. Enhanced Customer Satisfaction: The standard ensures that customer needs and
expectations are met or exceeded, leading to higher customer satisfaction and loyalty.
4. Access to Global Aerospace Market: AS 9100 certification is recognized globally,
making it easier for certified companies to operate and compete in international
markets.
5. Continuous Improvement: The standard promotes a culture of continuous
improvement by requiring regular audits, reviews, and corrective actions, thereby
driving long-term organizational growth.

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GE3752 Total Quality Management

Implementation of AS 9100 in Aerospace Organizations


Implementing AS 9100 involves several steps:
1. Gap Analysis: Conduct a gap analysis to understand the difference between current
practices and AS 9100 requirements.
2. Training and Awareness: Provide training to employees on AS 9100 requirements
and their role in achieving certification.
3. Documentation: Develop or update documentation, including procedures, work
instructions, and quality manuals, to comply with AS 9100.
4. Internal Audits: Conduct internal audits to identify areas of non-conformance and
implement corrective actions.
5. Management Review: Top management should review the quality management
system's effectiveness and ensure resources are available for improvement.
6. Certification Audit: Engage an accredited certification body to perform the
certification audit. If successful, the organization will receive AS 9100 certification.
Challenges in Implementing AS 9100
1. Resource Constraints: Smaller organizations may face challenges due to limited
resources for implementing the standard.
2. Change Management: Adapting to new requirements can be difficult, especially in
organizations with established processes.
3. Continuous Monitoring: Regular audits and monitoring are needed to maintain
certification, which can be time-consuming and costly.
Assessment questions to the lecture
Bloom’s
Qn No Question Answer Knowledge
Level
1 What is the main purpose of AS 9100 in the aerospace B Remembering
industry?
A) Reduce costs in production
B) Ensure product safety and quality
C) Increase sales volume
D) Develop new aerospace products
2 Which of the following is a unique requirement of AS C Remembering
9100 that is not present in ISO 9001?

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GE3752 Total Quality Management

A) Documentation and Records Control


B) Risk-Based Thinking
C) Counterfeit Parts Prevention
D) Customer Satisfaction
3 What does AS 9100 emphasize through its requirements B Remembering
for product safety?
A) Improving manufacturing speed
B) Implementing preventive actions throughout the
product life cycle
C) Reducing the number of suppliers
D) Lowering production costs
4 What is a major benefit of AS 9100 certification for C Remembering
aerospace organizations?
A) Ability to use uncertified suppliers
B) Elimination of all quality management processes
C) Improved access to global aerospace markets
D) Increased product pricing

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 Explain the importance of counterfeit parts 2 CO5 Understanding
prevention as required by AS 9100.
2 Describe how risk management is integrated into 2 CO5 Understanding
the AS 9100 standard.
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

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GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 40
No 5 No
Topic Sector-Specific Standards- TS16949 and TL 9000
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Explain specific standards TS16949 and TL 9000 to identify
LO1 Understand (K2)
their key requirements and differences.
Explain the impact of TS16949 and TL 9000 standards on
LO2 Understand (K2)
quality management systems in the respective sectors.
Introduction to Sector-Specific Standards
Sector-specific standards are quality management standards that have been developed to meet
the unique needs of specific industries. These standards build upon the general principles of
ISO 9001 but are tailored to address the particular requirements and challenges of various
sectors. Two prominent sector-specific standards are ISO/TS 16949 and TL 9000.
1. ISO/TS 16949: Automotive Industry Standard
ISO/TS 16949 is a technical specification for quality management systems specifically
designed for the automotive sector. It is based on the ISO 9001 standard but incorporates
additional automotive industry-specific requirements. Developed by the International
Automotive Task Force (IATF) in collaboration with ISO, it harmonizes the various quality
system requirements of different car manufacturers and simplifies the supply chain
requirements for the automotive industry.
 History and Evolution:
o Initially published in 1999 as a technical specification.
o The latest revision was replaced by IATF 16949:2016, which aligns with ISO
9001:2015.
 Key Objectives:
o To establish a common automotive industry quality system.
o To reduce variations and waste in the automotive supply chain.
o To provide a framework for continual improvement, defect prevention, and
reduction of variation and waste.

