P. Appalaraju , Deputy General Manager - Ashok Leyland
With the WTO becoming more prominent after the DOHA deliberations the
competitive edge of the Indian products must be improved. In this connection
Quality Management systems and their implementation assume very high importance.
A large number of Indian companies have already been certified for ISO 9000 –
1994 version and QS 9000 standards – 1998 version. The International Standards
Organization after a detailed analysis of the implementation of 1994 version of
ISO 9000 standards, problems faced by users in their organizations in
implementation of these standards, and to cater for all types of industries,
have now issued ISO 9000 – 2000 version of these standards. These are applicable
for all types of industries. Recently International Standards Organization
issued a stipulation that all OEMs who have acquired ISO 9000 certification must
ensure that all their vendors should be certified for ISO 9000 – 2000 version
before 31 December 2002.ISO 9000 – 2000 standards are so exhaustive and at the
same time so simple that they eliminate any confusion that the earlier version
of the standards might have created. It has imbibed a good number of features of
ISO 14000 and QS 9000 standards. A comprehensive summary of these standards is
given below. It is hoped that this brief will infuse interest in
individuals/organizations and motivate them to take steps to obtain ISO 9000 –
2000 standards and graduate from "Customer Satisfaction" to "Customer Delight".
ISO 9001 NOW
ISO 9001
ISO 9001
ISO 9002
ISO 9003
Let’s look into some of the important aspects of the new standard ISO 9000 –
2000.
Why are the standards being revised?
The main reason for the year 2000 revision to the ISO 9000 standards is to
give users the opportunity to add value to their activities and to improve
their performance continually by focussing on the major processes within the
organization.
Extensive surveys have been performed on a worldwide basis to understand
the needs of all the users of the quality management system standards. The new
revisions will take into account previous experience with quality management
systems standards (1987 and 1994 editions) and emerging insights into generic
management systems. They will result in a closer alignment of quality
management systems with the needs of organizations and better reflect the way
organizations run their business activities.
ISO directives also specify that standards be periodically revised to
ensure that those standards are current and satisfy the needs of the global
community.
The major reasons for the year 2000 revisions of the standards include
emphasizing the need to monitor customer satisfaction, meeting the need for
more user-friendly documents, assuring consistency between quality management
principles by organizations.
What are the benefits of the revised standards?
There are a number of major benefits with the revised quality management
system standards. The benefits are:
Applicability to all product categories, in all sectors and to all sizes
of organizations.
Simple to use, clear in language, readily translatable, and easily
understandable.
Significant reduction in the amount of required documentation.
Connection of quality management systems to organizational processes.
Provision of a natural move towards improved organizational performance.
Greater orientation towards continual improvement and customer
satisfaction.
Compatibility with other management systems such as ISO 14000.
Provision of a consistent basis to address the needs and interests of
organizations in specific sectors (e.g. medical devices, telecommunications,
automotive,etc)
The concept of the consistent pair – ISO 9001 covering the requirements
and ISO 9004 for going beyond the requirements in order to further improve the
performance of the organization.
Consideration of the needs of and benefits to all interested parties.
What are the main changes to the standards?
The main changes that have been introduced in the consistent pair of
quality management system standards are:
A new process – oriented structure and a more logical sequence of the
contents.
A continual improvement process as an important step to enhance the
quality management system.
Increased emphasis on the role of the top management, which includes its
commitment to the development and improvement of the quality management
system, consideration of legal and regulatory requirement, and establishment
of measurable objectives at relevant functions and levels.
The concept of "permissible exclusions" to the standard has been
introduced as a way to cope with the wide spectrum or organizations and
activities.
A requirement for the organization to monitor information on customer
satisfaction and / or dissatisfaction as a measure of system performance.
Significant reduction in the amount of required documentation.
Terminology changes/improvements for easier interpretation.
Increased compatibility with the environmental management system
standards.
Specific reference to quality management principles.
Consideration of the benefits and needs of all interested parties.
Addition of the concept of organizational self-assessment as a driver
for improvement (ISO 9004).
What new requirements have been introduced into the revised ISO 9001
standard?
Continual improvement.
Increased emphasis on the role of top management.
Consideration of legal and regulatory requirements.
Establishment of measurable objectives at relevant functions and levels.
Monitoring of information of customer satisfaction and / or
dissatisfaction as a measure of system performance.
Increased attention to resource availability.
Determination of training effectiveness.
Measurements extended to system, processes, and product.
Analysis of collected data on the performance of the quality management
system.
Quality Management Principles
A quality management principle is a comprehensive and fundamental rule or
belief, for leading and operating and organization, aimed at continually
improving performance over the long term by focussing on customers while
addressing the needs of all other stakeholders.
