Unit-5

Quality Standards : ISO-9000 and it concept of Quality management, ISO 14001, ISO 22000,
ISO 27001, OHSAS 18001 and QS 9000, Indian Quality standards, Quality Audit, Quality
Awards.

Overview and evolution of of IS 9000 series of standards .

The International Organization of Standardization (ISO) was founded in 1946 in
Geneva, Switzerland. The development of International Standards is to facilitate the
exchange of goods and services worldwide. ISO consists of more than 90 country members.
The ISO Technical Committee (TC) developed a series of International Standards for Quality
Systems, which were first published in 1987. The standards (ISO 9000, 9001, and 9004)
were intended to be advisory and developed for use in two-party contractual situations and
internal auditing.
These standards were adopted by European Community and have been accepted
worldwide with emphasis on quality and economic competitiveness.
The fourth edition of ISO 9001 was released in the year 2008 and it replaces the third
edition (ISO9001: 2000), which have been amended to clarify the points in the text and also
to enhance the compatibility with ISO 14001: 2004.
Most countries have adopted ISO 9000 series as their national standards.

(1) Explain briefly the scope and purpose of ISO 9000 Series standards.

The ISO 9000 series Standards is generic in scope. By design, the series can be
tailored to fit any organization’s needs. Whether it is large or small, a manufaturerer or a
service organization. It can be applied to construction, engineering, health care, legal, and
other professional services as well as the manufacturing of anything from nuts and bolts to
spacecraft. Its purpose is to unify quality terms and definitions used by industrialized nations
and use those terms to demonstrate the supplier’s capability of controlling the processes.
In very simplified terms, the standards require an organization to say what it is doing
to ensure quality, then do what it says, and, finally document or prove that it has done what it
said.

The ISO 9000 Series of Standards.

ISO 9000: 2005 - Quality Management Systems (QMS)

Fundamentals and Vocabulary discusses the fundamental concepts related to QMS
and provides the terminology used in the other two standards.
ISO 9001: 2008 – Quality Management Systems (QMS)
Requirements are the standards used registration by demonstrating conformity of the
QMS to customers, regulatory and organization’s own requirements.
ISO 9004 : 2000- Quality Management Systems (qms)
GUIDELINES FOR PERFORMANCE IMPROVEMENT provides guidelines that an
organization can use to establish a QMS focused on improving performance.
ISO 9000
ISO 9001
ISO 9002
ISO 9003
ISO 9001
Design, Development, Production, Installation & Servicing

ISO 9002
Production, Installation & Servicing

ISO 9003
Inspection & Testing
ISO 9004
Provides guidelines on the technical, administrative and human factors affecting the
product or services.

BENEFITS OF ISO 9000 STANDARDS :

 Achievement of international standard of quality.
 Value for money.
 Customer satisfaction.
 Higher productivity.
 Increased profitability
 Improved corporate image
 Access to global market
 Growth of the organization
 Higher morale of employees

CLAUSES (ELEMENTS) OF ISO 9000 (During the year 1987)

4.1 Management Responsibility
 Adequate resources for the verification activities
 Need for trained personnel
 Work and verification activities including audits
 A Management Representative to be identified
 Review the Quality System performance and customer complaints periodically
4.2 Quality System
4.3 Contract review
4.4 Design Control
4.5 Documents Control
4.6 Purchasing
4.7 Purchaser – Supplied Product
4.8 Product Identification and Traceability
4.9 Process Control
4.10 Inspection and Testing
4.11 Inspection Measuring and Test Equipment
4.12 Inspection and Test Status
4.13 Control of Non – Conforming Product
4.14 Corrective Action
4.15 Handling, Storage, Packaging and Delivery
4.16 Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Servicing
4.20 Statistical Techniques

CLAUSES (ELEMENTS) OF ISO 9000 (During the year 2000)

