The document is a presentation on ISO 9000, a family of quality management standards aimed at ensuring products and services meet customer requirements and promote continual improvement. It details the history, principles, certification process, and benefits of ISO 9001:2015, as well as guidelines for auditing management systems under ISO 19011:2011. The presentation emphasizes the importance of risk-based thinking and the shift from individual responsibility to holistic organizational accountability in quality management.

1. ISO 9000 - Quality
Management
Presentation By Kumuda J

2. CONTENTS
 INTRODUCTION
 ISO 9000- FAMILY OF STANDARDS
 HISTORY OF ISO 9000
 QUALITY MANAGEMENT PRINCIPLES
 ISO 9001:2015
 ISO 19011:2011
 CERTIFICATION
 BENEFITS OF ISO 9001:2015
 REFERENCES

3. INTRODUCTION
 ISO (International Organization for Standardization) has
published 22027 International Standards (As on 5th Feb, 2018).
 ISO 9000 is one among the most popular standards of ISO.
 ISO 9000 is
 A series of Quality Management System (QMS) standards,
 Provide guidance and tools for companies and
organizations,
 To ensure that their products and services consistently
meet customer’s requirements,
 For Consistent improvement in quality.

4. ISO 9000 vs. ISO 9001
 ISO 9000 is a series/family of standards.
 ISO 9001 is a standard within the family.
 The ISO 9000 family of standards also contains an
individual standard named ISO 9000.
 ISO 9001 is the only standard within the ISO 9000 family
to which organizations can certify.

5. ISO 9000-FAMILY OF STANDARDS
ISO 9000 is a series of quality management system
standards which includes the following:
 ISO 9000:2015 - This specifies the fundamentals and
vocabulary used in all these ISO 9000 standards.
 ISO 9001:2015 - This is the Requirement standard that
 provides directions on how to achieve quality
requirements,
 meet the significant regulatory requirements,
 improve satisfaction for all stakeholders (customers,
shareholders etc)
 have a method of identifying and implementing the
improvements.

6.  ISO 9004:2009 - This provides Guidelines for maintaining
the success of Quality Management Systems through evaluation
and performance improvement.
 ISO 19011:2011 - This sets out Guidance for any organization
on auditing management systems.
 Internal audits are used to confirm and improve the
effectiveness of a quality management system,
 External audits are generally the audits of suppliers but can
also be done by any interested third parties.
 ISO 9001 is the only auditable standard for which third party
certification and auditing organizations provide independent
confirmation that the requirements of that standard are met.

7. Older ISO 9000 quality standards
 ISO 9000:1994 originally had three QMS models:
 ISO 9001:1994- Model for quality assurance in design,
development, production, installation, and servicing.
This was for companies and organizations whose
activities included the creation of new products.
 ISO 9002:1994- Model for quality assurance in production,
installation, and servicing.
It had basically the same material as ISO 9001 but
without covering the creation of new products.

8.  ISO 9003:1994 Model for quality assurance in final
inspection
test covered only the final inspection of finished
product, with no concern for how the product was
produced.
 All of these were combined into ISO 9001:2000, which
was updated to ISO 9001:2008 and is now ISO
9001:2015 with the major difference in risk-based
thinking.

9. HISTORY OF ISO 9000
 Originally published in 1987 by the International
Organization for Standardization (ISO).
 Underwent major revision in 2000 with the concept of
process management.
 Revised again in 2008 which re-narrated ISO 9001:2000
with few clarifications to the existing requirements of ISO
9001:2000.
 Current versions of ISO 9000 and ISO 9001 were published
in September 2015

10. QUALITY MANAGEMENT PRINCIPLES
 The ISO 9000:2015 and ISO 9001:2015 standards are based on
seven quality management principles that senior management
can apply for organizational improvement.
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management

