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Chapter 4 discusses the Quality Management System (QMS) and its importance in minimizing variation to improve quality, emphasizing the role of standards and certification marks in enhancing consumer trust and marketability. It details the ISO 9000 series, particularly ISO 9001:2015, which provides a framework for organizations to meet customer and regulatory requirements while fostering continual improvement. The chapter outlines key principles, structure, benefits of implementing ISO 9001, and the certification process for organizations seeking to demonstrate their commitment to quality.

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0% found this document useful (0 votes)
29 views20 pages

Qu 4

Chapter 4 discusses the Quality Management System (QMS) and its importance in minimizing variation to improve quality, emphasizing the role of standards and certification marks in enhancing consumer trust and marketability. It details the ISO 9000 series, particularly ISO 9001:2015, which provides a framework for organizations to meet customer and regulatory requirements while fostering continual improvement. The chapter outlines key principles, structure, benefits of implementing ISO 9001, and the certification process for organizations seeking to demonstrate their commitment to quality.

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UPPSC Assistant Engineer Combined State Engineering Services Examination

Chapter-4 | Quality Management System

QUALITY MANAGEMENT SYSTEM

Chapter-4| Quality Management System


4.1 Standards
• The more the variation, the lesser will be the quality and vice-versa. Thus in order to
improve quality, the variation should be minimized.
• Thus standardisation leads to reduction of variation and thus improvement in quality.
Further, standardisation helps in interchangeability which makes mass production
possible.
• Standards lead to increase in confidence of investors and trust in consumers. Thus,
standards can also be used as a marketing strategy.
• Development of standards is a dynamic process. It means standards evolve over a
period of time depending on the changing requirements.
• Standardization can help to maximize environmental protection, compatibility,
interoperability, safety, accident reduction and quality.

4.2 Certification Marks used in India


• Agmark: It is used for all agricultural products. It is given by Directorate of Marketing
and Inspection, Ministry of Agriculture.
• BIS hallmark: It is a system of hallmarking of gold and silver jewellery sold in India
for certifying the purity of metal. If BIS Hallmark is present on the jewellery then it
means that it is certified and quality assured according to set of standards laid by Bureau
of Indian Standards.
• Ecomark: It is an ecolabel for various products issued by the Bureau of Indian
Standards.
• FPO mark: It is given for all processed fruit products in India. It certifies that the
product was manufactured in a hygienic 'food-safe environment.
• Geographical Indications marks: It is defined under the WTO Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS) Examples, include the
Darjeeling tea and Basmati mark.
• India Organic certification mark for organically farmed food products. It certifies that
the product conforms to the specifications of National Standards for Organic Products,
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Chapter-4 | Quality Management System


2000. The certification is issued by testing centres accredited by the Agricultural and
Processed Food Products Export Development Authority (APEDA) under the National
Program for Organic Production of the Government of India.
• ISI mark: It is used for industrial product. It certifies that a product conforms to a set
of standards laid by the Bureau of Indian Standards.
• Non Polluting Vehicle mark: It is given for mo vehicles certifying conformity to the
Bharat Stage emission standards. The standards and timelines for its implementation
are set by Central Pollution Control Boards.
• The International Organization for Standardization (ISO) is an international
standard-setting body composed of representatives from various national standards
organizations. The organization promotes worldwide proprietary, industrial and
commercial standards. It is headquartered in Geneva, Switzerland.
• The International Organization for Standardization, is an independent, non-
governmental organization, the members of which are the standards organizations of
the 162 member countries. It is the world's largest developer of voluntary international
standards and facilitates world trade by providing common standards between nations.
Over twenty thousand standards have been set covering everything from manufactured
products and technology to food safety, agriculture and healthcare.
• Use of the standards aids in the creation of products and services that are safe, reliable
and of good quality. The standards help businesses increase productivity while
minimizing errors and waste. By enabling products from different markets to be directly
compared, they facilitate companies in entering new markets and assist in the
development of global trade on a fair basis. The standards also serve to safeguard
consumers and the end-users of products and services, ensuring that certified products
conform to the minimum standards set internationally.
ISO has three membership categories:
Member bodies are national bodies considered the most representative standards body
in each country. These are the only members of ISO that have voting rights. BIS
represents India in this.
Correspondent members are countries that do not have their own standards
organization. These members are informed about ISO's work, but do not participate in
standards promulgation.

