ISO 9001:2015 Awareness

Copy Right © Dr. Madhu Aman Sharma ISO 9001:2015 Awareness
Employée Awareness
Training
ISO 9001:2015
by Dr. Madhu Aman Sharma
e-mail certifications@iso-certifications.com
Founder & Director K2A Management

ISO 9001:2015 in Brief
Quality Management System
ISO 9001 is the world’s most popular quality management
system standard and is all about keeping customers satisfied
whatever sector you operate in, from manufacturing to
Services.
Companies that work to adopt the principles of quality
management have benefited from more efficient ways of
working, better cost control and fast and more effective
implementation of new working practices.
This presentation tells you in more detail about ISO
9001:2015 making it work for your and department &
business.
ISO 9001:2015

ISO 9001:2015 in Brief
ISO 9001:2015
Known as Quality Management Standard is among ISO's most
well known standards ever.
QMS is implemented by more than a million organizations in
some 175 countries.
ISO 9001 helps organizations to implement quality management.

Quality Management
ISO 9001 is for quality management.
Quality refers to all those features of a product (or service) which are required by
the customer.
Quality management means what the organization does to ensure that its
products or services satisfy the customer's quality requirements and
comply with any regulations applicable to those products or services.
Quality management also means what the organization does to
enhance customer satisfaction, and achieve continual improvement
of its performance.

Generic Standard
ISO 9001 is a generic standard.
Generic means that the same standards can be applied:
to any organization, large or small, whatever its product or service,
in any sector of activity, and
whether it is a business enterprise, a public administration, or a government
department.
Generic also signifies that
no matter what the organization's scope of activity
if it wants to establish a quality management system, ISO 9001 gives the essential
features

Management System
Management system means what the
organization does to manage its processes, or
activities in order that
its products or services meet the organization’s
objectives, such as
satisfying the customer's quality requirements,
complying to regulations, or
meeting environmental objectives

Management System
To be really efficient and effective, the
organization can manage its way of doing things
by systemizing it.
Nothing important is left out.
Everyone is clear about who is responsible for
doing what, when, how, why and where.
Management system standards provide the
organization with an international, state-of-the-
art model to follow.

Management System
Large organizations, or ones with complicated
processes, could not function well without
management systems.
Companies in such fields as aerospace,
automobiles, defence, or health care devices
have been operating management systems for
years.
The ISO 9001 management system standard
now make these successful practices available
for all organizations.

Process Standard
ISO 9001 concern the way an organization goes
about its work.
This standard is not product standards.
This is not service standards.
This is a process standards.
This standard can be used by Product manufacturer
and service providers.

Certification & Registration
Certification is known in some countries as
registration.
It means that an independent, external body has
audited an organization's management system and
verified that it conforms to the requirements
specified in the standard (ISO 9001 or ISO 14001
etc).
ISO does not carry out certification and does not
issue or approve certificates.

Accréditation
Accreditation is like certification of the certification body.
It means the formal approval by a specialized body - an accreditation body - that a
certification body is competent to carry out ISO 9001:2015 or ISO 14001:2015 , ISO
45001 certification in specified business sectors.
Certificates issued by accredited certification bodies - and known as accredited
certificates - may be perceived on the market as having increased credibility.
ISO does not carry out or approve accréditations.

Certification
Certification is a decision to be taken for business
reasons:
if it is a contractual, regulatory, or market
requirement,
If it meets customer preferences
it is part of a risk management programme, or
if it will motivate staff by setting a clear goal.
Any organisation can implement ISO 9001:2015 for the benefits

ISO Do not Certify
ISO does not carry out ISO 9001 or ISO 14001 certification.
ISO does not issue certificates.
ISO does not accredit, approve or control the certification bodies.
ISO develops standards and guides to encourage good practice in accreditation and
certification.

Certification Body
Certification Body also called Conformity assessment
body
Certification Body Audit organisation and issue
Certificats
Certification Body get accréditation through an
Accréditation Body and called as accrédited
Certification Body
Accrédite Certification Bodies issue Certificates by
Auditing the management system of an organisation

ISO Révisions
ISO 9001 revisions since beginning

The ISO 9000 family
ISO 9001:2015 is the latest, improved version.
It is the only standard in the ISO 9000 family that can be used for certification.
There are 16 other standards in the family that can help an organization on specific
aspects such as performance improvement, auditing, training…
ISO 9001 is the standard that gives the requirements for a quality management system.

Looking to Future
ISO 9001:2015 QMS
The vision of standard preparation committee is looking a
head to the needs of future.

