UNIT-V

ISO 9000: A UNIVERSAL STANDARD OF QUALITY

INTRODUCTION TO ISO 9000
Standards are documented agreements containing technical specifications or other precise criteria to be
used consistently as to ensure that rules, guidelines, materials, products, processes and services are fit for
their purpose
Ex: In smart card, optical thickness - 0.76 mm. Paper size, symbols for automobile controls, ISO
international codes for country names, currencies and languages ,OSI ....etc;
ISO stands for international organization for standardization.
ISO (International Organization for Standardization) is an independent, non-governmental membership
organization established in 1947 in Geneva, Switzerland.  It has a membership of 163 national standard
organizations all across the world. It has 783 technical committees and subcommittees that gather and
distribute information all across the world in order to maintain international standards that are:

 voluntary
 consensus-based
 market-relevant
 innovative
 Designed to solve global challenges.

The International Organization for Standardization (ISO) is an international standard-setting body

composed of representatives from various national standards organizations.
KEY PRINCIPLES IN STANDARD DEVELOPMENT
1. Response to needs
ISO does not decide when to develop a new standard, but responds to a request from industry or other
stakeholders such as consumer groups. Typically, an industry sector or group communicates the need for a
standard to its national member who then contacts ISO.
2. Global expert opinion
ISO standards are developed by groups of experts from all over the world, that are part of larger groups
called technical committees. These experts negotiate all aspects of the standard, including its scope, key
definitions and content.
3. Multi-stakeholder process
The technical committees are made up of experts from the relevant industry, but also from consumer
associations, academia, NGOs and government.
4. Consensus
Developing ISO standards is a consensus based approach and comments from all stakeholders are taken
into account.

1
ISO 9000: A UNIVERSAL STANDARD OF QUALITY

ISO 9000 is defined as a set of international standards on quality management and quality assurance
developed to help companies effectively document the quality system elements needed to maintain an
efficient quality system. They are not specific to any one industry and can be applied to organizations of
any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual
improvement. It should be considered to be a first step or the base level of a quality system.

ISO-9000 set of standards are “generic management system standards”. This means that the same
standards can be applied:

 To any organization, large or small, whatever its product;

 Including whether its “product” is actually a service;

 In any sector of activity; and

 Whether it is a business enterprise a public administration, or a government department.

The “ISO-9000 quality management system” adopting organizations fulfill:

 The customer’s quality requirements;

 Applicable regulatory requirements;

 Enhance customer satisfaction; and

 Achieve continual improvement of its performance.

FUNCTIONAL STANDARDS

ISO 9000 standards also require documentation and follow-up performance for all functions affecting
quality. Functional requirements are illustrated by the following examples:

 Design — Sets a planned approach for meeting product or service specifications

 Process control — Provides concise instructions for manufacturing or service functions
 Purchasing — Details methods for approving suppliers and placing orders
 Service — Details instructions for carrying out after-sales service
 Inspection and testing — Compels workers and managers to verify all production steps
 Training — Specifies methods to identify training needs and keeping records
ISO 9000 OBJECTIVES
It defines quality system standards. To meet five objectives

2
 1. Achieve, maintain and seek to continuously improve product quality [including services] in
relationship to requirements
2. Improve the quality of operations
3. Provide confidence to internal management
4. Provide confidence to customers
5. Provide confidence that quality system requirements are fulfilled
NEED FOR ISO
 Main factors are "Quality and Standardization" around the world
 Worldwide progress in trade liberalization
 Interpenetration of sectors
 Worldwide communications systems
 Global standards needs for emerging technologies
 Developing countries
 The ISO 9000 family of standards is related to quality management systems and designed to help
organizations ensure that they meet the needs of customers and other stakeholders while meeting
statutory and regulatory requirements.
 ISO 9000 deals with the fundamentals of quality management systems, including the eight
management principles on which the family of standards is based.
 International standards promote international trade by providing one consistent set of
requirements recognized around the world.
 ISO 9000 can help a company satisfy its customers, meet regulatory requirements and achieve
continual improvement. It provides the base level of a quality system, not a complete guarantee of
quality.
 Originally published in 1987 by the International Organization for Standardization (ISO), a
specialized international agency for standardization composed of the national standards bodies of
90 countries.

ISO 9000 SERIES

ISO 9000
Explains fundamental quality concepts and provides guidelines for the selection and
application of each standard

ISO 9001 Model for quality assurance in design, development, production, installation and
servicing.

ISO 9002 Model for quality assurance in the production and installation of manufacturing
systems.

ISO9003 Quality assurance in final inspection and testing.

ISO9004 Guidelines for the applications of standards in quality management and quality
systems.