11. 1. Customer focus
 Statement: The primary focus of quality management is to
meet customer requirements and to strive to exceed customer
expectations.
 This principle includes,
 To recognize the needs of existing and future customers
 Aligning organizational objectives with customer needs and
expectations
 Meet customer requirements
 Assess customer satisfaction
 Handle customer relationships

12.  Statement: Leaders at all levels establish unity of purpose and
direction as well create conditions in which people are
engaged in achieving the organization’s quality objectives.
 This principle includes,
 Establish a vision and direction for the organization
 Set demanding goals
 Model organizational values
 Establish trust
 Train and empower employees
 Identify employee contributions
2. Leadership

13.  Statement: Competent, empowered and engaged people at all
levels throughout the organization are essential to enhance its
capability to create and deliver value.
 This principle concentrates on,
 Ensure that people’s skills are used and valued
 Make people responsible
 Enable participation in continual improvement
 Evaluate individual performance
 Facilitate learning and sharing of knowledge
 Enable open discussion of problems and constraints
3. Engagement of people

14.  Statement: Consistent and predictable results are achieved
more effectively and efficiently when activities are
understood and managed as interrelated processes that
function as a coherent system.
 This includes,
 Supervise activities as processes
 Assess the capability of activities
 Identify linkages between activities
 Prioritize improvement opportunities
 Organize resources effectively
4. Process approach

15.  Statement: Successful organizations have an ongoing focus
on improvement.
 This includes,
 Develop organizational performance and capabilities
 Align advanced activities
 Empower people to make improvements
 Measure improvement consistently
 Celebrate the improvements
5. Improvement

16.  Statement: Decisions based on the analysis and evaluation of
data and information are more likely to produce desired
results.
 This principle includes,
 Guarantee the accessibility of accurate and consistent data
 Use suitable methods to analyze data
 Make decisions based on analysis
 Balance data analysis with practical experience
6. Evidence-based decision making

17.  Statement: For sustained success, an organization manages
its relationships with interested parties, such as suppliers.
 This principle includes,
 Identify and select suppliers to manage costs, optimize
resources, and create value
 Establish relationships considering both the short and
long term
 Share expertise, resources, information, and plans with
partners
 Collaborate on improvement and development activities
 Recognize supplier successes.
7. Relationship management

18. ISO 9001:2015
 ISO 9001 is the requirement standard of the ISO 9000 family
of standards.
 It outlines the guidelines that an organization must follow in
order to implement and maintain a Quality Management
System.
 The latest version of ISO 9001 standard was introduced in the
month of September 2015.
 Hence, it is referred to as ISO 9001:2015.

19. Changes from
ISO 9001:2008 to ISO 9001:2015
 High Level Structure of 10 clauses is implemented. Now all new
standard released by ISO will have this High level structure.
 There is greater emphasis on the measurement of inputs into
processes and their outputs.
 Examples of inputs would be labor, raw materials, data,
specifications, etc.
 The output must be checked that it is of good quality

20.  The emphasis is on “Risk Based Thinking” which
effectively replaces “Preventive Actions” as it is no longer
mentioned.
 The Context of the Organization is used and includes all
Interested Parties whose expectations and requirements
must be considered in an organization's products and
services.
 The Management Representative is no longer required
and Quality is now the responsibility of the entire
organization.

21.  The Interested Party is now extended beyond customers to
include suppliers, employees, shareholders, the community,
etc.
 The terms “document” and “records” have been replaced
with the term “documented information”
 Documented Information is defined as “the information
that the organization has to control and maintain“.
 The information can therefore be in any format from
paper to electronic. There is also no longer a need for a
quality manual.

22. How is the ISO 9001:2015 Standard
STRUCTURED?
 ISO 9001:2015 Quality management systems
Requirements is a document of approximately 30 pages
which is available from the national standards organization in
each country.
 The purpose of the quality objectives is
 to determine the conformity of the requirements
(customers and organizations),
 facilitate effective deployment and
 improve the quality management system.

