Unit 3: Quality management

system
 Unit 3: Quality management system

The evolution of quality management, ISO 9000: Family (Series) of

standards and its implementation, elements of ISO 9000, principles
of quality management systems, internal audit, external audit, the
surveillance or quality audit visit, assessment of quality-
management systems, conformity assessment, Conformity
Assessment Bodies (CABs).

Department of AI and DS, VIIT, Pune-48 2

 The evolution of quality management
Total Quality Management (TQM) (1980s):

Focuses on continuous improvement, customer

satisfaction, and involvement of all employees.
Emphasizes process control, quality, and company-wide
quality awareness.

W. Edwards Deming, Joseph M. Juran, and Philip B.

Crosby.

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 The evolution of quality management
Six Sigma (1980s - 1990s):

Data-Driven Approach:

Developed by Motorola, Six Sigma aims to reduce

variation and defects in processes using statistical tools.

Focuses on DMAIC (Define, Measure, Analyze, Improve,

Control) methodology.

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 The evolution of quality management
ISO 9000 Series (1987 - Present):

Global Standards: Set of international standards for

quality management systems (QMS), providing a
framework for consistent quality assurance practices
across industries.

Continuous Evolution: Regular updates to reflect

changing industry needs and advances in quality
management practices.
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 The evolution of quality management
Current Trends:

Quality 4.0: Integration of digital technologies (IoT, AI, Big

Data) with traditional quality management to create
smarter, more efficient processes.

Sustainability in Quality: Focus on sustainable

practices, including environmental and social
responsibility as part of quality management.

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Introduction to ISO 9000 Series and
Elements of ISO 9001:2015

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 What is ISO 9000?
Overview:
ISO 9000 Family: A set of international standards for
quality management systems (QMS) developed by the
International Organization for Standardization (ISO).

First Published: 1987; the standards have been revised

periodically to stay relevant.

Purpose: Provides a framework for organizations to

ensure they meet customer and regulatory requirements
and improve overall quality management.
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 Core Standards in the ISO 9000 Family:
ISO 9000: Fundamentals and Vocabulary - Defines the
basic concepts and language used in the ISO 9000 family.

ISO 9001: Requirements - Specifies the criteria for a QMS that

organizations can be certified against.

ISO 9004: Quality Management for Sustained Success - Offers

guidelines for improving performance beyond ISO 9001.

ISO 19011: Guidelines for Auditing Management Systems

(w.r.t. auditor) - Provides guidance on auditing management
systems, including principles of auditing and managing audit
programs.
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 Key Elements of ISO 9001:2015
ISO 9001:2015: The most widely recognized standard in the ISO
9000 series, setting out the criteria for a quality management system.
Key Elements:
Context of the Organization: Understanding the internal and
external factors affecting the QMS.
Leadership: Commitment from top management to the QMS,
including defining quality policy and objectives.
Planning: Risk-based thinking to identify and address potential risks
and opportunities.
Support: Managing resources, including people, infrastructure, and
organizational knowledge.

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 Key Elements of ISO 9001:2015
Operation: The heart of the QMS, covering the entire product/service
life cycle, from design to delivery.

Performance Evaluation: Monitoring, measurement, analysis, and

evaluation of the QMS performance.

Improvement: Continuous improvement practices to enhance QMS

effectiveness and customer satisfaction.

Process Approach: ISO 9001 emphasizes a process-based

approach, integrating processes and focusing on the Plan-Do-Check-
Act (PDCA) cycle.

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 Key Elements of ISO 9001:2015
ISO 9001:2015: The most widely recognized standard in the ISO
9000 series, setting out the criteria for a quality management system.
Key Elements:
Context of the Organization: Understanding the internal and
external factors affecting the QMS.
Understanding the Needs and Expectations of Interested
Parties: Identifying stakeholders (customers, suppliers, regulators)
and their requirements.
Example: A manufacturing company identifies that a key external
issue is the increasing demand for eco-friendly products. Internally,
they recognize a need to improve their production processes to
reduce waste. They determine that their QMS will cover the entire
production process, from raw material procurement to final product
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delivery.
 Key Elements of ISO 9001:2015
ISO 9001:2015: The most widely recognized standard in the ISO
9000 series, setting out the criteria for a quality management system.
Key Elements:
Leadership: Commitment from top management to the QMS,
including defining quality policy and objectives.