3
ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish the
requirements outlined in standards 9001, 9002 or 9003.
STRUCTURE OF ISO 9000 STANDARDS
 The ISO 9000:2000 standards focus on developing, documenting and implementing procedures
 to ensure consistently of operations
 and performance in production and service delivery processes, with the aim of continual
improvement and also supported by fundamental principles of total quality
 It is a series of standards that are "generic rather than specific".
 It can be applied to all type of organizations, large or small scale industry, public, private,
 ISO standards are developed through consensus, applied industry wide and it is voluntary.
The standard consists of 3 documents
1. ISO 9000 (Fundamentals & Vocabulary)
2. ISO 9001 (Quality Management Systems – set of 4 minimum Requirements)
 Management Responsibility
 Resource Management
 Product Realization
 Measurement analysis & improvement
3. ISO 9004: 2000 Quality Management Systems – Guidelines for performance improvements
Relates to organizations who wish to improve beyond the scope of ISO 9001 Has an element of
self evaluation and this standard does not stand for certification

ISO AROUND THE WORLD

The International Organization for Standardization (ISO) is the specialized international agency for
standardization and at present comprises the national standards bodies of 91 countries. The American
National Standards Institute (ANSI) is the member body representing the U.S. ISO is made up of
approximately 180 technical committees. Each technical committee is responsible for one of many areas
of specialization, ranging from asbestos to zinc. The purpose of ISO is to promote the development of
standardization and related world activities in order to facilitate the international exchange of goods and
services and to develop cooperation in intellectual, scientific, technological, and economic activities. The
results of ISO technical work are published as international standards, and the ISO 9000 Series is a result
of this process.

In 1987 (the same year the ISO 9000 Series was published), the U.S. adopted the ISO 9000 Series
verbatim as the ANSI/ASQC Q-90 Series. Thus, the use of either of these series is equivalent to the use of
the other.2 The ISO standards are being adopted by a varying number of companies in over 50 countries
around the world that have endorsed them.

ISO 9000 QUALITY MANAGEMENT PRINCIPLES

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management principles that
senior management can apply to promote organizational improvement.

4
 ISO 9000 Quality Management Principles

 Customer focus
 Understand the needs of existing and future customers
 Align organizational objectives with customer needs and expectations
 Meet customer requirements
 Measure customer satisfaction
 Manage customer relationships
 Aim to exceed customer expectations
 Leadership
 Establish a vision and direction for the organization
 Set challenging goals
 Model organizational values
 Establish trust
 Equip and empower employees
 Recognize employee contributions
 Engagement of people
 Ensure that people’s abilities are used and valued
 Make people accountable
 Enable participation in continual improvement
 Evaluate individual performance
 Enable learning and knowledge sharing
 Enable open discussion of problems and constraints
 Process approach
 Manage activities as processes
 Measure the capability of activities
 Identify linkages between activities
 Prioritize improvement opportunities
 Deploy resources effectively
 Improvement
 Improve organizational performance and capabilities
 Align improvement activities
 Empower people to make improvements
 Measure improvement consistently
 Celebrate improvements
 Evidence-based decision making
 Ensure the accessibility of accurate and reliable data

5
  Use appropriate methods to analyze data
 Make decisions based on analysis
 Balance data analysis with practical experience
 Relationship management
 Identify and select suppliers to manage costs, optimize resources, and create value
 Establish relationships considering both the short and long term
 Share expertise, resources, information, and plans with partners
 Collaborate on improvement and development activities
 Recognize supplier successes

ADVANTAGES OF ISO 9000 CERTIFICATION

The advantages associated with ISO 9000 certification are numerous, as both business analysts and
business owners will attest. These benefits, which can impact nearly all corners of a company, range from
increased stature to bottom-line operational savings. They include:

