SUMMARY OF ISO 9001:2008 AND ISO 9001:2015:

 ISO 9001: 2008:

ISO 9001: 2008 is related with quality management system in which the company provide
the products to the customers that satisfy the customer needs and also enhance the
satisfaction level of customer through the product. The organization must improve his
processes system in continual bases that improve the quality of product that also meet the
requirement of the customers and must provide the conformity to customer in product.
 The business makes decision on quality system based on recorded data.
 Must evaluate the quality system for conformance and effectiveness.
 You must know the customer requirement.
 The business must make the communicating system for giving the information to
customer for product.
 The business makes sure no one use the bad product.

 ISO 9001 : 2015:

ISO 9001 : 2015 more focus on input and output in your production. You must monitor the
information that are provides in the production for making the product. In ISO 9001 : 2015 is
risk base thinking you must encourage the organization to use the risk analysis to decide your
self which challenges you see in your management business processes. You must know the
internal and external factors of the organization for making the quality product for interested
parties. Issues of internal or external it may positive or negative occur in the organization you
must determine. Use the best applications forms for recruiting the best employees that may
save your time. Top management must demonstrate the leadership and commitment with
respect to the quality management system, for taking the accountability for the effectiveness
in the quality management.
 Ensuring the quality policy according the quality management.
 Objectives
 Promoting the risk base thinking.
 Customer focus
Difference between ISO 9001 : 2015 and ISO 9001 : 2008:
There are some changes in ISO 9001 : 2015 that differentiate the ISO 9001 : 2009 are given
below,
 Context of the organization
 Leadership
 Planning
 Support
 Operation
 Performance Evaluation
 Improvement
ISO 9001- 2015 ISO 9001- 2008
1)Context of the organization: Quality Manual:

You must understand the organizational The organization must establish the quality
internal and external issue and strategic manual and also include the scope of the
direction that are directly related with the quality management system that provide
quality management system. The organization justification for any exclusion.
must monitor these issues:
 Issues may be positive or negative that
can affect the QMS.
 You must understand the external
issues like PEST.
 You must understand the internal
context like culture, environment, etc
Understand the interested party needs and
expectation:
 Supplier
 Employees
 contractor
General Requirement:
 Shareholder
The organization continually improve the
Determine the Scope of the Quality
management system: process and its effectiveness according to
If organization wants to establish his scope international level.
for quality management system they must  Determine the process needed for the
consider these things, quality.
 Internal and external issues.  Sequence and interaction of the
 Interested parties needs and process.
requirement.  Identify the resources and information
 Organization product and services. necessary to support the process for
The organization must implement these effectiveness.
requirements according to the international
standard. When we meet these requirement
according to the international level in our
product and services you must have the
conformity in your product that can enhance
the customer satisfaction.
Quality management System:
The organization must establish the
continually improvement in process from
input to output according to international
level.
 Determine input and expected output.
 Sequence and interaction of the
process.
 Identify the resources that we need in
the process.
 Assign the responsibilities.

Management Commitment:
2)Leadership:
Top management provide the evidence of its
Top management demonstrate the leadership
commitment to the development in the quality
and commitment with respect to the quality
management process.
management.
  Ensure the quality policy and quality  The organization must communicate
objective according to quality the importance of customer meeting.
management,  Develop quality policy
 Promoting the risk base thinking.  Objective\
 Communicating the quality  Management review.
management system.
 Promote improvement.
Customer Focus:
Top management make commitment
according to the customer focus. Customer Focus:
 You make the product according to Management ensure that the customer needs
the customer requirement. are identify and met to enhancing the
 Your product must satisfy the customer satisfaction.
customer.
Developing the quality policy:
Top management make the quality policy in
this policy management include the Quality policy:
organization context to the strategic direction. In quality policy make the framework that
Also provide the structure for quality setting. review the quality setting and also include the
Include the continually improvement in the continual improvement for effectiveness in
quality management system process. process.
3)Planning:
Action to address risk and opportunity:
When we plan for the quality management
system we must kept in mind about the risk
and opportunity during action.
 You must give assurance that the
quality management system can
achieve its intended result.
 enhance desirable effects;
 prevent, or reduce, undesired effects
  achieve improvement
When address risks can include avoiding risk,
when we take risk it may be change into
opportunity eliminating the risk source,
changing the likelihood or consequences,
sharing the risk, or retaining risk by informed
decision.
Opportunities may be create the adoption of
new practices, launching new products,
opening new markets, addressing new clients,
building partnerships, using new technology
and other desirable and viable possibilities to
address the organization’s or its customer
needs.
Quality objectives and planning to achieve
them:
The organization must establish the quality
objective to maintain the quality management Quality management system planning:
system. Top management maintain the quality
 be consistent with the quality policy management system throughout the process to

 be monitored meet the requirements as well as the quality

 be communicated objective and the quality management.

 be updated as appropriate.
 Support:
Resources:
The organization must establish which
Provision of resources:
resources we need for implementing and
The organization must provide the resources:
improve the quality management system.
 Continually improve the effectiveness
 What we need from the external
and maintain the quality management.
provider.
People:  to increase the customer satisfaction
The organization identify and provide the by meet the customer requirements.
persons necessary for the effective
implementation of its quality management
system and for the operation and control of its
processes.
Infrastucture:
The organization must maintain the
infrastructure to improve the quality
management system:
 buildings and associated utilities
 equipment, including hardware and Infrastructure:
software; The organization identify and provide the
 transportation resources; infrastructure needed to achieve the

 information and communication conformity to product requirement.

technology.  buildings, workspace and associated
utilities.

