This document discusses ISO 9001:2008 quality management system standards. It provides an overview of the benefits of ISO 9001 certification for growing organizations, including improved quality, productivity, financial performance and long-term sustainability. It also summarizes the key requirements of the ISO 9001:2008 standard, including establishing documented procedures, conducting management reviews, ensuring customer focus, setting quality policies and objectives, and defining responsibilities.

1. ISO 9001:2008
Benefits for growing
organizations

2. Standards
 Unit Measurement.
1. Measuring Tapes :Ex-Meter, Kilo Meter Etc
2. Weighing Balance: Ex - Grams, Kg Etc

3. Standards
 Indian  International
Standards Standards
: ISI : ISO
Indian International
Standards Organization for
Institutes Standardization

4. Quality
 Future of the product.
 Conformance to the requirement.
 Expectation of the customer.
 Inheritant characteristics of the
product.

5. Organizations already have established
management systems
 These systems do have some or the other operating
problem
• Inability to ensure consistency in quality
 of inputs
 in processes
 of deliverables
• Ongoing confusions in employee functionalities
• Repeating mistakes
• Absence of customer satisfaction assurance
• Employee unrest
• Increasing ‘Cost of Poor Quality’ (cost incurred due to absence
of quality)
 Long term continuity can not be guaranteed with
traditional systems

6. Organizations need a Sustainable Operating
System
 A system which should be
able to
• Assure quality at all times
• Increase productivity
• Improve financial
performance
• Keep all
stakeholders, employees
and customers satisfied
• Ensure error-free operations
• Sustain in the long run!

7. ISO 9001:2000 offers a sustainable
management operating system
 ISO 9001:2000 is an internationally
recognized Quality Management System
• With the process approach, it covers all aspects of
every organization – right from procurement to
end service delivery
• It aligns businesses for long term sustainability
• Generic in nature, it can fit into any environment
 Commercial organizations – Manufacturers, service
providers
 Non Profit organizations – Trusts, Governments, NGOs
• Best of all, it is a voluntary standard
 NO legal enforcement
 One need to adopt it on will

8. The Quality Standard is a result of years of
research
 ISO (International Organization for Standardization)
• Founded in 1947
• Is a Non-Profit Organization
• More than 150 countries are developing & promoting ISO
standards as members (India is one of them)
 Till date ISO has published more than 4000 standards
 The Quality Management System – ISO 9000 is in use for
more than 18 years
• First released in 1987
• Revised in 1994 and 2000

9. ISO 9000 is actually a series of standards
Reference ISO QUALITY SERIES Type
ISO 9000:2000 Quality Management Systems - Fundamentals and Support
Vocabulary
Specifies the terminology for (9000:2000) quality
management systems.
ISO 9001:2000 Quality Management Systems– Requirements Primary
Outline requirements (9001:2000) which exhibits
where an organization must evidence a focus on
customer service and demonstrate its ability to
provide products that meet customer and applicable
regulatory requirements.
IS0 9004:2000 Quality Management System– Guidelines for Secondary*
performance improvements
*ISO (9004:2000) is not a Conformance Standard. It
is an internal quality management standard. Its
elements are not intended for external quality
assurance systems. The aim of this standard is to
monitor the effectiveness and efficiency of the quality
management system, focusing on overall performance,
improvement, and customer satisfaction.

10. ISO 9001:2000 is a certifiable standard
 The certification of ISO 9001:2000 demonstrates
• The organization’s customer focus
• Long term continuity aspect of the organization
 Before the certification body audits the system, the
organization must have
• Documented the Quality Manual and Procedures
• Evidence of system generated quality records
• Conducted the internal audits and reviews
• Ensured the smooth functioning of the system for a specific
period

11. Once certified to ISO 9001:2000, the
organization enjoys lot of benefits
 Internal Benefits
 External Benefits
• Clarity in organizational
roles, responsibilities
and authorities - Better brand image
• No repetition of errors
• Increased productivity -Improved customer trust level.
• Increased employee
satisfaction - Increased market opportunities due to
• Better supplier co- international recognition.
operation
• Establishment of proper
control over processes
• Timely availability of
critical information to
key personnel

12. Quality Management Systems –
Requirements
 1. Scope
 1.1 General
 This International standard specifies requirements for a
quality management system where an organization.
 a)Needs to demonstrate its ability to consistently provide
product that meets customer and applicable regulatory
requirements.
 b) aims to enhance customer satisfaction through the
effective application of the system, including processes for
continual improvement of the system and the assurance of
conformity to customer and applicable regulatory
requirements.

