The document provides an overview of ISO 9001 and key concepts for quality management systems. It discusses seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. It also covers the purpose and benefits of documentation, objectives, scope, audits and continual improvement in ISO 9001 certified organizations. The goal of ISO 9001 is to help organizations meet customer and regulatory requirements through an effective, systematic approach to management.

1. ISO 9001 Fundamentals
Presentation by :
Ravikeerthi Rao
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2. Management Systems
Business Concepts
• Win- Lose
• Lose – Win
• Win- Win
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3. Management Systems
• The purpose of a business is to create and keep a customer.
• Traditionally, we have been told that “Customer is King” and we have to
tune our business to suit them.
• – and that not satisfying them is likely to lead to business failures.
• That means, to please the customer, sometimes, the supplier may get in
to ‘Lose-Win” situation, by accepting the lose.
• If we follow this concept or philosophy, the business will not run very long.
• So, the best concept is “ Win-Win”.
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4. Management Systems
• Management Systems means “what an organization does to manage
its processes and activities” in order to:
– Acquire the customers
– Fulfil customers’ requirements
– Comply with regulations
– Enhance customer satisfaction
– Achieve continual improvement of its performance
• ISO 9001 is the only standard that specifies the requirements of a
good (quality) management system.
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5. Management Systems
Definitions:
•Management : coordinated activities to direct and control an organization
•Quality management is the act of managing all activities and functions
needed to maintain a consistent level of excellence in an organization,
product or service.
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6. Management Systems
• The use of the word “quality” creates an anomaly and tends to
represent the ISO 9001 standard as simply a tool to meet customer
quality requirements and nothing else.
• Then, what is ISO 9001 Standard?
• Actually, ISO 9001 standard is a guide to manage the company nicely
and systematically.
• In other words, this standard is not a : “Product Quality Management”
Guide.
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7. Management Systems
What is quality?
•There are many meanings for “quality”. Some of them are :
• Excellence
• Superiority
• Worth
• Distinguishing
• Elegant
• Good
• ---
• Characteristic
• Trait
• Classic
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8. Management Systems
• In context of (for) ISO 9001 standards, take meaning of “Quality” as
“Good”.
• Hence, we have to take – “Quality Management System” as “Good
management system”.
• Meaning of ‘Quality’ in ISO9001 is similar to one used bellow:
–He posses good qualities
–Qualitative activities
–Quality time
–Management is of good quality
–People are of good quality
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9. Management Systems
• When we say a particular company / organization is doing good and
running successfully ?
• Companies run successfully only when they are managed nicely, and
those companies only grow well.
• So, How to run the company successfully?
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10. Management Systems
• Basically, the Owner has to take care of the following points / activities to
manage the company systematically and to achieve the success.
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11. Business Point 1- Customer Focus
• Every business, needs customers, and until you get them, you don't really
have a business.
• Organizations depend on their customers.
• Hence, the primary focus of good management should be to understand
current and future needs of the customer, deliver it ,and at the same time
strive to exceed their expectations.
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12. Business Point 2 - Leadership
• The business should have clear goals & objectives, and its employees
actively involve in achieving those objectives.
• “The management / Leaders” should encourage and develop a culture
and environment with in the organisation in which employees do what
needs to be done to satisfy customers.
• For this, ensure better communication between all levels and functions of
the organization.
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13. Business Point 3 – People Engagement
• Employee engagement is the emotional commitment employees have
toward their organization, and it can affect productivity and profit.
• The most effective way to achieve business success is “by involving
people” across all levels of the organization.
• Ensuring everyone is familiar with “the organization’s activities and how
they fit together” will ultimately improve efficiency.
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14. Business Point 4 – Good Approach
• First work out what activities / processes you need in order to create your
product / provide the service.
• Then, have a consistent ways to do and manage those activities, rather
than ad hoc 'making it up' and/or just being reactive.
• For example, you have to decide what are the tasks (process), how and
where they relate, in what sequence it should be done, what resources
and inputs you need, and how to do them in order to arrive at the result
you want.
• This management strategy is referred as Process Approach
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15. Business Point 4 – Process Approach
• The benefits of the process approach are :
- increased ability to embrace new opportunities,
- organisational flexibility, and
- improved performance.
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16. Business Point 5 – Continues Improvement
• Great processes reduce costs, improve consistency, eliminate waste and
promotes continuous improvement.
• Keep trying to “continually improve” processes to ensure that :
• it is efficient by the way of using the least amount of resources, and
• increased productivity.