Principle 1 – Customer – Focussed Organization
Organizations depend on their customers and therefore should understand
current and future customer needs, meet customer requirements and strive to
exceed customer expectations.
Principle 2 - Leadership
Leaders establish unity of purpose and direction of the organizations. They
should create and maintain the internal environment in which people can become
fully involved in achieving the organization’s benefit.
Principle 3 – Involvement of People
People at all levels are the essence of organizations and their full
involvement enables their abilities to be used for the organization’s benefit.
Principle 4 – Process Approach
A desired result is achieved more effectively when related resources and
activities are managed as a process.
Principle 5 - System Approach to Management
Identifying, understanding and managing a system of interrelated processes
for a given objective improves the organization’s effectiveness and
efficiency.
Principle 6 – Continual Improvement
Continual improvement should be a permanent objective of the organization.
Principle 7 – Factual approach to decision making
Effective decisions are based on the analysis of data and information.
An organization and its suppliers are interdependent, and a mutually
beneficial relationship enhances the ability of both to create value.
Examples of application of the Quality Management Principles in Quality
Assurance and Quality Management
Quality Management
Principles
Application for ISO 9001
(1994 edition)
Quality Management
application (additive to ISO 9001)
Principle 1 – Customer
focussed organization
Organizations depend on their customers
and therefore should understand current and future customer needs, meet
customer requirements and strive to exceed customer expectations.
Assured conformance to defined
customer requirements.
Understand current and future
customers needs and expectations. Measure customer satisfaction and act
on it.
Principle 2 – Leadership
Leaders establish unity of purpose and direction of the organization.
They should create and maintain the internal environment in which people
can become fully involved in achieving the organization’s objectives.
Set policy and verifiable
objectives, deploy policy, provide resources and establish an
environment for Quality.
Establish vision, direction
and shared values. Set challenging targets and goals and implement
strategies to achieve them. Coach, facilitate, and empower people.
Principle 3 – Involvement
of People
People at all levels are the essence of an
organization and their full involvement enables their abilities to be
used for the organization’s benefit.
Establish competency levels,
train and qualify personnel. Provide clear authority and responsibility.
Create personal ownership of
an organizations targets and goals, by using it’s peoples knowledge and
experience, and through training achieve involvement in operational
decisions and process improvement.
Principle 4 – Process
Approach
A desired result is achieved more efficiently when
related resources and activities are managed as a process.
Establish, control and
maintain documented processes.
Explicitly identify
internal/external customers and suppliers of processes. Focus on the use
of resources in process activities, leading to effective use of people,
equipment, methods and materials.
Principle 5 – System
Approach to Management
Identifying, understanding and managing
a system of interrelated processes for a given objective improves the
organization’s effectiveness and efficiency.
Establish and maintain a
suitable and effective documented Quality System.
Identify a set of processes in
a system. Understand their interdependencies Align the processes with
the organization's goals and targets. Measure results against key
objectives.
Principle 6 – Continual
Improvement
Continued improvement should be a permanent
objective of the organization.
Through management review,
internal/external audits and corrective/preventive actions, continually
improve the effectiveness of the Quality System.
Set realistic and challenging
improvement goals, provide resources and give people the tools,
opportunities and encouragement to contribute to the continual
improvement of the processes.
Principle 7 – Factual
Approach to Decision Making
Effective decisions are based on
the analysis of data and information.
Management decisions and
actions on the Quality system are based on the analysis of the factual
data and information gained from reports on audits, corrective action,
non conforming product, customer complaints and other sources.
Decisions and actions are
based on the analyses of data and information to maximize productivity
and to minimise waste and rework. Effort is placed on minimizing cost,
improving performance and market share through the use of suitable
management tools and technology.
An organization and its
suppliers are interdependent, and a mutually beneficial relationship
enhances the ability of both to create value.
Adequately define and document
requirements to be met by sub-contractors. Review and evaluate their
performance to control the supply of quality products and services.
Establish strategic alliances
or partnerships, ensuring early involvement and participation defining
requirements for joint development and improvement of products,
processes and systems. Develop mutual trust, respect and commitment to
customer satisfaction and continual improvement.
ISO 9001: 2000 MAIN CLAUSES
QUALITY MANAGEMENT SYSTEM
MANAGEMENT RESPONSISBILITY
RESOURCE MANAGEMENT
PRODUCT REALIZATION
MEASUREMENT, ANALYSIS AND IMPROVEMENT
HIGHLIGHTS OF REVISED STANDARDS
Quality management system instead of Quality assurance system.