1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management System (QMS)
4.1.1 General Requirements
4.1.2 Documentation
5. Management Responsibility
5.1.1 Management Commitment
5.1.2 Customer Focus
5.1.3 Quality Policy
5.1.4 Planning
5.1.5 Responsibility, Authority and Communication
5.1.6 Management Review
6. Resource Management
6.1.1 Provision of Resources
6.1.2 Human Resources
6.1.3 Infrastructure
6.1.4 Work Environment
7. Product Realization
7.1 Planning of Product Realization
7.2 Customer related processes
7.3 Design and Development
7.4 Purchasing
7.4.1 Production and Service Provision
7.4.2 Control of Monitoring and Measuring devices
8. Monitoring and Measurement
8.1.1 General
8.1.2 Monitoring and Measurement
8.1.3 Control of Non-Conforming Product
8.1.4 Analysis of Data
8.1.5 Improvement

IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM :

1. Top Management Commitment

2. Appoint the Management Representative
 3. Awareness
4. Appoint an Implementation Team
5. Training
6. Time Schedule
7. Select Element Owners
8. Review the Present System
9. Write the Documents
10. Install the New System
11. Internal Audit
12. Management Review
13. Pre-assessment
14. Registration

PITFALLS OF SUCCESSFUL IMPLEMENTATION :

1. Using a generic documentation program or another organization’s documentation
program
2. Over-documentation or documentation that is too complex
3. Using External Consultants without involvement
4. Neglecting to obtain top management’s involvement
5. Developing a system that does not represent what actually occurs

DOCUMENTATION
In every organization, the quality system must be documented properly. The
documentation of the system can be seen as a hierarchical format as shown.
1
POLICY

2
PROCEDURE

3
PRACTICE

4
PROOF

Quality Audit
Systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled.
Types of audit
3 types

o Process audits

o Product audits
 o System audits

Process audits
• Evaluation of the content and effectiveness of specific processes and work
activities

• To confirm the process parameters and improve capability of the process

• To ensure the realization of process quality characteristics

• To ensure improvement of process control during service provision

• Product audits

-To identify opportunities for improvement to establish the quality level of units before final
inspection and testing
-To establish the capability of the inspection function
-To determine the usefulness of inspection/tests
• Audits are distinguished by the party requesting:

• 1st party audit (internal audits) – the auditee audits its own quality system according to
a quality standard.

• 2nd part audits (supplier audits) – the customer audits the supplier’s quality system

• 3rd party audits – these are external certification audits by an independent institution
in order to certify the quality system

Products audits
Investigation of products conformance to specified characteristics
-To obtain additional neutral assessment of product’s level of quality
-To obtain additional assurance that specified quality requirements are met
System audits
• Evaluation all the elements of the quaity system in order to:-

• Verify usefulness, suitability and effectiveness

• Verify adequate documentation

• Verify compliance with requirements

• Determine weak points

Purpose of audits
• Registration / certification audit

• Verify that the organization's QMS meet the requirements of ISO 9001 : 2000

Internal audit
• Identify opportunities for improvement
 • Maintain ISO 9001 certification

(2) What are the objevtives of Internal audit?

Objectives of the Internal audit

• To verify conformance to applicable standards

• To verify conformance to documented procedures

• To verify effectiveness of the processes in the system

• To identify opportunities to improve the system

• Creating and environment for successful audits (1)

QUALITY AUDITING

The term Audit refers to a regular examination and checking of accounts or financial records,
settlement or adjustment of accounts.
It also refers to checking, inspection and examination of Production Processes.

PURPOSE OF QUALITY AUDIT :

 To establish the adequacy of the system.
 To determine the effectiveness of the system.
 To afford opportunities for system analysis.
 To help in problem solving.
 To make decision making easier etc.

TYPES OF QUALITY AUDIT :

1. First – Party Audit.
2. Second – Party Audit.
3. Third – Party Audit.

Quality audit can also be classified on the basis of the area taken into account for the audit such as
 System Audit.
 Process Audit.
 Product Audit.
 Adequacy Audit.
 Compliance Audit.