Environment for the operation of  process equipment (both hardware

processes: and software)
Operation environment must be suitable for  You provide supporting services like
the humans who work in the organization. transportation, communication etc.
 social (e.g. non-discriminatory, calm,
nonconfrontational); Work environment:

 psychological (e.g. stress-reducing, Work environment relate to those condition

burnout prevention, emotionally where employees work including physically
protective); and other factor like noise, lighting, or

 physical ( these factors include weather.

temperature, heat, light, airflow etc)
4)Operattions:
Operational planning and control:
The organization must plan the operations and
hoe to control it and implement according to
product and services. Planning of product realization:
 identify the necessities for the In planning product realization, the
products and services organization identify the following, as
 establishing criteria for: appropriate:
1) the processes  quality objectives and requirements
2) the acceptance of products and for the product.
services.  provide resources specific to the
Customer communication: product.
Communication with customers shall include:  required verification, validation.
 providing information relating to
products and services; Customer communication:
 handling enquiries, contracts or The organization determine and implement
orders, including changes; effective arrangements for communicating
 getting the customer feedback about with customer for:
the product and services.  product information,
Design and development controls:  enquiries, contracts or order handling,
Design reviews, verification and validation including amendments,
have distinct purposes. It can be conducted  customer feedback, including
in any combination and suitable for the customer complaints.
products and services of the organization.
 Design and development outputs
 Design and development changes Monitoring and measurement of processes:

5)Performance Evaluation: When determining suitable methods, to

Monitoring, measurement, analysis and monitoring the measurement processes and

evaluation: see the impact of conformity to your product

 what needs to be monitored and and quality management.

measured
 for valid result we monitored,
measure, and analyses the data.
 when the monitoring and measuring
Customer Satisfaction:
 shall be performed.
Monitoring customer perception about the
Customer satisfaction:
product through survey, user of product,
Customer perception about the product and
buyer of your product that can maintain the
services we get from the survey, feedback,
customer satisfaction about the product
market analysis, warranty and dealer report.
according to his need.
Analysis and evaluation of data:
Analysis the data:
The result of analysis used to evaluate:
The analysis of data provide the information
 conformity of products and services
about:
 the degree of customer satisfaction;
 customer satisfactions
 if planning has been implemented
 conformity to product requirements
effectively
 characteristics and trends of
 the effectiveness actions take risks and
processes .and products, including
opportunities
opportunities for preventive action.
Methods to analyses data can include
Continual Improvement:
statistical techniques.
Continually improve the effectiveness of the
6)Improvement:
quality management we see quality policy,
Organization select the opportunity for the
quality objective and management review.
improvement and take necessary action to
meet the customer requirement and increase
the customer satisfaction.

Improvement can include corrective action,

continual improvement, breakthrough Corrective action:
change, innovation and reorganization.  reviewing nonconformities (including
customer complaints),
Nonconformity and corrective action:  causes of nonconformities,
 evaluating the error that
React to nonconformity and take corrective
nonconformity does not create again.
action on it and also review the
 identify and implementing action
nonconformity and cause of non- conformity.
needed.
 Review the effectiveness and take
 action.

Implementation of ISO 9001: 2015:

ISO 9001: 2015 is the new business improvement tools that help to maintain the continually and
deliver the result to your organization. It help your company in growing position. Its more than
the quality management system, its complete operational tools that improve your performance.
Now I apply this in ABC manufacturing company through which we improve the manufacturing
level of the company some times company not meet the order to the end customer when we
implement the ISO 9001: 2015 give some benefit to your business:
 Improve your product and services
 Reducing the mistakes
Better Your Business:
 Inspiring trust in your business
 Attracting the new customers
 Increasing the competitive edge
Some core points that support your business:
 Context of the organization:
You must know your internal and external issues that help to your business for growing and
sustain in the market and also affect your organization
 Issues:
Some issues that effect our business in positive or negative way. Like internal and external for
external to make pest analysis and check the pest support to our business or not. When we
discuss the all issues it help to enhance your business in a positive way.
 Interested parties:
The interested parties effect our business you maintain your relation with interested parties like
supplier, customers, competitor etc.
 Leadership:
Top management lead the organization and set the responsibility to the employees at the highest
level. When top management control the all things in a good way they must meet the order of the
organization.
 Risk:
Organization must take risk that create the opportunity for the organization due to which we get
the new ideas that meet the customer requirements.
Key Requirements for ISO 9001 : 2015:
When we know the context of the organization means we know the internal and external issues
for organization that help the organization for growth and the top management must the leader
who take or make the responsibilities to the employees who work for the organization at highest
level. The planning must be set for the future to maintain the quality management system and
also kept in mind the customer and his requirement. Your supporting material must according to
the requirements like infrastructure, HR, people, etc who work in the organization and must the
meet the requirement of the customers. If you provide the quality product it will create the long-
term relation with customer that are helpful for the firm. You must make improvement on
continuous bases and to take new opportunities for enhancing the customer value. Most
important thing is performance evaluation throughout the process that reduce the error that occur
during the manufacturing and produce the quality product for customer.
Key Tips for making ISO 9001- 2015 more Effective for the firm:
 Top management commitment is key for success.
 You must informed the staff what’s going on at this situation that motivate the
employees.
 Make sure that the organization work as team for the benefit of customer and the
organization.
 Must review the system, polices, procedure and prosses.
 Talk to your customers and supplier.
 Train your employees for internal audit that help to understand the problem.