International Journal of Management, Technology And Engineering ISSN NO : 2249-7455

A Study of Quality Management System ISO 9001:2015

with Industrial Application
Ratnesh Kumar Sharma, Laksh Mathur*, Krishan Matoliya,
Department of Mechanical Engineering, Poornima Group of Institutions, Jaipur. INDIA
(lakshmathur09@gmail.com)

Abstract:
ISO 9001 is the quality administration standard issued by the worldwide standard
association. It gives the fundamental technique of how the quality administration ought to be
finished. The new form i.e. ISO 9001:2015 manages the amendment of past variant ISO
9001:2008. It had presented in September 2015 and a large portion of the businesses or
association tails it.
ISO 9001:2015 manages the modification of preventive activities with hazard
administration. It portrays the effect on the venture and show fundamental changes in quality
administration framework. It depends on the PLAN-DO-CHECK-ACT philosophy and gives
the procedure arranged way to deal with evaluating the structures, obligations and
techniques required to accomplish better quality administration framework in an association.
There are a few changes which are presented in this adaptation of ISO 9001 these are as per
the following presentation of new phrasing, rebuilding a portion of the data, an emphasis on
hazard based reasoning to upgrade use of process approach, enhanced appropriateness for
administrations and expanded initiative necessities.
Keywords: ISO 9001:2015, QMS, Risk Based Management

Introduction:
ISO 9001 is the quality administration standard issued by the worldwide standard association.
It gives the Fundamental technique of how the quality administration ought to be finished.
The new form i.e. ISO 9001:2015 manages the amendment of past variant ISO 9001:2008. It
had presented in September 2015 and a large portion of the businesses or association tails it.
ISO 9001:2015 manages the modification of preventive activities with hazard administration.
It portrays the effect on the venture and show fundamental changes in quality administration
framework. It depends on the PLAN-DO-CHECK-ACT philosophy and gives the procedure
arranged way to deal with evaluating the structures, obligations and techniques required to

accomplish better quality administration framework in an association. There are a few

changes which are presented in this adaptation of ISO 9001 these are as per the following
presentation of new phrasing, rebuilding a portion of the data, an emphasis on hazard based
reasoning to upgrade use of process approach, enhanced appropriateness for administrations
and expanded initiative necessities.
2. Literature Review:
New form of ISO 9001 standard issued in 2015 replaces preventive activities with hazard
administration. The article talks about the allure of this change, its causes, and also new
difficulties for endeavors and quality supervisors. The principle issue with preventive
activities is recognizable proof of potential individualities. The ISO 9001 standard does not