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GE3752 Total Quality Management

 Scope:
o Applies to all organizations involved in the production of automotive
components, assemblies, and services.
o Encompasses entire supply chains, from raw material suppliers to Tier 1 and
Tier 2 suppliers to Original Equipment Manufacturers (OEMs).
 Key Requirements:
o Process Approach: Emphasizes the importance of managing processes and the
interrelationships between them.
o Customer-Specific Requirements (CSRs): Companies must meet specific
requirements set by their automotive customers in addition to the general
standard requirements.
o Product Safety: Addresses product safety requirements throughout the entire
lifecycle, including design, production, and delivery.
o Contingency Planning: Requires organizations to have plans to address
potential interruptions in the supply chain.
o Continual Improvement: Promotes the use of Plan-Do-Check-Act (PDCA)
cycles for process improvement.
 Benefits:
o Improved product quality and reduced defects.
o Increased customer satisfaction through consistent compliance with customer-
specific requirements.
o Enhanced global supply chain efficiency by standardizing requirements.
2. TL 9000: Telecommunications Industry Standard
TL 9000 is a quality management system standard developed specifically for the
telecommunications industry. It was created by the QuEST (Quality Excellence for Suppliers
of Telecommunications) Forum to address the unique requirements of the telecommunications
industry supply chain, including service providers and equipment manufacturers.
 History and Development:
o First published in 1999.
o Regularly updated to align with changes in ISO 9001 and to address evolving
telecommunications industry needs.
 Key Objectives:
o To establish and maintain a common set of quality system requirements and
metrics for the telecommunications industry.

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GE3752 Total Quality Management

o To foster continual improvement and cost reduction throughout the supply


chain.
o To enhance the performance and reliability of telecommunications products and
services.
 Scope:
o Encompasses hardware, software, and service organizations in the
telecommunications industry.
o Covers product development, production, installation, and service.
 Key Components:
o Requirements Handbook: Specifies the quality management system
requirements based on ISO 9001 with additional telecom-specific requirements.
o Metrics Handbook: Defines performance-based metrics to measure the quality
and reliability of products and services.
o Performance Metrics: Includes measurements for product reliability, software
defects, on-time delivery, service interruptions, and customer satisfaction.
 Key Requirements:
o Product Lifecycle Requirements: Covers all stages of the product lifecycle,
from design to decommissioning.
o Software Quality: Emphasizes the need for software quality in both
development and maintenance phases.
o Service Quality: Focuses on performance metrics that track service outages,
network downtime, and response times.
o Performance Benchmarking: Provides a framework for benchmarking
performance against industry peers.
 Benefits:
o Improved product and service quality with reduced defects and downtime.
o Better alignment of quality management practices with industry-specific needs.
o Enhanced customer satisfaction and loyalty by providing reliable products and
services.
o Reduced costs due to improved processes and reduced rework or scrap.
3. Comparison Between TS 16949 and TL 9000
 Commonalities:
o Both are sector-specific derivatives of ISO 9001.

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GE3752 Total Quality Management

o Both focus on customer satisfaction, continual improvement, and defect


prevention.
o Both require comprehensive documentation and adherence to strict quality
management principles.
 Differences:
o Industry Focus: TS 16949 is tailored for automotive manufacturing, while TL
9000 is specific to telecommunications.
o Unique Requirements: TS 16949 includes requirements for automotive
product safety and CSR; TL 9000 includes telecom-specific metrics and
software quality requirements.
o Performance Metrics: TL 9000 includes a detailed metrics handbook for
benchmarking against peers, while TS 16949 focuses more on process control
and defect reduction.
Assessment questions to the lecture

Bloom’s
Qn No Question Answer Knowledge
Level
1 What is the main objective of ISO/TS 16949? B Remembering
A. To provide a common set of quality requirements for
the telecommunications industry
B. To establish a common automotive industry quality
system
C. To develop software quality standards for all industries
D. To measure and benchmark performance in service
industries
2 What is a unique feature of the TL 9000 standard C Remembering
compared to ISO 9001?
A. Emphasis on product safety
B. Requirement for customer-specific requirements
C. Telecom-specific metrics for performance
measurement
D. Contingency planning for supply chain disruptions

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GE3752 Total Quality Management

3 Which organization developed the TL 9000 standard? C Remembering


A. International Automotive Task Force (IATF)
B. International Organization for Standardization (ISO)
C. QuEST Forum
D. Automotive Industry Action Group (AIAG)
4 What does ISO/TS 16949 emphasize to ensure quality in C Remembering
automotive production?
A. Software quality management
B. Supplier selection criteria
C. Process approach and customer-specific requirements
D. Product lifecycle decommissioning requirements

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 Explain the significance of performance metrics 2 CO5 Understanding
in the TL 9000 standard.
2 How does ISO/TS 16949 help in reducing 2 CO5 Understanding
variations and waste in the automotive supply
chain?
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