Example: The CEO of a healthcare organization establishes a quality

policy that emphasizes patient safety and continuous improvement.

Management holds regular meetings to review quality objectives and

ensure alignment with the overall strategy.

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 Key Elements of ISO 9001:2015
ISO 9001:2015: The most widely recognized standard in the ISO
9000 series, setting out the criteria for a quality management system.
Key Elements:
Planning: Risk-based thinking to identify and address potential risks
and opportunities.

Example: An IT services company identifies a risk of data breaches

and an opportunity to enhance customer trust through improved data
security. They set a quality objective to achieve ISO 27001
certification (information security) within two years and plan the
necessary changes to their processes.

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 Key Elements of ISO 9001:2015
ISO 9001:2015: The most widely recognized standard in the ISO
9000 series, setting out the criteria for a quality management system.
Key Elements:
Support: Managing resources, including people, infrastructure, and
organizational knowledge.

Example: A food processing company invests in training

its employees on food safety standards and upgrades its
machinery to ensure compliance with hygiene regulations.
They also establish clear communication channels to
report any quality issues.
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 Key Elements of ISO 9001:2015
Operation: The heart of the QMS, covering the entire product/service
life cycle, from design to delivery.

Explanation: Operation involves planning, implementing, and

controlling the processes needed to meet quality requirements,
including product design, production, and service delivery.
Example: A software development company follows a
structured development process that includes requirements
analysis, design, coding, testing, and deployment. They use a
project management tool to monitor progress and ensure that
each stage meets customer requirements.

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 Key Elements of ISO 9001:2015
Performance Evaluation: Monitoring, measurement, analysis, and
evaluation of the QMS performance.

Explanation: Organizations must monitor, measure, analyze, and

evaluate the performance of the QMS. This includes conducting
internal audits, management reviews, and assessing customer
satisfaction.
Example: A retail chain conducts quarterly customer satisfaction
surveys to gather feedback on service quality. They also perform
regular internal audits to check compliance with the QMS and hold
management reviews to assess the effectiveness of their quality
objectives.

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 Key Elements of ISO 9001:2015
Improvement: Continuous improvement practices to enhance QMS
effectiveness and customer satisfaction.
Explanation: The standard emphasizes the need for continual
improvement of the QMS, addressing nonconformities, and
implementing corrective actions.
Example: A pharmaceutical company identifies a
nonconformity related to incorrect labeling of products. They
conduct a root cause analysis, implement corrective actions
(such as enhanced labeling procedures and employee
training), and monitor the effectiveness of these actions to
prevent recurrence.

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 Key Elements of ISO 9001:2015
Process Approach: ISO 9001 emphasizes a process-based
approach, integrating processes and focusing on the Plan-Do-Check-
Act (PDCA) cycle.

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 Quality Systems:Continuous Improvement: Plan-Do-
Check-Act (PDCA)
Plan: Identify the problem, set objectives, and develop a detailed plan
to address the issue.

Do: Implement the plan on a small scale or pilot basis to test its
effectiveness.

Check: Evaluate the results by comparing them to the objectives and

gathering feedback.

Act: Standardize successful changes, refine the approach if

necessary, and continue to monitor and improve..

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 Example: Improving Customer Service Response Time

Plan:
Identify the problem: Customers are dissatisfied with long response
times.
Goal: Reduce average response time from 24 hours to 4 hours.
Strategy: Implement a new ticketing system and train staff on quick
resolution techniques.
Do:
Implementation: Deploy the new ticketing system and conduct staff
training.
Pilot Test: Run the new system with a small team for two weeks.

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 Example: Improving Customer Service Response Time

Check:
Measure performance: Compare the new response times against
the target.
Analyze data: Review customer feedback and response time
metrics.

Act:
Standardize improvements: If the response time meets the goal, roll
out the new system across the entire department.
Continuous Improvement: If not, adjust the strategy and repeat the
cycle.

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 Implementation and Certification Process
Steps to Implement ISO 9001:
1. Gap Analysis: Compare existing processes with ISO 9001
requirements to identify gaps.
2. Develop an Implementation Plan: Define the scope, timeline, and
resources needed for ISO 9001 implementation.
3. Documentation: Create or update necessary documentation,
including quality manuals, procedures, and records.
4. Training: Train employees on the QMS requirements and their
roles in ensuring compliance.