ISO 14000 – ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)

The overall aim of the Environmental Management systems is to provide protection to the
environment and to prevent pollution.
 The success of ISO 9000 along with increased emphasis on Environmental issues was
instrumental in ISO’s decision to develop Environmental Management Standards.

 In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE) which led
to the formation of Technical Committee (TC) 207 in 1992.
  Mission of TC207 is to develop standards for an Environmental Management System (EMS)
which was identified as ISO 14000.

 TC 207 has Established six sub-committees

1. Environmental Management System (EMS)
2. Environmental Auditing (EA)
3. Environmental labeling (EL)
4. Environmental Performance Evaluation (EPE)
5. Life-Cycle Assessment (LCA)
6. Terms & Definitions

Environmental Management System (EMS) :

EMS has two Evaluation Standards. They are

1. Organization Evaluation Standards 2. Product Evaluation Standards

REQUIREMENT OF ISO 14001

There are six elements
1. GENERAL REQUIREMENTS

 EMS should include policy, planning implementation & operation, checking & corrective
action, management review.

2. ENVIRONMENTAL POLICY (Should be based on mission)

 The policy must be relevant to the organization’s nature.

 Management’s Commitment (for continual improvement & preventing pollution).
 Should be a framework (for Environmental objectives & Targets).
 Must be Documented, Implemented, & Maintained.

3. PLANNING

 Environmental Aspects
 Legal & other Requirements
 Objectives & Targets
 Environmental Management Programs

4. IMPLEMENTATION & OPERATION

 Structure & Responsibility

 Training, Awareness & Competency
 Communication
 EMS Documentation
 Document Control
 Operational Control
 Emergency Preparedness & Response

5. CHECKING & CORRECTIVE ACTION

  Monitoring & Measuring
 Nonconformance & Corrective & Preventive action
 Records
 EMS Audit

6. MANAGENMENT REVIEW

 Review of objectives & targets

 Review of Environmental performance against legal & other requirement
 Effectiveness of EMS elements
 Evaluation of the continuation of the policy

ISO 14000: Environmental Standards

ISO 14000

The International Organization for Standards published its Quality Management System
(ISO9000) in 1987. ISO9000 became an instant worldwide success.

In 1991, ISO formed Strategic Advisory Group on the Environment (SAGE). The purpose of
formation of this group was worldwide increase in emphasis of management of environmental issues
a part of quality management systems. This group proposed the formation of Technical Committee to
develop standards that deal with environmental management system. This technical committee, TC
207 developed the standards called ISO14000.

The EMS is part of a comprehensive management system that addresses with the overall
business activities, including its products and services, affect the environment.

ISO14000 Series Standards

ISO14000 is a generic standard. When we state the term generic, we mean that- like
ISO9000-it is not an industry specific standard.

The series is divided into two separate areas-the organization evaluation standards and the
product evaluation standards. The first deals with Environmental Management System (EMS),
Environmental Auditing (EA), and Environmental Performance Evaluation (EPE), whereas later deals
with Environmental Aspects in Product Standards (EAPS), Environmental Labeling (EL), and Life-
Cycle Assessment (LCA).

See following figures to understand the division of standards as mentioned above:

Concepts of ISO 14001:2004 Standards

In this post we will particularly discuss ISO 14001:2004 because this standard is the heart of
all the environmental standards. This standard provides organizations with the elements of for
environmental systems, which can be integrated into other management systems to help achieve
environmental and economic goals.

This standard provides guidelines for registration and/or self-declaration of the organization’s
environmental management systems. This standard is written in a manner that it can be applicable to
all types and sizes of organizations. This standard is also capable to accommodate diverse
geographical, cultural, and social conditions.