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GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 41
No 5 No
Topic ISO 9001 Requirements
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Explain the core principles and requirements of ISO 9001
LO1 Understand (K2)
standards.
Distinguish between the key elements of ISO 9001 and their
LO2 Understand (K2)
impact on quality management systems.
Introduction to ISO 9001
ISO 9001 is an international standard that specifies the requirements for a Quality Management
System (QMS). Organizations use ISO 9001 to demonstrate their ability to consistently provide
products and services that meet customer and regulatory requirements and to enhance customer
satisfaction through the effective application of the system. The latest version of the standard
is ISO 9001:2015.
Structure of ISO 9001:2015
ISO 9001:2015 is organized into 10 clauses, where clauses 4 to 10 outline the mandatory
requirements for organizations. The standard follows the High-Level Structure (HLS), which
aligns with other ISO management system standards, providing a uniform framework for easier
integration.
Key Requirements of ISO 9001:2015
1. Clause 4: Context of the Organization
o Understanding the Organization and Its Context: Organizations need to
determine external and internal issues that are relevant to their purpose and that
affect their ability to achieve the intended outcomes of the QMS.
o Understanding the Needs and Expectations of Interested Parties:
Identifying and understanding the needs and expectations of stakeholders (e.g.,
customers, suppliers, employees, regulators) that may affect the QMS.
o Determining the Scope of the QMS: The organization must define the
boundaries and applicability of the QMS. The scope should consider the
external and internal issues, requirements of interested parties, and the products
and services of the organization.

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GE3752 Total Quality Management

o Quality Management System and Its Processes: The organization must


establish, implement, maintain, and continually improve the QMS, including
the needed processes, interactions, and their sequences.
2. Clause 5: Leadership
o Leadership and Commitment: Top management must demonstrate leadership
and commitment to the QMS by taking accountability for its effectiveness,
providing necessary resources, and promoting continual improvement.
o Quality Policy: The organization must establish a quality policy that is
appropriate to its purpose, provides a framework for setting quality objectives,
and commits to fulfilling applicable requirements and continual improvement.
o Organizational Roles, Responsibilities, and Authorities: The responsibilities
and authorities for relevant roles within the QMS must be assigned,
communicated, and understood throughout the organization.
3. Clause 6: Planning
o Actions to Address Risks and Opportunities: Organizations must plan
actions to address risks and opportunities that could affect the QMS's ability to
achieve its intended results. This includes assessing potential risks and
implementing strategies to mitigate them.
o Quality Objectives and Planning to Achieve Them: The organization must
establish quality objectives that are measurable, consistent with the quality
policy, and relevant to product conformity and customer satisfaction.
o Planning of Changes: When planning changes to the QMS, organizations must
consider the purpose of the changes and their potential impact on the QMS.
4. Clause 7: Support
o Resources: The organization must determine and provide necessary resources
(human, infrastructure, environment, and monitoring resources) for the
establishment, implementation, maintenance, and continual improvement of the
QMS.
o Competence: Ensuring that personnel performing work affecting the QMS are
competent based on education, training, or experience.
o Awareness: All employees should be aware of the quality policy, their role in
the QMS, and the benefits of improved performance.

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GE3752 Total Quality Management

o Communication: The organization must determine internal and external


communications relevant to the QMS, including what, when, and with whom to
communicate.
o Documented Information: The organization must control the creation,
updating, and control of documented information required by the QMS.
5. Clause 8: Operation
o Operational Planning and Control: Organizations must plan, implement, and
control processes needed to meet requirements for the provision of products and
services, including determining the criteria for processes, resources, and
documented information.
o Requirements for Products and Services: Determination of customer
requirements and regulatory requirements, and ensuring communication with
customers.
o Design and Development: Where applicable, organizations must establish,
implement, and maintain a design and development process.
o Control of Externally Provided Processes, Products, and Services: Ensuring
that externally provided processes, products, and services conform to
requirements.
o Production and Service Provision: Control of production and service
provision to ensure conformance with specifications.
o Release of Products and Services: Establishing criteria for verifying that
products and services meet requirements before delivery.
o Control of Nonconforming Outputs: Organizations must have processes in
place to ensure that nonconforming outputs are identified, controlled, and
corrected.
6. Clause 9: Performance Evaluation
o Monitoring, Measurement, Analysis, and Evaluation: Organizations must
determine what needs to be monitored and measured, methods to be used, and
when monitoring and measuring shall be performed.
o Internal Audit: Organizations must conduct internal audits at planned intervals
to provide information on whether the QMS conforms to the organization’s
requirements and the standard.

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GE3752 Total Quality Management

o Management Review: Top management must review the QMS at planned


intervals to ensure its continuing suitability, adequacy, effectiveness, and
alignment with strategic direction.
7. Clause 10: Improvement
o General: Organizations must determine and select opportunities for
improvement and implement necessary actions to meet customer requirements
and enhance customer satisfaction.
o Nonconformity and Corrective Action: Organizations must address
nonconformities by taking appropriate actions to control, correct, and deal with
the consequences.
o Continual Improvement: Organizations must continually improve the
suitability, adequacy, and effectiveness of the QMS.
Assessment questions to the lecture
Bloom’s
Qn No Question Answer Knowledge
Level
1 Which clause of ISO 9001:2015 focuses on understanding C Remembering
the context of the organization?
A) Clause 5: Leadership
B) Clause 6: Planning
C) Clause 4: Context of the Organization
D) Clause 9: Performance Evaluation
2 What is required by Clause 7 of ISO 9001:2015? D Remembering
A) Design and Development
B) Leadership and Commitment
C) Actions to Address Risks and Opportunities
D) Provision of Resources and Competence
3 What is the purpose of the Management Review in Clause B Remembering
9 of ISO 9001:2015?
A) To review customer complaints
B) To ensure the QMS's alignment with strategic direction
C) To create a quality policy
D) To plan the design and development process