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 Implementation and Certification Process
Steps to Implement ISO 9001:
5. Implement the QMS: Put the documented procedures into
practice, ensuring they align with ISO 9001 standards.
6. Internal Audit: Conduct an internal audit to assess the
effectiveness of the QMS and identify areas for improvement.
7. Management Review: Review the QMS with top management to
ensure its ongoing suitability, adequacy, and effectiveness.
8. Corrective Actions: Address any non-conformities found during
the internal audit.

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 Steps to Implement ISO 9001: Example
Gap Analysis
Action: Assess your current processes against ISO 9001
requirements.
Example: Your company has no formal document control system.
ISO 9001 requires a controlled process for managing documents
(Clause 7.5.3.2).

Develop an Implementation Plan

Action: Create a detailed plan to address identified gaps.
Example: Plan to establish a document control system, including
responsibilities, timeline, and resources needed.

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 Steps to Implement ISO 9001: Example
Training and Awareness
Action: Train employees on ISO 9001 requirements and their role in
the Quality Management System (QMS).
Example: Conduct workshops to educate staff on document control
processes and their importance.

Document Control and Management

Action: Create or update documents and procedures to comply with
ISO 9001 standards.
Example: Develop a documented procedure for controlling the
creation, review, approval, and distribution of documents.

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 Steps to Implement ISO 9001: Example
Implement the Quality Management System (QMS)
Action: Apply the new or revised processes throughout the
organization.
Example: Start using the document control system across all
departments.

Internal Audits
Action: Conduct internal audits to ensure compliance and identify
any issues.
Example: Audit the document control system to verify that it meets
ISO 9001 requirements.

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 Steps to Implement ISO 9001: Example
Management Review
Action: Review the performance of the QMS with top management.
Example: Discuss the effectiveness of the document control system
and any improvements needed.

Certification Audit
Action: Undergo an external audit by a certification body.
Example: A certification body evaluates your QMS, including
document control, to ensure compliance.

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 Steps to Implement ISO 9001: Example
Continuous Improvement
Action: Regularly review and improve the QMS.
Example: Continually refine the document control process based on
feedback and audit results.

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 Implementation and Certification Process
Certification Process:
1. Pre-Assessment: Optional review by a certification body to
identify potential issues before the official audit.
2. Stage 1 Audit: The certification body reviews the organization’s
documentation to ensure it meets ISO 9001 requirements.
3. Stage 2 Audit: On-site audit to verify that the QMS is effectively
implemented and complies with ISO 9001.
4. Certification: If the audit is successful, the organization receives
ISO 9001 certification.
5. Surveillance Audits: Regular audits by the certification body to
ensure continued compliance with ISO 9001.

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Quality Management Principles

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Quality Management Principles
ISO 9000 is built on seven core quality management principles, which
provide a framework for improving an organization's processes and
outcomes:
Customer Focus: Understanding and meeting customer needs and
expectations.
Leadership: Establishing unity of purpose and direction within the
organization.
Engagement of People: Ensuring that employees at all levels are
competent, empowered, and engaged in delivering value.

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Quality Management Principles
Process Approach: Managing activities and resources as processes
that function together as a coherent system.
Improvement: Continuously seeking to improve all aspects of the
QMS.
Evidence-Based Decision Making: Making decisions based on the
analysis of data and information.
Relationship Management: Managing relationships with interested
parties (such as suppliers) to optimize performance.

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 Introduction to QMS Principles
Quality Management Systems (QMS) are based on seven key
principles that guide organizations in achieving consistent quality,
continuous improvement, and customer satisfaction.
These principles form the foundation of ISO 9001 and are essential
for effective quality management.
Principles:
Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence-Based Decision Making
Relationship Management
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 Principle 1 & 2 - Customer Focus and Leadership

Quality Management Systems (QMS) are based on seven key

principles that guide organizations in achieving consistent quality,
continuous improvement, and customer satisfaction.
These principles form the foundation of ISO 9001 and are essential
for effective quality management.
Principles:
Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence-Based Decision Making
Relationship Management
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 Principle 1 & 2 - Customer Focus and Leadership

1. Customer Focus:
Objective: Meet and exceed customer expectations.
Key Points:
Understanding and fulfilling customer needs is crucial for
long-term success.
Focusing on customer satisfaction drives business
performance and loyalty.
Example: Tailoring products/services based on customer
feedback.

