ISO and its concepts for QMS

1. RME-085
Total Quality Management
Topic: ISO and its concept of quality management system
By:
Dr. Vinod Kumar Yadav
Department of Mechanical Engineering
G. L. Bajaj Institute of Technology and Management
Greater Noida
Email: vinod.yadav@glbitm.org

2. ISO and its concept of Quality Management System (QMS)
Need for ISO certifications [1]
1. Meet customer’s demand and ensure
Customer’s satisfaction.
2. Improve reputation to develop new
customers.
3. Improve product quality.
4. Manage and control processes
effectively.
5. Employee morale enhancement.
6. Develop healthy interaction between
employee and management.
7. Improve Efficiency.
8. Waste reduction.
9. Improve economy.
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester
2019-20, and is not intended for wider circulation.
Elements of QMS [2,3]
1. The organization’s quality policy and quality objectives
2. Quality manual.
3. Procedures, instructions, and records.
4. Data management.
5. Internal processes.
6. Customer satisfaction from product quality.
7. Improvement opportunities.
8. Quality analysis
ISO (Estd. 1947) International Organization for standardization
Worldwide federation of about 100 companies.

3. Five Clauses of QMS (Customer requirements
and Customer satisfaction)
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester
2019-20, and is not intended for wider circulation.
Continuous
improvement
Measurement,
analysis and
improvement
QMS Management
responsibility
Resource
management
Product /
service
realization
Benefits
of ISO
9000
series
Quality
improvement
Market
credibility
Customer’s
satisfaction
Healthy
competition Improved
marketability
Benefits of ISO 9000 series
General

4. ISO and its concept of QMS contd.
ISO 9000 series
(originally published 1987 by ISO (A group of 90-100 countries))
- The 9000 series (Standardized QMS) approved by over 100
countries [4].
- Based on 8 management principles
- Model for Fundamental quality concept and vocabulary.
- Provide guidelines for selection and application of each standard.
ISO9000 (1987) 3 models
ISO 9001: Model for quality assurance in design, development,
production, installation, and servicing was for companies and organizations
whose activities included the creation of new products.
ISO 9002: Model for quality assurance in production,
installation, and servicing had basically the same material as
ISO 9001 but without covering the creation of new products.
ISO 9003: Model for quality assurance in final inspection and test
covered only the final inspection of finished product, with no concern for
how the product was produced.
-------------------------------------------------------------------------------------------------
ISO 9004: Standards in quality management and quality system.
Management Principles of
ISO 9000
1. Customer focus
2. Leadership
3. Involve people
4. Process approach
5. Management system
6. Continuous improvement
7. Evidence based decision making
8. Develop good supplier relationship
ISO 9000 and 9004 are the guiding standards.
They specify what needs to be followed to
attain the targets of ISO 9001, 9002 and 9003

5. Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester
2019-20, and is not intended for wider circulation.
Evolution of ISO 9000 standards [5]
Edition Year
1 1987
2 1994
3 2000
4 2008
5 2015
1. ISO 9000:1987 (3 models) - ISO 9001, ISO 9002 and ISO 9003.
2. ISO 9000:1994 - Focused on quality assurance via preventive actions,
instead of just checking final product, and continued to require evidence of
compliance with documented procedures.
3. ISO 9001:2000
- Replaced ISO 9001, ISO 9002 and ISO 9003 of 1994 issue.
- Design and development only applicable in case of product creation.
- Monitoring and optimization of a company's tasks and activities, instead of
just inspection of the final product.
- Involvement of upper level management.
- Improved effectiveness through process performance metrics: numerical
measurement of the effectiveness of tasks and activities.
- Continuous process improvement and tracking customer satisfaction.

6. Evolution of ISO 9000 standards contd.
4. ISO 9001:2008
- ISO 9001:2000 re-narrated. Clarifications to the existing requirements of ISO
9001:2000 and some changes to improve its consistency with ISO 14001:2004 was
made.
- ISO 9001 is supplemented directly by two other standards of the family:
(a) ISO 9000:2005 Quality management systems + Fundamentals and vocabulary
(b) ISO 9004:2009 - Managing for the sustained success of an organization. + Quality management
approach.
5. ISO 9001:2015
- Management system standard helps ensure that consumers get reliable, desired
quality goods and services.
- Increased benefits for business.
- Less prescriptive than its predecessors and focuses on performance.
- Process approach with risk-based thinking.
- Apply PDCA at all levels in the organization.

7. Evolution of ISO 9000 standards contd.
Important moderations of ISO 9001:2015
- Management system standard helps ensure that consumers get reliable, desired quality
goods and services.
- Increased benefits for business.
- Less prescriptive than its predecessors and focuses on performance.
- Process approach with risk-based thinking.
- Apply PDCA at all levels in the organization.
- Implementation of high-level structure of 10 clauses.
- Emphasis on building a management system suited to each organization's specific needs.
- Involvement and accountability of top management.
- Aligning quality with wider business strategy.
- Risk-based decision for continuous improvement.
- Less prescriptive requirements for documentation.
- Inclusion of Knowledge Management principles.
- Quality Manual & Management representative (MR) are no longer mandatory.

