Module 5

Presented by
Dr. Arun Jacob
Asst. Professor
Mechanical Engg. Dept.
MESITAM
Chathannoor

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 Syllabus
Quality System: ISO 9000 family of standards- ISO
9001:2000 model, quality management system-
management responsibility- resource management-
product realisation- measurement analysis and
improvements- ISO 14000 family of standards- Quality
auditing- types and benefits.

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 Quality Management System (QMS)
❖ A quality management system (QMS) is a collection of business
processes and procedures which aims to ensure that the quality of
products or services meets - or exceeds - customer expectations.
❖ Such systems are typically repeatable and measurable, and rely
on the concept of continuous improvement.

❖ 4 Types of QMS
1. ISO 9001,
2. AS9100,
3. Six Sigma,
4. CMMI

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 ISO 9000 Family of Standards
❖ ISO is international organisation for standardization.
❖ This is the standard which publishes ISO standard.
❖ Its head quarter is based in Geneva.
❖ TQM is total quality management.
❖ This is a methodology which says quality in every department
leading to customer satisfaction.
❖ ISO 9000 is a quality management standard that presents guidelines
intended to increase business efficiency and customer satisfaction.
❖ The goal of ISO 9000 is to embed a quality management system
within an organization, increasing productivity, reducing
unnecessary costs, and ensuring quality of processes and products.
❖ It is an independent organisation that provides standards in terms of
quality, safety, and efficiency of products and services provided by
businesses.
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 ISO 9000 Quality Management Guidelines
❖ There are seven quality management principles included in ISO
9000:
1. Customer focus:-
Businesses must understand customer requirements and aim to
exceed customer expectations. Organizations should measure
customer satisfaction with their product or service as well.
Surveys are one way to do this, monitoring customer
complaints is another.
2. Leadership:-
Organizational leaders should establish a vision for the
direction of the company and empower employees to reach that
goal. Leaders should establish trusted relationships with
employees and recognize their contributions.
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 ISO 9000 Quality Management Guidelines
3. Engagement:-
Employees at every level should be involved.
4. Process:-
Organizations should manage resources as a process. They
should use process analysis tools to measure what the
organization is capable of, identify links between activities to
streamline processes and look for ways to improve processes.
5. Continuous improvement:-
Companies should take a continual improvement approach and
empower people to make improvements, measure improvement
consistently and celebrate those improvements.

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 ISO 9000 Quality Management Guidelines
6. Evidence-based decision-making:-
Organizations should make decisions based on sound data
analysis, balanced with practical experience and qualitative
evidence. This involves using techniques like decision matrices
to evaluate and rank options and multi voting, which helps a
group narrow down a list of options.
7. Relationship management:-
Organizations should focus on fostering a mutually beneficial
relationship with partner organizations, including suppliers,
service providers and contractors. They should share resources,
collaborate on development efforts and recognize successes to
achieve efficient supply chain management.

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 Elements of ISO 9000 Quality Management Systems
The standards of ISO 9000 detail 20 requirements for an organization's
quality management system in the following areas:
Management Responsibility
1. Quality System
2. Order Entry
3. Design Control
4. Document and Data Control
5. Purchasing
6. Control of Customer Supplied Products
7. Product Identification and Tractability
8. Process Control
9. Inspection and Testing
10. Control of Inspection, Measuring, and Test Equipment
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 Elements of ISO 9000 Quality Management Systems

12. Inspection and Test Status

13. Control of Nonconforming Products
14. Corrective and Preventive Action
15. Handling, Storage, Packaging, and Delivery
16. Control of Quality Records
17. Internal Quality Audits
18. Training
19. Servicing
20. Statistical Techniques

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 Models of ISO 9000
❖ The ISO 9000 quality standards were broken into three model sets—
ISO 9001, ISO 9002, and ISO 9003.
❖ In the late 2003 revision of the ISO 9000 these three standards were
combined into a single ISO 9001:2000.
❖ The new standard was published in 2000 and companies migrated to
the new standards during the first three years of the new century.
❖ Organizations and companies that were certified under the older ISO
9000, ISO 9001, ISO 9002, and ISO 9003 systems were required to
take steps to transfer or upgrade their certification to the new
standard.
❖ An organization was required to demonstrate to an accredited
registration body that its quality management system met the
requirements of the new ISO 9001:2000.
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 Advantages of ISO 9000 System
❖ Increased marketability
❖ Reduced operational expenses
❖ Better management control
❖ Increased customer satisfaction
❖ Improved internal communication
❖ Improved customer service
❖ Reduction of product-liability risks
❖ Attractiveness to investors

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 Disadvantages of ISO 9000 System
❖ Owners and managers do not have an adequate understanding of the
ISO 9000 certification process or of the quality standards themselves
❖ Funding for establishing the quality system is inadequate
❖ Heavy emphasis on documentation
❖ Length of the process

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 Quality Management System
❖ A quality management system (QMS) is a collection of business
processes focused on consistently meeting customer requirements
and enhancing their satisfaction.
❖ It is aligned with an organization's purpose and strategic direction
(ISO 9001:2015).
❖ It is expressed as the organizational goals and aspirations, policies,
processes, documented information, and resources needed to
implement and maintain it.