The demonstration of successful implementation of the system can be used to assure other
parties that an appropriate EMS is in place. The basic approach to Environmental System can be
understood with the help of following diagram:
 Environmental Management System
Model
ISO 14001:2004 works as follows:

 As stated earlier in this post that ISO14000 is generic in nature. It does not intend to
specify the level of environmental performance of an organization. If that had been the case,
ISO would have written it according to the specific activity of each business.
 However, ISO has developed many other environmental standards that deal with specific
environmental standards. These standards are beyond the scope of ISO14001:2004 standards
at the moment.
 ISO14001:2004 provide a framework to the organizations so that they could communicate
about EMS matters with the other stakeholders including customers, environmental
regulators, the public and so forth.
 It also provides framework to the organizations-irrespective of their current level of
environmental maturity-to remain committed for environmental management and its
continual improvement as well.

BENEFITS OF ENVIRONMENTAL MANAGEMENT SYSTEM :

GLOBAL BENEFITS
 Facilitate trade & remove trade barrier
 Improve environmental performance of planet earth
 Build consensus that there is a need for environmental management and a
common terminology for EMS

ORGANIZATIONAL BENEFITS
 Assuring customers of a commitment to environmental management
 Meeting customer requirement
 Improve public relation
 Increase investor satisfaction
  Market share increase
 Conserving input material & energy
 Better industry/government relation
 Low cost insurance, easy attainment of permits & authorization

ISO 22000 and ISO 27001 are two important standards developed by the International Organization for
Standardization (ISO) that address different aspects of organizational management.
ISO 22000:
ISO 22000 is a food safety management standard that specifies the requirements for a food safety management
system (FSMS) that can be used by organizations in the food industry. The standard focuses on the entire food
supply chain, from farm to fork, and is designed to ensure the safety of food products for consumers.

The key elements of ISO 22000 include:

Hazard analysis and critical control points (HACCP): This is a systematic approach to identifying and
controlling hazards that can affect food safety.
Management system requirements: This includes documentation, record-keeping, internal audits, and
management review to ensure that the FSMS is effective and continually improving.

Prerequisite programs: These are basic programs and procedures that are necessary to maintain a hygienic
environment and prevent food safety hazards.

Communication: This involves communicating effectively with stakeholders, including customers, suppliers, and
employees, about food safety issues.

ISO 22000 provides several benefits to organizations, including:

Enhanced food safety: By implementing the requirements of the standard, organizations can ensure that their
food products are safe for consumers.
Increased customer confidence: Certification to the ISO 22000 standard can help organizations demonstrate their
commitment to food safety and increase customer confidence in their products.
Improved operational efficiency: The standard requires a systematic approach to food safety management, which
can improve operational efficiency and reduce costs.

ISO 27001:
ISO 27001 is an information security management standard that provides a framework for managing and
protecting sensitive information. The standard is designed to help organizations of all sizes and types manage the
security of their information assets.

The key elements of ISO 27001 include:

Risk assessment: This involves identifying and evaluating the risks to the organization's information assets.
Security controls: This includes implementing security controls to mitigate the risks identified in the risk
assessment.
Management system requirements: This includes documentation, record-keeping, internal audits, and
management review to ensure that the information security management system (ISMS) is effective and
continually improving.
Continual improvement: This involves monitoring and measuring the effectiveness of the ISMS and making
improvements as necessary.

ISO 27001 provides several benefits to organizations, including:

Improved information security: By implementing the requirements of the standard, organizations can improve the
security of their information assets and reduce the risk of security breaches.

Regulatory compliance: Certification to the ISO 27001 standard can help organizations demonstrate compliance
with regulatory requirements for information security.
Increased customer confidence: Certification to the ISO 27001 standard can help organizations demonstrate their
commitment to information security and increase customer confidence in their products and services.

In summary, ISO 22000 and ISO 27001 are two important standards developed by ISO that address different
aspects of organizational management. While ISO 22000 focuses on food safety management, ISO 27001 focuses
on information security management. Both standards provide a framework for organizations to manage their
operations effectively and efficiently, and to continually improve their performance.

