5. ISO is an independent, non-governmental
membership organization and the world's
largest developer of voluntary
International Standards.
ISO is an international standard that direct & control the organization to
achieve their goal or target, that released by International Organization for
Standardization
What is ISO ?What is ISO ?
6. International Organization for Standardization
Founded in 1946 , Switzerland
Made up of over 160 National Standards Bodies (“NSB’s”)
Almost 20,000 standards in the ISO portfolio
All standards are based on INTERNATIONAL CONSENSUS
International Organization for Standardization would have different acronyms in different
languages
English - IOS
French - OIN or Organisation internationale denormalisation
ISO standards are usually developed by its Technical Committees (“TC’s”) and Sub-
committees (“SC’s”)
ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001
Decided to give it the short form ISO.
ISO is derived from the Greek isos, meaning equal.
What ever the country, what ever the language, we are always ISO.
8. All ISO standards are reviewed every five years
Keep it current and ensure it stay up-to-date
Compatible with other management system
Responds to the latest trends
Year of
Revision
Key changes
1987 This release gained popularity across Europe however US
remained focused on other customer requirements
1994 This revision put ISO 9001 on the map across the US and was
led by auto industry
2000 Significant changes from what was termed as the elemental
approach to process approach
2008 Changes based upon gaps in the standard
2015 Moving the standard beyond process to performance and
integration with business priority through risk and
opportunity identification
9. New standard is
proposed to
relevant
technical
committee
1
Working group
of experts start
the discussion to
prepare a
working draft
2
1st
working draft
shared with
technical
committee and
with ISO CS
3
Draft shared
with all ISO
national
members , who
are asked to
comment
4 Final draft to all
ISO members
5 ISO International
Standard
6
Proposal
Stage
Preparatory
stage
Committee
stage
Enquiry
stage
Approval
stage
Publication
stage
1-2
Months
4-5
Months 10-12
Months
3-4
Months
5-6
Months
10-12
Months
10. 3 Years transition period from September 2015
11. Essential background for
the proper understanding
and implementation of
ISO 9001
Essential background for
the proper understanding
and implementation of
ISO 9001
Requirements aimed
primarily at giving
confidence in the products
and services
an organization provides,
thereby improving
customer satisfaction
Requirements aimed
primarily at giving
confidence in the products
and services
an organization provides,
thereby improving
customer satisfaction
Guidance for organizations
that choose to progress
beyond ISO 9001
requirements to address
a broader range of topics
that can lead to continual
improvement of the
organization's overall
performance
Guidance for organizations
that choose to progress
beyond ISO 9001
requirements to address
a broader range of topics
that can lead to continual
improvement of the
organization's overall
performance
ISO 9000
Three standards in the series
ISO 9001 ISO 9004
Quality management
systems—Fundamentals
and vocabulary
Quality management
systems—Fundamentals
and vocabulary
Quality management
systems—Requirements
Quality management
systems—Requirements
Managing for the
sustained success of an
organization—
A quality management
approach
Managing for the
sustained success of an
organization—
A quality management
approach
ISO 9001 are among ISO's most well known standards ever
It is implemented by more than a million organizations in some 175 countries.
All requirements of ISO 9001 are generic and are intended to be applicable to all organizations,
regardless of type, size and product provided
12. Potential benefits
The ability to consistently provide products and services that meet customer and applicable
statutory requirements and regulatory requirements
Facilitating opportunities to enhance customer satisfaction
Addressing risk and opportunities associated with its context and objectives
The ability to demonstrate conformity to specified quality management system requirements
Better process integration
Improve your evidence for decision making
Engagement of employees
Improvement of your credibility and image
14. Fitness for use
Conformance to requirements
Accuracy
Perfection
Zero Defect
Adequacy
Cost Effectiveness
“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR UPON ITS
ABILITY TO SATISFY STATED OR IMPLIED NEEDS “
15. A group of interacting, interrelated, or interdependent
elements forming a complex whole
Set of detailed methods ,procedures and routines
established or formulated to carry out a specific activity ,
perform a duty , or solve a problem
16. Quality Management
System
A System of coordinated activities which is meant to “direct”
and “control” an organization with regard to quality.
17. “ Quality management principles ” are a set of fundamental beliefs, norms,
rules and values that are accepted as true and can be used as a basis for
quality management.
18. ISO 9001:2008
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to management
6. Continual Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
ISO 9001:2015
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence – based decision making
7. Relationship management
19. The primary focus of quality management is to meet customer requirements and to strive to
exceed customer expectations.
Every aspect of customer interaction provides an opportunity to create more value for the
customer
Understanding current and future needs of customers and other interested parties contributes to
sustained success of the organization
Increased customer value
Increased customer satisfaction
Improved customer loyalty
Enhanced repeat business
Enhanced reputation of the organization
Expanded customer base
Increased revenue and market share
Benefits
21. Leaders at all levels establish unity of purpose and direction and create conditions in which people
are engaged in achieving the organization’s quality objectives.