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Subscriber members are countries with small economies. They pay reduced
membership fees, but can follow the development of standards.

4.3 ISO 9000 Series


ISO 9000 is a set of international standards on quality management developed to help
companies effectively document the quality system elements to be implemented to
maintain an efficient quality system. They are not specific to any one industry and can
be applied to organizations of any size.
ISO 9000 series can help a company satisfy its customers, meet regulatory requirements,
and achieve continual improvement. However, it should be considered to be a first step,
the base level of a quality system, not a complete guarantee of quality. Third-party
certification bodies provide independent confirmation that organizations mest the
requirements of ISO 9001.
• ISO 9000:2015: Quality management systems. Fundamentals and vocabulary
• ISO 9001:2015: Quality management systems. Requirements
• ISO 9004:2009: Quality management systems - Managing for the sustained success of
an organization (continuous improvement)

4.4 Other Popular Standards


• ISO 14001 Environmental management
• ISO 19011 Guidelines for auditing management systems
• ISO 31000 Risk management
• ISO 50001 Energy management
• ISO 45001 Occupational health and safety
• ISO 13485 Medical devices
• ISO 17025 Testing and calibration laboratories
• ISO 27001 Information security management
• ISO 16949 automotive industry supply chain

4.5 ISO 9001


ISO 9001 is a globally recognized standard for Quality Management Systems (QMS)
that provides organizations with a framework to ensure they consistently meet customer
and regulatory requirements, while also enhancing customer satisfaction. It is part of the

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broader ISO 9000 family of standards, which focus on quality management principles.
ISO 9001 is applicable to any organization, regardless of size, type, or the products or
services it offers.
The latest version of ISO 9001 is ISO 9001:2015, released in September 2015. It
introduced some important changes, including a greater emphasis on risk-based thinking
and a focus on leadership engagement, strategic alignment, and continual improvement.
Here’s a detailed breakdown of ISO 9001, its structure, principles, and the benefits of
implementing the standard.

4.6 Key Principles of ISO 9001


ISO 9001 is built upon seven key principles of quality management. These principles
guide organizations in creating and improving their QMS. They are:
a) Customer Focus: The organization must understand customer needs, meet their
requirements, and strive to exceed their expectations. This is the core of a quality
management system.
b) Leadership: Leaders at all levels should establish a unified vision and set clear
directions to align the organization with its goals, ensuring everyone works towards
a common objective.
c) Engagement of People: Employees at all levels should be involved in the processes
and decisions of the organization. Engaging people helps in leveraging their abilities
and fostering a culture of continuous improvement.
d) Process Approach: ISO 9001 advocates for managing activities as processes, where
each process is interlinked and managed effectively to achieve consistent and
predictable results.
e) Improvement: Continual improvement is a permanent objective of the organization.
Through regular reviews, the organization identifies opportunities to enhance
efficiency, effectiveness, and quality.
f) Evidence-based Decision Making: Organizations are encouraged to make decisions
based on data and factual analysis. This helps in reducing risks and improving
processes.

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Chapter-4 | Quality Management System


g) Relationship Management: Organizations should maintain good relationships with
external stakeholders (such as suppliers and partners) to create value and ensure long-
term success.