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 Principle 1 & 2 - Customer Focus and Leadership

2. Leadership:
Objective: Establish a clear vision and direction.
Key Points:
Leaders must create a unified purpose and set quality
objectives.
Leadership fosters a culture of quality and continuous
improvement.
Example: Management commitment to quality initiatives.

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 Principle 3 & 4 - Engagement of People and Process

3. Engagement of People:
Objective: Empower and involve all employees.
Key Points:
Employees at all levels should be engaged and motivated.
Empowered employees contribute to organizational
success and innovation.
Example: Encouraging employee participation in quality
improvement initiatives.

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 Principle 3 & 4 - Engagement of People and Process

4. Process Approach:
Objective: Manage activities as processes that work
together.
Key Points:
Understanding processes and their interactions improves
efficiency and effectiveness.
A process approach enhances consistency and
predictable outcomes.
Example: Using the Plan-Do-Check-Act (PDCA) cycle for
continuous improvement.
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 Principle 5, 6 & 7 - Improvement, Evidence-Based

5. Improvement:
Objective: Continuously improve the QMS.
Key Points:
Continuous improvement is essential for maintaining and
enhancing performance.
Organizations should always seek opportunities for
improvement.
Example: Implementing corrective actions based on
feedback.

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 Principle 5, 6 & 7 - Improvement, Evidence-Based

6. Evidence-Based Decision Making:

Objective: Make informed decisions based on data.
Key Points:
Decisions should be based on the analysis of data and
information.
Accurate data leads to better decisions and effective
solutions.
Example: Using performance metrics to guide decision-
making.

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 Principle 5, 6 & 7 - Improvement, Evidence-Based

7. Relationship Management:
Objective: Foster strong relationships with stakeholders.
Key Points:
Effective relationship management with suppliers,
customers, and other stakeholders is crucial.
Strong relationships help optimize performance and
create value.
Example: Collaborating with suppliers to improve product
quality.

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 Internal Audit in Quality Management Systems (QMS)

Purpose of Internal Audit:

Assess the effectiveness of the Quality Management
System (QMS).
Ensure compliance with ISO 9001 standards and
organizational procedures.
Identify areas for improvement and potential non-
conformities.

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 Internal Audit in Quality Management Systems (QMS)

Key Components:
Planning: Establishing audit scope, objectives, and schedule.
Execution: Conducting the audit by reviewing documents, observing
processes, and interviewing personnel.
Reporting: Documenting findings, including non-conformities and
areas of improvement.
Follow-Up: Ensuring corrective actions are implemented and
effective.
Benefits:
Enhances process efficiency and effectiveness.
Identifies risks and opportunities for improvement.
Prepares the organization for external audits.

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 External Audit in Quality Management Systems
(QMS)
Purpose of External Audit:
Objective Evaluation: Provides an independent
assessment of the organization’s Quality Management
System (QMS) by a third-party auditor.
Certification: Determines compliance with ISO 9001
standards, leading to certification or re-certification.
Validation: Validates the effectiveness and efficiency of
the QMS in meeting customer and regulatory
requirements.

Department of AI and DS, VIIT, Pune-48 45

 External Audit in Quality Management Systems
(QMS)
Key Components:
Pre-Audit Preparation: Review of documents,
processes, and previous audit findings by the external
auditor.
On-Site Audit: The auditor conducts interviews, observes
processes, and reviews records to assess conformity with
ISO standards.
Audit Report: A detailed report is issued, highlighting
conformity, non-conformities, and areas for improvement.
Certification Decision: Based on the audit results, the
organization may receive or maintain ISO certification.
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 External Audit in Quality Management Systems
(QMS)

Benefits:
Credibility: Enhances the organization’s reputation and
customer trust.
Continuous Improvement: Drives ongoing
improvements in quality and operational efficiency.
Regulatory Compliance: Ensures adherence to relevant
laws and regulations.