Increased effectiveness and efficiency in meeting
the organization’s quality objectives
Better coordination of the organization’s processes
Improved communication between levels and
functions of the organization
Development and improvement of the capability
of the organization and its people to deliver
desired results
Benefits
22. The revised principle still describes the involvement of people at all levels .
It adds that it is essential for these people to be competent , empowered , and engaged to
create and deliver value .
Benefits
Improved understanding of the organization’s quality objectives
Enhanced involvement of people in improvement activities
Enhanced personal development , initiatives and creativity
Enhanced people satisfaction
Enhanced trust and collaboration throughout the organization
Increased attention to shared values and culture throughout the
organization
23. Activities
+
Resources
Input Output
Control
Process :
Any Activity that takes “ input ” and converts them to “outputs”
Process Approach :
The systematic identification and management of these activities and the
interaction between activities.
24. Example - Purchasing Process
Performance Measurements
•Delivery status – On-time, On spec, etc
•Supplier evaluation
Performance Measurements
•Delivery status – On-time, On spec, etc
•Supplier evaluation
Outputs
• Receipt of Material
on right condition
• Right Quality Right
Quantity
• Right Time
Outputs
• Receipt of Material
on right condition
• Right Quality Right
Quantity
• Right Time
Purchasing
Process
Purchasing
Process
Interactions to
•Storage
•Inspection and Testing
•Manufacturing
•Finance
Interactions to
•Storage
•Inspection and Testing
•Manufacturing
•Finance
Inputs
• Demand for
material
• Item specs and
Date
• Supplier source
• Suppliers capability
to meet our
requirements
Inputs
• Demand for
material
• Item specs and
Date
• Supplier source
• Suppliers capability
to meet our
requirements
25. Benefits
Enhanced ability to focus effort on key processes and
opportunities for improvement
Consistent and predictable outcomes through a system of
aligned processes
Optimized performance through effective process
management, efficient use of resources, and reduced cross-
functional barriers
Enabling the organization to provide confidence to interested
parties as to its consistency, effectiveness and efficiency
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 .
27. Benefits
Improved process performance, organizational
capabilities and customer satisfaction
Enhanced focus on root-cause investigation and
determination, followed by prevention and corrective
actions
Enhanced ability to anticipate and react to internal and
external risks and opportunities
Enhanced consideration of both incremental and
breakthrough improvement
Improved use of learning for improvement
Enhanced drive for innovation
Successful organizations have an ongoing focus on improvement.
28. Benefits
Improved decision-making processes
Improved assessment of process performance and ability
to achieve objectives
Improved operational effectiveness and efficiency
Increased ability to review, challenge and change opinions
and decisions
Increased ability to demonstrate the effectiveness of past
decisions
Decisions based on the analysis and evaluation of data and information are more likely to
produce desired results
29. Benefits
Enhanced performance of the organization and its
interested party
Common understanding of goals and values among
interested parties
Increased capability to create value for interested parties
A well-managed supply chain that provides a stable flow of
goods and services
For sustained success, an organization manages its relationships with interested parties, such as
suppliers.
38. The clause structure and some of the terminology have been changed to improve
alignment with other management systems standards
46. Difference between documents & records
It provides guidelines
Documents are dynamic and can be
revised
It provides guidelines
Documents are dynamic and can be
revised
It provides evidence of work done
Records cannot be changed
It provides evidence of work done
Records cannot be changed
Examples
- Procedure for production
planning
- Drawing
- Quality Standard
- Work Instruction
Examples
- Production Report
- Inspection Report
Document Record
47. Why ?
Who ?
When ?
Where ?
How ?
Evidence
Must be a book and must address every
shall
Purpose
Scope
Responsibility
Procedure
For everything linked to a procedure
For everything is a record linked to work
instruction
48. Scope of the QMS (clause 4.3)
Quality policy (clause 5.2)
Quality objectives (clause 6.2)
Criteria for evaluation and selection of suppliers (clause 8.4.1)
Mandatory Documents
49. Mandatory Records
Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
Records of training, skills, experience and qualifications (clause 7.2)
Product/service requirements review records (clause 8.2.3.2)
Record about design and development outputs review* (clause 8.3.2)
Records about design and development inputs* (clause 8.3.3)
Records of design and development controls* (clause 8.3.4)
Records of design and development outputs *(clause 8.3.5)
Design and development changes records* (clause 8.3.6)
Characteristics of product to be produced and service to be provided (clause 8.5.1)
Records about customer property (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Record of conformity of product/service with acceptance criteria (clause 8.6)
Record of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal audit program (clause 9.2)
Results of internal audits (clause 9.2)
Results of the management review (clause 9.3)
Results of corrective actions (clause 10.1)