4.7 Structure of ISO 9001:2015


The structure of ISO 9001:2015 follows a common framework known as Annex SL,
which is used across all ISO management system standards. This structure makes it easier
for organizations to integrate multiple management systems (e.g., ISO 14001 for
environmental management) as they all share the same high-level structure.
Here’s a breakdown of the main sections of ISO 9001:2015:
a) Clause 1: Scope
This section defines the purpose of the standard and its applicability. It specifies that
ISO 9001 applies to all organizations, regardless of their size or sector, aiming to
improve their overall performance.
b) Clause 2: Normative References
This section lists any referenced documents that are required for implementing ISO
9001.
c) Clause 3: Terms and Definitions
This section provides key terms and definitions used in the standard, ensuring clarity
and consistency in interpretation.
d) Clause 4: Context of the Organization
Organizations must understand the context in which they operate, including external
and internal factors that can impact their quality management system. This includes
identifying stakeholders and their needs.
e) Clause 5: Leadership
Top management must demonstrate leadership and commitment by ensuring that
quality management is integrated into the organization’s strategy and culture. This
section also highlights the need for establishing roles and responsibilities.

f) Clause 6: Planning
Planning is central to ISO 9001. Organizations are required to establish quality
objectives and determine the actions needed to address risks and opportunities. This

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section also emphasizes the need for setting measurable goals and defining actions
for improvement.
g) Clause 7: Support
This clause outlines the resources required for the QMS, including human resources,
infrastructure, and organizational knowledge. It also includes requirements for
competence, awareness, communication, and documented information (such as
procedures and records).
h) Clause 8: Operation
This section focuses on the core processes of the organization. It includes
requirements for managing operations, meeting customer requirements, and
controlling any external resources or suppliers involved in the process.
i) Clause 9: Performance Evaluation
The organization must monitor, measure, analyze, and evaluate the performance of
its QMS. This includes internal audits, management reviews, and assessment of
customer satisfaction.
j) Clause 10: Improvement
Organizations must continually improve the QMS. This section addresses corrective
actions, how to address nonconformities, and ensure that improvements are made to
the system in response to performance evaluations or customer feedback.

4.8 Benefits of Implementing ISO 9001


Implementing ISO 9001 brings a variety of benefits to organizations:
a) Enhanced Customer Satisfaction: By focusing on customer needs and delivering
quality products and services, ISO 9001 helps improve customer satisfaction,
leading to repeat business and improved customer loyalty.
b) Improved Efficiency: ISO 9001 promotes process optimization, reducing waste,
and improving resource utilization. This results in greater operational efficiency.
c) Better Risk Management: The 2015 version of the standard places a strong
emphasis on risk-based thinking. By identifying and addressing potential risks,
organizations can proactively manage uncertainties and prevent disruptions.

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d) Consistency: ISO 9001 helps standardize processes and workflows, ensuring that
quality is consistent across the organization and that employees understand their
roles in delivering quality.
e) Market Advantage: ISO 9001 certification is widely recognized and respected. It
demonstrates to customers, regulators, and stakeholders that the organization is
committed to maintaining high standards of quality, which can provide a
competitive edge in the marketplace.
f) Continuous Improvement: ISO 9001 fosters a culture of continuous improvement.
By regularly evaluating performance, identifying opportunities for enhancement,
and implementing corrective actions, organizations can adapt to changing market
conditions and customer expectations.
g) Regulatory Compliance: ISO 9001 helps organizations meet regulatory
requirements and industry standards, reducing the risk of legal issues and penalties.
h) Employee Engagement and Motivation: With a focus on leadership and people,
ISO 9001 encourages employee involvement in decision-making and process
improvements, boosting morale and motivation.

4.9 Certification Process


While ISO 9001 is not a mandatory certification, many organizations choose to become
certified to gain credibility and demonstrate their commitment to quality. The
certification process typically involves the following steps:
a) Preparation: The organization assesses its current processes and identifies gaps in
meeting the ISO 9001 requirements.
b) Implementation: The organization implements the necessary changes, including
documentation of the quality management system (QMS) and staff training.
c) Internal Audits: Conduct internal audits to ensure that the QMS is working
effectively and that all ISO 9001 requirements are being met.
d) Management Review: The top management reviews the system to ensure that it
aligns with organizational goals and is effective.
e) Certification Audit: An external ISO certification body conducts an audit to assess
compliance with the standard. If the organization meets all requirements, the
certification is granted.

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f) Surveillance Audits: After certification, regular surveillance audits (usually
annually) are conducted to ensure ongoing compliance and continual improvement.

