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Sr.
No.
PRINCIPLES ISO/FDIS 9001: 2015 APPROACH
1.
Principle �C 1
Customer focus
Meet customer needs and expectations
determine levels of customer satisfaction /
dissatisfaction. Strive to exceed customer
expectations
2.
Principle �C 2
Leadership
Establish unit y of purpose and engage
people in achieving quality objectives
3.
Principle �C 3
Engagement of
people
Focus on competency empowered and
engaged people in delivering value. Identify
and manage human factors of the work
place.
4.
Principle �C 4
Process approach
Systematically identify and manage the
process employed. Understand activities
and manage it as interrelated processes to
get consistent predicted results
Seven principle of
ISO 9001:2015

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PLAN DO CHECK ACT
and corrective
improvement
review
Control of
Nonconforming
outputs
Release of
products and
services
Production of
goods and
provision of
services
Documented
information
Control of
external
provision of
products,
processes and
services
Communication
QMS and its
processes
Management
Design and
development of
product and
services
AwarenessPlanning of
changes
Roles,
responsibilities
and
authorities
Scope of
management
system
ContinualInternal audit
Requirements
for products
and services
Competence
Quality
objectives and
planning
Quality policy
Needs &
Expectations of
interested parties
Nonconformity
action
Monitoring,
measurement,
analysis and
evaluation
Operations of
planning and
control
Resources
Actions to
address risk
and
opportunity
Leadership and
commitment
Understanding
the
organization
and its context
10 Improvement9 Performance
and evaluation
8 Operation7 Support6 Planning5 Leadership
4 Context of
the
organization
ISO 9001 2015 QMS Structure

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Internal
Context
Organizatio
n Culture
Governanc
e
Organizatio
nal
Structure
Current
Roles &
Resp.
Strategy
Current
capabilities
Resource
levels
Current
system and
tools
Process
maturity
Decision
making
process
Relationshi
p with
internal
stake
holders
Internal
Context

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Structure of Standards as per ISO 14001:2015
4 Context of the organization
? Understanding the organization and
its context
? Understanding the needs and
expectations of interested parties
? Determining the scope of the
environmental management system
? Environmental management system
5 Leadership
? Leadership and commitment
? Environment policy
? Organizational roles,
responsibilities and authorities
6 Planning
? Actions to address risks and
opportunities
? Environmental objectives and
planning to achieve them
7 Support
? Resources
? Competence
? Awareness
? Communication
? Documented information
8 Operation
? Operational planning and
control
? Emergency preparedness
and response
9 Performance evaluation
? Monitoring, measurement,
analysis and evaluation
? Internal audit
? Management review
10 Improvement
? General
? Nonconformity and
corrective action
? Continual improvement

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Environmental Aspect
COMMON ASPECTS :
? Energy Use
? Solid Waste
? Water Use
? Air Pollution
? Emission To Air
? Release To Water
? Waste Management
OTHER ASPECTS :
? Contamination of Land
? Heavy Metal Waste Drain
? Industrial Waste Drain
? Product End-of-Life
? Radioactive Waste
? Medical Waste
? Solvent Waste
? Use of Raw Materials
? Use of Natural Resources
? Impact on Comminities
? Noise

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Four Phases of Risk
? The objective of this presentation are to appreciate and
understand how an QMS is established in terms of:
Risk Analysis
? Intended user Identification
? Area wise risk identification
? Risk estimation
Risk Evaluation
? Risk acceptability decisions
Risk monitoring and control
? OPTION analysis
? Implementation of measures
? RESIDUAL RISK evaluation
? Overall RISK acceptance
Post production information
? Post-production experience
? Review of Risk management
experience- customer use
? Take appropriate actions
Risk and Opportunity

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Skills an Auditor needs to develop, being:
? Diplomatic ? Patient
? Honest ? Fair minded
? Impartial ? Articulate
? Communicative ? Analytical
? Helpful ? Co �C operative
? Persistent ? Observant
? Ethical ? Professional
? Conscientious ? Assertive
Auditor Characteristics

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1. Audit Plan
4. Gather Evidence
3. Opening Meeting
5. Record Results
2. Develop Checklists
6. Closing Meeting
7. Audit report
Audit Steps

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