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17. Business Point 6 – Good decision making
• Management should use suitable information / facts / data when making
decisions -- as opposed to opinions, feelings, knee jerk responses,
implusive reactions, 'gut instinct' etc.
• A logical approach to “decision making, based on data and analysis”, is
good business sense.
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18. Business Point 7- Managing Relationship
• Sustained success is more likely to be achieved when an organization
“manages relationships” with its customers, suppliers, employees,
unions, bankers, or members of the general public.
• Once you have gained new customers, it will be possible to build a
long-term relationship with them to ensure repeat business.
• It's significantly easier and cheaper to do business with existing
profitable customers than find new ones.
• A focus on customer service will help retain your most valuable
customers.
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19. Management Principles
• These seven points referred in previous slides are called as Management
Principles (QMPs) in ISO 9001 standards and a management can apply
them to run their organization successfully.
• “These principles” are fundamental norms and rules that can be used as a
basis for good management.
• So, what is Principle?
• One of the definitions of a “principle” is that it is a theory or rule that has a
major influence on the way in which something is done.
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20. Management Principles
To sum up, these seven good management principles are:
– QMP 1 – Customer focus
– QMP 2 – Leadership
– QMP 3 – Engagement of people
– QMP 4 – Process approach
– QMP 5 – Improvement
– QMP 6 – Evidence-based decision making
– QMP 7 – Relationship management
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21. How is the standard structured?
ISO 9001:2015 Structure
•ISO 9001:2015 (the most recent version of the standard) is made up of a
number of different sections, each concentrating on the requirements involved in
different aspects of a good management system.
• Clause 0 to 3 – Introduction about the Standard, and scope of the QMS
• Clause 4 – Context of the organization
• Clause 5 – Leadership
• Clause 6 – Planning
• Clause 7 – Support
• Clause 8 – Operation
• Clause 9 – Performance evaluation
• Clause 10 – Improvement
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22. Company Policy
What is a Policy?
•A ‘Policy’ is a predetermined course of action, which is established to
provide a guide toward accepted business strategies and objectives by
the Organisation or its governing body.
•From good policy we get the expectations of our owners / managers
about what we are doing and – just as important – why.
•In other words, it is a direct link between an organization’s ‘Vision’ and
their day-to-day operations.
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23. Example of Quality Policy
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24. Company Policy
• Some other types of policies are:
– 1) Refund policy (ex: No-Questions-Asked Refund Policy – it
increases the trust)
• Some of the examples of organisational policies are:
– an enterprise may follow a policy of selling its products only
on a cash basis ,or
– may adopt a policy of employing only local people, or
– may have a policy not to employ any person over 60 years of
age.
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25. Quality policy
• Quality policy indicates our commitment and focuses on what is
important to us as an organization.
• To achieve these commitments the organisations set the action plan -
that is called “objectives”.
• Policies and procedures ensures consistency in practice and helps to
maintain product quality.
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26. Procedure
What is a Procedure?
•A procedure is a way of doing something, especially the usual or correct
way.
•The ultimate goal of every ‘Procedure’ is to provide the employee with a
clear and easily understandable plan of action required to carry out or
implement a policy.
•Procedures and process dictate “where,” “when” and “how” policies will
be executed.
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27. Procedure
What information included in the procedure manual?
•Procedure Manual will define: who does what and when they do it.
•A well-written procedure will help eliminate common misunderstandings
by identifying job responsibilities and establishing boundaries for the
employees.
•And, good procedures actually allow managers to control activities in
advance and prevent the organization (and employees) from making
costly mistakes.
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28. Scope
• To manage the company , one of the first step is to identify the activities of
the organization.
• All the activities / functions may not directly affect the output or
performance or even make the company fail in delivering what is asked by
the customer.
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29. Scope
• In a Buying office like us, what are the functions / activities we do :
– Sourcing & Merchandising
– QA
– Logistics Control
– Transport – pick-up & drop of customers, ticket booking, etc.
– Hospitality – including hotel booking
– Training the exporters
– Market Intelligence - Political, Social, Commercial, Business policies of
Government, foreign policies, raw material price trend, Socio – cultural
factors, economic factors, technology factors, political factors, etc.
– Marketing,
– Sourcing and developing vendors for / and behalf of suppliers,
– Finance – billing, collection, taxes, banking, etc.
– Development of software – similar to ERP
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30. Scope
• Trying to streamline or improve the process, all at a time, may not give
desired result in short time.
