This document provides an overview of an ISO 9001:2015 Awareness Program. The purpose of the program is to increase awareness of ISO 9001:2015 and promote self-improvement and improvements to an organization's quality management system. The program covers background information on ISO, the ISO family of standards, quality management principles, ISO 9001:2015 requirements, and more. Key topics include the process approach, management principles like customer focus and continual improvement, ISO 9001 clauses, documentation requirements, and the PDCA cycle used in ISO management systems. The program aims to help participants better understand ISO 9001:2015 and how to implement or improve their organization's quality management system.

1. ISO 9001:2015
Awareness Program

2. Purpose of Program
➢ Awareness of ISO 9001:2015.
➢ Self Improvement
➢ Improvements in routine working
➢ To improve the health of
organization’s Quality Management
System

3. FAQ?
➢What is ISO?
➢From where it comes?
➢How it is helpful for us?
➢How it works?
➢What we have to do?

4. Contents Of Program
➢ Background of ISO
➢ ISO Family
➢ Quality Management Principle
➢ Process Approach
➢ ISO 9001:2015 Overview
➢ Detail Of Different Clauses Of
ISO 9001:2015

5. What is ISO 9001:2008?
➢ ISO = International Organization for
Standardization
➢ ISO has representation from 162 countries
and has issued many standards
➢ ISO 9001:2008 is a model for a quality
management system.

6. Who created the standard?
➢ International Organization for
Standardization - Geneva
➢ Standards created in 1987
▪ To eliminate country to country differences
▪ To eliminate terminology confusion
▪ To increase quality awareness

7. ISO 9000:2005 Consists of 3 Areas
➢ ISO 9000:2005 Quality Management Systems:
fundamentals and vocabulary
➢ ISO 9001:2008 Quality Management Systems –
Requirements (required for certification)
Management responsibility Resource
management Product/service realization
Measurement, analysis, improvement
➢ ISO 9004-2009 Quality Management Systems –
Guidelines for performance improvement

8. Generic standards
ISO 9001 is a generic standards.
Generic means that the same standards can
be applied:
➢to any organization, large or small,
whatever its product or service,
➢in any sector of activity, and
➢whether it is a business enterprise, a public
administration, or a government department.

9. Generic standards (cont.)
Generic also signifies that
➢no matter what the organization's scope of
activity
➢if it wants to establish a quality
management system, ISO 9001 gives the
essential features

10. Certification and registration
➢ Certification is known in some countries as
registration.
➢ It means that an independent, external
body has audited an organization's
management system and verified that it
conforms to the requirements specified in the
standard (ISO 9001).
➢ ISO does not carry out certification and
does not issue or approve certificates,

11. Accreditation
➢ Accreditation is like certification of the certification
body.
➢ It means the formal approval by a specialized body -
an accreditation body - that a certification body is
competent to carry out ISO 9001:2008 certification in
specified business sectors.
➢ Certificates issued by accredited certification bodies
- and known as accredited certificates - may be
perceived on the market as having increased
credibility.
➢ ISO does not carry out or approve accreditation.

12. Certification not a requirement
➢ Certification is not a requirement of ISO
9001.
➢ The organization can implement and take
benefit from an ISO 9001 system without
having it certified.
➢ The organization can implement them for the
internal benefits without spending money
on a certification programme.

13. Certification is a business
decision
➢ Certification is a decision to be taken for
business reasons:
➢ if it is a contractual, regulatory, or market
requirement,
➢ If it meets customer preferences
➢ if it will motivate staff by setting a clear goal.

14. Ten Steps to ISO Registration
2. Select the appropriate standard
1. Set the registration objective
3. Develop and implement the quality system
4. Select a third-party registrar and apply
5. Perform self-analysis audit
6. Submit quality manual for approval
7. Pre-assessment by registrar
8. Take corrective actions
9. Final assessment by registrar
10. Registration!

15. What is a Quality Management
System?
➢A Quality Management System is a
web of interconnected processes
that are used to manage a
business.

16. Operating Cycle of ISO.
➢ The Plan – Do – Check – Act (PDCA) cycle is the
operating principle of ISO's management system
standards
➢ Plan – establish objectives and make plans (analyze your
organization's situation, establish your overall objectives
and set your interim targets, and develop plans to
achieve them).
➢ Do – implement your plans (do what you planned to).
➢ Check – measure your results (measure/monitor how far
your actual achievements meet your planned objectives).
➢ Act – correct and improve your plans and how you put
them into practice (correct and learn from your mistakes
to improve your plans in order to achieve better results
next time).

17. ISO 9001:2008
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT
SYSTEM
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT
SYSTEM
Measuremen
t, analysis
and
improvement
Measuremen
t, analysis
and
improvement
Produc
t
Product
Input
Output
Managemen
t
responsibilit
y
Resource
manageme
nt
Resource
manageme
nt
Clause 5Clause 6
Clause
8
Clause 7
Requirement
s
Product
realizatio
n
Satisfaction
Value adding activities
Information flow
Customer
s
Customers

18. Inputs
With What?
(Materials / Equipment)
How?
(Methods / Procedure)
Measur
e
WHO?
Special Skills? / Competence?
Outputs
Process
Linkages
Objective
s and
Targets
Proces
s
PROCESS REQUIREMENTS

19. Management Principles
➢ A Quality Management Principle is a
comprehensive and fundamental rule or
belief, for leading and operating an
organization, aimed at continually improving
performance over the long term by
focusing on customers while addressing
the needs of all stakeholders.

