Project on ISO 9001:2015 MGT-408

PROJECT……………….. SEMESTER FALL-2019

Submission Date (December 18, 2019)
BY
SABAHAT RANI

Roll No.
16400920-080

MGT-408 (Total Quality Management)

BBA 7th (B)

Submitted To:
Dr. Muhammad Ajmal
Department of Management Sciences

UNIVERSITY OF GUJRAT

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Project

ISO 9001:2015

What Is An ISO 9001: 2015 Quality Management System?

ISO 9001 quality management system is a system that specifies requirement for QMS, needs to
disclose its ability to consistently provide product and services that meet customer requirements
includes process for improvement of the system aims to enhance customer satisfaction through
the effective application of the system. Based on seven quality management principles, the ISO
9001:2015 defines the way an organization operates and meets the requirements of its customers
and stakeholders:

 Customer focus
 Leadership
 Engagement of people
 Process approach
 Improvement
 Evidence-based decision-making
 Relationship management

What is the Difference between ISO 9001: 2015 and ISO

9001: 2008?

4 CONTEXT OF THE ORGANIZATION

 Identify both external and internal issues:

The new ISO 9001 standard now requires organizations to identify both issues within the
organization and outside the organization that are relevant to its context and that can help
to achieve the planned outcomes of its quality management system. In ISO 9001 2008

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more focus to solve internal issues of organization like if any problem in machines then
resolve that problems and continue the production.

5 Leadership

 Greater emphasis on leadership than management:

 ISO 9001:2015 certification requires management to have direct involvement and

ownership of the process and to ensure that the QMS is achieving its intended results and
drive continual improvement within the organization.

6 Planning

 Focus on organizational planning:

 This is a new requirement which helps businesses to identify those risks and
opportunities that are possible to effect (negatively or positively) on the procedure and
performance of their Quality Management System. In 2008 focus on planning but in
context to maintain quality but in 2015 there are more focus on planning and establish
quality objective and planning to achieve them.

 Evaluation of resources:

Organizations require to take into account both internal and external resource essentials
and abilities to implement, maintain and improve its QMS. In ISO 9001 2008 main focus
on resource management in clause 6 but in new version 2015 resources is use as sub
clause 7.1.

7 support

 Open-communication with customers:

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 There is now a requirement that these processes must include where relevant
communicating with customers in relation to the handling or treatment of customer
property and specific requirements for contingency actions. In ISO 9001 2008 internal
communication is sub clause 5.5.3 but in ISO 9001 2015 it is a sub clause 7.4.

8 Operation

 Product and services:

This clause focusing more on product and services and its and release of product
and services to the customer until the planned arrangement have been completed
satisfactorily or approved by a relevant authority or applicable by the customer. In
2008 more focus on product realization and in ISO 9001 2015 more focus on
operation planning and control.

9 Performance evaluation

In ISO 9001:2008 the main clause was measurement analysis and improvement but in
2015 this clause is dividing into two parts the first one is performance evaluation and the
second is improvement. The purpose of dividing this clause is to individual focus on
performance evaluation which include in sub clause 9.1 and improvement clause 10.

 Identifies the ‘what’ ‘how’ and ‘when’ of the monitoring and measurement:

ISO 9001:2015 now requires organizations to observe information relating to the degree
to which their needs and assumption have been fulfilled.

10 improvement

 Improvement:

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An extra requirement for organizations to address is the ‘consequences’ of non-

conformities, which is identification that not all of its processes and/or activities will
appear for the same level of risk in terms of the organization’s ability to meet its
objectives. The reason of this clause was to achieve continual improvement of suitability
and effectiveness of quality management system.

Summary (ISO 9001:2015):

The introduction clause of the ISO 9001:2015 introduce the reason, standards and key
ideas of the standard, including risk-based reasoning and the procedure approach. The
scope of ISO 9001:2015 includes determining prerequisites for a QMS of any
organization. The supporting standard referenced in ISO 9001:2015 and is crucial for its
application is ISO 9000:2015 which covers terminology and essentials. This and other
supporting make up the 9000 arrangement. The ISO 9001:2015 also describes the terms
and definitions of Quality Management System. The 4 th clause of Context of the
Organization describe that At the point when an organization implement Quality
management System (QMS), the initial step for ISO 9001 prerequisites is to insightfully
adjust your business goals and purpose with the QMS. Understand the organization and
its context. Decide external and internal issues, understand the needs and expectations of
interested parties. Determine the scope of the quality management system. Understand
Quality management system and its processes. Clause 5 of the ISO 9001:2015
requirements covers leadership and commitment. Top management must show leadership
and commitment with QMS, set up and convey a quality strategy, and guarantee duties
and authorities are communicated, assigned and comprehended. All procedures have
inputs, yields, operational control and fitting estimation and observing. The following
provision incorporates the administration. In this proviso clarify about that, the top
administration lead by their own model. Top administration must have responsibility for
the viability of their association's quality administration framework, guarantee that their
association's quality approach and quality destinations are steady with the association's
general vital course and the setting in which the association is working, lead individuals
to add to the successful activity of the framework, drive constant improvement and