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Questions
Q1. Which of the following is NOT a requirement for leadership under ISO 9001:2015?

a) Assigning clear responsibilities and authorities for quality management

b) Ensuring engagement of people at all levels of the organization

c) Establishing a quality policy that aligns with the organization’s strategy

d) Ensuring customer satisfaction through routine audits

Q2. ISO 9001:2015 requires organizations to use which type of approach for decision-making?

a) Intuition-based approach

b) Risk-based approach

c) Experience-based approach

d) Analytical approach

Q3. Which of the following is part of Clause 6, 'Planning,' in ISO 9001:2015?

a) Determining the organization's internal and external context

b) Conducting customer satisfaction surveys

c) Addressing risks and opportunities

d) Setting up the management review process

Q4. Which of the following activities is NOT part of the 'Support' clause of ISO 9001:2015?

a) Managing organizational knowledge

b) Ensuring employee competence

c) Conducting internal audits

d) Controlling documented information

Q5. In ISO 9001:2015, which clause requires organizations to define their quality policy?

a) Clause 4

b) Clause 5

c) Clause 6

d) Clause 7

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Q6. What is the main objective of Clause 10: Improvement in ISO 9001?

a) To ensure corrective actions are implemented when there are nonconformities

b) To ensure the quality policy is communicated to all employees

c) To manage resources effectively

d) To assess the effectiveness of quality audits

Q7. Which of the following is a key benefit of adopting ISO 9001?

a) Guaranteeing a 100% defect-free product

b) Reducing the need for quality audits

c) Enhancing customer satisfaction and business performance

d) Reducing the need for employee training

Q8. Which of the following would typically be considered a nonconformity in ISO 9001:2015?

a) A document has been incorrectly filed

b) A new product is being developed

c) Customer complaints are received

d) A new employee is hired without formal training

Q9. In ISO 9001:2015, which of the following best describes the role of management reviews?

a) To monitor customer satisfaction

b) To evaluate the effectiveness of the QMS and identify areas for improvement

c) To define new quality objectives

d) To conduct internal audits

Q10. Which of the following activities should be considered when assessing customer
satisfaction in ISO 9001:2015?

a) Reviewing feedback from suppliers

b) Conducting market research on competitors

c) Monitoring complaints, returns, and surveys

d) Analyzing employee performance reviews

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UPPSC Assistant Engineer Combined State Engineering Services Examination

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1. Answer: d) Ensuring customer satisfaction through routine audits
Explanation of Options:
a) Assigning clear responsibilities and authorities for quality management: Correct. This
is a requirement under ISO 9001 for top management to establish clear leadership.
b) Ensuring engagement of people at all levels of the organization: Correct. Leadership in
ISO 9001 emphasizes the need for engagement of all employees to ensure the success of the
quality management system.
c) Establishing a quality policy that aligns with the organization’s strategy: Correct. Top
management must define a quality policy that reflects the organization’s overall strategic
direction.
d) Ensuring customer satisfaction through routine audits: Incorrect. While audits assess
QMS effectiveness, they do not directly ensure customer satisfaction. Customer satisfaction is
addressed more through process management and continual improvement.
2. Answer: b) Risk-based approach
Explanation of Options:
a) Intuition-based approach: Incorrect. ISO 9001 requires decisions to be based on evidence
and data, not intuition.
b) Risk-based approach: Correct. ISO 9001 emphasizes a risk-based approach to decision-
making, which helps organizations identify and mitigate risks and opportunities that can affect
product or service quality.
c) Experience-based approach: While experience can be helpful, ISO 9001 stresses the need
for data and evidence-based decisions, not solely experience.
d) Analytical approach: Analytical thinking is important, but the standard specifically calls
for a risk-based approach to manage uncertainty.
3. Answer: c) Addressing risks and opportunities
Explanation of Options:
a) Determining the organization's internal and external context: This is addressed in
Clause 4, ‘Context of the Organization,’ not Clause 6.
b) Conducting customer satisfaction surveys: This is part of performance evaluation (Clause
9), not planning.