Applicability to all product categories, in all sectors and to all sizes
of organizations.
Connection of Quality Management systems to organizational processes.
Provision of a natural move towards improved organizational performance.
Greater orientation toward Continual Improvement and customer
satisfaction.
Compatibility with other Management systems such as ISO 14000.
Process based model and PDCA methodology
Consideration of the needs and benefits to all interested parties.
Lays emphasis on :
Top management commitment.
Enhance customer satisfaction.
Process conformity.
Continual improvement of product, process and QMS
Statistical techniques and analysis of data.
effectiveness and efficiency.
List of Mandatory QMS Records
MANAGEMENT REVIEW
EDUCATION,TRAINING, SKILLS AND EXPERIENCE
REALIZATION PROCESS AND PRODCUT FULFIL REQUIREMENT
REQUIREMENT OF REVIEW RESULTS AND ACTIONS
INPUTS REQUIREMENTS FOR PRODUCT
DESIGN AND DEVELOPMENT REVIEW
DESIGN AND DEVELOPMENT VERIFICATION
DESIGN AND DEVELOPMENT VALIDATION
DESIGN AND DEVELOPMENT REVIEW OF CHANGES
SUPPLIER EVALUATION.
VALIDATION OF PROCESS FOR PRODUCTION & SERVICE.
UNIQUE IDENTIFICATION
CUSTOMER PROPERTY UNSUITABLE.
IMTE CALIBRATION AND VERIFICATION.
IMTE ASSESSMENT OF VALIDITY.
LIST OF IMTE.
INTERNAL AUDIT.
PRODUCT ACCEPTANCE.
NATURE OF NON-CONFORMITIES AND DISPOSITION.
CORRECTIVE ACTIONS
PREVENTIVE ACTIONS.
Comparision of ISO 9001 – 2000 Standards vis-ŕ-vis ISO 9001 – 1994 version
is given below
ISO 9001:2000 Vs ISO 9001:1994
CLAUSE
DESCRIPTION
CLAUSE
DESCRIPTION
4.0
QMS
4.1
GENERAL REQMTS
4.2.1
GENERAL
4.2
DOCUMENTATION REQMTS
4.2.1
GENERAL
4.2.2
QUALITY SYSTEM PROCEDURE
4.2.2
QUALITY MANUAL
4.2.1
GENERAL
4.2.3
CONTROL OF DOCUMENTS
4.5.1
GENERAL
4.5.2
DOCUMENT & DATA
APPROVAL & ISSUE
4.5.3
DOCUMENT & DATA
CHANGES
4.2.4
CONTROL OF RECORDS
4.16
CONTROL OF QUALITY RECORDS
5.0
MANAGEMENT RESPONSIBILITY
5.1
MANAGEMENT COMMITMENT
4.1.1
QUALITY POLICY
5.2
CUSTOMER FOCUS
4.3.2
REVIEW
5.3
QUALITY POLICY
4.1.1
QUALITY POLICY
5.4
PLANNING
5.4.1
QUALITY OBJECTIVES
4.1.1
QUALITY POLICY
5.4.2
QUALITY MANAGEMENT SYSTEM
PLANNING
4.2.3
QUALITY PLANNING
5.5
RESPONSIBILITY,AUTHORITY AND
COMMUNICATION
5.5.1
RESPONSIBILITY AND AUTHORITY
4.1.2.1
RESPONSIBILITY AND AUTHORITY
5.5.2
MANAGEMENT REPRESENTATIVE
4.1.2.3
MANAGEMENT REPRESENTATIVE
5.5.3
INTERNAL COMMUNICATION
5.6
MANAGEMENT REVIEW
5.6.1
GENERAL
4.1.3
MANAGEMENT REVIEW
5.6.2
REVIEW INPUT
5.6.3
REVIEW OUTPUT
6.0
RESOURCE MANAGEMENT
6.1
PROVISION OF RESOURCES
4.1.2.2
6.2
HUMAN RESOURCES
6.2.1
GENERAL
4.1.2.2
RESOURCES
6.2.2
COMPETENCE, AWARENESS & TRAINING
4.18
TRAINING
6.3
INFRASTRUCTURE
4.9
PROCESS CONTROL
6.4
WORK ENVIRONMENT
4.9
PROCESS CONTROL
7.0
PRODUCT REALIZATION
7.1
PLANNING OF PRODUCT REALIZATION
4.2.3
4.10.1
QUALITY PLANNING
GENERAL
7.2
CUSTOMER RELATED PROCESSES
7.2.1
DETERMINATION OF REQUIREMENTS
RELATED TO THE PRODUCT
4.3.2
4.4.4
REVIEW
DESIGN INPUT
7.2.2
REVIEW OF REQUIREMENTS RELATED TO
THE PRODUCT
4.3.2
4.3.3
4.3.4
REVIEW
AMENDMENT TO CONTRACT
RECORDS
7.2.3
CUSTOMER COMMUNICATION
4.3.2
REVIEW
7.3
DESIGN AND DEVELOPMENT
7.3.1
DESIGN AND DEVELOPMENT PLANNING
4.4.2
4.4.3
DESIGN AND DEVELOPMENT PLANNING
ORGANISATIONAL AND TEC. INTERFCACES
7.3.2
DESIGN AND DEVELOPMENT INPUTS
4.4.4
DESIGN INPUT
7.3.3
DESIGN AND DEVELOPMENT OUTPUTS
4.4.5
DESIGN OUTPUT
7.3.4.