• More over, we may lose the focus, and the core process may not get the
due attention.
• The scope is a vital part of the quality manual, as it defines which are the
operations / process the Top management want to focus under intended
QMS.
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31. Scope
• The QMS can include the whole organization, or, specifically identified
functions of the organization, or, specifically identified sections of the
organization, or one or more functions across a group of organizations in
the Scope.
• It is up to us to decide which one is the core process for us and then focus
on them / target them to achieve our business objective of “Win-Win”.
• These identified core process are referred as “Scope” of QMS.
• Hence, in our organization we have taken “Sourcing, Merchandising, QA
& Logistics” under the scope for Management System implementation.
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32. Objective
• For effective management, the solving of day-to-day problems is not
enough.
• What is required is the proper assessment of all kinds of activities and
operations taking place in the organization.
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33. Quality Objective
• KPI / Quality Objective is to measure the performance of the
organisation, to identify whether the organisation has met the
requirements of the product / service and the customer.
• They also provide a scope for continual improvement.
• Quality objectives must reflect the quality policy, should be logical, and
align with the overall business plan, including customer expectations.
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34. Management Objectives
• “Reports (Matrix)” are used to understand and communicate system’s
performance relative to company’s objectives.
• This data will instantly give top management the ability to assess
overall performance of the organisation at any given point in time
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35. Documentation
• Supporting an organization’s aims and objectives, a good(quality)
management system (QMS) - documents the processes, procedures,
and responsibilities for achieving company policies and objectives.
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36. Documentation
The following are some of the main objectives of an organization’s
documentation,
a) Communication of Information
b) Evidence of conformity
- provision of evidence that “what was planned, has actually been
done”.
c) Knowledge sharing
- to disseminate and preserve the organization’s experiences. A typical
example would be a technical specification, which can be used
as a base for design and development of a new product.
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37. Documentation
What documentation hierarchy is adopted?
•It is common practice to follow this hierarchy:
– Level 1: Policies - key system objectives, Quality approach and responsibility
– Level 2: Procedures - methods (Who, What, Where, How and When)
– Level 3: Work Instructions - description of processes (Internal - QAP)
– Level 4: Work Instructions - description of processes (External)
– Level 5: Forms, Data and Records - evidence of conformance
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38. Audit
Why Audit?
•Evaluation of the conformance and effectiveness of the management system
with applicable standard(s) requirements, as well as
•Evaluation of the effectiveness of the management system to ensure the
organization is continually meeting its specified objectives, and
•Evaluation of the ability of the management system to ensure the
organization meets applicable statutory, regulatory and contractual
requirements, in order to determine if the facility / organisation can be
recommended for Certification
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39. Summary
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40. Focus of ISO 9001 Standard
• All organizations have a way of doing things.
• For some it rests in the mind of the Owner/leaders, for others it is
translated onto paper and for most it is a mixture of the two.
• The logical step is to improve these working method and make them
systematic, more efficient and more effective – optimizing performance
across the whole organization.
• ISO 9001 standard is concerned with the way an organization carries out
its business and controls its processes..
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41. Benefits of ISO 9001:2015 QMS
The ISO 9001 standard encourage the focus on those parts of the system
that serve the achievement of management objectives.
Implementation of ISO 9001 QMS will enable the organization to:
• Operate more efficiently
• Meet statutory and regulatory requirements
• Reach new markets
• Identify and address risks
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42. Benefits ISO 9001 QMS
Do you aim for continuously improving your performance ?
•Adopting a good(quality) management system is a strategic decision for
an organization and supports the aim of continuously improving
performance.
Or
Are you aiming for sustainable development?
•ISO 9001:2015 certification is an integral part of any organization’s
efforts towards the broader aim of sustainable development.
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43. 43

44. Reference :
•https://www.slideshare.net/IvanBendiola/characteristics-of-a-good-policy
•https://ebrary.net/7761/management/policy
•https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/pub100080.pdf
•https://www.universalclass.com/articles/business/writing-effective-policy-and-
procedure-manuals.htm
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45. Reference :
•You can preview the freely available sections of the standard on ISO’s Online Browsing
Platform (www.iso.org/obp).
•http://www.pqm-online.com/assets/files/lib/books/holye2.pdf
•http://registrar.utm.my/kualalumpur/files/2016/12/8.-ASQ-A-Risk-Based-Thinking-Model-
for-ISO-9001-2015.pdf
•https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/iso_9001-2015_-
_how_to_use_it.pdf
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