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c) Addressing risks and opportunities: Correct. Clause 6 focuses on planning for the QMS,
which includes addressing risks and opportunities that could affect the ability to meet
objectives.
d) Setting up the management review process: This is covered in Clause 9, not Clause 6.
4. Answer: c) Conducting internal audits
Explanation of Options:
a) Managing organizational knowledge: Correct. Clause 7 includes managing organizational
knowledge to ensure that employees have the information necessary to perform their jobs
effectively.
b) Ensuring employee competence: Correct. Clause 7 emphasizes the need to assess and
ensure employee competence through training and development.
c) Conducting internal audits: Incorrect. Internal audits are part of the 'Performance
Evaluation' (Clause 9), not 'Support'.
d) Controlling documented information: Correct. This is addressed in Clause 7, which
emphasizes the control of documents and records related to the QMS.
5. Answer: b) Clause 5
Explanation of Options:
a) Clause 4: This clause defines the context of the organization, including its external and
internal environment, not quality policy.
b) Clause 5: Correct. Clause 5 requires top management to define a quality policy that is
aligned with the organization’s strategy and direction.
c) Clause 6: Clause 6 is related to planning and addressing risks and opportunities, not quality
policy.
d) Clause 7: This clause deals with support, such as resources, competence, and
documentation, not quality policy.
6. Answer: a) To ensure corrective actions are implemented when there are nonconformities
Explanation of Options:
a) To ensure corrective actions are implemented when there are nonconformities: Correct.
Clause 10 focuses on the continual improvement of the QMS, which includes addressing
nonconformities and taking corrective actions.
b) To ensure the quality policy is communicated to all employees: This is part of Clause 5, not
Clause 10.

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c) To manage resources effectively: This is part of Clause 7 (Support), not Clause 10.
d) To assess the effectiveness of quality audits: This is covered in Clause 9 (Performance
Evaluation).
7. Answer: c) Enhancing customer satisfaction and business performance
Explanation of Options:
a) Guaranteeing a 100% defect-free product: ISO 9001 does not guarantee a 100% defect-
free product but helps in reducing defects through quality management.
b) Reducing the need for quality audits: Audits are necessary to assess the effectiveness of
the QMS, so ISO 9001 does not reduce the need for them.
c) Enhancing customer satisfaction and business performance: Correct. ISO 9001 aims to
improve processes, reduce inefficiencies, and increase customer satisfaction, which leads to
better business performance.
d) Reducing the need for employee training: Training is essential for maintaining quality,
and ISO 9001 emphasizes its importance.
8. Answer: a) A document has been incorrectly filed
Explanation of Options:
a) A document has been incorrectly filed: Correct. A nonconformity is any deviation from
established procedures or standards, such as improper document control.
b) A new product is being developed: This is part of regular business operations and is not a
nonconformity unless it does not meet established quality standards.
c) Customer complaints are received: Customer complaints may highlight a nonconformity
but are not inherently a nonconformity on their own.
d) A new employee is hired without formal training: While this could be a risk, it does not
directly qualify as a nonconformity unless it violates a specific quality requirement.
9. Answer: b) To evaluate the effectiveness of the QMS and identify areas for improvement
Explanation of Options:
a) To monitor customer satisfaction: Monitoring customer satisfaction is part of performance
evaluation, not management reviews.
b) To evaluate the effectiveness of the QMS and identify areas for improvement: Correct.
Management reviews are conducted to evaluate the performance of the QMS, review
opportunities for improvement, and align the system with the organization’s strategic direction.

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UPPSC Assistant Engineer Combined State Engineering Services Examination

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c) To define new quality objectives: Defining quality objectives is part of the planning
process, not the management review.
d) To conduct internal audits: Internal audits are a separate process, usually conducted by
internal auditors, not during management reviews.
10. Answer: c) Monitoring complaints, returns, and surveys
Explanation of Options:
a) Reviewing feedback from suppliers: This is part of the relationship with suppliers, not
directly related to customer satisfaction.
b) Conducting market research on competitors: This is important for strategic planning but
is not a direct measure of customer satisfaction.
c) Monitoring complaints, returns, and surveys: Correct. ISO 9001 recommends
organizations monitor customer satisfaction through direct feedback, such as complaints,
returns, and surveys.
d) Analyzing employee performance reviews: This is part of internal performance
management, not customer satisfaction.

