Unit-III

ISO
(International Organization
for Standardization)
 Contents

• About ISO
• Structure of ISO-9000,
• ISO 9000 origin,
• Elements of ISO-9001,
• Benefits from ISO-9001 certification
• Aspects of quality systems,
• Certification methodology and cost involved,
• ISO 14001 (Environmental Management)
 What is IS0 ?
 ISO is an independent, non-governmental international
organization with a membership of 162 
national standards bodies.

 Through its members, it brings together experts to share

knowledge and develop voluntary, consensus-based, market
relevant International Standards that support innovation and
provide solutions to global challenges.

 Theygive world-class specifications for products, services and

systems, to ensure quality, safety and efficiency.

 ISO has published 21833  International Standards and related

documents, covering almost every industry, from technology, to
food safety, to agriculture and healthcare.
 International Standards
Organization
 The ISO specifies requirements for a quality management
system

 Basic form of the Standard requires:

 Understand product and service requirements
 Establish processes to meet those requirements
 Provide resources to run the processes
 Operate, monitor, and measure the processes
 Improve continuously, based on analysis of the results
 Origin of ISO 9000
The story of ISO 9000 is a story of standards, methods and
regulation. The brief history that follows is in no way
comprehensive but is intended to illustrate things:
 Standards are an ancient concept that survived several
millennia; that a means of verifying compliance often
follows the setting of standards;
 Formalizing of working practices is centuries old and seen
as a means to consistently meet standards;
 Market regulation (relative to the standard of goods and
services) has been around for centuries for the protection of
both craftsmen and traders.
 What is the purpose of ISO
9000?
The purpose of these standards is to assist organizations of
all types to implement and operate effective quality
management systems.

This provide a vehicle for consolidating and

communicating concepts in the field of quality
management that have been approved by an international
committee of representatives from national standards
bodies.
ISO is an independent, non-governmental
international organization to give world-class
specifications for products, services and
systems, to ensure quality, safety and
efficiency.

True/ False
 ELEMENTS OF ISO 9000/9001
The standards of ISO 9000/9001 detail 20 requirements for an
organization's quality management system in the following
areas:
 Management Responsibility Equipment
 Quality System  Inspection and Test Status
 Order Entry  Control of Nonconforming
 Design Control Products
 Document and Data Control  Corrective and Preventive Action

 Purchasing  Handling, Storage, Packaging, and

 Control of Customer Supplied Delivery

Products  Control of Quality Records

 Product Identification and  Internal Quality Audits

Tractability  Training
 Process Control  Servicing
 Inspection and Testing Control of  Statistical Techniques
Inspection, Measuring, and Test
ADVANTAGES OF ISO 9000

• Increased marketability
• Reduced operational expenses
• Better management control
• Increased customer satisfaction
• Improved internal communication
• Improved customer service
• Reduction of product-liability risks
• Attractiveness to investors
 Benefits to Society
Businesses
◦ Allows them to produce a product under worldwide
standards
Customers
◦ Provides a wider range of products
◦ More competition between producers
Governments
◦ Provide standards on health, safety and
environmental legislation
Trade Officials
◦ Helps create a more level playing field for all competitors
 Benefits to Society
Developing Countries
◦ Helps these countries invest their scarce resources more
wisely in order to produce products that meet worldwide
standards
Consumers
◦ Provides assurance of quality, safety, and reliability
Everyone
◦ Assures the things we use in everyday life are of the highest
quality
Planet
◦ Provides standards on air, water and soil quality
Purpose of ISO is to assist organizations to
implement and operate effective quality
management systems.

True/ False
 ISO 9000 family standards
The three standards in the family are
• ISO 9000 Quality management systems
– Fundamentals and vocabulary

• ISO 9001 Quality management systems

– Requirements

• ISO 9004 Quality management systems

– Guidelines for performance improvements
• ISO 9000 provide an appreciation of the
fundamental principles of quality management
systems and an explanation of the terminology
used in the family of standards.

• ISO 9001 states that the standard can be used to

assess the organization’s ability to meet customer,
regulatory and the organization’s own
requirements.

• ISO 9004 is to provide guidance for improving the

efficiency, effectiveness and overall performance of
an organization.
 ISO 27001-
ISO 20000-1:2011
2005
Service Management Information
Security
Management
System

Management
Systems
ISO 9001:
2008
Quality ISO 31000
Management Risk
System Management

ISO 22301
Business Continuity
Management
https://www.youtube.com/watch?v=qSVqDNOkOTo&ab_channel=AGFConsultingGroup
• Service- It specifies requirements for the service
provider to plan, establish, implement, operate,
monitor, review, maintain and improve an SMS.

• Information Security- Using this family of

standards will help your organization manage the
security of assets such as financial information,
intellectual property, employee details or
information entrusted to you by third parties.
 Risk- Risks affecting organizations can have
consequences in terms of economic performance and
professional reputation, as well as environmental,
safety. Therefore, managing risk effectively helps
organizations to perform well in an environment full
of uncertainty.

 Business continuity - encompasses planning and

preparation to ensure that an organization can
continue to operate in case of serious incidents or
disasters and is able to recover to an operational
state within a reasonably short period.
 Benefit/Aspect of QMS
• Conformance to the quality specification as documented
by organization.
• Ensure corrective action is taken whenever defects occur.
• Early detection of defects and avoidance of wastage.
• Defect rates decrease and reduce costs.
• Procedures identify current practices and that
continuously improved upon.
• Increase in market share, increasing in sales or revenue.
• Better management control and reporting.
• Consistent quality.
 various aspects of quality management

• They specify requirements and recommendations for the

design and assessment of management systems.