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advancement and create initiative in their supervisors. The following thing is the
consumer loyalty, see every one of the things which are conveyed and which are more
should be change as indicated by the client necessities. The following thing incorporates,
the approach making process and discuss the procedure with every one of the
representatives. At that point designate the management framework show the position
and dole out the jobs and the duties to the representatives, recalling the clients constantly,
and control every one of the exercises and improve the exercises and procedure. And
develop the quality policy top management establish, implement and maintain quality
policy. Clause 6 of the ISO 9001:2015 requirements covers Organizational Quality
Management System planning and actions to address organizational risks, opportunities,
changes and quality objectives. Quality objectives and planning to achieve them and
Planning for changes. A Client communication is extensive point, impart what you offer
and what is unique in relation to other people. Discover the approaches to convey
merchandise and enterprises and afterward audit the things due to that to get ready for
further systems. In ISO 2001-2015 it is imperative to documentation of everything, in
light of the fact that it shows the grouping and framework for the presentation. Product
and improvement is significant, to battle for the new product and the advancement and
report the plans and survey these all plans and make control on that. Generation of
merchandise and convey the products and control the non-confirming products and keep
up the exhibition everything related with this condition. Clause 7 of the ISO 9001:2015
requirements covers the resources required for the establishment, implementation,
maintenance and continual improvement of the quality management system. And provide
necessary competence and awareness and also determine the internal and external
communication relevant to QMS. Provide documented information. Clause 8 of ISO
9001:2015 covers the plan and control processes needed to meet the requirements for
products and services design and development, external providers, and control of
production and service provision organization implement production and service
provision under controlled condition, release of products and services, and control of
nonconforming outputs. clause 9 of the ISO 9001 requires an organization’s QMS to
monitor, measure, analyze, and evaluate their quality management system to satisfy their
customers. Organization conduct internal audit at planed intervals to check their

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effectiveness of implementation and maintenance process. And collect reviews from

management. ISO 9001:2015 requirements for clause 10 are based around continual
improvement. Select opportunities for development, make a move against
nonconformities, execute corrective actions as vital, and continual improve quality
management system. Organization consider the result of analysis and evaluation and the
outputs from the management review to determine if there are needs that needs to
addressed as part of continual improvement.

Implementation of ISO 9001:2015 on Chenab Textile Mills:

The ISO 9001:2015 quality standard is a set of requirements that affect almost all aspects of the
operations of corporate enterprises, non-profit organizations and government entities. Companies
generally achieve increased sales and profitability by implementing ISO 9001.

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ISO 9001 sets the necessities for an organization's Quality Management System (QMS), however
a QMS is altogether different from quality control. Quality control refers to checking item or
service features to confirm they comply with necessities, while a Quality Management System is
about the management of the whole enterprise and its operational procedures.

ISO 9001 is designed for any company (in fact, for any organization) of any size and in any
industry. This wide application results in ISO 9001 Standard being somewhat wide, and its
prerequisites fairly hard to read and comprehend. The following is the implementation of ISO
9001:2015 in Chenab Textile Mills Limited.

This wide application results in ISO 9001 Standard being somewhat wide, and its
prerequisites fairly hard to read and comprehend.

Clauses 0-3: Introductory Chapters:

For textile firms, clauses 0-3 of ISO 9001:2015 are introductory chapters that not contain any
requirements.
1. Introduction
2. Scope of ISO 9001
3. Normative references
4. Terms and definitions
The Chenab Textile Mills Ltd. implements the QMS and the introduction includes information
on the quality management principles and the process approach, both of which form the basis of
ISO 9001:2015. There is also some information on how ISO 9001:2015 relates to other ISO
standards.

Clause 4: Context of the Organization

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The ISO 9001 QMS is implemented in Chenab Textiles and this section sets the prerequisites for
the establishment of the ISO 9001 Quality Management System. The "context of the
organization" is the business condition in which the organization works.

The first requirement is to distinguish external and internal strengths and weaknesses that are
significant to the organization and the ISO 9001 Quality Management System.

Next, the needs and desires of not only the customers but a wide scope of "interested individuals"
(or stakeholders) need to be determined, and how they are important to the ISO 9001 Quality
Management System.