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Practice questions | Quality Management System-4.

Q.1 What is the purpose of Clause 4 (Context of the Organization) in ISO 9001:2015?

To establish internal and external audit requirements

b) To ensure alignment of the QMS with the organization’s strategic objectives

c) To provide guidelines on employee competency

d) To monitor performance indicators

Q2. What does the term "documented information" in ISO 9001:2015 refer to?

Only the quality policy

b) All records and documents necessary for the effective operation of the QMS

c) The final product design specifications

d) The cost of quality reports

Q3. In the context of ISO 9001:2015, what is the role of risk-based thinking?

To eliminate risks in the production process

b) To ensure all risks are avoided

c) To identify and address risks that could affect the QMS’s ability to achieve objectives

d) To identify opportunities for growth outside the organization

Q4. How often is an external audit required for ISO 9001 certification?

Every 2 years

b) Every 3 years

c) Annually

d) Every 5 years

Q5. Which of the following is a direct benefit of performing an internal audit in the ISO
9001:2015 standard?

Identify and correct nonconformities

b) Assess customer satisfaction

c) Improve external stakeholder relationships

d) Increase product sales

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Q6. What is the primary purpose of the management review in ISO 9001?
To ensure the quality policy is updated
b) To assess whether the quality management system is operating effectively
c) To evaluate employee performance
d) To conduct risk analysis for business opportunities
Q7. Which of the following is NOT a requirement for documented information in ISO
9001:2015?
It must be controlled and maintained
b) It must be readily available for use
c) It must be updated at least annually
d) It must be protected from unauthorized access
Q8. In ISO 9001:2015, what is the term for a formal review of the QMS to ensure it is
compliant and effective?
Internal audit
b) Risk assessment
c) Management review
d) Performance evaluation
Q9. Which clause of ISO 9001:2015 requires organizations to ensure they have the
necessary resources for their QMS?
Clause 6: Planning
b) Clause 7: Support
c) Clause 8: Operation
d) Clause 9: Performance Evaluation
Q10. Under ISO 9001:2015, what should an organization do if they identify
nonconformities during the internal audit?
Conduct a risk assessment
b) Take immediate corrective actions and document the findings
c) Notify customers
d) Ignore the findings if they are minor

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UPPSC AE 2024 Combined State Engineering Services Examination
1. Answer: b) To ensure alignment of the QMS with the organization’s strategic objectives

Explanation of Options:

a) To establish internal and external audit requirements: This is part of Clause 9


(Performance Evaluation), not Clause 4.

b) To ensure alignment of the QMS with the organization’s strategic objectives:


Correct. Clause 4 focuses on understanding the internal and external context to ensure the
QMS supports the strategic objectives of the organization.

c) To provide guidelines on employee competency: This is part of Clause 7 (Support),


not Clause 4.

d) To monitor performance indicators: This is part of Clause 9 (Performance Evaluation),


not Clause 4.

2. Answer: b) All records and documents necessary for the effective operation of the QMS

Explanation of Options:

a) Only the quality policy: Incorrect. Documented information refers to more than just the
quality policy.

b) All records and documents necessary for the effective operation of the QMS:
Correct. Documented information includes procedures, records, and other documentation
required to manage and operate the QMS.

c) The final product design specifications: This is specific to product design, not all the
required documentation under ISO 9001.

d) The cost of quality reports: Cost of quality reports are not part of "documented
information" as defined by ISO 9001.

3. Answer: c) To identify and address risks that could affect the QMS’s ability to achieve
objectives

Explanation of Options:

a) To eliminate risks in the production process: This is not the objective of risk-based
thinking. Risks may be managed rather than eliminated.

b) To ensure all risks are avoided: While some risks may be avoided, the objective is to
address risks to ensure the QMS remains effective, not to avoid all risks.

