General Awareness On Iso 9001

INTEGRATED CONSULTANCY SERVICES
(A Consultancy and Training Firm on Management System and Technical Standards)
GENERAL AWARENESS TRAINING FOR ISO- 9001:2015 QMS

ISO 9001:2015 QUALITY MANAGEMENT SYSTEM REQUIREMENTS (QMS)
.
CHANGING CONCEPT OF QUALITY

By the term 'QUALITY' we conventionally mean 'The Best'. But now the meaning is shifting to fulfillment of
customer expectations - both stated & obligatory, implied and achievement of full customer satisfaction
leading to customer delight
WHY QUALITY?
 Quality reduces cost. (In long term)
 Poor quality results in losses.
 Customer expects better quality.
 Competitors are constantly working for better quality.
 We all like quality.
 Quality improves business and Mitigate Risk.
 It improves teamwork and work culture.
 Total quality means win/win situation (i.e. win-win for both the parties)
WHAT IS ISO?
“The International Organization for Standardization (ISO)” is the specialized- international agency for
Standardization, at present comprising the national standard bodies of over 175 + countries including India is
a member country.
The result of ISO Technical Sub-committee (TC176),Geneva, Switzerland in the field of Quality System
Standardization is published as ISO-9000 family of Standards.
Many people tend to think that ISO-9001 Certification is guarantee of the Product Quality. But it is not so.
Quality of end product is certainly the final objective of the exercise ISO-9001 ensures that the systems and
procedures of the organization are capable of producing consistently the expected quality of product / service.
It means that every individual of the organization - be it a workmen or a Manager - will try his best to fulfill
customers expectations & delight!
There are three main standards in ISO 9OOO family of standards of QMS
ISO-9000:2015 Describes fundamentals of quality management systems and specifies the terminology for
Quality Management Systems- Definition
ISO 9001:2015 (A Certification series) specifies requirements for Quality Management Systems for use
where an organization’s capability to provide products that meet customer and applicable statutory &
regulatory requirements needs to be demonstrated as per standard.
Corporate Office : 257 ; LANDMARK ; SILVASSA-KHANVEL ROAD ; SILVASSA ; UT OF

DADRA AND NAGAR HAVELI ; INDIA ; PIN : 396 230 ; Contact No: 09714204382 ; E-mail :
[email protected]
ISO 9004:2009 Provides guidance on quality management system, Performance Improvement including the
processes for continual improvement, which contribute to the satisfaction of an organization’s customers and
other interested parties.
ISO 19011:2011 criteria for Internal Auditors in Quality , Environment and other Management System
About Principals and Structures of ISO-9001:2015 QMS
7NOS. QUALITY MANAGEMENT PRINCIPLES OF ISO 9001:2015 QMS.
1 Customer Focus
2 Leadership
3 Engagement of People
4 Process Approach
5 Improvement
6 Evidence-based Decision Making
7 Relationship Management
STRUCTURE OF QUALITY MANAGEMENT SYSTEM REQUIREMENTS

( Main Clauses of ISO 9001:2015)
Clause 1 to 3 General Requirements
Clause 4.0 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 process
Clause 5. Leadership
5.1 Leadership and commitment
5.1.1 General

[email protected]
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

Clause 6. Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them

6.3 Planning of changes
Clause 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 process
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
7.5.3 Control of documented information
Clause 8 Operation
8.1 Operational planning and control

[email protected]
8.2 Requirements for products and services

8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided process, products and services
8.4.1 General
8.4.2 Type of extent of control
8.4.3 Information for external providers
8.5 Production and services provision
8.5.1 Control of production and services provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customer or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
Clause 9. Performance Evaluation
9.1 Monitoring ,measurement, analysis and evaluations
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
Clause10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
WHY AUDITS?
Audits are carried out to find out whether work is being done as per the Requirements of the ISO
9001:2015 Standard / Customers requirements…? Its main purpose is to find out non-conformities
[email protected]
in the system, So as to facilitate corrective action to eliminate them and to initiate preventive action
to continually improve the product, processes, risk analysis & Quality Management System.
Following benefits will be achieved if the above requirements are met:

 Consistency in Quality of product and services.
 Scope for increase in export to 175 Countries.
 Knowledge and understanding about customer requirements & expectations.
 Competitive edge in the market.
 Efficient use of 9 M's "Men, Money, Machine, Material, Methods, Millieus ( other
Resources), Measurements, Marketing, Management etc.
 Reduction in 5 R's "Rework, Recall (from customer), Regrets, Returns and
Rejections".
 Improved customer confidence in our organizational excellence.
Yellow background highlighted : Addition in New Version ( 2015 Standard)

Grey background highlighted : Modification in New Version ( 2015 Standard )
Prepared by :
Er.SIDDHARTHA SANKAR ROY M.Tech ( IIT-Delhi) ,AMIE

INTERNATIONAL TRAINER, CONSULTANT and LEAD AUDITOR ( QMS,EMS,FSMS,EnMS,NABL,OHSAS)
for Technical and Management Systems

[email protected]

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INTEGRATED CONSULTANCY SERVICES

(A Consultancy and Training Firm on Management System and Technical Standards)

GENERAL AWARENESS TRAINING FOR ISO- 9001:2015 QMS

CHANGING CONCEPT OF QUALITY

Corporate Office : 257 ; LANDMARK ; SILVASSA-KHANVEL ROAD ; SILVASSA ; UT OF

About Principals and Structures of ISO-9001:2015 QMS

7NOS. QUALITY MANAGEMENT PRINCIPLES OF ISO 9001:2015 QMS.

6 Evidence-based Decision Making

STRUCTURE OF QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Corporate Office : 257 ; LANDMARK ; SILVASSA-KHANVEL ROAD ; SILVASSA ; UT OF

5.1.2 Customer focus

5.2.2 Communicating the quality policy

5.3 Organizational roles, responsibilities and authorities

6.2 Quality objectives and planning to achieve them

7.1.4 Environment for the operation of process

7.1.5 Monitoring and measuring resources

7.1.6 Organizational knowledge

7.5 Documented information

8.1 Operational planning and control

8.2 Requirements for products and services

Following benefits will be achieved if the above requirements are met:

Yellow background highlighted : Addition in New Version ( 2015 Standard)

Er.SIDDHARTHA SANKAR ROY M.Tech ( IIT-Delhi) ,AMIE

Corporate Office : 257 ; LANDMARK ; SILVASSA-KHANVEL ROAD ; SILVASSA ; UT OF

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