20. 8 Management Principles
➢ Principle 1 : Customer Focus
➢ Principle 2 : Leadership
➢ Principle 3 : Involvement Of People
➢ Principle 4 : Process Approach
➢ Principle 5 : System approach to management
➢ Principle 6 : Continual Improvement
➢ Principle 7 : Factual approach to decision making
➢ Principle 8 : Mutually beneficial supplier
relationships

21. Principle 1 : Customer Focus
➢Organizations depend on their customers &
therefore should understand current & future
customer needs, should meet customer
requirements & strive to exceed customer
expectations

22. Principle 2 : Leadership
➢ Leaders establish unity & direction of the
organization. They should create & maintain
the internal environment in which people can
become fully involved in achieving the
organization's objectives.

23. Principle 3 : Involvement Of
People
➢ People at all levels are the essence of an
organization and their full involvement
enables their abilities to be utilized for the
organization's mutual benefit.

24. Principle 4 : Process Approach
➢ The application of a system of processes within
an organization, together with the identification
and interaction of these processes, and their
management to produce the desired outcome,
can be called “Process Approach”

25. Principle 5 : System approach to
management
➢ Identifying, understanding & managing
interrelated processes as a system
contributes to the organization's
effectiveness & efficiency in achieving its
objectives.

26. Principle 6 : Continual
Improvement
➢Continual Improvement of the organization's
overall
performance should be the primary driver of the
organization’s Quality Management System.
Continuous
Improvement
Continual Improvement

27. Principle 7 : Factual approach to
decision making
➢ Effective decisions are based on the analysis
of data & information

28. Principle 8 : Mutually
beneficial supplier
relationships
➢ An organization & its suppliers are
interdependent, and a mutually beneficial
relationship enhances the ability of both to
create value

29. Clauses of ISO 9001-2008
➢ 1.Scope
➢ 2.Normative References
➢ 3.Term & Definitions
➢ 4.Quality Management System
➢ 5.Management Responsibility.
➢ 6.Resources Management
➢ 7.Product Realization
➢ 8.Measurment,Analysis and Improvement

30. SCOPE OF STANDARD
1. Scope
❑ General
❑ Application
2. Normative reference
3. Terms and definition
e.g., Supplier Organization Customer

31. QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
1. General requirements
➢Document, implement, maintain and
continually improve
➢Identify and determine sequence and
interaction of processes
➢Determine criteria and methods needed
➢Ensure availability of resources
➢Monitor, measure and analyze processes
➢Implement actions to achieve planned
results

32. QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
2. Documentation requirements
➢Management system documentation
➢Quality Manual
➢Control of documents
➢Control of records

33. QUALITY SYSTEM
DOCUMENTATION STRUCTURE
1st Level
Quality Manual
2nd Level
Procedures
3rd Level
Work
Instructions
◆Machine
instructions
◆Computer inputs
◆Detailed work
instructions
4th
LevelTechnical Data
◆International
standards
◆Computer operating
manuals
Policy and
ObjectivesWhat the company wishes to
achieve
How the company
implements its policy
Structured to reflect process
flow of events
Detailed instructions
How to complete
a job or task

34. MANAGEMENT RESPONSIBILITY
1. Management commitment
2. Customer focus
3. Quality policy
➢Must be documented
➢Must be used for setting objectives
1. Planning
➢Document objectives- Must be Measurable
➢Quality management system planning

35. MANAGEMENT RESPONSIBILITY
5. Responsibility, authority and
communication
➢Responsibility and authority
➢Management representative
➢Internal communication

36. MANAGEMENT RESPONSIBILITY
6. Management Review
➢General
➢Review input
➢Review output

37. RESOURCE MANAGEMENT
1. Provision of resources
2. Human resources
➢General
➢Competence, awareness and training
3. Infrastructure
4. Work environment

38. PRODUCT REALIZATION
1. Planning of product
realization
2. Customer-related
processes
➢ Determination of requirements related to the
product
➢ Review of requirements related to the product
➢ Customer communication

39. PRODUCT REALIZATION
3. Design and development
➢Planning, inputs, outputs, systematic
reviews, verification and validation, control
of changes
3. Purchasing
➢Supplier evaluation and selection
➢Relevant purchasing information
➢Verification of purchased product
- receiving, source

40. PRODUCT REALIZATION
5. Production and service provision
➢Controlled conditions including product
characteristics, work instructions (as
necessary), suitable equipment, monitoring and
measuring devices, monitoring and
measurement, and release, delivery and post-
delivery activities
➢Validation of processes when no other method
➢Identification and traceability of product and it’s
status
➢Care of customer property
➢Preservation of product

41. PRODUCT REALIZATION
6. Control of monitoring and
measuring devices
➢Calibrated or verified where necessary
➢Adjusted and re-adjusted as
necessary
➢Identified to enable calibration status
➢Safeguarded from invalid adjustment
➢Protected from damage and
deterioration

42. MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
1. General
2. Monitoring and measurement
➢Customer satisfaction
➢Internal audit
➢Monitoring and measurement of
processes
➢Monitoring and measurement of product

43. MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
3. Control of nonconforming product
4. Analysis of data
5. Improvement
➢Continual improvement
➢Corrective action
➢Preventive action

44. Any Questions or
Query?

45. Thank
s Varinder Sandhu
Abhived Bhardwaj
Balram Sharma