8. ISO Clauses
1. Management responsibility.
2. Quality system.
3. Contract review.
4. Design control.
5. Document control.
6. Purchasing.
7. Purchaser supplied product.
8. Product identification and traceability.
9. Process control.
10. Inspection and testing.
11. Inspection, measuring and test equipment.
12. Inspection and test status.
13. Control of non- conforming product.
14. Corrective action.
15. Handling, storage, packaging and delivery.
16. Quality records.
17. Internal quality audit.
18. Training.
19. Servicing.
20. Statistical techniques.
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech
Mechanical Engineering at AKTU Lucknow in VIII semester 2019-20, and is not intended for wider circulation.
ISO 9000:1994 ISO 9000:2000
1. Quality Management system
General requirement, document requirement, and
quality manual record.
2. Resource Management
Competence, awareness, training, infra, working
environment.
3. Product or service realization
Planning of product realization, customer related
process, communication with customer.
4. Management responsibility
Customer focus, quality objective, quality policy, quality
management planning, internal committee etc.
5. Measurement, analysis and improvement
General requirement, monitoring, measuring, customer
satisfaction, internal audit, data analysis, continuous
improvement.

9. QS 9000 (Introduced in 1994)
- Developed with joint efforts of American
automakers: GM, Chrysler and Ford [6].
- Also adopted by several heavy truck
manufacturers in U.S.
- With QS9000, the middle certification between
ISO 9001 and ISO/TS 16949, no longer valid.
- Manufacturers can opt ISO 9001 or TS 16949.
- QS9000 is considered superseded by ISO/TS 16949,
now a standard published by IATF, thus renamed
IATF 16949:2016 (current version).
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester
2019-20, and is not intended for wider circulation.
QS 9000
Customer
specific section:
(System
requirement
unique to
automotive and
truck mfg.)
Additional
requirements:
(GM, Chrysler
and Ford)
ISO 9001 +
Automotive
requirements
Sub sections of QS 9000QS 9000 - An industry specific adaptation of ISO 9000
(Generic standard) for use in the automotive industry.
IATF: International Automotive Task Force

10. ISO/TS 16949 Quality Management System
- ISO/TS 16949: ISO technical specification (QMS)- Aims: Continual improvement,
emphasizing defect prevention and the reduction of variation and waste in the
automotive industry supply chain and production.
- It is based on the ISO 9001 standard and the first edition was published in June 1999 as
ISO/TS 16949:1999.
- It was prepared by the International Automotive Task Force (IATF – A group of
automotive manufacturers that aims to provide quality components worldwide) and the
"Technical Committee" of ISO.
- It harmonizes the country-specific regulations of QMS.
- About 30% of more than 100 automobile companies follows.
- Large Asian manufacturers have differentiated, own requirements for the QMS of their
corporate group and suppliers.
- Applies to the design/development, production and, when relevant, installation and
servicing of automotive-related products and supply chain.
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester
2019-20, and is not intended for wider circulation.

11. IATF 16949: 2016 Quality Management System
- IATF 16949:2016 (1st Ed.) – Most widely used automotive standard – based on global industry
standards set by IATF. (Evolved from TS16949 / ISO9001) : Key aspects: Innovative document and
Customer orientation. Contain the contents from previous customer specific needs [7].
- ISO/TS 16949 (1st Ed.) was originally created in 1999 by the International Automotive Task Force (IATF)
with the aim of harmonizing the different assessment and certification systems worldwide in the
supply chain for the automotive sector.
- 2nd ed. (2002) and 3rd ed. (2009): Necessary for either automotive sector enhancements or ISO
9001 revisions.
- ISO/TS 16949 (along with supporting technical publications developed by original equipment
manufacturers (OEMs) and the national automotive trade associations introduced a common set of
techniques and methods for common product and process development for automotive
manufacturing worldwide [7].
- In preparation for migrating from ISO/TS 16949:2009 (3rd ed.) to this Automotive QMS Standard,
IATF 16949, feedback was solicited from certification bodies, auditors, suppliers, and OEMs to
create IATF 16949:2016 (1st ed.), which cancels and replaces ISO/TS 16949:2009 (3rd ed.).
- The IATF maintains strong cooperation with ISO by continuing liaison committee status ensuring
continued alignment with ISO 9001.
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester 2019-20, and is not
intended for wider circulation.

12. Quality Management System (QMS)
ISO 14000
- International standard for an Environmental
Management System (EMS).
- It provides organizations with the EMS elements
that can be integrated into other management
systems to help achieve environmental and
economic goals [4].
- The standard describes the requirements for
registration and/or self-declaration of the
organization’s EMS.
- Applicable to all types and sizes of organizations
and to accommodate diverse geographic,
cultural, and social conditions.
- The requirements are based on the process and
not on the product or service.
- It does, however, require commitment to the
organization’s EMS policy, applicable
regulations, and continual improvement.
Note: The contents used in this slide is being used for academic purposes only, and is intended only for students registered in B.Tech Mechanical Engineering at AKTU Lucknow in VIII semester
2019-20, and is not intended for wider circulation.
ISO 14000: Logical sequence of events to achieve continual
improvement
Management
review
Environmental
policy
Planning
Implementation
Checking
Corrective
action

13. References:
[1] https://www.bizmanualz.com/obtain-iso-certification/what-are-10-reasons-why-you-need-iso-9001-certification.html (Accessed on
12.04.2020).
[2] https://asq.org/quality-resources/quality-management-system (Accessed on 12.04.2020).
[3] https://asq.org/quality-resources/quality-management-system (Accessed on 12.04.2020).
[4] Dale H. Besterfiled. A Text book on Quality Improvement. 9th Edition. Pearson (ISBN 10: 0-13-262441-9) pp: 2-4.
[5] https://en.wikipedia.org/wiki/ISO_9000 (Accessed on 12.04.2020).
[6] https://en.wikipedia.org/wiki/QS9000 (Accessed on 12.04.2020).
[7] https://www.iatfglobaloversight.org/iatf-169492016/about/ (Accessed on 12.04.2020).

14. Thank you