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 22 of 41


GE3752 Total Quality Management

4 Which clause deals with controlling nonconforming A Remembering


outputs?
A) Clause 8: Operation
B) Clause 5: Leadership
C) Clause 10: Improvement
D) Clause 6: Planning

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 Explain the significance of Clause 6: Planning in 2 CO5 Understanding
ISO 9001:2015.
2 What are the key elements of Clause 7: Support in 2 CO5 Understanding
ISO 9001:2015?
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 23 of 41


GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 42
No 5 No
Topic Implementation-Documentation Internal Audits
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Explain and differentiate between various documentation
LO1 Understand (K2)
requirements for internal audits.
Explain the effectiveness of different internal audit
LO2 Understand (K2)
documentation practices.

Introduction:
Internal audits are a critical component of any quality management system (QMS), especially
in organizations adhering to ISO standards. Internal audits help verify the effectiveness and
compliance of the QMS with the defined requirements, policies, procedures, and objectives.
The implementation and documentation of internal audits are vital to ensuring continuous
improvement and maintaining the effectiveness of the QMS.
1. Understanding Internal Audits:
Internal audits are systematic, independent, and documented processes for obtaining audit
evidence and evaluating it objectively to determine the extent to which audit criteria are
fulfilled. The primary purpose of internal audits is to assess the conformity of the QMS to ISO
standards and other organizational requirements. Internal audits help identify non-
conformities, potential risks, and opportunities for improvement.
2. Importance of Internal Audits:
 Ensuring Compliance: Internal audits ensure compliance with ISO standards,
organizational policies, regulatory requirements, and customer expectations.
 Identifying Non-Conformities: They help in identifying non-conformities, gaps, and
deviations from defined processes, which can lead to potential risks if left unaddressed.
 Promoting Continuous Improvement: Audits encourage a culture of continuous
improvement by highlighting areas for enhancement and recognizing good practices.
 Risk Management: Internal audits help organizations manage risks effectively by
identifying vulnerabilities and ensuring that corrective actions are implemented.
3. Phases of Internal Audit Implementation:

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GE3752 Total Quality Management

The internal audit process generally involves three key phases:


 Planning: This phase involves defining the audit scope, objectives, and criteria. It
includes preparing an audit schedule, selecting the audit team, and developing an audit
plan. The audit plan must align with the organization's goals and cover all areas of the
QMS.
 Execution: During this phase, auditors collect and verify evidence by conducting
interviews, reviewing documents, and observing processes. Auditors should be
impartial and objective, following the audit plan and checklist. The findings are then
categorized into conformities, non-conformities, observations, and opportunities for
improvement.
 Reporting and Follow-Up: In this phase, audit findings are documented in an audit
report, which includes a summary of the audit, details of non-conformities, and
corrective actions required. The follow-up process ensures that corrective actions are
implemented and verified to prevent recurrence.
4. Documentation of Internal Audits:
Proper documentation is crucial for the effectiveness of internal audits. The documentation
process includes the following key elements:
 Audit Plan and Schedule: The audit plan outlines the audit's scope, objectives, and
criteria, while the schedule specifies the timing and frequency of audits. Both
documents should be approved by top management and made available to relevant
stakeholders.
 Audit Checklist: An audit checklist is a tool that helps auditors systematically evaluate
processes against audit criteria. It provides a standardized format for recording findings,
observations, and evidence.
 Audit Findings Report: The findings report is a detailed document that includes a
summary of the audit, non-conformities identified, corrective actions required, and
timelines for closure. It should be communicated to relevant stakeholders for review
and action.
 Corrective Action Records: These records document the corrective actions taken to
address non-conformities and prevent recurrence. They should be reviewed and
approved by the relevant authorities to ensure effectiveness.
 Audit Records: Audit records include all documents, reports, checklists, and evidence
collected during the audit. These records serve as a reference for future audits and are
essential for demonstrating compliance during external audits.