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UPPSC AE 2024 Combined State Engineering Services Examination
c) To identify and address risks that could affect the QMS’s ability to achieve
objectives: Correct. Risk-based thinking helps identify and manage risks that could prevent
the organization from meeting its quality objectives.

d) To identify opportunities for growth outside the organization: This is unrelated to


risk-based thinking, which focuses on managing risks related to the QMS.

4. Answer: c) Annually

Explanation of Options:

a) Every 2 years: Incorrect. Audits are typically required annually to ensure ongoing
compliance.

b) Every 3 years: Incorrect. Annual audits are required for certification maintenance.

c) Annually: Correct. Organizations with ISO 9001 certification must undergo surveillance
audits annually.

d) Every 5 years: Incorrect. Surveillance audits are required annually, not every 5 years.

5. Answer: a) Identify and correct nonconformities

Explanation of Options:

a) Identify and correct nonconformities: Correct. Internal audits help identify areas
where the QMS is not conforming to requirements and facilitate corrective actions.

b) Assess customer satisfaction: This is part of performance evaluation but not a direct
goal of internal audits.

c) Improve external stakeholder relationships: While internal audits may identify


improvements that indirectly improve stakeholder relationships, this is not their primary
purpose.

d) Increase product sales: Sales are impacted by many factors, but internal audits
themselves do not directly influence sales.

6. Answer: b) To assess whether the quality management system is operating effectively

Explanation of Options:

a) To ensure the quality policy is updated: The management review may discuss quality
policy but its primary purpose is to evaluate the QMS's effectiveness.

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UPPSC AE 2024 Combined State Engineering Services Examination
b) To assess whether the quality management system is operating effectively: Correct.
Management reviews ensure the QMS is functioning as expected and identify opportunities
for improvement.

c) To evaluate employee performance: Employee performance reviews are separate from


management reviews.

d) To conduct risk analysis for business opportunities: While risk analysis may be part
of the review, the primary goal is to evaluate the QMS.

7. Answer: c) It must be updated at least annually

Explanation of Options:

a) It must be controlled and maintained: Correct. Documented information must be


controlled to ensure it is accessible and accurate.

b) It must be readily available for use: Correct. Documented information must be easily
accessible to those who need it for operational purposes.

c) It must be updated at least annually: Incorrect. The frequency of updates is based on


the needs of the organization, not a set annual requirement.

d) It must be protected from unauthorized access: Correct. Documented information


must be secure to prevent unauthorized access.

8. Answer: c) Management review

Explanation of Options:

a) Internal audit: While audits help ensure compliance, they are not formal reviews of the
entire QMS like management reviews.

b) Risk assessment: This process is about identifying risks, not formally reviewing the
QMS’s effectiveness.

c) Management review: Correct. Management reviews assess the overall effectiveness of


the QMS, looking for areas of improvement.

d) Performance evaluation: This is related to monitoring performance indicators, not a


formal review of the QMS.

9. Answer: b) Clause 7: Support

Explanation of Options:

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a) Clause 6: Planning: This clause is focused on planning for achieving objectives and
addressing risks, not resources.

b) Clause 7: Support: Correct. Clause 7 focuses on providing the necessary resources,


including human resources, infrastructure, and knowledge.

c) Clause 8: Operation: This clause addresses the operation and delivery of the product or
service, not resources.

d) Clause 9: Performance Evaluation: This focuses on evaluating the effectiveness of the


QMS, not resources.

10. Answer: b) Take immediate corrective actions and document the findings

Explanation of Options:

a) Conduct a risk assessment: While a risk assessment might help in some situations, the
main requirement is to take corrective actions for nonconformities.

b) Take immediate corrective actions and document the findings: Correct.


Nonconformities should be addressed with corrective actions, and the findings should be
documented for traceability.

c) Notify customers: Customers should be informed if a nonconformity affects them, but


it is not the first step after an internal audit.

d) Ignore the findings if they are minor: Nonconformities should never be ignored, even
if they seem minor.

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