Quality Management System

1. International Organization For
Standardization (ISO)
Represented by :- SONAL GUPTA
M. Pharm 1st Year, Quality Assurance
Institute of Pharmaceutical Education and Research Wardha, Borgaon
(Meghe)

2. Definition and Concept Of ISO
• ISO is a non-governmental organization that forms a bridge between the
public and private sectors and is the largest standards organization in the
world.
• International organization for standardization is an independent ,non-
govermental organization the member of which are standard organization of
164 members countries.
• In this organization which maintain the standard of institutions and
companies and then they provides the certification a/c to their services or
their products.

3. ISO certification in India
In today’s competitive world, you have to provide people with better quality
services and to maintain a good image in the market. Even if your organization
wants to sell and reach the international market, you have to prove your
organization and your products in the market.
ISO Certification certifies that your goods/ services, as well as your
organization, provide quality and other standards as per the international
standards. ISO as the develop international standard such as ISO 9001 and
ISO14001 but they are not involved in ISO certification and do not issues ISO
certificates.
• Objectives of ISO Certification:
The aim of getting ISO Certification is to advance the improvement of
standardization in technology of an organization.

4. Types of ISO certification :
• ISO 9000 : The ISO 9000 Certification is most widely known family of
standards. ISO 9000 is a generic name given to a family of standards
developed to provide a framework around which quality management system
can effectively be implemented.
• ISO 9001 : ISO 9001:2008 is used if you are establish a quality management
system that provides confidence in the conformance of your product to
established or specified requirements.
• ISO 3100: Risk management system
• ISO 14001 : An Environmental Management System (EMS) is a systematic
approach to dealing with the environmental aspects of an organization.

5. • ISO ITAR :The International Traffic in Arms Regulations (ITAR) and the
Export Administration Regulations (EAR) are two important United States
export control laws that affect the manufacturing, sales and distribution
of technology.
• ISO 10002: Complaint Management System
• ISO 2600: Social responsibility
• OHSAS 18001 :Occupational Health and Safety Assessment
Series.(OHSAS) 18001
• ISO 2800: Security Management System
• ISO 27001: Information Security Management System

6. Quality management ISO 9001
• ISO 9001 is the internationally recognized Quality Management
System (QMS) standard that can benefit any size organization.
Designed to be a powerful business improvement tool, ISO 9001
Quality Management certification can help you to:
• Continually improve, streamline operations and reduce costs
• Win more business
• Satisfy more customers
• Be more build a sustainable business
• Show you have strong corporate governance

7. ISO 9001:2008
• ISO 9001:2008 is a company level certification based on standard published by International
Organization for standardization titled “Quality Management System Requirement”
• ISO 9001:2008 becomes converted into ISO 9001:2015 in September 2018
• ISO 9001:2008 is focused on meeting customer expectation and delivering customers
satisfaction so you must pay attention to the customers.
Management Responsibility:
• a) Management commitment -Evidence of commitment to development and improvement of
quality management system
• b) customer focus -Ensure the customer needs and expectation are understood and
satisfied.
• c) Quality policy -Appropriate for company communicated and reviewed.
• d) planning - Quality objectives and planning
• e) Administration - Responsibility and authorities management representative and internal
communication
• f) Review - QMS to be reviewed at planned interval

8. Steps of implementation ISO
9001:2008 QMS
• Establish a quality policy
• set your quality objective
• establish QMS organization
• establish communication channels
• product design and development
• product monitoring and measurement
• monitoring equipment management
• product conformity
• measure performance
• analyze performance
• customers satisfaction measurement
• improve performance by corrective and preventive process

9. Requirement:
• 1) Management responsibility -
• establish quality policy
• quality objective and planning
• ensure responsibility and authorities are defined
• establishing customer focus
• 2) resource
• provide adequate manpower resources
• staff are properly trained
• work environment does not affect performance such as temp. moisture,
humidity, weather
• Adequate supporting facilities

10. • 3) measurement, analysis and improvement
• measurement and analysis of plan
• control non-conformity
• analysis of data
• 4)control of documents
• review and approve document before issues
• change and current revision status identified
• document are legible and identifiable
• 5)planning of product realization
• 6)measurement ,analysis and improvement
• 7)control of record
• 8) Determination of Quality objectives and Requirement for the products

11. ISO 9001:2015
• ISO 9001:2015 certification means your company meets quality standards
as identified by ISO. It means an independent third-party, or registrar,
confirms that your organization’s quality management system (QMS)
meets the requirements of the relevant Standard.
ISO 9001:2015 set out criteria for a quality management system and is the
only standard in family that can be certified to. It can be used by any
organization ,large or small of its field of activity. In fact there are over one
million companies and organization in over 170 countries certified to ISO
9001:2015.
ISO 9001:2015 helps ensuring that safety, good quality and efficiency.

12. • Content of ISO 9001:2015 are as follows :
• Scope
• Normative reference
• Terms
• Contents of organization
• Leadership
• Planning
• Supports
• Operation
• Performance evaluation
• Continual improvement

13. risk based thinking
• organization shall determine risk and opportunities -
• In A/c with the requirement
• that can affect conformity of product and services and ability to
enhance customer satisfaction
• prevent or reduce undesired effect
• evaluate effectiveness of these product
• post delivery associated with product or service
• effectiveness of action management review

14. Implementation
• Identify the reasons why you want to become ISO 9001
accredited
• Purchase a copy of the standard
• Strategy definition
• Planning resources
• Identify your processes
• Training needs
• Develop documentation
• Pre-assessment audit
• Get certified

15. Quality management ISO 14001
• The ISO 14000 family of standards provides practical tools for
companies and organizations of all kinds looking to manage their
environmental responsibilities.
• ISO 14001 applicable to any organization that wish to establish
implementation and improve an environmental management
system to assures itself to conformity with its stated environmental
policy.

16. Cont…
• ISO14001:2004 Environmental management system certification enable on
organization to demonstrate its commitment to environment . The standard
provide aspects of your business activities more effectively while taking into
environmental protection and pollution prevention .
• ISO 14001:2004 Standard family help to Organization for:
• A)minimize how their operation negatively affect the environment and also
• B) follow with applicable laws, regulation and other environmentally oriented
requirement .

17. Cont..
• ISO- 14001:2004 is tools to :-
• Demonstrate that internal environmental objective have been achieved.
• provide assurance to management that it is in control of organizational
processes and activities that impact environment.
• assure employees that they are working for an environmentally responsible
organization.

18. Implementation steps :
• obtain management support -management support is critical without this support
your implementation of ISO 14001will almost certainly fail.
• identify legal requirement : making sure that your have identified the legal
requirement for your EMS is another step to make sure your implentation
succeeds.
• Perform internal audits
• Implementation of corrective action
• define EMS scope
• define EMS procedure and processes
• perform training: It is important that everyone in your organization know what you
are doing with your EMS and how they fit into equation.
• perform management review
• certification audit