OHSAS 18001 is an international occupational health and safety (OH&S) management system standard
developed by the Occupational Health and Safety Assessment Series (OHSAS) Project Group. The standard
provides a framework for organizations to manage their OH&S risks and improve their performance.

The key elements of OHSAS 18001 include:

Policy: Organizations are required to establish an OH&S policy that includes a commitment to comply with
relevant OH&S laws and regulations, to continually improve OH&S performance, and to prevent injuries and ill
health.

Planning: Organizations are required to establish a systematic approach to identifying and assessing OH&S risks
and to establish objectives and targets for improving OH&S performance.

Implementation: Organizations are required to implement the OH&S management system by allocating
resources, communicating with stakeholders, and establishing operational controls.

Checking: Organizations are required to monitor and measure OH&S performance, conduct internal audits, and
conduct management reviews to ensure the effectiveness of the OH&S management system.

Improvement: Organizations are required to continually improve OH&S performance by taking corrective
actions, preventing nonconformities, and implementing preventive measures.

OHSAS 18001 provides several benefits to organizations, including:

Improved OH&S performance: By implementing the requirements of the standard, organizations can improve
their OH&S performance, prevent injuries and ill health, and reduce the risk of occupational accidents and
diseases.
Regulatory compliance: Certification to the OHSAS 18001 standard can help organizations demonstrate
compliance with regulatory requirements for OH&S management.

Increased stakeholder confidence: Certification to the OHSAS 18001 standard can help organizations
demonstrate their commitment to OH&S management and increase stakeholder confidence in their products and
services.

In summary, OHSAS 18001 is an international OH&S management system standard that provides a framework
for organizations to manage their OH&S risks and improve their performance. By implementing the requirements
of the standard, organizations can improve their OH&S performance, demonstrate compliance with regulatory
requirements, and increase stakeholder confidence in their operations.

Quality Audit: A quality audit is a process of examining an organization's quality management system (QMS) to
ensure it complies with the applicable quality standards, regulations, and customer requirements. The objective of
a quality audit is to identify opportunities for improvement in the QMS and ensure that it is effective in achieving
the organization's quality objectives. Quality audits can be conducted by internal auditors within an organization
or by third-party auditors.

There are three types of quality audits:-

1. Internal audit: This is a self-assessment process conducted by an organization to evaluate its own QMS.
2. External audit: This is a process of evaluating an organization's QMS by an independent third-party
auditor.
3. Supplier audit: This is a process of evaluating the QMS of a supplier by a customer organization.
Benefits of quality audit:
Improved quality performance: A quality audit helps an organization identify areas of improvement in its QMS,
leading to better quality performance.
Compliance: Quality audits ensure that an organization is complying with relevant quality standards and
regulations.
Reduced risks: Quality audits help identify and mitigate risks associated with the QMS, leading to a reduction in
the likelihood and impact of quality issues.

Quality Awards: Quality awards are recognition programs that recognize and celebrate organizations that
have achieved a high level of quality performance. Quality awards are based on a set of criteria that evaluates an
organization's QMS and its effectiveness in achieving quality objectives. Quality awards provide an opportunity
for organizations to benchmark their QMS against best practices and industry standards.

There are several quality awards that are recognized internationally, including:
1. Malcolm Baldrige National Quality Award: This is a United States-based award that recognizes
organizations that have achieved excellence in quality management.
2. European Foundation for Quality Management (EFQM) Excellence Award: This award is based on the
EFQM Excellence Model, which is a framework for evaluating an organization's QMS.
3. Deming Prize: This is a Japanese award that recognizes organizations that have achieved excellence in
quality management and is based on the Deming management method.

Benefits of quality awards:

1. Recognition: Quality awards provide recognition and validation for an organization's QMS and its
achievements.
2. Improvement: Quality awards provide a framework for benchmarking an organization's QMS against
best practices, leading to continuous improvement.
3. Competitive advantage: Winning a quality award can provide a competitive advantage for an
organization, enhancing its reputation and customer confidence.