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 25 of 41


GE3752 Total Quality Management

5. Conducting Internal Audits: Roles and Responsibilities:


 Lead Auditor: The lead auditor is responsible for planning the audit, coordinating with
the audit team, conducting opening and closing meetings, and preparing the final audit
report.
 Audit Team Members: Team members assist in collecting evidence, conducting
interviews, and evaluating processes. They provide inputs to the lead auditor and help
in preparing the findings report.
 Process Owners: Process owners are responsible for providing access to documents,
records, and facilities. They are also responsible for implementing corrective actions
and ensuring compliance.
6. Internal Audit Best Practices:
 Independence and Objectivity: Auditors should be independent of the processes they
audit to ensure unbiased assessments.
 Competence: Auditors should be trained and qualified, with a good understanding of
the audit process, standards, and organizational processes.
 Effective Communication: Clear communication is vital during audits to ensure that
findings are understood, and corrective actions are agreed upon.
 Continuous Improvement: Regular reviews and updates of the audit process help in
maintaining its effectiveness and relevance.
Assessment questions to the lecture
Bloom’s
Qn No Question Answer Knowledge
Level
1 What is the primary purpose of internal audits in a Quality C Remembering
Management System (QMS)?
a) To punish employees
b) To ensure customer satisfaction
c) To verify compliance and identify non-conformities
d) To create new policies
2 Which phase of internal audit involves defining the audit B Remembering
scope, objectives, and criteria?
a) Execution
b) Planning

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 26 of 41


GE3752 Total Quality Management

c) Reporting
d) Follow-up
3 What document is used by auditors to systematically C Remembering
evaluate processes against audit criteria?
a) Audit Schedule
b) Audit Plan
c) Audit Checklist
d) Corrective Action Record
4 Who is responsible for implementing corrective actions B Remembering
after an internal audit?
a) Lead Auditor
b) Process Owners
c) Top Management
d) External Auditors

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 What are the key components of documentation 2 CO5 Understanding
required for internal audits?
2 Explain the importance of independence and 2 CO5 Understanding
objectivity in conducting internal audits.
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 27 of 41


GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 43
No 5 No
Topic Registration of ISO 9001
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Describe the key principles and requirements of ISO 9001
LO1 Understand (K2)
registration.
Compare the benefits and challenges of implementing ISO
LO2 Understand (K2)
9001 within an organization.
Introduction to ISO 9001
ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS),
published by the International Organization for Standardization (ISO). The standard provides
a framework for organizations to ensure consistent quality in their products and services,
increase customer satisfaction, and continuously improve their processes. The ISO 9001
standard is applicable to any organization, regardless of its size, type, or sector. The current
version, ISO 9001:2015, emphasizes a process approach and risk-based thinking.
Importance of ISO 9001 Registration
Registration of ISO 9001, often referred to as "ISO 9001 certification," is a formal process
whereby an independent third-party (a Certification Body or Registrar) assesses an
organization's Quality Management System (QMS) to ensure it conforms to the ISO 9001
standard. Organizations pursue ISO 9001 registration for various reasons, including:
1. Enhanced Credibility and Reputation: ISO 9001 certification is recognized globally
and provides a competitive edge in the market. It signifies a commitment to quality and
customer satisfaction.
2. Customer Requirements: Some clients or industries mandate ISO 9001 certification
as a prerequisite for doing business.
3. Operational Efficiency: Certification drives organizations to optimize processes,
minimize waste, and improve overall efficiency.
4. Risk Management: The standard helps identify risks and implement controls to
mitigate them, leading to more predictable and stable operations.
5. Continuous Improvement: ISO 9001 promotes a culture of continual improvement
through regular audits, management reviews, and corrective and preventive actions.

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 28 of 41


GE3752 Total Quality Management

Steps for ISO 9001 Registration


1. Understanding the Requirements: Organizations should thoroughly understand the
ISO 9001:2015 requirements. The standard is based on several key principles, including
customer focus, leadership, engagement of people, process approach, improvement,
evidence-based decision-making, and relationship management.
2. Gap Analysis: Conduct a gap analysis to identify the differences between the
organization's current quality management practices and the ISO 9001 requirements.
This helps in planning the steps needed to align the organization's processes with the
standard.
3. Development of Quality Management System (QMS):
o Documentation: Develop or update documents such as the Quality Manual,
Quality Policy, Standard Operating Procedures (SOPs), work instructions, and
records. Ensure that the documentation meets the standard's requirements and
is easy to understand and implement.
o Process Identification and Mapping: Identify key processes and map them to
ensure alignment with ISO 9001 requirements. Clearly define the inputs,
outputs, responsibilities, and interactions between processes.
4. Training and Awareness: Provide training to employees on ISO 9001 requirements,
the organization's QMS, and their specific roles within it. Awareness sessions help in
cultivating a quality culture and ensuring that everyone understands the importance of
compliance.
5. Internal Audits: Conduct internal audits to assess the effectiveness of the QMS and its
conformity to the ISO 9001 standard. Internal audits identify non-conformities and
areas for improvement, providing an opportunity to take corrective actions before the
certification audit.
6. Management Review: The organization's top management should review the QMS to
ensure its continued suitability, adequacy, and effectiveness. This includes reviewing
audit results, customer feedback, process performance, and any needed changes to the
QMS.
7. Pre-assessment Audit (Optional): Some organizations opt for a pre-assessment audit
by a third-party registrar to identify potential non-conformities before the formal
certification audit. This helps in minimizing the risk of failing the certification audit.
8. Certification Audit: The certification process involves two stages:

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 29 of 41


GE3752 Total Quality Management

o Stage 1 Audit (Documentation Review): The auditor reviews the


organization's documentation to ensure it meets the ISO 9001 requirements.
o Stage 2 Audit (On-site Assessment): The auditor assesses the implementation
and effectiveness of the QMS on-site. They evaluate processes, records,
interviews, and observe activities to ensure compliance with ISO 9001.
9. Corrective Actions: If any non-conformities are identified during the certification
audit, the organization must take corrective actions to address them. These actions are
reviewed by the auditor to ensure that they are effective.
10. Issuance of Certificate: Once the organization successfully passes the Stage 2 audit
and addresses any non-conformities, the certification body issues the ISO 9001
certificate. The certificate is typically valid for three years, with surveillance audits
conducted annually to ensure ongoing compliance.
11. Surveillance and Recertification Audits:
o Surveillance Audits: These are conducted annually to ensure the QMS remains
in compliance with ISO 9001 requirements.
o Recertification Audit: At the end of the three-year certification period, a full
audit (similar to the initial certification audit) is conducted to renew the ISO
9001 certificate.
Challenges in ISO 9001 Registration
 Resource Allocation: ISO 9001 registration requires significant time, effort, and
resources, especially for small and medium-sized organizations.
 Change Management: Implementing a new QMS or aligning an existing one with ISO
9001 standards often requires cultural and operational changes, which can be
challenging.
 Maintaining Certification: Achieving ISO 9001 registration is not a one-time task.
Organizations must continually maintain their QMS, comply with changes in the
standard, and undergo regular audits.

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 30 of 41


GE3752 Total Quality Management

Assessment questions to the lecture


Bloom’s
Qn No Question Answer Knowledge
Level
1 What is the primary purpose of ISO 9001 certification? B Remembering
A) To increase sales
B) To enhance credibility and customer satisfaction
C) To reduce the workforce
D) To comply with financial regulations
2 Which of the following is an optional step before the c Remembering
certification audit for ISO 9001 registration?
A) Gap Analysis
B) Internal Audit
C) Pre-assessment Audit
D) Management Review
3 What is the validity period of an ISO 9001 certificate after C Remembering
initial registration?
A) 1 year
B) 2 years
C) 3 years
D) 5 years
4 During the ISO 9001 certification process, which audit A Remembering
stage involves reviewing the organization’s
documentation?
A) Stage 1 Audit
B) Stage 2 Audit
C) Surveillance Audit
D) Recertification Audit

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 31 of 41


GE3752 Total Quality Management

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 Explain the significance of the Management 2 CO5 Understanding
Review in the ISO 9001 registration process.
2 What are the key differences between a Stage 1 2 CO5 Understanding
and Stage 2 audit in the ISO 9001 certification
process?

Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 32 of 41


GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 44
No 5 No
ENVIRONMENTAL MANAGEMENT SYSTEM-Introduction—ISO 14000 Series
Topic
Standards
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Explain the purpose and key components of the ISO 14000
LO1 Understand (K2)
Series standards.
Differentiate between the requirements of various ISO 14000
LO2 Series standards and their applications in environmental Understand (K2)
management.

1. Introduction to Environmental Management System (EMS)


An Environmental Management System (EMS) is a framework that helps an organization
achieve its environmental goals through consistent review, evaluation, and improvement of its
environmental performance. The EMS focuses on reducing the environmental footprint of a
company by optimizing processes, reducing waste, and improving sustainability. It serves as a
tool for organizations to systematically manage their environmental impacts and comply with
environmental regulations.
2. Purpose of EMS
The primary purposes of an EMS are to:
Ensure compliance with environmental regulations.
Reduce environmental impact and enhance sustainability.
Improve resource efficiency and reduce waste.
Enhance corporate reputation and stakeholder confidence.
Identify opportunities for cost savings through better resource management.
3. Overview of ISO 14000 Series Standards
The ISO 14000 series of standards, developed by the International Organization for
Standardization (ISO), provides a framework for organizations to manage their environmental
responsibilities. These standards help organizations to minimize their environmental impact,
comply with applicable laws and regulations, and continuously improve their environmental
performance.