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 Quality Management System

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 Elements of Quality Management System
❖ Quality objectives
❖ Quality manual
❖ Organizational structure and responsibilities
❖ Data management
❖ Processes – including purchasing
❖ Product quality leading to customer satisfaction
❖ Continuous improvement including corrective and preventive action
❖ Quality instrument
❖ Document control
❖ Employee training and engagement
❖ Supplier quality management

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 Management Responsibility
❖ Management is responsible for establishing internal controls.
❖ In order to maintain effective internal controls, management should:
❖ Maintain adequate policies and procedures;
❖ Communicate these policies and procedures; and
❖ Monitor compliance with policies and practices.
7 functions of management—
❖ Planning,
❖ Organizing,
❖ Staffing,
❖ Directing,

❖ Coordinating,
❖ Reporting

❖ Budgeting.

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 Resource Management
❖ Resource management is the practice of planning, scheduling,
and allocating people, money, and technology to a project or
program.
❖ In essence, it is the process of allocating resources to achieve the
greatest organizational value.
❖The key factors of production that revolve around
management are known as the 5 Ms of Management.
❖They include – Manpower, Money, Materials, Machinery
and Methods.

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 Types of Resource Management
❖ HR Management:-
Employees are the heart of an organization. Human resource
management includes all the activities that an organization
undertakes to find, attract and retain qualified employees. It
also includes training and development of employees so that
they can perform their duties efficiently.
❖ Project Resources Management
Project resources management is an important aspect of
project management. It includes the planning and allocation
of resources required for a project, monitoring their progress
and performance during execution, and evaluating how well
they have met expectations at the end of the project.

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 Types of Resource Management
❖ Infrastructure Management
Infrastructure management is an important aspect of project
management. It includes the planning, designing, and
implementation of the required infrastructure for a project.
Infrastructure can be anything that supports the business’s
operations; it may include facilities, machinery, or software
systems.
❖ Natural Resources Management
Natural resources management is the process of planning,
implementing, and monitoring actions to ensure that natural
resources are used in a way that sustainably meets human needs.
This can include renewable and non-renewable resources, such
as water, soil, air, plants, and animals.

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 Benefits of Resource Management

❖ Reduce costs,
❖ Improve efficiencies,
❖ Boost productivity.

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 Product Realization
❖ Product Realization combines market requirements,
technological capabilities, and resources to define new product
designs and the requisite manufacturing and field support
processes.
❖ Product realization means a clear idea of what the product will
be, usually expressed in drawings, statements of work,
functional product specs, or their equivalents.
❖ Based on this clear idea, quality management can objectively
determine if the product was "realized" and how efficient the
process was.

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 Planning of Product Realization
❖ Establish the quality requirements for your product(s).
❖ Define what your required processes will be and what
supporting documentation will be needed for those processes.
❖ Outline the company infrastructure that will need to be created
and what the work environment should be like.
❖ Define employee qualification and training requirements.
❖ Establish your processes for verification, validation,
measurement, monitoring, handling, inspection, storage,
distribution, and traceability.

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 Measurement Analysis and Improvements
❖ Appropriate monitoring, measurement analysis and improvement
processes are adopted to evaluate the effectiveness of system, which
includes use of suitable statistical techniques for continually
improving the effectiveness of the quality management system.
❖ The purpose of Measurement and Analysis is to develop and sustain
a measurement capability used to support management information
needs.
❖ Measurement System Analysis is a statistical tool that can be used to
assess data quality.
❖ This tool can be used to determine measurements' accuracy and
identify sources of error. Measurement System Analysis can assess
data quality from various sources, including surveys, experiments,
and observational studies.
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 ISO 14000 Family of Standards
❖ ISO 14000 is a set of standards created to help organizations
minimize the environmental impact of their operations.
❖ The standards were developed by a non-governmental organization
and are intended for use worldwide.
❖ The U.S. Environmental Protection Agency is among the many
agencies that had input into the standards.
❖ The ISO 14000 series addresses the following aspects of
environmental management:
❖ Environmental Management Systems (EMS)
❖ Environmental Auditing & Related Investigations (EA&RI)
❖ Environmental Labels and Declarations (EL)
❖ Environmental Performance Evaluation (EPE)
❖ Life Cycle Assessment (LCA)
❖ Terms and Definitions (T&D)
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 Quality Auditing
❖ Quality auditing is the systematic, independent, and documented
review and evaluation of an organization's quality management
system (QMS) to determine whether quality activities and results
comply with a strategic arrangement that is effectively implemented
and appropriate to achieve the objectives.
❖ Quality auditing aims to determine if an organization complies with the
requirements within a specific quality system.
❖ Because quality audits are a critical component of the ISO 9000 quality
system standard, internal or external auditors or an auditing team usually
perform them.

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 Types of Quality Auditing
❖ The following is a list of 10 commonly performed quality audit
types:
1. Internal Quality System Audit. This type of audit is an examination of the
tool used to measure quality itself. ...
2. Supplier Audit. ...
3. Production Team Audit. ...
4. Safety Audit. ...
5. Facilities Audit. ...
6. Environmental Audit. ...
7. Risk Assessment Audit.
8. Design Control Audit
9. Regulatory Audit
10. Method Validation Audit
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 Benefits of Quality Auditing

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 Resource Management

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 THANK YOU

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