Session 07-10

Quality Standards:

Introduction to ISO 9000 Series, Certifying bodies Accreditation agencies,

Necessity for certification & Certification process, Benefits of certification
Study of ISO 9000 Series clauses, such as Quality Management System,
Management Responsibility, Resource Management, Product Realization,
Measurement, Analysis and Improvement.

Purpose & Benefits of TQM:

Introduction to TQM, Need, Importance, purpose & benefits of TQM.

External & Internal Customer-Supplier relationship
SIBM-MBA III -TQM-Session 07-10
What is ISO 9000 Certification Introduction to ISO 9000 Series

ISO 9000 is defined as a set of international standards on quality management and quality
assurance developed to help companies effectively capture the Process & document the
quality system elements needed to maintain an efficient quality system called QMS – Quality
Management System. The most after thought few series are:

ISO 9001: 2015: Quality Management
OHSAS 18001: Occupational Health &
Safety Management System Compliance
ISO 14001: Environment Mgmt system
ISO 37001: Anti-bribery management systems
ISO 31000 – Risk Management
ISO 27001–Information Security Mgmt System
ISO 26000 – Social Responsibility
ISO 28000 – Security Management
ISO 22008 – Food Safety Management
SO/IEC 17025 – Testing and calibration laboratories
SO 13485 – Medical devices
ISO 4217 – Currency codes
ISO 3166 – Country codes
ISO 8601 – Date and time format
SO/IEC 27001 – Information security management

SIBM-MBA III -TQM-Session 07-10

What is ISO 9000 Certification Introduction to ISO 9000 Series

These standards are not specific to any one particular industry and can be applied to any
Industry, Segment, Organizations of any size as well, ISO 9000 can help a company :

• Satisfy its customers- Interms of Quality-OTD-Price

• Meet & Comply regulatory statutory requirements,
• Achieve continual Improvement

It’s the Passport to qualify Orders with national & International Customers.

It’s also considered to be a basic but mandatory first step-base level of a quality system.
SIBM-MBA III -TQM-Session 07-10
History & Revisions Introduction to ISO 9000 Series

Customer
ISO9000:2000 Focus ISO 9000 was first published
Leadership in 1987 by the International
ISO9000:2008 Organization for
Relationship Standardization –ISO.
ISO9000:2015 Management
Quality A specialized international
Engagement agency for standardization
Management of People composed of the national
Principles standards bodies of more
Evidence than 160 countries.
based
decision The standards underwent
Process major revisions in 2000 &
making approach 2008.
The most recent versions of
Improvement the standard,
ISO 9000:2015 &
ISO 9001:2015 - Sept

SIBM-MBA III -TQM-Session 07-10

9000 Certification - Major advantages Introduction to ISO 9000 Series

1. QMS improves your working system – Interms of Quality-OTD-Price

2. Organization becomes system dependent rather than person dependent.

3. Professionally implemented ISO 9001 standard eliminates business losses.

4. ISO 9001 certification comes handy & help-full in getting overseas business.

5. ISO certification is basic required at various Government, Private, National, International

tenders.

6. ISO 9001 certificate improves corporate & social image of your organization
SIBM-MBA III -TQM-Session 07-10
 Certifying Bodies – Accrediting Bodies Introduction to ISO 9000 Series

Who in reality grant’s the ISO 9001 certification ?

Is it ISO – The International Standards Organization ?

Certainly No

It’s a Registrar or certification body - CB will be the one to grant certification.

Therefore while choosing the Registrar one should make sure that they too are accredited.

Registrar should be a member of the International Accreditation Forum- IAF

ask for the credentials and verify online before zeroing down on a CB or Registrar.

Registrar need’s to be ISO / IEC 17021:2015 certified.