Here the organization additionally needs to decide on the scope of the ISO 9001 Quality
Management System (and the ISO 9001 certification). While it is conceivable to reject
dimensions and certain products or services, the degree will much of the time be the whole
organization.

Finally the organization should utilize the process approach to determine the processes of the ISO
9001 Quality Management System. The Quality Management System should be actually
implemented, maintained, and consistently enhanced.

The documentation of the Quality Management System must incorporate strategies and work
directions to guarantee the successful activity and control all processes and procedures. This
documentation must be controlled to guarantee the right individuals approach current
modifications.

Records are set up and controlled to give proof of an appropriately maintained ISO 9001 Quality
Management System.

Remember that "Quality Management System" refers to incorporated management forms all
through the whole organization.

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Clause 5: Leadership
According to Textile organization, this section of ISO 9001:2015 is about the association of top
management in the ISO 9001 Quality Management System.

The first part of this clause summarizes the various responsibilities of top management with
respect to the ISO 9001 Quality Management System. Among those is the necessity that top
management coordinate the ISO 9001 Quality Management System into the operational
procedures of the organization, and adjusts objectives and policy to the organizational strategy.

Importantly, top management must take leadership with regards to customer focus, including
deciding client prerequisites, deciding related risks and tending to them, and keeping up an
attention on consumer satisfaction and loyalty.
Top management sets up its quality policy. Specific consideration is given to commitment to
meeting prerequisites and to consistent improvement, and a structure for setting up and
investigating quality goals and objectives.

Top management ensures that responsibilities and authorities inside the organization are clearly
settled. An undertaking task or job must be practiced on the off chance that it is clear who is
responsible for it.

Top management is ultimately responsible for the ISO 9001 Quality Management System
however they may appoint an ISO 9001 Management Representative who takes on several
responsibilities and obligations of the ISO 9001 Quality Management System.

The organization is utilizing good standard forms to simplify compliance. For instance
responsibilities and authorities are best established using job descriptions; a good standard
format will save much time when creating new job descriptions, when advertising positions,
when performing employee evaluations, etc.

Clause 6: Planning

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In perspective to textile firms, this part focuses on planning and the concept of risk-based
thinking.

The first part is about how the organization needs to take part in risk and opportunity management.
ISO 9001 doesn't dictate activity to address all risks and opportunities yet requires setting up a
system of assessing risks and opportunities so as to settle on an informed decision with respect to
imagine where an activity is required.

The planning is most important thing in the business which needs to be considerable, because of
that everything done in the sequence and in effective way. Actions to address the risks, simply
understanding what the risks are best capturing this in a business plan. Plan how all the elements
come together, the business plan and how it will be run, and a means of checking these things
work and the business plan is on track.

Secondly, senior management needs to build up quantifiable quality objectives and plan how to
accomplish them. Those quality objectives are basically strategic objectives of organization that
are related to product and service requirements, and also customer satisfaction. Confirm that the
objectives that an organization implement they should be SMART.

Specific

Measurable

Achievable

Realistic

Time Oriented

All above points are important when makes the quality plans and objectives of the firm.

Lastly, clause 6 tends to the planning of changes, which must be done in a systematic way.
Presently a days, everything will change, e.g: customer requirements, the demand, the style,
competitors, innovation, technology, and numerous different things. Continuously study and
research for the following stages and make due in the market to accomplish the more portion of

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the market and contend different ones. Exactly when a business changes something, the impact
of the change ought to be considered before a change is made. You should show that you have,
pondered for what reason are you changing it and what could happen when you reveal the
improvement, ensured that the QMS doesn't get impacted unfavorably, for instance something is
absurd any progressively drawn out once you have changed a method, for instance you quit
recording the amount of explanations you are doing and along these lines you don't have an
ability to review change rates, thought about what you need to achieve it (for instance
people/development, etc. Considered what changes ought to be made in the relationship to make
it go.

Clause 7: Support

In textile firms this section of ISO 9001:2015 is all about support functions: various resources,
competence and training, communication and documentation.
The first part of this clause explains the prerequisite for an organization to decide and give, in an
opportune way, resources needed to execute and improve the processes and procedures of the
Quality Management System.

Resources include individuals (HR) and their skills, just as preparing important to accomplish the
necessary abilities.
Further, the organization must distinguish, give and keep up the infrastructure expected to
accomplish the similarity of its products or services. Infrastructure incorporates structures,
equipment , transportation and communications innovation.

The organization must distinguish and deal with those human and physical factors of the
workplace expected to accomplish similarity of its products or services.

Maintenance activities of equipment, apparatus just as the workplace are a piece of this area.

The organization must take exceptional consideration of all measuring devices and appropriately

adjust them.