23.  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 quality
management system.
 Clause 0-3 – Introduction and scope of the standard
 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

24. ISO 19011:2011- Guidelines for
auditing management systems
 ISO 19011:2011 provides guidance on auditing management
systems,
 including the principles of auditing,
 managing an audit programme and conducting management
system audits,
 guidance on the evaluation of competence of individuals
involved in the audit process, including the person managing
the audit programme, auditors and audit teams.

25.  ISO 19011:2011 is applicable to all organizations that need to
conduct internal or external audits of management systems
or manage an audit programme.
 The application of ISO 19011:2011 to other types of audits is
possible, provided that special consideration is given to the
specific competence needed.
 Two types of auditing are required to become registered to
the standard:
 External Audit: auditing by an external certification
body and
 Internal Audit: auditing by internal staff trained for this
process.

26.  It is considered healthier for internal auditors to audit
outside their usual management line, so as to bring a
degree of independence to their judgments.
 The aim is a continual process of review and assessment
 to verify that the system is working as it is supposed to;
 to find out where it can improve; and
 to correct or prevent problems identified.

27. CERTIFICATION
 International Organization for Standardization (ISO) does not
certify organizations itself.
 Numerous certification bodies exist, which audit organizations and,
upon success, issue ISO 9001 compliance certificates.
 Although commonly referred to as "ISO 9000" certification, the
actual standard to which an organization's quality management
system can be certified is ISO 9001:2015.
 Many countries have formed accreditation bodies to authorize the
certification bodies.
 Both the accreditation bodies and the certification bodies charge
fees for their services.
 Refer https://www.slideshare.net/kumudajayaram/iso-in-general
for Accreditation and certification.

28.  Certification bodies themselves operate under another quality
standard, ISO/IEC 17021, while Accreditation bodies operate
under ISO/IEC 17011. (IEC- International Electro-technical
Commission
 An organization applying for ISO 9001 certification is audited
based on an extensive sample of its sites, functions, products,
services and processes.
 The auditor presents a list of problems (defined as
"nonconformities", "observations", or "opportunities for
improvement") to management.
 If there are no major nonconformities, the certification body will
issue a certificate.

29.  Where major nonconformities are identified, the organization
will present an improvement plan to the certification body.
 Once the certification body is satisfied that the organization
has carried out sufficient corrective action, it will issue a
certificate.
 An ISO 9001 certificate is not a once-and-for-all award, but
must be renewed at regular intervals recommended by the
certification body, usually once every three years.
 There are no grades of competence within ISO 9001: either a
company is certified or it is not.
 In this respect, ISO 9001 certification contrasts with
measurement-based quality systems.

30. BENEFITS OF ISO 9001:2015
 By assessing their context, organizations can define who is
affected by their work and what they expect. This enables
clearly stated business objectives and the identification of
new business opportunities.
 Organizations can identify and address the risks associated
with their organization.
 By putting customers first organizations can make sure they
consistently meet customer needs and enhance customer
satisfaction. This can lead to more repeat custom, new clients
and increased business for the organization.

31.  Organizations work in a more efficient way as all their
processes are aligned and understood by everyone. This
increases productivity and efficiency, bringing internal
costs down.
 Organizations will meet necessary statutory and
regulatory requirements.
 Organizations can expand into new markets, as some
sectors and clients require ISO 9001 before doing
business.

32. REFERENCES
 https://www.iso.org/files/live/sites/isoorg/files/arc
hive/pdf/en/iso_9001-2015_-_how_to_use_it.pdf
 https://www.iso.org/files/live/sites/isoorg/files/arc
hive/pdf/en/iso_9001_-
_moving_from_2008_to_2015.pdf
 http://asq.org/learn-about-quality/iso-
9000/overview/overview.html
 https://www.lennoxhill.co.uk/regulations/what-is-
iso-9000.html

33. THANK YOU!
Next Presentation is on
ISO 22000