DESIGN AND DEVELOPMENT REVIEW
4.4.6
DESIGN REVIEW
7.3.5
DESIGN AND DEVELOPMENT
VERIFICATION
4.4.7
DESIGN VERIFICATION
7.3.6
DESIGN AND DEVELOPMENT VALIDATION
4.4.8
DESIGN VALIDATION
7.3.7
DESIGN AND DEVELOPMENT CHANGES
4.4.9
DESIGN CHANGES
7.4
PURCHASING
7.4.1
PURCHASING PROCESS
4.6.2
EVALUATION OF SUB CONTRACTORS
7.4.2
PURCHASING INFORMATION
4.6.3
PURCHASING DATA
7.5
PRODUCTION AND SERVICE PROVISION
7.5.1
CONTROL OF PRODUCTION AND SERVICE
PROVISION
4.9
4.15.6
4.19
PROCESS CONTROL
DELIVERY
SERVICING
7.5.2
VALIDATION OF PROCESSES FOR
PRODUCTION AND SERVICE PROVISION
4.9
PROCESS CONTROL
7.5.3
IDENTIFICATION AND TRACEABILITY
4.8
4.10.5
4.12
PRODUCT IDENTIFICATION AND
TRACEABILITY
INSPECTION &TESTRECORDS
INSPECTION & TEST STATUS
7.5.4
CUSTOMER PROPERTY
4.7
CONTROL OF CUSTOMER SUPPLIED
PRODUCT
7.5.5
PRESERVATION OF PRODUCT
4.15.2
4.15.3
4.15.4
4.15.5
HANDLING
STORAGE
PACKAGING
PRESERVATION
7.6
CONTROL OF MONITORING AND
MEASURING DEVICES
4.11.1
4.11.2
GENERAL
CONTROL PROCEDURE
8.0
MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.1
GENERAL
4.10.1
4.20.1
4.20.2
GENERAL
IDENTIFICATION OF NEED
PROCEDURES
8.2
MONITORING AND MEASUREMENT
8.2.1
CUSTOMER SATISFACTION
8.2.2
INTERNAL AUDIT
4.17
INTERNAL QUALITY AUDITS
8.2.3
MONITORING AND MEASUREMENT OF
PROCESSES
4.17
4.20.1
4.20.2
INTERNAL QUALITY AUDITS
IDENTIFICATION OF NEED
PROCEDURES
8.2.4
MONITORING AND
MEASUREMENT OF PRODUCT
4.10.2
RECEIVING INSPECTION & TESTING
4.10.3
IN-PROCESS
INSPECTION & TESTING
4.10.4
FINAL INSPECTION &
TESTING
4.10.5
INSPECTION &TESTRECORDS
4.20.1
IDENTIFICATION OF
NEED
4.20.2
PROCEDURES
8.3
CONTROL OF NON CONFORMING PRODUCT
4.13.1
4.13.2
GENERAL
REVIEW & DISPOSITION OF
NC PRODUCT
8.4
ANALYSIS OF DATA
4.20.1
4.20.2
IDENTIFICATION OF NEED
PROCEDURES
8.5
IMPROVEMENT
8.5.1
CONTINUAL IMPROVEMENT
4.13
CONTROL OF NON CONFORMING PRODUCT
8.5.2
CORRECTIVE ACTION
4.14.1
4.14.2
GENERAL
CORRECTIVE ACTION
8.5.3
PREVENTIVE ACTION
4.14.1
4.14.3
GENERAL
PREVENTIVE ACTION
Conclusion
As can be seen ISO 9000 – 2000 Standards are user friendly and universal
and if implemented by all concerned with sincerity and commitment in the
organization there will be universal acceptance of Quality of Indian products
both nationally and internationally.