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Organizational knowledge is another resource that must be resolved, kept up and, critically, shared
with the goal that the organization can completely use it. Organizational knowledge is a wide-
running term, which incorporates best practices.

When tending to the required competence of its people, the organization must consider training as
well as hiring and reassignment of individuals.

Awareness is another part of clause 7. Management and staff must know about the quality policy
and relevant objectives, just as their part in the ISO 9001 Quality Management System.

Further, the organization needs to have set up internal and external communications channels.

The next clause is the creating and control of information. Records that a business should use,
have clear report control. It furthermore foresees a sensible association and for it to be avowed.
This is to stay away from anyone essentially using documents that they see fit. It gives off an
impression of being to some degree unnecessary when you are a SME as there may be a little
gathering or even 1 of you. For greater associations this is amazingly noteworthy with the
objective that chronicles are used fittingly and changes that have been intertwined for the
extraordinary don't get lost when someone else doesn't get them or ousts them. The composed
procedure is so significant, for the reason to keep up the record and the other one vital thing is to
refresh the things as indicated by the adjustments in the market.

The following thing which considered under the ISO 9001-2015, that is the control of
documentation. Organizations are required to guarantee that they ensure whoever needs an
archive/format approaches it and it is correct one. There is additionally an update that heaps of
business archives have classified information, for example, addresses, costs (which in the hands
of contenders is unhelpful), secure data about a customer's site (which could be utilized
inappropriately in an inappropriate hands).

Last but not least, clause 7 tends to documents and records. Basically, the organization must
control its documents and records to guarantee that the ideal individuals have the present form of
the right document available. Records must be kept for various activities.

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Clause 8: Operation

The textile firms in this section, the ISO 9001:2015 standard sets the prerequisites for the
procedures expected to accomplish the product or service. This is how the product or service is
designed, produced, tested, handled, shipped, etc.

Emphasis is put on how the organization comprehends, communicates and meets customer

requirements, and what it does if customer requirements change. Design and development
reviews, confirmation, and validation must be planned for at the very beginning of the design
and improved process. This clause additionally addresses the purchasing of products and services
and outsourcing. Controls incorporate supplier evaluations, selection, disqualification and
receiving inspections.

The clause indicates a few controls for the actual production and service provision, ranging from
work instructions to QC inspections. There are prerequisites for the identification of components
and the ability of following a product or service back, just as for handling products that have its
place to customers or suppliers.

Then the standard tends to how the final product or service can in the long run be released to the
customer.
At last, this clause tends to cases in which output is found as not conforming with requirements,
that include the cases for which such a nonconformance is just recognized only after the product
has been delivered or the service provided.

Clause 9: Performance Evaluation

According to textile firms, this section of ISO 9001:2015 is all about measuring and evaluating.

Measurement and monitoring activities expected to guarantee conformity and accomplish

improvement must be defined, planned and executed. Measuring and monitoring enables the

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organization to manage by fact, not by presumption. The business must monitor and identifying
the information relating to customer perception  whether the organization has fulfilled customer
requirements.

Further, this section centers around the analysis of data rising from monitoring and measurement
actions. There are a few strategies to analyze data, including statistically measurable techniques,
however the result of the analysis is designed to pick up the essential information to settle on
reality based choices.

Internal auditing of the organization must be done at prearranged pauses to comprehend if the
ISO 9001 Quality Management System is functioning as arranged. Audits are keep an eye on the
system, not on people.

Finally, management reviews should be completed.

Mentions to external issues as well as internal ones (however this was constantly suggested).
Efficiency of acts made to address risk and opportunities.

The outputs required same as before. Guarantee that there is:

chance to improve
changes required for the QMS to accomplish this
assets. There is currently a more clear reference to keeping records to show the survey occurred
rather than minutes of it. The management audits spread a wide scope of subjects identified with
the ISO 9001 Quality Management System, running from customer satisfaction to the act of
suppliers. The consequence of management assessments are choices and activities with respect to
improvements, changes and source needs.

Clause 10: Improvement

The textile firms implement the ISO 9001:2015 and according to the last section ISO 9001:2015
needs firms to govern and recognize opportunities for improvement.

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There is a prerequisite for the improvement of products and services with an eye to present and
future market needs. This clause likewise incorporates necessities with respect to the
modification of nonconformities. To begin with, organizations must respond to
the nonconformity. Besides, the firms must participate in corrective action to to address the basic
reasons for existing issues, just as take part in preventive activity to address circumstances that
could prompt potential problems.

To wrap things up, the business must plan and deal with the processes for the continual
improvement of the ISO 9001 Quality Management System. The firm must utilize the quality
policy, aims, internal audit consequences, analysis of data, corrective and preventive act and
management analysis to enable continual improvement.

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