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GE3752 Total Quality Management

3.1. Key Components of the ISO 14000 Series:


ISO 14001: The most widely recognized standard in the ISO 14000 series, ISO 14001 specifies
the requirements for an effective Environmental Management System (EMS). It provides a
systematic approach for organizations to manage their environmental responsibilities and
improve their environmental performance.
ISO 14004: Provides general guidelines on principles, systems, and support techniques for
environmental management.
ISO 14005: Offers guidelines for a phased implementation of an EMS, including the use of
environmental performance evaluation.
ISO 14006: Offers guidelines for incorporating ecodesign in an EMS.
ISO 14015: Provides guidelines for environmental assessment of sites and organizations.
ISO 14031: Focuses on environmental performance evaluation.
ISO 14040 to ISO 14049: Series of standards related to Life Cycle Assessment (LCA), covering
principles, framework, requirements, guidelines, and case studies.
4. Benefits of Implementing ISO 14001 Standard
Implementing ISO 14001 within an organization offers multiple benefits:
Regulatory Compliance: Helps organizations comply with current and future statutory and
regulatory requirements.
Environmental Risk Management: Identifies, manages, monitors, and controls environmental
issues in a holistic manner.
Improved Reputation: Enhances the image and credibility of the organization among
stakeholders, customers, and the public.
Cost Reduction: Reduces waste, improves efficiency, and reduces costs associated with energy,
materials, and waste disposal.
Employee Engagement: Encourages better environmental practices among employees and
fosters a culture of continuous improvement.
5. Key Principles of ISO 14001:2015
ISO 14001:2015 is the latest version of the ISO 14001 standard. It is based on the Plan-Do-
Check-Act (PDCA) cycle, which is a systematic approach for the continual improvement of
the EMS.

Plan: Establish environmental objectives and processes needed to deliver results in accordance
with the organization's environmental policy.

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 34 of 41


GE3752 Total Quality Management

Do: Implement the processes as planned.


Check: Monitor and measure processes against the environmental policy, objectives, legal and
other requirements, and report the results.
Act: Take actions to continually improve the performance of the EMS.
6. ISO 14001 Certification Process
The certification process involves several steps:
Gap Analysis: A thorough analysis to identify gaps between the current state of the
organization’s EMS and the requirements of ISO 14001.
Implementation: Developing and implementing the required processes and systems to close
identified gaps.
Internal Audit: Conducting internal audits to ensure compliance with the EMS requirements.
Management Review: Top management reviews the EMS for effectiveness and alignment with
the organization’s goals.
Certification Audit: An external auditor assesses the EMS to determine compliance with ISO
14001 requirements.
Certification and Surveillance Audits: Upon successful completion of the audit, the
organization is awarded ISO 14001 certification. Surveillance audits are conducted
periodically to ensure ongoing compliance.

Assessment questions to the lecture

Bloom’s
Qn No Question Answer Knowledge
Level
1 Which of the following is the most recognized standard in B Remembering
the ISO 14000 series for Environmental Management
Systems?
A) ISO 9001
B) ISO 14001
C) ISO 14004
D) ISO 45001
2 What is the primary purpose of an Environmental C Remembering
Management System (EMS)?

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 35 of 41


GE3752 Total Quality Management

A) To reduce labor costs


B) To ensure quality control
C) To manage environmental impacts and improve
sustainability
D) To enhance product design
3 Which principle is NOT a part of the ISO 14001:2015 B Remembering
standard?
A) Plan
B) Design
C) Do
D) Check
4 What is the final step in the ISO 14001 certification C Remembering
process?
A) Internal Audit
B) Management Review
C) Certification Audit
D) Gap Analysis

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 What is the Plan-Do-Check-Act (PDCA) cycle, 2 CO5 Understanding
and how is it applied in ISO 14001:2015?
2 List any four benefits of implementing the ISO 2 CO5 Understanding
14001 standard within an organization.
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 36 of 41


GE3752 Total Quality Management

Unit Lecture
QUALITY MANAGEMENT SYSTEM 45
No 5 No
Topic Concepts of ISO 14001—Requirements of ISO 14001-Benefits of EMS.
Bloom’s
Learning Outcome (LO) At the end of this lecture, students will be able to Knowledge
Level
Define the key requirements and principles of ISO 14001 for
LO1 Understand (K2)
Environmental Management Systems (EMS).
Explain the benefits and impact of implementing an EMS based on
LO2 Understand (K2)
ISO 14001 standards.
Introduction to ISO 14001
ISO 14001 is an internationally recognized standard for environmental management systems
(EMS). It provides a framework for organizations to manage and reduce their environmental
impact, ensuring they comply with regulations and continually improve their environmental
performance.
Key Concepts:
1. Environmental Management System (EMS):
o An EMS is a systematic approach to managing an organization’s environmental
responsibilities. It helps organizations reduce their environmental impact and
ensure compliance with environmental regulations.
2. ISO 14001 Standard:
o The ISO 14001 standard outlines the requirements for an EMS. It provides a
structured approach for organizations to set up, implement, maintain, and
improve their EMS.

