Project Report

_Total Quality Management (MGT- 408)_

ISO ISO 9001:2008 and ISO 9001:2015

Submitted to

Sir Dr. Muhammad Ajmal

Submitted by

Zeshan Munir

Roll no.

18550920-043

Section

BBA 7th “C”

Department of Management Science

University of Gujrat (Hafiz Hayat Campus)

Session 2018-22

March 16, 2022

Introduction

ISO 9001 is a standard of the QMS, which is established by ISO in 1987. This standard was
designed to help the organization to meet the requirements of its customers and stakeholders.
ISO 9001 ensures the business runs with the best practices, which ultimately improve the quality.
It also helps the businesses to provide their customer's value quality products and services, which
ultimately leads to customer satisfaction. This standard is not specified to any industry or product
but organizations of all types can be certified against ISO 9001 to improve the quality of
products and services consistently. ISO standard is considered as a key factor for doing business
in the international market and for improvement of work and processes.

ISO 9001 specifies the requirements from organizations that organizations need to fulfil the
requirements of their customers and improve processes and products that fulfil the customer’s
needs in future. The requirements of ISO 9001 are generic and are not specified to any
organization or product so they can be implemented to every organization and product.

ISO 9001 applies to all the organizations that wish to establish, implement, maintain and
improve the quality seem. The organizations make sure the conformity with their quality policy,
which is stated.

The ISO standard has eight clauses, which are scope, normative, reference, definitions, QMS,
management responsibility, resource management, product and services realization and
measurement analysis and improvement. The first three clauses of ISO are providing information
but the others are very important and organization smuts meet these requirements for continuous
improvement and customer satisfaction.

1. Scope

1.1 General

The international standard has specified some requirements for quality management, for this an
organization need to prove its consistency by providing products, which fulfil the customer’s
needs and requirement. Through effective implementation, the organization must satisfy
customers' needs by continuous improvement in process, assurance of customer and applicable
statutory and regulatory requirements.

1.2 Application
ISO standards are a general application and apply to all types of organizations and all types of
products. Exclusions may be considered if these international standards do not apply to an
organization or product due to the nature of the product or organization. If exclusions are made,
such exclusions are limited to the requirements of Section 7 unless such exclusions meet the
needs of the customer and affect the organization's ability or responsibility to provide applicable
products. , Claims of conformity to this international standard are not accepted. For legal and
regulatory requirements.

2. Normative reference

The accompanying reference documentation is essential to use this archive. For dated references,
only the cited version applies. For references without dates, the latest version (including
corrections) of the referenced document applies. ISO 9000: 2005, QMS-Basics and Vocabulary

3. Terms and definitions

For this standard terms and conditions of ISO 9000 applies.

4. QMS

4.1 General requirements

To improving the process, organizations need to set up, document, implement, and maintain
QMS according to quality standards. The organization shall establish the processes required for
the quality control framework, their application throughout the association, the definition of how
these processes behave, and the interactions between them. Organizations need to establish the
expected rules and strategies to ensure that both the activities and controls of these cycles are
compelling and that they monitor, measure, and analyze processes. Organizations need to carry
out important activities to achieve agreed results and continuous improvement in these cycles.

4.2 Documentation requirements

The organization shall maintain records created to demonstrate compliance with requirements
and effective operation of the QMS. The organization shall establish documented procedures to
define the controls required to identify, store, protect, store, retain, and dispose of records.

5. Management responsibility

5.1 Management commitment

For the development and implementation of quality management systems, senior management
must demonstrate their commitment to quality for the development and implementation of QMS.
Management continually improves commitment by informing the organization of customer
requirements, setting quality policies, setting quality goals, running management views, and
making resources available.

5.2 Customer Oriented

Management understands customer requirements and ensures that they meet the expectations of
future customers.

5.3 Quality policy

It is important to ensure that the quality policy is in line with the organization's objectives, that
the quality policy is in line with the requirements, and that the effectiveness of the QMS is
continuously improving for quality establishment and review. It is the responsibility of top
management. A framework is required for system quality policies. The quality policy must be
communicated to the organization and understandable to all. Quality policies should be checked
regularly to ensure their suitability.

5.4 Plan

Management needs to ensure that quality goals designed to improve products and satisfy
customers are properly developed. The goals set for quality control must be measurable and
consistent with company policy. Administrators need to ensure that the plan is implemented
according to their overall needs and goals. Once the changes to the QMS are implemented, the
QMS is guaranteed to be maintained.

