ISO 9001 and ISO 14001 Changes and Challenges

ISO 9001:2015 & ISO 14001:2015 -
New Changes & Challenges
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Learning Outcomes
At the end of this session, you will able to understand:
Quality Management Principles
Brief on ISO 9001:2015
Brief on ISO 14001:2015
Life Cycle Analysis
Context of Organisation
Interested parties Analysis
Needs and expectation of Interested parties
Changes and Challenges
Q/A
7 Quality management principles
Customer focus
Organization depends on customers

Understand current & future customer
needs.
Meet / exceed customer expectations
Leadership
Leaders establish purpose & direction

of the organization
Leaders should create & maintain
environment to achieve organizations
objectives
Engagement of people
People of all levels are essence of an

organization
Their full involvement is for organizations

benefit
Process approach
Desired results are achieved more efficiently

when activities and resources are managed as
process
Improvements
Improvement of the organizations overall

performance should be a permanent objective
of the organization
PDCA Cycle
Process approach
continual improvements of process
Understandings &
meeting requirements
PLAN
Continual improvements
Processes in terms
of Processes based on
Of Added Value PDCA Cycle
objective measurements
DO
ACTION
Measure results of process

Performance and effectiveness
- Objective Measurements
CHECK
Evident based decision making
Effective decisions are based on the analysis of

data and information
Relationships management
An organization & its suppliers are

interdependent
Relationship enhances the ability of both to
create value
What are the changes in ISO 9001:2015 & ISO
14001:2015 ?
new concepts are considered - more risk based thinking
a new common ISO format has been developed for use across
all Management System Standards
a significant re-ordering of the key clauses.
High Level Structure
the new standard adopts the high-level structure and terminology of Annex
SL (used for the development of all new ISO standards)
High Level Structure - identical core text and common terms and core
definitions for use in all Management System Standards:
purpose - enhance the consistency and alignment of different
management system standards
organisations that integrate multiple standards (eg QMS, EMS, OHS) will
see the most benefit
uses simplified language and writing styles to aid understanding and
consistent interpretations of requirements.
Common structure for MSS
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement.
Clause structure (4-6)
Understanding the organisation and its context
Understanding the needs and expectations of interested parties
Determining the scope of the XXX management system
XXX management system
5. Leadership
Leadership and commitment
Policy
Organisational roles, responsibilities and authorities
6. Planning
Actions to address risks and opportunities
Objectives and plans to achieve them.
Clause structure (7-10)
7. Support
Resources
Competence
Awareness
Communication
Documented information
8. Operation
Operational planning and control
9. Performance evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
10. Improvement
Nonconformity and corrective action
Continual improvement.
Context of organisation

Understanding the organisation and its context
Understanding the needs and expectations of interested parties
Determining the scope of the XXX management system
XXX management system
4 Clause 4.1
Context of organization
Determine what the relevant external and internal issues are for your
4.1
organization, and that are relevant to its strategic direction
Understanding context
4.2
Interested parties
4.3
Scope
4.4
QMS
ISO/TC 176/SC 2/ N1282
2016 3FOLD Education Centre . All rights reserved . online@3foldtraining.com . www.3foldtraining.com . 800 3FOLD 20
4 Clause 4.2
Identify the relevant interested parties and their relevant requirements
4.1
4.2
Interested parties
4.3
Scope
4.4
QMS/EMS
ISO/TC 176/SC 2/ N1282
Interested parties
Organizations are required to understand the needs and

expectations of interested parties.
It is a mandatory requirement of the management systems
standards.
Interested parties
Stakeholders are referred to synonymously as interested
parties by ISO management systems standards ISO 9000
states their importance clearly:
Organizations attract, capture and retain the support of the
relevant interested parties they depend upon for their
success.
Step 1 identify relevant interested parties.
Use the examples from the ISO management systems

standards,
Create a table with a column for interested parties, add
columns for needs and expectations, power/interest and
objectives.
Step 2 determine their needs and expectations.
Use different research methods as necessary to

confirm your knowledge of each group or significant
stakeholder.
Summarize the findings and add them to the relevant

column in your table of interested parties.
Step 3 rank them in terms of power and interest:
Consider their strength of interest and level of

influence over your decisions and actions. Plot them
in the power/interest matrix to determine their
rank.
Add the rank to the relevant column in your table of