Requirements of ISO 14001


ISO 14001:2015 is the latest version of the standard. It includes several key requirements that
organizations must fulfill to achieve certification:
1. Context of the Organization:
o Understanding the Organization and its Context: Organizations need to
determine internal and external issues that are relevant to their environmental
management.

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GE3752 Total Quality Management

o Understanding the Needs and Expectations of Interested Parties:


Identifying stakeholders and their needs helps tailor the EMS to address external
pressures and expectations.
2. Leadership:
o Leadership and Commitment: Top management must demonstrate leadership
and commitment to the EMS, ensuring that it is integrated into the
organization’s strategic direction.
o Environmental Policy: The organization must establish an environmental
policy that is appropriate, communicates its commitment to environmental
protection, and provides a framework for setting and reviewing environmental
objectives.
3. Planning:
o Actions to Address Risks and Opportunities: Organizations must identify
and assess risks and opportunities related to environmental aspects and
compliance obligations.
o Environmental Objectives and Planning to Achieve Them: Objectives
should be measurable and aligned with the environmental policy. Plans should
detail how these objectives will be achieved.
4. Support:
o Resources: Adequate resources must be provided to establish, implement,
maintain, and improve the EMS.
o Competence: Ensuring that employees are competent and aware of their roles
within the EMS.
o Awareness: Employees should be aware of the environmental policy,
objectives, and their role in achieving them.
o Communication: Effective internal and external communication strategies are
essential.
o Documented Information: Proper documentation and control of documents
and records are required to support the EMS.
5. Operation:
o Operational Planning and Control: Organizations must plan and control
processes to meet environmental management requirements and objectives.
6. Performance Evaluation:

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 38 of 41


GE3752 Total Quality Management

o Monitoring, Measurement, Analysis, and Evaluation: Regularly monitoring


and measuring environmental performance to ensure compliance and
effectiveness of the EMS.
o Internal Audit: Conducting internal audits to evaluate the EMS’s performance
and identify areas for improvement.
o Management Review: Top management must review the EMS at planned
intervals to ensure its continuing suitability, adequacy, and effectiveness.
7. Improvement:
o Nonconformity and Corrective Action: Addressing and correcting
nonconformities to prevent recurrence.
o Continual Improvement: Continually improving the EMS to enhance
environmental performance.
Benefits of ISO 14001
Implementing ISO 14001 offers several advantages for organizations, including:
1. Regulatory Compliance:
o Helps organizations comply with environmental laws and regulations, reducing
the risk of legal penalties and fines.
2. Improved Environmental Performance:
o Facilitates the reduction of waste, resource consumption, and emissions, leading
to a lower environmental footprint.
3. Enhanced Reputation:
o Demonstrates commitment to environmental responsibility, improving public
perception and enhancing corporate reputation.
4. Cost Savings:
o Reduces costs associated with waste management, energy consumption, and
raw material use through efficient practices.
5. Employee Engagement:
o Involves employees in environmental initiatives, fostering a culture of
sustainability and increasing job satisfaction.
6. Competitive Advantage:
o Differentiates the organization from competitors by showcasing environmental
credentials, which can be advantageous in the marketplace.
7. Risk Management:

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 39 of 41


GE3752 Total Quality Management

o Identifies and mitigates environmental risks, minimizing potential impacts on


business operations.
8. Customer Satisfaction:
o Meets customer expectations for environmental responsibility, potentially
increasing customer loyalty and satisfaction.
Assessment questions to the lecture
Bloom’s
Qn No Question Answer Knowledge
Level
1 Which of the following is NOT a requirement of ISO C Remembering
14001:2015?
A) Understanding the organization and its context
B) Leadership and commitment
C) Annual financial audits
D) Environmental policy
2 What is the purpose of setting environmental objectives in C Remembering
an ISO 14001 EMS?
A) To increase operational costs
B) To ensure compliance with financial regulations
C) To measure and improve environmental performance
D) To develop new products
3 How often should top management review the EMS B Remembering
according to ISO 14001?
A) Every month
B) Annually
C) Every five years
D) Biannually
4 Which of the following is a benefit of implementing ISO C Remembering
14001?
A) Increased employee turnover
B) Decreased customer satisfaction
C) Reduced environmental footprint
D) Higher raw material costs

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 40 of 41


GE3752 Total Quality Management

Students have to prepare answers for the following questions at the end of the lecture
Marks CO Bloom’s
Qn
Question Knowledge
No
Level
1 What is the role of internal audits in an ISO 14001 2 CO5 Understanding
EMS?
2 Describe one benefit of ISO 14001 certification 2 CO5 Understanding
for a company.
Reference Book

Library Book
Author(s) Title of the book
Accession No
Dale H.Besterfiled Total Quality Management 5624

Notes Prepared by Mr.M.Anthony Kingston, AP/Mech Page 41 of 41

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