Department of AI and DS, VIIT, Pune-48 47

 Surveillance Audit in Quality Management Systems

Purpose of Surveillance Audit:

Ongoing Compliance: Ensure continued adherence to
ISO 9001 standards between certification audits.
Performance Monitoring: Regularly assess the
effectiveness of the Quality Management System (QMS)
and ensure that improvements are sustained.
Risk Identification: Identify new risks, non-conformities,
or areas requiring corrective action.

Department of AI and DS, VIIT, Pune-48 48

 Surveillance Audit in Quality Management Systems

Key Components:
Frequency: Typically conducted annually by the certifying
body.
Scope: Focuses on critical processes, previously
identified non-conformities, and any changes in the QMS.
Audit Activities: Includes document review, process
observation, and interviews with staff.
Outcome: Provides a report on compliance status and
recommendations for maintaining certification.

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 Surveillance Audit in Quality Management Systems

Example:
Scenario: A manufacturing company undergoes a
surveillance audit one year after initial ISO 9001
certification. During the audit, the auditor focuses on the
implementation of corrective actions from the previous
audit and the consistency of product quality. The audit
report confirms compliance, with minor recommendations
for further enhancing process efficiency.

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Assessment of Quality Management Systems

Purpose of QMS Assessment:

Evaluate Effectiveness: Assess how well the Quality
Management System (QMS) meets organizational goals
and ISO 9001 requirements.
Identify Strengths & Weaknesses: Determine areas of
strength and opportunities for improvement within the
QMS.
Continuous Improvement: Foster a culture of ongoing
enhancement to maintain high-quality standards.

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Assessment of Quality Management Systems

Key Components:
Criteria: Review alignment with ISO 9001 standards,
customer satisfaction levels, process performance, and
overall quality objectives.
Methods: Use internal audits, management reviews,
performance metrics, and employee feedback for
comprehensive assessment.
Outcome: Develop an action plan to address gaps,
enhance processes, and improve overall system
efficiency.
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Assessment of Quality Management Systems

Example:
Scenario: A healthcare provider conducts a QMS
assessment to ensure compliance with ISO 9001. The
assessment reveals that while patient satisfaction is high,
there are delays in service delivery. The provider
implements process changes to reduce wait times,
leading to improved efficiency and enhanced patient
experience.

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Conformity Assessment in Quality Management

Purpose of Conformity Assessment:

Verify Compliance: Ensure that the Quality Management
System (QMS) adheres to ISO 9001 standards and
regulatory requirements.
Certify Quality: Validate that processes and products
meet specified quality criteria and organizational
standards.
Enhance Credibility: Build trust with customers and
stakeholders by demonstrating adherence to established
quality benchmarks.
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Conformity Assessment in Quality Management

Key Components:
Evaluation: Systematic review of processes, products,
and documentation against ISO 9001 requirements.
Methods: Includes internal audits, external audits
(certification or surveillance), and inspections.
Documentation: Review of quality records, policies, and
procedures to confirm compliance.
Outcome: Issuance of certification or identification of non-
conformities, with recommendations for corrective actions.

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Conformity Assessment in Quality Management

Example:
Scenario: A software development company undergoes a
conformity assessment to achieve ISO 9001 certification.
The assessment involves a thorough review of software
development processes, documentation, and customer
feedback. The company is found to conform to the
standards, resulting in the award of ISO 9001 certification
and increased customer confidence.

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Conformity Assessment Bodies (CABs)

Role of CABs:
Purpose: Independent organizations that assess and
certify compliance with standards like ISO 9001.
Functions: Conduct audits, review quality management
systems, and issue certifications or reports based on
conformity assessment.

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Conformity Assessment Bodies (CABs)

Example:
Scenario: XYZ, a well-known CAB, conducts an ISO
9001 certification audit for a manufacturing company. TÜV
SÜD reviews the company’s QMS, processes, and
documentation. After verifying compliance, TÜV SÜD
issues ISO 9001 certification, enhancing the company’s
credibility and market trust.

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Conformity Assessment Bodies (CABs)

Key Responsibilities:
Certification: Verify that organizations meet specific
standards and criteria.
Surveillance: Perform ongoing assessments to ensure
continued compliance with standards.
Reporting: Provide detailed reports on findings and
recommendations for improvement.

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THANK YOU!