interested parties.
.
Power v/s Interest
POWER
Keep Manage
Satisfied Closely
Keep
Monitor
Informed
INTEREST
Power : how much power or influence do they have over your decisions and activities? This
could be interpreted as their significance or risk.
Interest : how much interest do they have in your decisions and activities? This could be
interpreted as the strength of their relevance.
Step 4 set objectives and priorities.
Define what results are necessary to deliver to those

relevant interested parties to reduce the risk that their
needs and expectations are not met.
Set smart objectives wherever possible and document

them in the table of interested parties.
INTERESTED PARTY NEEDS AND PI RANK OBJECTIVES PRIORITY
EXPECTATION
CUSTOMERS
QUALITY PRODUCTS KEEP SATISFIED ACHIEVE EXPECTED SALES HIGH
EMPLOYEES SAFE ENVIRONMENT KEEP SATISFIED ACHIEVE EXPECTED ZERO HIGH

IMPACT ON ENVIRONMENT
4 Clause 4.3 and 4.4
The requirement for the scope is now better defined, must be
4.1
documented and consider:
external and internal issues
4.2
Interested parties requirements of relevant interested parties
the products and services covered (must also be stated in scope)
4.3
Scope allowing applicability of specific requirements
4.4 justification for any case where a requirement cannot be applied (exclusion)
QMS
ISO/TC 176/SC 2/ N1282
Section 3 Terms and Definitions
environmental aspect element of an organisations activities,
products or services that interacts or can interact with the
environment the activity
environmental impact change to the environment (adverse
or beneficial), wholly or partly resulting from the organisations
environmental aspects potential change or harm.
Some more terms
environmental performance performance related to the
management of environmental aspects
life cycle consecutive and interlinked stages of a product (or
service) system, from raw material acquisition or generation from
natural resources to final disposal.
New Additions
Understanding the organization

Context (4.1)
Understanding needs &
expectations of interested parties
(4.2)
Risk based thinking & Approach
(6.1)
Organizational Knowledge (7.1.6)
New Requirements-
Changes in Approach ISO 9001:2015
Risk Based Thinking Which might influence the MSS Performance
Risks & Opportunities to be considered prior to design of Context,
Products, Services, Processes, Projects, Scope and Changes
Risks : Violations, Penalties/Notices, No customers, Delays, Customer
dissatisfaction, Customer Complaints, Rejections, Reworks, Product re-
call, Bad reputation in the market, Incompetence, High Staff Turnover,
Cost of Quality failures, etc.
Opportunities : New Customers, New Markets, New Products / Services,
New Scope, Customer Goodwill, Staff Goodwill, Employee Participation,
Innovation & Creativity, Organizational Competence, Business
Excellence, etc.
E.g. HR Planning , Operation Planning (Technology), Improvements &
Suggestions
Changes and Challenges:
ISO 14001:2015
Upcoming Training Schedule for Lead Auditor Courses
ISO 9001:2015 ISO 14001:2015

Batch Start Date: 5TH MAY,2017 Batch Start Date: 13TH MAY,2015
Batch End Date: 2ND JUNE,2017
Batch End Date: 10TH JUNE,2017
Frequency: Every Friday
Timing: 8 am onwards Frequency: Every Saturday
Timing: 2 pm onwards
Product Managers
Mr Ashish
ashish@3foldtraining.com
050 1261084
Mr. Dinesh
dinesh@3foldtraining.com
050 - 1036364
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ISO 9001:2015 & ISO 14001:2015 -

New Changes & Challenges

Return the feedback form at the reception!

Organization depends on customers

Leaders establish purpose & direction

People of all levels are essence of an

Their full involvement is for organizations

Desired results are achieved more efficiently

Improvement of the organizations overall

Measure results of process

Effective decisions are based on the analysis of

An organization & its suppliers are

4. Context of the organisation

Organizations are required to understand the needs and

Use the examples from the ISO management systems

Use different research methods as necessary to

Summarize the findings and add them to the relevant

Consider their strength of interest and level of

Add the rank to the relevant column in your table of

Define what results are necessary to deliver to those

Set smart objectives wherever possible and document

EMPLOYEES SAFE ENVIRONMENT KEEP SATISFIED ACHIEVE EXPECTED ZERO HIGH

Understanding the organization

ISO 9001:2015 ISO 14001:2015

END OF THE SESSION

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