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demonstrate where to search for them, nor what ought to be system of the recognizable proof.
Two fundamental markers of hazard level are likelihood of event and outcomes of the
occasion. Likelihood can be resolved subjectively or quantitatively. In the event of large scale
manufacturing or successive event of dissected marvels it is conceivable to survey likelihood
in view of figures. [1]
Both in the generation and non-creation endeavors new quality focuses on that depend on the
corporate procedure are yearly set up and are then partitioned into the primary and side
corporate procedures as the key lattices of those procedures. While breaking down and
improving the business forms, there are changes of use of those techniques and strategies.
The principle drive for such changes are the external condition changes especially being
developed of the data advances, expanded request on nature of the items or administrations
and additionally necessities on quick supplies or shortening of the item advancement
times.[2]
The point of the paper is to distinguish chosen targets and substance of arranged changes in
ISO 9001: 2015 with specific accentuation on the requirement for chance evaluation in
association administration. The paper exhibits the current prerequisites of ISO 9001: 2008
and arranged changes to 2015 version. The examination strategy embraced was a similar
investigation of ISO 9001 standard of 2008 release and a draft of the arranged version of
2015.The second piece of the examination depicts trademark highlights of hazard and its
evaluation techniques that will enable acting substances to meet the prerequisites of ISO
9001: 2015 concerning presentation of hazard administration framework.
Common hazard that may happen amid business action is a circumstance on the work
showcase, a cheat, account holders' indebtedness, an exhibit, a strike, a thievery, lost
machines fundamental in the creation procedure, e.g., because of terminate, administration
botches, lost a worker/representatives of key significance for organization activity, modern
surveillance, disrupt, generation surrenders (e.g. arrangement withdrawal), a difference in the
proprietorship structure, outside impact of intrigued outsiders, hazard associated with
interests, FICO score, resources liquidity and other. [3]
Speculation testing is a critical action of confirmation based research. An all around worked
up theory is a large portion of the response to the examination question. For this, both
information of the subject got from broad survey of the writing and working learning of
essential factual ideas are alluring. This paper talks about the strategies for working up a
decent theory and measurable ideas of speculation testing. ISO 9001:2015 will enable
associations to guarantee their clients reliably get great items and administrations, which thus
will realize numerous advantages, including fulfilled clients, administration, and workers –
and benefits. ISO 9001:2015 indicates the prerequisites for a compelling quality
administration framework and not simply daze adjustment to necessities [4]
A modification of a few ways for the Quality voyage is displayed: from Quality Gurus and
Total Quality Management (TQM) models to the ISO 9000 International Standards Series.
Since ISO 9001:2008 is presently in the update procedure to the normal ISO 9001:2015
rendition, an investigation is rolled out of the proposed improvements and the fundamental
reasons and the effects predicted on the in excess of 1.3 Million affirmed associations. This
update ought to be a stage towards TQM and mirror the progressions of an undeniably mind
boggling, requesting and dynamic condition, while guaranteeing that going along associations

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can give congruity items and administrations that fulfill their clients. Real advantages are
normal, for example, less accentuation on documentation and new/strengthened
methodologies: thought of Organizational Context and (important) Stakeholders, Risk Based
reasoning and Knowledge Management [5].

Implementation of ISO 9001:2015:

So as to help associations to have a full comprehension of the new ISO 9001:2015, it might
be helpful to have an understanding on the correction procedure, how this update mirrors the
information sources got from clients of the standard, and the thought given to advantages and
effects amid its improvement. Preceding the initiation of a modification (or change) to an
administration framework standard, a "Defense Study" is set up to display a case for the
proposed venture which diagrams subtle elements of the information and data sources used to
help its contentions. In connection to the improvement of ISO 9001:2015 client needs were
recognized from the accompanying:
ISO Annex SL gives a typical structure, content, terms and definitions for administration
framework guidelines.
The after effects of a formal "Efficient Review" on ISO 9001:2008 that was performed by the
individuals from ISO/TC 176/SC2
Input from the ISO/TC 176/SC2 Working Group on Interpretations.
A broad around the world "Client Feedback Survey" on ISO 9001 was performed by ISO/TC
176/SC 2
The Justification Study recognized the requirement for an update to:
Adjust to a changing world
Improve an association's capacity to fulfill its clients
Give a steady establishment to what's to come
Mirror the undeniably complex situations in which associations work
Guarantee the new standard mirrors the requirements of all important invested individuals
Line up with other administration frameworks.
User Groups:
Current Users of ISO 9001:2008
This user group is defined as having completed or being in the process of implementing ISO
9001:2008, regardless of whether they are certified or not, or whether they intend to be
certified or not.
New users
These are defines as the organization that are either beginning to use ISO 9001:2008 or ISO
9001:2015 for the first time or is the potential user of the standard in the future.

Users of Industry Sector Schemes in view of ISO 9001:2015

The groups that are defined as those using quality management system programs based on
ISO 9001:2015 that include additional requirements, which either can be certified or
accredited under the guidance of a particular Industry Sector Scheme.

Clauses of ISO 9001:2015:

Scope: This first clause gives the details about the scope of the standard.