Benefits of ISO 9001
• Provides Systematic Approach to Quality Management
• Improve Efficiency by Increasing Productivity
• Provides Factual Decision making Power
• Provides Cost control by eliminating repeated errors
and duplicate tasks
• Increase employee morals by providing safer work
environment
• Increase confidence in stake holders and Investors
• Provides international Image
• Improves customer satisfaction
• Increase sales by retaining old customers and new
customers
• Increase confidence of customers in your product or
service that meets international standards

ISO 9001:2015 QMS
Quality Principles

Understanding Principles
Establish objectives and draft your plans
(analyze your organization’s current systems,
establish overall objectives, set interim targets
for review and develop plans to achieve them).
Implement your plansMeasure and monitor your actual
results against your planned
objectives
Correct and improve your plans to meet
and exceed your planned results

Quality Management Principles
Mutually beneficial supplier relationships
Your suppliers can be key to your business and it’s important
to work closely with them in a mutually beneficial way to create
value for both organizations.
Customer focus
You need to understand current and future customer needs.
You should meet customer requirements and strive to exceed
customer expectations
Leadership
Leaders are responsible for defining the organization’s goals
and objectives and maintain an environment where people
can operate effectively
Involvement of people
Everyone in your organization is key to its success and their
full involvement enables their skills to be used to the maximum
benefit for themselves and you
Process approach
When activities are seen, understood, managed and delivered
through clear business processes, your objectives are more
likely to be achieved
System approach to management
When you identify, understand and manage interrelated
processes as a system, it contributes to achieving your
goals and objectives
Continual improvement
Continually improving your organization ensures that your
performance will increase and change over time to react
to future challenges
Factual approach to decision making
Effective decisions are based on understanding real
data and information and this will help you make the
right decisions

Key Emphasis
Emphasis on Risk-based management
– Preventive action
Increase emphasis on achieving value for organization and its
customers
Documented Information
– Decreased emphasis on documentation
– Expands concept of documentation
–Organizational Context
– Responsiveness to business environment
Enhanced leadership requirements

Tools You will Get
Risk Based Approach
Focus on Quality Management
Leadership
Operational Control
Performance Evaluation
Improvement
Fact Based Decision Making
Internal Audit
Customer Satisfaction

Risk Based Thinking
Risk Based Approach
Consistent and predictable results are achieved more effectively
and efficiently when activities are understood and managed as
interrelated processes that function as a coherent system.
The QMS is composed of interrelated processes. Understanding
how results are produced by this system, including all its
processes, resources, controls and interactions, allows the
organization to optimize its performance.
Each department within the organisation should adopt the Risk assessment to all its functions
and processes and plan to mitigate them

Quality Management
Quality Management
The primary focus of quality management is to meet customer
requirements and to strive to exceed customer expectations.
Sustained success is achieved when an organization attracts and retains
the confidence of customers and other interested parties on whom it
depends. Every aspect of customer interaction provides an opportunity
to create more value for the customer. Understanding current and future
needs of customers and other interested parties contributes to sustained
success of an organization.
Each department should have its own quality Objectives aliened to Organizational objectives
and plan to achieve them.

Leadership
Leadership
Leaders at all levels establish unity of purpose and
direction, and create conditions in which people are
engaged in achieving the quality objectives of the
organization.
Creation of unity of purpose, direction and engagement
enable an organization to align its strategies, policies,
processes and resources to achieve its objectives

Operational Control
Operational Control
It defined responsibility and ownership and gives better control on
operations at all levels within Organization
Save time, repeated errors and increase performances.

Performance
Evaluation
Performance Evaluation
• Determines what to Monitor and what to measure
• Determine methods of Monitoring
• Evaluate the Quality performance

Improvement
Improvement
• Determine and select the opportunities for
Improvements
• Implement necessary action to improve processes
• Improve product and services

Factual Decision Making
Fact Based Decision Making
• It provides fact based decision making to avoid errors and
mistakes
• Helps to take right decision at right time.
• Avoids favors and personal likening
• Provide sense of confidence among all stake holders and decision
makers

Internal
Audit
Internal Audit
• Internal audits ensure that operational controls are maintained
• Reduced non conformances and financial losses
• Create a action plan to mitigate risk factors
• Maintain legal compliance
• Drive continual improvement

Customer
Satisfaction
Customer Satisfaction
• Customer Focus
• Monitor Customer requirements
• Monitor Customer Expectations
• Creates process to identify Quality Complaints
• Evaluate and analysis to achieve and increase level of
customer satisfaction.

Build Strong
Relation
• Creates confidence among your suppliers
• They know your requirements in advance
• They feel part of your Business
• Creates best supply chain
• Supplier evaluation save cost and time

Conclusion
More leadership and commitment from top management
Process approach as a requirement
Risk definition and management
Quality objectives at relevant functions, levels and Processes
Organizational knowledge as a resource
Documented information
Planned and controlled operation
Performance evaluation

Thank You
For any Further clarification Please write to
madhu.sharma@k2amanagement.com
Cell +855-70460000

ISO 9001:2015 Awareness

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