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Quality Control ISO 9000 – 2000

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.

  1. 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.

  2. 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:

bulletApplicability to all product categories, in all sectors and to all sizes of organizations.
bulletSimple to use, clear in language, readily translatable, and easily understandable.
bulletSignificant reduction in the amount of required documentation.
bulletConnection of quality management systems to organizational processes.
bulletProvision of a natural move towards improved organizational performance.
bulletGreater orientation towards continual improvement and customer satisfaction.
bulletCompatibility with other management systems such as ISO 14000.
bulletProvision of a consistent basis to address the needs and interests of organizations in specific sectors (e.g. medical devices, telecommunications, automotive,etc)
bulletThe 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.
bulletConsideration of the needs of and benefits to all interested parties.
  1. 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:
    bulletA new process – oriented structure and a more logical sequence of the contents.
    bulletA continual improvement process as an important step to enhance the quality management system.
    bulletIncreased 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.
    bulletThe concept of "permissible exclusions" to the standard has been introduced as a way to cope with the wide spectrum or organizations and activities.
    bulletA requirement for the organization to monitor information on customer satisfaction and / or dissatisfaction as a measure of system performance.
    bulletSignificant reduction in the amount of required documentation.
    bulletTerminology changes/improvements for easier interpretation.
    bulletIncreased compatibility with the environmental management system standards.
    bulletSpecific reference to quality management principles.
    bulletConsideration of the benefits and needs of all interested parties.
    bulletAddition of the concept of organizational self-assessment as a driver for improvement (ISO 9004).

     

  2. What new requirements have been introduced into the revised ISO 9001 standard?
     
    bulletContinual improvement.
    bulletIncreased emphasis on the role of top management.
    bulletConsideration of legal and regulatory requirements.
    bulletEstablishment of measurable objectives at relevant functions and levels.
    bulletMonitoring of information of customer satisfaction and / or dissatisfaction as a measure of system performance.
    bulletIncreased attention to resource availability.
    bulletDetermination of training effectiveness.
    bulletMeasurements extended to system, processes, and product.
    bulletAnalysis of collected data on the performance of the quality management system.

     
  3. 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.

    Principle 8 – Mutually beneficial supplier relationships

    An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

  4. 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.
    Principle 8 – Mutually Beneficial Supplier Relationships

    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.


     

  5. ISO 9001: 2000 MAIN CLAUSES
  1. QUALITY MANAGEMENT SYSTEM
  2. MANAGEMENT RESPONSISBILITY
  3. RESOURCE MANAGEMENT
  4. PRODUCT REALIZATION
  5. MEASUREMENT, ANALYSIS AND IMPROVEMENT
  1. HIGHLIGHTS OF REVISED STANDARDS
bulletQuality management system instead of Quality assurance system.
bulletApplicability to all product categories, in all sectors and to all sizes of organizations.
bulletConnection of Quality Management systems to organizational processes.
bulletProvision of a natural move towards improved organizational performance.
bulletGreater orientation toward Continual Improvement and customer satisfaction.
bulletCompatibility with other Management systems such as ISO 14000.
bulletProcess based model and PDCA methodology
bulletConsideration of the needs and benefits to all interested parties.
bulletLays emphasis on :
bullet

Top management commitment.

bullet

Enhance customer satisfaction.

bullet

Process conformity.

bullet

Continual improvement of product, process and QMS

bullet

Statistical techniques and analysis of data.

bullet

effectiveness and efficiency.
 

  1. List of Mandatory QMS Records
bulletMANAGEMENT REVIEW
bulletEDUCATION,TRAINING, SKILLS AND EXPERIENCE
bulletREALIZATION PROCESS AND PRODCUT FULFIL REQUIREMENT
bulletREQUIREMENT OF REVIEW RESULTS AND ACTIONS
bulletINPUTS REQUIREMENTS FOR PRODUCT
bulletDESIGN AND DEVELOPMENT REVIEW
bulletDESIGN AND DEVELOPMENT VERIFICATION
bulletDESIGN AND DEVELOPMENT VALIDATION
bulletDESIGN AND DEVELOPMENT REVIEW OF CHANGES
bulletSUPPLIER EVALUATION.
bulletVALIDATION OF PROCESS FOR PRODUCTION & SERVICE.
bulletUNIQUE IDENTIFICATION
bulletCUSTOMER PROPERTY UNSUITABLE.
bulletIMTE CALIBRATION AND VERIFICATION.
bulletIMTE ASSESSMENT OF VALIDITY.
bulletLIST OF IMTE.
bulletINTERNAL AUDIT.
bulletPRODUCT ACCEPTANCE.
bulletNATURE OF NON-CONFORMITIES AND DISPOSITION.
bulletCORRECTIVE ACTIONS
bulletPREVENTIVE ACTIONS.
  1. 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

     

  2. 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.

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