5.5 Responsibility, authority and communication

It is the responsibility of top management to ensure that employee authority and responsibilities
are defined and communicated to the organization. In addition to fulfilling other responsibilities,
the organization's management needs to have the authority and responsibility to ensure the
implementation and maintenance of the processes required for the QMS, report performance to
top management, and raise customer awareness. There is. Select. It is the responsibility of top
management to design effective communication channels for internal communication within the
organization.

5.6 Management Review

This review includes an assessment of improvement opportunities and the need for changes to
the QMS, including quality policies and goals. QMS data records are retained. Input to
management reviews includes audit results, customer feedback, process performance and product
compliance, preventive and corrective status, follow-up actions from previous management
reviews, and changes that may affect the QMS. Suggestions for improvement are also included.
The results of the management review should include all decisions and actions related to
improving the effectiveness of the QMS and its processes and improving the product in relation
to customer requirements and resource needs.
6 Resource management

6.1 Provision of resources

The organization shall determine and provide the resources needed to implement and maintain
the QMS and continually improve its effectiveness and enhance customer satisfaction by meeting
customer requirements.

6.2 Human resources

Personnel performing tasks that affect compliance with product requirements must be competent
based on appropriate education, training, skills, and experience. The organization determines the
required capabilities of personnel to perform tasks related to conforming to product
requirements, provides training as needed, or takes other steps to achieve the required
capabilities. Is needed. To assess the effectiveness of the actions taken, make sure your
employees are aware of the relevance and importance of their activities. How they contribute to
achieving quality goals and maintain a good record of education, training, skills and experience.

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve
conformity to product requirements. Infrastructure includes, as applicable, buildings, workspace
and associated utilities, process equipment, and supporting services.

6.4 Work environment

The organization shall determine and manage the work environment needed to achieve
conformity to product requirements.
7 Product realization

7.1 Planning of product realization

Its organization's liability is to foster the plans and cycles, which are required for item
acknowledgment. The organization should utilize these means improper preparation. The
organization will decide the goals of value and item prerequisites. The need to lay out cycles and
records, and to give assets explicit to the item. Required confirmation, approval, observing,
estimation, investigation and test exercises explicit to the item and the models for item
acknowledgment.

7.2 Customer-related processes

The organization may use the requirements specified by the customer, including the need for
transportation and post-transport exercises, not expressed by the customer, but to the extent
known, in relation to known, legal and administrative requirements. Determine important
requirements. Items and additional essentials that are considered essential to the association.
Associations collect the requirements associated with an object. This collection precedes the
association's obligation to provide items to clients (egg, acceptance of offers, confirmation of
orders or orders, confirmation of contracts or changes to orders), and the essentials for these
items have been identified, agreed upon and agreed upon. Alternatively, resolved by a recently
contacted one whose purpose is to ensure that they meet the set requirements, the club can meet
the specified requirements. Organizations determine and implement best practices for
communicating with customers, as well as processing inquiries, including item data, inquiries,
agreements, or modifications, and customer input, including customer protests.

7.3 Design and development

Inputs connecting with item necessities not set in stone and records kept up. These information
sources will incorporate practical and execution necessities, appropriate legal and administrative
prerequisites, where relevant, data got from past comparable plans, and different prerequisites
fundamental for plan and improvement. Design and advancement yields will meet the
information prerequisites for plan and improvement, give fitting data to buying, creation and
administration arrangement, contain or reference item acknowledgement models, and determine
the qualities of the item that are fundamental for its protection and appropriate use.

.8. Measurement, analysis and improvement

It is organization`s responsibility to make effective planning and implementation for the process
of monitoring, analysis and improvement. The organization will measure customer satisfaction,
the internal audits and other processes. It is also organizations responsibility to control non-
conformity and analyzing the data. The organization shall continuously improve the QMS by
taking the corrective actions, which will eliminate the reasons of non-conformity. To prevent the
occurrence of non-conformity organization will determine the actions needed to eliminate the
occurrence of non-conformity.

ISO 9001 2015

Introduction

Organizations can improve performance by adopting a QMS. There are several advantages to
deploying this QMS system. Organizations can provide products or services that continuously
satisfy their customers. Organizations can demonstrate compliance, increase customer
satisfaction, and eliminate risks associated with the organization. This ISO is based on the
quality control principles described in ISO 9000. Quality control principles are customer focus,
leadership, people involvement, process approaches, improvements, evidence-based decision-
making, and relationship management.