 Increased marketability—Nearly all observers agree that ISO 9000 registration provides
businesses with markedly heightened credibility with current and prospective clients alike.
Basically, it proves that the company is dedicated to providing quality to its customers, which is
no small advantage whether the company is negotiating with a long-time customer or
endeavoring to pry a potentially lucrative customer away from a competitor. This benefit
manifests itself not only in increased customer retention, but also in increased customer
acquisition and heightened ability to enter into new markets; indeed, ISO 9000 registration has
been cited as being of particular value for small and mid-sized businesses hoping to establish a
presence in international markets.
 Reduced operational expenses—Sometimes lost in the many discussions of ISO 9000's public
relations cache is the fact that the rigorous registration process often exposes significant
shortcomings in various operational areas. When these problems are brought to light, the
company can take the appropriate steps to improve its processes. These improved efficiencies can
help companies garner savings in both time and money. "The cost of scrap, rework, returns, and
the employee time spent analyzing and troubleshooting various products are all considerably
reduced by initiating the discipline of ISO 9000, "
 Better management control—The ISO 9000 registration process requires so much
documentation and self-assessment that many businesses that undergo its rigors cite increased
understanding of the company's overall direction and processes as a significant benefit.
 Increased customer satisfaction—Since the ISO 9000 certification process almost inevitably
uncovers areas in which final product quality can be improved, such efforts often bring about
higher levels of customer satisfaction. In addition, by seeking and securing ISO 9000
certification, companies can provide their clients with the opportunity to tout their suppliers'
dedication to quality in their own business dealings.
 Improved internal communication—The ISO 9000 certification process's emphasis on self-
analysis and operations management issues encourages various internal areas or departments of
companies to interact with one another in hopes of gaining a more complete understanding of the
needs and desires of their internal customers.
 Improved customer service —The process of securing ISO 9000 registration often serves to
refocus company priorities on pleasing their customers in all respects, including customer service
areas. It also helps heighten awareness of quality issues among employees.
 Reduction of product-liability risks—Many business experts contend that companies that
achieve ISO 9000 certification are less likely to be hit with product liability lawsuits, etc.,
because of the quality of their processes.
 Attractiveness to investors—Business consultants and small business owners alike agree that
ISO-9000 certification can be a potent tool in securing funding from venture capital firms.

6
THE THIRD-PARTY AUDIT

Audit - Planned, independent, and documented examination and verification of activities, records,
processes, and other elements of a quality system to determine their conformity with the requirements of a
quality standard.

Different types of standards

• International standards – ISO 9000, ISO 22000

• Global Food Safety Initiative (GFSI) audit schemes

• Other GMP/GHP, HACCP standards

The third-party audit is a quality system audit performed by an auditor on the supplier in order to
achieve certification for one of the ISO 9000 Standards. The third-party auditor must be independent of
both the customer and the supplier.

Third-party audits cannot be performed by the customer or the supplier.

Third Party Auditing carried out by independent accredited organizations

Mainly for the purpose of granting or to confirm continuation of (for ongoing surveillance audit)
ISO9001 certification.

DOCUMENTATION

There are three basic steps to the registration process:

1. Appraisal of the organization’s quality manual

2. Evaluation of conformance to documented procedures
3. Presentation of findings, with recommendations for corrective action

The amount of documentation depends on the nature and complexity of the business. A hierarchical
approach involving three levels is generally acceptable:

 Level 1 — An overview type of quality manual consisting of policies that meet the requirements
of the ISO standard for which certification is sought
 Level 2 — Functional or departmental operating procedures in terms of “who does what”
 Level 3 — Work instructions that explain how each task is to be accomplished
THE COSTS OF CERTIFICATION IMPLEMENTING ISO 9000
 Implementing ISO 9000 can be beneficial, but costly. The cost can be affected by:
 Multiple Locations
 Design
 Non-existence of a Quality Program
 Significant Corporate Changes
 Registering for ISO 9000 creates additional costs which vary based upon:
 Design Responsibility

7
  Number of Locations
 Size of Facility in Terms of Employment
Cost and certification
 Contracting a Registrar - The registration audit is performed by a Registrar and the cost will
depend on how big and how complex the organization is. They will charge depending on how
many audit days they spend at the organization.
 Auditor's fees
 Auditor's Travel and living expenses
 Application fee
 Registration fee
 Initial assessment (optional)
 Certification audit (Year 1)
 Surveillance audits (Year 2 and 3)
 Reassessments (optional)
 Internal Cost - The time the employees will need to spend building and implementing the
system.
 Learn about ISO 9001
 Graph Analysis
 Plan the project
 Train Employees
 Document your Quality Management System (QMS)
 Quality Manual
 Procedures/Work Instructions/Flowcharts
 Forms/Records
 Implementation of the Quality Management System
 Audit the QMS
 Registration
 Outside help - This is either consultant fees or the purchasing of tools to help with the project.
 1-25 Employees, no quality system in place yet - Estimated costs of doing the implementation
using ISO authority, All-in-One Documentation & Training Package, and by hiring a consultant

Implementing the system

Although the series provides guidance on the required attributes of the quality system, the standards do
not spell out the means of implementation. Once a decision is made to adopt the standards and seek
certification, the following major steps will facilitate successful change:

1. Recognize the need for change and get the commitment of top management.
2. Incorporate quality in the strategic plan as the linchpin of differentiation.
3. Formulate and adopt a holistic quality policy statement adapted to ISO requirements. Get support
and commitment from all managers.
4. Determine the scope of the business to be certified. Will it be a particular process, related
facilities, a geographical site, or the whole company?
5. Determine the status of the current quality system through an internal audit. Define the gap
between where you are and what it will take to close the gap.
6. Estimate the cost in time and money, and implement the plan by organizing the necessary action
steps.