• The standards provide guidance and tools for companies and

organizations who want to ensure that their products and
services consistently meet customer’s requirements, and that
quality is consistently improved.

• ISO 9000 is a series of three International Standards for

Quality Management Systems.
 DISADVANTAGES OF ISO 9000
• Owners and managers do not have an
adequate understanding of the ISO 9000
certification process or of the quality
standards themselves
• Funding for establishing the quality
system is inadequate
• Heavy emphasis on documentation
• Length of the process
Quality management system requirements are
provided by::
a) ISO 9000
b) ISO 9001
c) ISO 22000
d) ISO 14001
 What is ISO 9001 ?
• ISO 9001 is an International Standard that gives requirements
for an organization’s quality management system (QMS).

• It is part of a family of standards published by the

International Organization for Standardization (ISO) and
often referred to collectively as the“ ISO 9000 series ” or “
ISO 9000 family ”.

• The objective of ISO 9001 is to provide a set of

requirements.
• That, if effectively implemented, will give you
confidence that your supplier can consistently
provide products and services that: Meet your
needs and expectations and Comply with
applicable regulations.
 The Benefits of ISO 9001….
Over 3,50,000 companies world are registered to
ISO 9001. The benefits they find include:
• Improved consistency of service and product
performance
• Higher customer satisfaction levels.
• Improved customer perception
• Improved productivity and efficiency
• Cost reductions
• Improved communications, morale and job satisfaction
• Competitive advantage and increased marketing and
sales opportunities.
Start seeing these benefits in your organization

• Benefits start with your implementation

project; you do not need to wait until
registration is achieved to start seeing the
improvements.
 Quality Manual, Procedures and Forms

• All documented in Microsoft Word and Excel, they

are easy to edit and use.

• These documents have been used by many

different types of industries in many different
countries for successful registration to ISO 9001.
 Computer Based Training
• Employees can take the training at any convenient
time.

• Appealing visual and audio content keep the

employees attention.

• Quizzes measure the effectiveness of the training.

• Group licensing for as little as $5 per employee.

 Documentation and Training Packages
are available at a Package price

• This package includes:

– Project manager’s guide
– Project manager online training
– Gap Analysis Checklist
– Quality Manual, Procedures and Forms
– Internal Auditor Training Materials package
– Employee Training
– Online support for answers to your questions
 ISO 9000:2015 describes the fundamental concepts and
principles of quality management which are universally
applicable to the following.
• organizations seeking sustained success through the
implementation of a quality management system;
• customers seeking confidence in an organization's ability to
consistently provide products and services conforming to
their requirements;
• organizations seeking confidence in their supply chain that
their product and service requirements will be met;
• organizations and interested parties seeking to improve
communication through a common understanding of the
vocabulary used in quality management;
• organizations performing conformity assessments against the
requirements of ISO 9001;
• providers of training, assessment or advice in quality
management;
Certification Methodology and Cost Involved

Stages of Certification
• Submit application to registrar
– Stage 1: Assessment of readiness
– Stage 2: Assessment for registration audit
• Registration/certification awarded for 3 years
• Surveillance audits (at least annually)
• Recertification audit at the end of 3rd year
Certification Methodology and Cost Involved

Registration:
• Usually takes 1 or possibly 2 auditors 1 to 3 days
depending on scope, size, locations and personnel
• You will be told whether or not you will be
recommended for registration at the completion of
the Stage 2 audit
• Certificate usually arrives a 2 – 6 weeks later
• Maintaining your ISO Certification(s) is the first step
in continuous improvement
Certification Methodology and Cost Involved
Cost Involved:
• Costs can be substantial.
• Copies of standards alone can cost $120 or more
per copy.
• Costs include any courses that quality team
members or others need, consultants fees, and the
auditor’s time.
• According to Nichols, auditor costs are
approximately $1,300 per day.
• For a small organization, the minimum for
everything might be $10,000 to $15,000. 
Certification Methodology and Cost Involved
Cost Involved:
The ISO certification body will compute the fee for
ISO certification by considering the below mentioned
different parameters:
• Size of an organization
• Number of employees
• Processes of Organization
• Level of risk associated with the scope of services
of the organization
• The complexity of the management system
• The number of working shifts
 Certification Methodology and Cost Involved

Registrar/Auditor Selection Criteria

• Accreditation and scope of accreditation
• Reputation and customer acceptance
• Availability, cost, and location
• Knowledge of your business
• Culture fit with your organization
• Ability to audit all of your future standards

Note: The external auditor is hired by the Registrar and

presented with qualifications to you upon agreement of audits.
You cannot go out and hire your own external auditor.
 Certification Methodology and Cost Involved
Preparation for audit
• Determine team, set budget
• Internal auditor(s) training if using in-house resources
• Hire consulting firm if applicable
• Gap Assessment
• Implement requirements of standard to meet your business needs against the gap
assessment
• Go-Live
• Hold Management Review Meeting
• Conduct Internal Audit
• Refine documentation
• Employee involvement training
• System adjustment
• Registration audit – Stage 1
• System adjustment
• Registration audit – Stage 2
ISO 14000 provided standard for
a) Food safety
b) Quality management
c) Environment management

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