General

This international standard facilitates the adoption of process approaches to develop, implement,
and improve the effectiveness of QMS in order to increase customer satisfaction by meeting
customer requirements. PDCA apply to all process cycles and is described as follow:
Plan to establish the resources needed to achieve squeal according to the purpose and operation
of the system, as well as customer requirements and laboratory programs, and identify and
address threats and opportunities. Do apply what was planned.

Check observer and (where applicable) means processes and the responding things and services
against procedures, objects, conditions and planned conditioning, and report the results.

Act take behavior to improve performance, as required.

QMS Requirements;

1. Scope

This ISO specify the requirements for a QMS, which an organization needs to prove its ability to
provide the products, which satisfy its customers. The QMS aims to increase the customer
satisfaction by effective implication of processes.

2. Normative references

The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies. ISO 9000:2015, QMSs — Fundamentals and vocabulary

3. Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
4 Context of the organization

Organization shall monitor and review these internal and external issues. The organization shall
define the accessibility and boundaries of QMS to solve the internal and external issues, satisfy
customers needs and keep the requirements of interested parties.

5. Leadership

5.1 Leadership and commitment

5.1.1 General

Senior managers ensure that the QMS is responsible for the effectiveness of the QMS, that
quality policies and objectives are established for the QMS, and that they are relevant to the
strategic direction of the organization and integrate the QMS requirements. With that, we need to
define leadership and commitment. Organization encourage the application of process
approaches and risk-based thinking, ensure that the resources needed for your QMS are
available, and communicate the importance of effective quality control and compliance with
QMS requirements. Engage, direct and assist people in making sure that the QMS achieves the
intended results and contributes to the effectiveness of the QMS. Drive improvement, support
other relevant leadership roles, and exercise leadership in relation to responsible areas.

5.1.2 Customer focus

Top management must demonstrate leadership and commitment to customer centricity by

making sure that customers and applicable legal and regulatory requirements are identified,
understood and consistently meet. We will continue to focus on improving customer satisfaction
while identifying and addressing risks and opportunities that may affect our ability to improve
product and service compliance and customer satisfaction.
5.2 Policy

Communicating the quality policy The quality policy shall be available and be maintained as
documented information, be communicated, understood and applied within the organization and
be available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Top management needs to ensure that the responsibilities and authorities of the relevant roles
within the organization are assigned, communicated and understood. Top Management shall
assign responsibility and authority to ensure that the QMS complies with the requirements of this
international standard. Senior management ensures that the process provides the intended results,
reports on the performance and opportunities for improvement of the QMS, especially to top
management, and promotes customer focus throughout the organization. We ensure that the
integrity of your QMS is maintained as you plan and implement changes to your QMS.

6. Planning

6.1 Actions to address risks and opportunities

When planning a QMS, the organization considers issues and requirements and determines the
risks and opportunities that need to be addressed to enable the QMS to achieve the intended
results and achieve the desired effect. Need to do it. Make improvements to prevent or mitigate
unwanted effects. Organizations need to plan actions to address these risks and opportunities,
integrate the actions into their QMS, and implement processes to assess the effectiveness of
those actions.

6.2 Quality objectives and planning to achieve them

When planning a QMS, the organization considers issues and requirements and determines the
risks and opportunities that need to be addressed to enable the QMS to achieve the intended
results and achieve the desired effect. Need to do it. Make improvements to prevent or mitigate
unwanted effects. Organizations need to plan actions to address these risks and opportunities,
integrate the actions into their QMS, and implement processes to assess the effectiveness of
those actions.

6.3 Planning of changes

If the organization determines the need for changes to the QMS, the changes should be
implemented according to the plan. Organizations should consider the purpose of the change and
its possible consequences, the integrity of the QMS, the availability of resources, and the
assignment or reassignment of responsibilities and privileges.