SIBM-MBA III -TQM-Session 07-10
Necessity for certification & Certification process-Video ISO 9000

SIBM-MBA III -TQM-Session 07-10

Certifying Bodies – Accrediting Bodies Introduction to ISO 9000 Series

List of Leading Accrediting Bodies:

1.TUV , USA & Germany

2.Bureau Veritas, USA
3.National Quality Assurance, USA
4.Intertek, USA
5. SAI Global, Canada

India Present Accrediting Bodies:

1.DNV GL Business Assurance Ltd

2.TUV India Pvt Ltd
3.Bureau Veritas India Pvt Ltd
4.TUV Rhineland India Pvt Ltd
5.TUV SUD India Pvt Ltd
6.SGS India Pvt Ltd
7.Bureau of Indian Standards
SIBM-MBA III -TQM-Session 07-10
Necessity for certification & Certification process ISO 9000

For Better growth

To Enhance Productivity
decisions
growth, profitability savings
For Value Matrix of OTD

To Boost Employee To Reduce |

Performance QMS eliminate waste
ISO 9000

To Provide value to Money
for the Customer
To Improve efficiency of
Team & Product
For Extended Customer
Serviceability

SIBM-MBA III -TQM-Session 07-10

Clauses of ISO 9000 ISO 9000 – QMS

Act
• Quality Management System,
Management Responsibility,
• Resource Management, Check
• Product Realization,
• Measurement, Analysis and
Improvement. Do

Plan

SIBM-MBA III -TQM-Session 07-10

Clauses of ISO 9000 ISO 9001 Clauses - PLAN ISO 9000 – QMS

1 Scope
2 Normative references
3 Terms and Definitions
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership And Commitment For The Quality Management System
5.1.2 Customer Focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities How to address risk in ISO 90001
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
SIBM-MBA III -TQM-Session 07-10
 Introduction to ISO 9000 Series

SIBM-MBA III -TQM-Session 07-10

 Introduction to ISO 9000 Series

SIBM-MBA III -TQM-Session 07-10

Clauses of ISO 9000 ISO 9001 Clauses - DO ISO 9000 – QMS

7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating documented information
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control & 8.5 Productions and service provision
8.2 Requirements for products and services & 8.6 Release of products and services
8.3 Design and development of products and services & 8.7 Control of nonconforming outputs
8.4 Control of externally provided processes, products and services
SIBM-MBA III -TQM-Session 07-10
Clauses of ISO 9000 ISO 9000 – QMS

ISO 9001 Clauses - CHECK

9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.2 Customer Satisfaction
9.2 Internal Audit
9.3 Management Review

ISO 9001 Clauses - ACT

ISO 9001 Clauses - ACT

10 Improvement
10.1 General
10.2 Nonconformity in ISO 9001
10.2 What is Non-conformance?
10.2 Corrective Action
10.3 Continual Improvement SIBM-MBA III -TQM-Session 07-10
Structure of ISO 9001 Standard: External & Internal Customers
 External & Internal Customers

Sample Quality Manual

Mythical Airlines
Mythical True Value Metrology
a department of
Mythical Airlines
Legendary Safety, Service, Speed and Strength Around the World from
Smallville, Kansas, USA

BUSINESS OPERATING MANUAL

(QUALITY MANUAL)

Revision Date: 2020-09-14

Approved By: Director, Mythical True Value Metrology Date: 2020-09-14

This document is authenticated in whole by verification of the above digital signature, using the signer's public key.
This is a complete re-issue of the manual with all previous changes incorporated, therefore there are no revision marks. This version replaces all prior issues.

This manual is the property of Mythical True Value Metrology. It must not be reproduced in whole or in part or otherwise disclosed without prior written consent from Mythical True Value Metrology.

The official controlled copy of this manual is the digitally signed PDF document on the Mythical True Value Metrology network server and visible to all authorized users. All printed copies, and all electronic copies and versions except the
ones described above, are considered uncontrolled copies used for reference only.

This document is controlled as a single entity, as any change – however slight, even a single character – to any part of the document by definition changes the entire document. For this reason, as well as the fact that the concept of “page”
varies with the publication format, page-level revision is not practiced with this or any other Mythical True Value Metrology document.

SIBM-MBA III -TQM-Session 07-10

 Thank You
End of Session 10

SIBM-MBA III -TQM-Session 07-10