Your Expectations?

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What is a successful Audit?

Critical Success Factors

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ManagementSystems

Basic Assumptions

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The ISO Approach : Global Objectives Say What You DoDo What You SayProve it !

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The Global Certification SystemsISO-9001:2000Quality ManagementISO-14001:1996Environmental Mgmt.

OHSAS-18001:1999Occupational Health & Safety

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Integrated Management MaterialStakeholders RequirementsHappy StakeholdersMaterialManEMSQMSOHSAS

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Quality, Environment, Safety : the connection?

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The global trend in Certification(Source: 11th Cycle of survey by ISO)

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Global GrowthISO 9000 CertificatesISO 14000 Certificates

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Evolution of System Standards1. 1987: ISO-9000 Standards2. ISO-9000 was revised in 19943. Environmental Management Systems: 14001 created in 1996December 2000 : Whole series updatedOHSAS-18001 was created on same line with ISO-14001.

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Quality Management Basic Concepts

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What is Quality?

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QUALITY DEFINITIONDEMINGRemoval Of VariationCROSBYConformance To SpecificationJURANFitness to UseTAGUCHIMinimum Loss To SocietyISO (Earlier version)Totality Of Characteristics Of An Entity That Bear On Its Ability To Satisfy Stated And Implied Needs

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QualityDegree to Which a Set of Inherent Characteristics Fulfils Requirements

Characteristic: A distinguishing featureRequirement: need or expectation that is stated, generally implied or mandatory

Quality : ISO 9000 Definition

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Evolution of Quality ManagementCountry craftsmanFactory system (industrial revolution)TAYLORIAN system (scientific management)Inspection based quality

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Exercise TextThe necessity of the fatherly handling of farm livestock is the foremost focus in the minds of farm owners. Since often the forefathers of the farm owners trained the farm hands for first class farms in the fatherly handling of fine farm livestock, the farm owners feel they should fully carry on with the family tradition of training farm hands of first class farms in the fatherly handling of farm livestock because they believe as if it is by far the basis of good fundamental farm management.

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Main Objective of IMSPREVENTION rather than DETECTION & CONTINUAL IMPROVEMENT

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Evolution of TQMCOUNTRY CRAFTSMAN FACTORY SYSTEM (INDUSTRIAL REVOLUTION) TAYLORIAN SYSTEM (SCIENTIFIC MANAGEMENT) INSPECTION BASED QUALITYQC APPROACHPROCESS CONTROL/COMPLIANCE (QA APPROACH)TOTAL QUALITY MANAGEMENT

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PrinciplesofQuality Management

Universal Principles of Quality Management

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Quality Management Principles1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach 6. Continuous improvement7. Factual approach to decision making8. Mutually beneficial supplier relationship

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1. Customer FocusOrganizations should meet customer requirements and strive to exceed customer expectations .

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Customers perception of the degree to which the Customers requirements have been fulfilled

Absence of customer complaint does not mean satisfactionFulfillment of agreed requirement doesnt mean high customer satisfactionCustomer Satisfaction

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2. LeadershipLeader establishes unity of purpose and direction of the organizationLeader should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

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3. Involvement of peoplePeople at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.

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4. Process orientationA desired result is achieved more efficiently when related resources and activities are managed as a process.

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Process Approach

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5. System approachA system comprises of many Processes, having inter-relationships.A system comprises interacting elements to achieve common goals.System approach is essential to manage the processes in the system.It improves effectiveness and efficiency of the organization

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5. System approach consists of1. Clear objectives2. Organizational structure with well defined authority and responsibility.3. Planning for Quality 4. Control of functions affecting quality.5. Coordination of interrelated processes.6. Audit mechanism for self regulated organization.

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6. Continuous ImprovementContinuous improvement should be a permanent objective of the organization.

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PDCA cycleThe PDCA cycle isalso known as theDeming cycle

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7. Factual approach to decision makingEffective decisions are based on the analysis of data and information . Performance

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8. Mutually beneficial supplier relationships. An organization and its suppliers are interdependentA mutually beneficial Supplier-Customer relationship enhances the ability of both to create value

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BasicsAssumptionsinISO 9000

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The ISO Approach to Quality Management ISO-9000 provides Quality AssuranceAssurance to:CustomerManagementEmployeesSociety

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What is ISO?International Organization for Standardisation, established since 1947HQ : GenevaIssued over 13000 Product StandardsMember Countries : 140Purpose: remove technical barriers to trade"

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ISO Systems standards1. First time 1987: ISO-9000 Standards were created for Systems rather than Products2. ISO-9000 was revised in 1994Environmental Management Systems: 14001 created in 1996OHSAS-18001 was created in 19994. A number of supporting documents/guidelines and standards are now created5. December 2000 : Whole 9000 series updated

Some Misconceptions about ISO

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ISO 9000 is not ISO 9000Its rather a familyISO 9000:Fundamentals and VocabularyISO 9001:QMS Requirements(Certifiable)ISO 9004:Guidelines for Performance Improvement

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ISO 9000 Basic PremisesSystem Standard, not Product StandardThere is nothing like ISO CertificationNo ISO-9000 certification ExistsFor any organization/systemAny Product category: Hardware, Software, Services, Process MaterialAddresses the interests of Customers primarily but helps other interested parties as well

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ISO 9000 FamilyISO-9000IS0-9001ISO-9004IS0-19011

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Major StandardsISO 9000:2000, Quality management systems - Fundamentals and vocabulary Establishes a starting point for understanding the standards and defines the fundamental terms and definitions used in the ISO 9000 family needed to avoid misunderstandings in their use.

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Major StandardsISO 9001:2000Quality management systems - Requirements

This is the requirement standard used to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried. .

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Major StandardsISO 9004:2000Quality management systems Guidelines for performance improvements

This guideline standard provides guidance for continual improvement of your quality management system to benefit all parties through sustained customer satisfaction.

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Relationship with ISO-9004Consistent pair approachISO-9001 is requirementISO-9004:To move beyond the requirementContinual improvementNot for certification

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Major StandardsISO 19011Guidelines on Quality and/or Environmental Management Systems Auditing Provides you with guidelines for verifying the system's ability to achieve defined quality objectives. You can use this standard internally or for auditing your suppliers. .

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How toRead the Standards

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The Expressions

ShallTo express a provision that is binding between two or more partiesWillTo express a declaration of purpose of intent by one partyShouldTo express a recommendation among other possibilitiesMayTo indicate a course of action permissible within the limits of the systemNoteInformation for guidance and clarity