7. Support

7.1 Resources

The general organization shall identify and allocate the resources needed to establish, implement,
maintain and continuously improve the QMS. Organizations need to identify, deliver, and
maintain the infrastructure needed to operate their processes and achieve product and service
compliance. Process Operational Environment The organization shall determine, provide, and
maintain the environment required to operate the process and achieve product and service
conformance. The organization shall determine and provide the resources needed to ensure valid
and reliable results when monitoring or measuring is used to verify the conformity of products
and services to requirements. The organization shall ensure that the resources provided are
suitable for the specific type of monitoring and measurement activities being undertaken are
maintained to ensure their continuing fitness for their purpose. The organization shall retain
appropriate documented information as evidence of fitness for purpose of the monitoring and
measurement resources.
7.2 Competence

The organization determines the required abilities of those who work under its control, which
affect the performance and effectiveness of the QMS, and such persons are competent based on
appropriate education, training, or experience. We guarantee that it is. If necessary, take steps to
acquire the required capabilities, assess the effectiveness of the measures taken, and retain
appropriate documented information as evidence of competence.

7.3 Awareness

The organization shall ensure that those who work under the control of the organization are
aware of the quality policies and associated quality goals. Contribution to the effectiveness of the
QMS, including the benefits of improved performance and the impact of violations of QMS
requirements.

7.4 Communication

The organization shall set up internal and external communications related to the QMS.

7.5 Documented information

Your organization's QMS shall include: documented information required by this international
standard that the organization has determined to be necessary for the effectiveness of the QMS.
When creating and updating documented information, organizations must ensure that
identification and description, format and media, and conformity and validity reviews and
approvals are appropriate. Management of documented Information the QMS and the
documented information required by this international standard are suitable and appropriate for
use where and when they are needed, where they are available. It shall be managed to ensure that
it exists. To manage documented information, organizations need to engage in the following
activities: distribution, access, search and use, storage and retention. Documented information of
external origin determined by the organization required to plan and operate the QMS must be
identified and managed accordingly. Documented information that is retained, as evidence of
compliance should be protected from unintended changes.
8. Operation

8.1 Operational planning and control

Organizations plan, implement, and control the processes required to meet product and service
delivery requirements, and establish measures, process definitions, and product and service
acceptance when determining product and service requirements. Establish, maintain, and retain
documented information to the extent necessary to ensure that the process was performed as
planned to demonstrate compliance with product and service requirements.

. 8.2 Requirements for products and services

The organization shall ensure that contract or order requirements differing from those previously
defined are resolved.

8.3 Design and development of products and services

Organizations need to establish, implement, and maintain appropriate design and development
processes to ensure subsequent delivery of products and services. Organizations need to
determine essential requirements for the particular type of product and service they design and
develop. Organizations need to apply controls to the design and development process.
Organizations need to ensure that design and development results meet input requirements. The
Organization shall identify, review, and control changes made during or after the design and
development of products and services to the extent necessary to ensure compliance with the
requirements is not compromised.

8.4 Control of externally provided processes, products and services

Organizations need to ensure that externally provided processes, products, and services meet
their requirements. The organization shall establish and apply criteria for assessing, selecting,
and monitoring performance and reassessing external providers based on their ability to deliver
processes or products and services according to their requirements. The organization shall retain
documented information about the actions required because of these activities and reviews.
Organizations must ensure that externally sourced processes, products, and services do not
interfere with the organization's ability to consistently deliver the compliant products and
services to its customers. Organizations need to ensure that their requirements are appropriate
before submitting them to an external provider.

8.5 Production and service provision

Organizations need to perform production and service delivery under controlled conditions. The
organization shall use appropriate means to identify results when necessary to ensure product
and service compliance. Organizations need to identify the status of results related to monitoring
and measurement requirements throughout production and service delivery. The organization
shall control the assets of the customer or a third party while it is under the control of the
organization or used by the organization. The organization shall identify, verify, protect, and
protect customer or third party assets provided for use or integration into products and services.
If a customer or third party property is found to be lost, damaged, or otherwise inappropriate, the
organization reports this to the customer or third party and documented information about what
happened. Must be maintained. The organization shall retain results during production and
service delivery to the extent necessary to ensure compliance with the requirements. Your
organization must meet the requirements for post-delivery activities related to products and
services. The organization shall review and control changes in production or service delivery to
the extent necessary to ensure continuous compliance with the requirements. The organization
shall maintain documented information that describes the results of the change review, which
approves the change, and the actions required because of the review.

