iso 9001:2015 & iso 14001:2015 - new changes & challenges · iso 9001:2015 & iso...

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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 organization’s objectives


Engagement of people

• People of all levels are essence of an organization

• Their full involvement is for organization’s benefit


Process approach

Desired results are achieved more efficiently when activities and resources are managed as

process


Improvements

Improvement of the organization’s overall performance should be a permanent objective

of the organization


PDCA Cycle


Process approach –continual improvements of process

PDCA Cycle

Processes in terms

Of Added Value

DO

Continual improvements

of Processes based on

objective measurements

ACTION

Measure results of process

Performance and effectiveness

- Objective Measurements

CHECK

Understandings &

meeting requirements

PLAN


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 MSSIntroduction

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)

4. Context of the 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

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

4. Context of the 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

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Clause 4.1 Determine what the relevant external and internal issues are for your organization, and that are relevant to its strategic direction

4 Context of organization

4.1 Understanding context

4.2 Interested parties

4.3 Scope

4.4QMS


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Clause 4.2Identify the relevant interested parties and their relevant requirements




4.3 Scope

4.4QMS/EMS


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..


Keep Satisfied

Manage Closely

MonitorKeep

Informed

Power v/s 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.

POWER

INTEREST


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

CUSTOMERS

EMPLOYEES

NEEDS AND EXPECTATION

QUALITY PRODUCTS

SAFE ENVIRONMENT

PI RANK

KEEP SATISFIED

KEEP SATISFIED

OBJECTIVES

ACHIEVE EXPECTED SALES

ACHIEVE EXPECTED ZERO IMPACT ON ENVIRONMENT

PRIORITY

HIGH

HIGH


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Clause 4.3 and 4.4

The requirement for the scope is now better defined, must be documented and consider:

external and internal issues

requirements of relevant interested parties

the products and services covered (must also be stated in scope)

allowing applicability of specific requirements

justification for any case where a requirement cannot be applied (exclusion)




4.3 Scope

4.4QMS


Section 3 – Terms and Definitions

• environmental aspect – element of an organisation’s 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 organisation’s

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)


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

New Requirements-Changes in Approach ISO 9001:2015


Changes and Challenges: ISO 14001:2015


Upcoming Training Schedule for Lead Auditor Courses

ISO 9001:2015• Batch Start Date: 5TH MAY,2017• Batch End Date: 2ND JUNE,2017• Frequency: Every Friday• Timing: 8 am onwards

Product ManagersMr [email protected] – 1261084Mr. [email protected] - 1036364

ISO 14001:2015

• Batch Start Date: 13TH MAY,2015

• Batch End Date: 10TH JUNE,2017

• Frequency: Every Saturday

• Timing: 2 pm onwards


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iso 9001:2015 & iso 14001:2015 - new changes & challenges · iso 9001:2015 & iso...

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