13. 1.2 Application
 All requirements of this International Standard are generic
and are intended to be applicable to all
organizations, regardless of type, size and product
provided.
 Where any requirement(s) of this International Standard
cannot be applied due to the nature of an organisation and
its product, this can be considered for exclusion.
 Where exclusions are made, claims of conformity to this
International Standard are not acceptable unless these
exclusions are limited to requirements within clause 7, and
such exclusions do not affect the organisation’s ability, or
responsibility, to provide product that meets customer and
applicable regularly requirements.

14. 2 Terms and definitions
 The following terms, used in this edition of ISO 9001 to
describe the supply chain, have been changed to reflect the
vocabulary currently used:
Supplier Organisation Customer

15. 4 Quality Management System
 The organisation shall establish, document, implement and maintain a
quality management system and continually improve its effectiveness in
accordance with the requirements of this International Standard.
 The organisation shall
a) identify the processes needed for the quality management system
and their application throughout
the organisation (see 1.2).
b) determine the sequence and interaction of these processes.
c) determine criteria and methods needed to ensure that both the
operation and control of these
processes are effective,
d) ensure the availability of resources and in formation necessary to
support the operation and monitoring of these processes,
e) monitor, measure and analyse these processes, and
f) Implement actions necessary to achieve planned results and
continual improvement of these processes.
These processes shall be managed by the organisation in accordance with
the requirements of this International Standard.

16. 4.2 Documentation requirements
 The quality management system documentation shall include
a) documented statements of a quality policy and quality
objectives,
b) a quality manual,
c) documented procedures required by this International
Standard
d) documents needed by the organization to ensure the
effective planning, operation and control of its
processes, and
e) records required by this International Standard (see
4.2.4)

17. 4.2.2 Quality manual
The organisation shall establish and maintain a
quality manual that includes
 the scope of the quality management
system, including details of and justification for
any exclusions (see 1.2),
 the documented procedures established for the
quality management system, or reference to
them, and
 a description of the interaction between the
processes of the quality management system.

18. 4.2.3 Control of documents
Documents required by the quality management system
shall be controlled. Records are a special type of
document and shall be controlled according to the
requirements given in 4.2.4.
A documented procedure shall be established to define the
controls needed
 to approve documents for adequacy prior to issue.
 to review and update as necessary and re-approve
documents.
 to ensure that changes and the current revision status of
documents are available at points of use.
 to ensure that changes and the current revision status of
documents are identified.
 to ensure that documents remain legible and ready
identifiable,
 to ensure that documents of external origin are identified
and their distribution controlled, and
 to prevent the unintended use of obsolete documents, and
to apply suitable identification to them it they are retained
for any purpose.

19. 4.2.4 Control of records
 Records shall be established and maintained
to provide evidence of conformity to
requirements and of the effective operation
of the quality management system.
 Records shall remain legible, readily
identifiable and retrievable. A documented
procedure shall be established to define the
controls needed for the identification,
storage, protection, retrieval, retention time
and disposition of records.

20. 5 Management responsibility
5.1 Management commitment
Top management shall provide evidence of its commitment to
the development and implementation of the quality
management system and continually improving its
effectiveness by
 communicating to the organization the importance of meeting
customer as well as statutory and regulatory requirements,
 establishing the quality policy,
 ensuring that quality objectives are established,
 conducting management reviews, and
 ensuring the availability of resources.

21. 5.2 Customer focus
Top management shall ensure that the customer
requirements are determined and met with the
aim of enhancing customer satisfaction ( see
7.2.3 and 8.2.1)

22. 5.3 Quality Policy
 Top management shall ensure that the Quality
Policy
 is appropriate to the purpose of the organisation,
 includes a commitment to comply with
requirements and continually improve the
effectiveness of the quality management system,
 provides a framework for establishing and
reviewing quality objectives,
 is communicated and understood within the
organization, and
 is reviewed for continuing suitability.

23. 5.4 Planning
5.4.1 Quality objectives
 Top management shall ensure that quality
objectives, including those needed to meet
requirements, for product are established at
relevant functions and levels within the
organisation.
 The quality objectives shall be measurable and
consistent with the quality policy.

24. 5.4.2 Quality management system planning
 Top management shall ensure that
 the planning of the quality management system
is carried out in order to meet the requirements
given in 4.1, as well as the quality objectives,
and
 the integrity of the quality management system
is maintained when changes to the quality
management system are planned and
implemented.

25. 5.5 Responsibility, authority and
communication
 5.5.1 Responsibility and authority
 Top management shall ensure that responsibilities
and authorities are defined and communicated
within the organization.