8.6 Release of products and services

Organizations need to plan at the right time to ensure that product and service requirements are
met. Products and services will not be released to customers until the planned arrangements have
been fully completed, unless otherwise approved by the competent authority and, where
applicable, the customer. Organizations need to maintain documented information about product
and service releases. The documented information should include evidence of compliance with
acceptance criteria and traceability to those who approve the release.
8.7 Control of nonconforming outputs

Organizations need to ensure that results that do not meet that requirement are identified and
controlled to prevent unintended use or delivery. The organization shall take appropriate action
based on the nature of the nonconformity and its impact on product and service compliance. This
also applies to defective products and services found after the product has been delivered, during
or after the service has been provided. The organization handles nonconformity results in one or
more of the following ways to modify, separate, contain, return, or suspend the delivery of
products and services, notify customers, and approve approval under concessions. Suppose you
get. If you want to correct an incorrect result, you need to make sure that it meets your
requirements. The Organization shall retain documented information explaining the
nonconformity, the measures taken, the concessions acquired, and the authority to determine the
measures related to the nonconformity.

9. Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

Organizations need to monitor and measure, the methods of monitoring, measurement, analysis,
and evaluation necessary to ensure valid results, when to perform monitoring and measurement,
and the results of monitoring and measurement. You need to decide when to analyze and
evaluate. To. The organization shall evaluate the performance and effectiveness of the QMS. The
organization shall retain appropriate documented information as evidence of the results.
Organizations need to monitor their perceptions of how well their needs and expectations are
met. The organization shall establish a method for obtaining, monitoring, and validating this
information. The organization shall analyze and evaluate the appropriate data and information
obtained from monitoring and measurement.

9.2 Internal audit

Organizations conduct internal audits at planned intervals to obtain information on whether a

QMS that meets their own QMS requirements meets the requirements of this international
standard and is effectively implemented and maintained. It shall be carried out. The organization
shall plan, establish, implement, and maintain an audit program that includes frequency,
methods, and responsibilities, planning requirements, and reporting. This should take into
account the importance of the relevant processes, changes affecting the organization, and the
results of previous audits. Establish auditing standards and scope for each audit, select auditors to
conduct audits, ensure the objectivity and fairness of the audit process, ensure that audit results
are reported to appropriate management, and overdo it. Take appropriate corrections and
corrective actions immediately.

9.3 Management review

Top Management shall review the organization's QMS at planned intervals to ensure its
continued suitability, validity, effectiveness, and consistency with the organization's strategic
direction. Management reviews are planned and implemented taking into account the behavior of
previous management reviews, changes in external and internal issues related to the QMS,
information about the performance and effectiveness of the QMS, and the adequacy of resources.
Is needed. .. The results of the management review should include improvement options, the
need for QMS, and decisions and actions related to resource requirements. The organization shall
retain documented information as evidence of the results of the management review.

10. Improvement

10.1 General

This organization determines the opportunity to improve and set the necessary measures to take
the necessary measures to meet customer requirements, and improve customer satisfaction.
These improve the product and service to meet the requirements and future needs and
expectations, correct, prevent, or correct, improve, improve, and improve performance
management system and efficiency.
10.2 Nonconformity and corrective action

Compliance Failure, non-compliance causes, non-compliance causes, non-compliance causes,

etc. may occur if non-compliance failures, such as compliance failure. Determine the cause of
incompatibility. If a similar nonconformity is present, or if it may be necessary, the necessary
measures may be performed. If necessary, check the validity of corrective action, update risk,
and opportunity determined during the plan. Make changes to the quality control system as
needed. It is appropriate to handle the impact of incoming faults. The organization shall retain
documented information as evidence of the nature of the nonconformity and the actions taken
thereafter and because of corrective action.

10.3 Continuous improvement

Organizations need to improve the suitability, validity, and effectiveness of their QMSs.
Organizations should consider the results of analysis and evaluation, as well as the results of
management reviews, to determine if there is an opportunity or need to address it as part of
continuous improvement.

Comparison between IS0 9001 2008 and ISO 9001 2015

ISO 9001: 2008 ISO 9001: 2015

Structure contain eight clauses contain ten clauses

Context of organization Is not required Organization shall monitor

internal and external issues
and also monitor interested
 parties

Documented information Document the QMS scope

Six required procedures
objectives,

quality policy

any process the organization

determines needs to be
documented

Risk based thinking Preventative Actions Organization shall take actions

to manage the risks

Exclusions & requirements Excluding a standard Any requirement that cannot

requirement was specific to be applied may be excluded as
Product Realization long as it is justified.

Objects, outputs, products and Process Based Only The process model is
services expanded to include anything
that affects quality.
Terminology Product Products and services
Supplier External provider
Preventative actions Risks and opportunities
Documents and records Documented information