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Normative References: ISO 9001, Quality Management System- fundamentals and

vocabulary is referenced and provide valuable guidance.
Terms and Definition: Every one of the terms and definitions are contained in ISO
9001:2015 – Quality Management – Fundamentals.
Context of the organization: This clause underpins the rests of the standard. It gives
organization the chance to understand the effects of factors that supports QMS.
The starting point is to identify the all the external and internal issues related to the QMS.
Then after that we have to include all the stakeholders and their relevance to the QMS.
At the end by using process approach, we will need to show how we establish, maintain,
implement and continually upgrade the QMS in relation to the standard.
Leadership: This clause tells us about the top level management, which is the group of
individuals who direct and control the organization at the top most level.
They need to make sure that the QMS and its requirements and very well incorporated in the
organization’s process and policies.
They also have to focuses on the customer satisfaction and how it could be enhanced. The
SWOT analysis should be taken care by the top management levels.
Top management can assign authorities and responsibilities but in the end they are the one
who takes the final decision.
Planning: This clause focuses on how an organization plans actions against risk and
opportunities.
These actions to address risks and opportunities must be analyzed, monitored, managed and
should be spread throughout the organization.
All in this entire clause covers the Planning of Changes; this has to be done in systematic
manner. For example, organization should consider who is involved, what changes were
made and what are the consequences of those changes are?
Support: This clause tells us about getting right resources, to the right resources and the right
infrastructure in place to meet the requirements.
Organizational knowledge relating to the QMS is also covered in this clause.
Operation: This clause is all about the execution and operation of plans and processes that
enable the organization to meet customer requirement.
This clause also covers the requirements for product and services. There is need for
communicating with customers which could be useful to achieve future goals.
Finally in the end there is a section which deals with the post-delivery activities which
includes maintenance and repair.
Performance Evaluation: This is all about the measuring and evaluating QMS to ensure that
it is effective and it helps in continue up gradation.
This can be takes place by actively seeking out of the information on customer perception by
conducting surveys and feedbacks regarding products and services.
Improvement: This clause requires organizations to determine the opportunities for
continual improvement of the QMS.
There are some actions that are required that cover the handling of corrective actions. There
are a few activities that are required that cover the treatment of remedial activities. Right off
the bat associations need to respond to the dissentions and make a move. Also they have to
recognize whether comparative dissentions exist or could conceivably happen.

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Conclusion:
Subsequent to experiencing all the data about ISO 9001:2015 we can state that this standard
is in charge of the smooth working of the business as far as quality. In this report we
essentially center on how the procedure necessities obligation, specialist and exercises,
errands and so on and comes about with supporting target confirm.
The issue matter of hazard administration in an undertaking is as yet a delicate zone of
administration, contrasted with chance administration in a bank or an insurance agency, for
which exercises inside the extent of hazard administration are a result of directions. The goal
was to see if these techniques are usable for the activities to address chance that came about
because of the new prerequisites of the ISO 9001:2015 - Quality administration framework.

References:
[1] Slawomir Wawak, 9th global Quality Conference, June 2015, “Preventive Actions versus
Hazard Management in ISO 9001:2015”.
[2] Lucie Hrbackova, Journal of Systems Integration 2016, “Risk based reasoning in the
generation procedure utilizing the strategies for quality confirmation lattice and FMEA
Process”.
[3]International Journal of Managerial Studies and Research (IJMSR) Volume 3, Issue 10,
October 2015, PP 14-23, “Possibilities and Methods of Risk Assessment under ISO 9001:
2015”.
[4] SendilMourougan, Dr. K. Sethuraman, IOSR Journal of Business and Management
(IOSR-JBM) Volume 19, May. 2017), “Understanding and Implementing Quality
Management System”.
[5]Luís Miguel Fonseca, International Journal for Quality Research, “From quality masters
and TQM to ISO 9001:2015: an audit of a few quality ways”.
[6] ISO 9001:2008 Quality management systems – requirements, ISO, Geneva 2008.
[7] ISO 31000:2009 Risk management – principles and guidelines, ISO, Geneva 2009.
[8] Department of the Navy (2009). Time Critical Risk Management. Washington.
[9] Cooper D., Grey S., Raymond G., & Walker P. (2005). Project Risk Management
Guidelines.Chichester: Wiley & Sons.
[10] Enterprise risk management: tools and techniques for effective implementation. Institute
of Man-agreement Accountants, Montvale 2007.

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