2 WHAT IS ISO 9000ISO is a ‘nickname’ to “International Organization for Standardization”.An international standard more than 100 countriesISO is a non-governmental organization established in 1947 by International Standard Agency headquartered in Geneva.Principles are applicable to all organizations
3 WHAT IS ISO 9000ISO 9000 is a written set of standard which describe and define the basic elements/clauses of the quality system needed to ensure that an organization’s products/or services meet or exceed customer needs and expectations
4 Principles of ISO 9000ISO 9000 is a standard for a quality system, not product.ISO 9000 is based on documentation and is premised on the following:-- Document what you do;- Do what your document;- Prove it and improve itISO 9000 emphasizes prevention.ISO 9000 is a universal standard; the focus is on what needs to be done and not on how it is to be carried out
5 WHY QUALITY SYSTEM - ISO 9000 to satisfy customers through a quality productto gain self confidence – we get what we plannedto achieve competitiveness in both the local and overseas markets.as a blueprint for efforts to improve the quality system of the organization.
8 WHAT IS IT INTENDED FOR?This International Standard specifies quality system requirements for use where organization’s capability to design and supply conforming product needs to be demonstrated.The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from design through to servicing
9 BENEFITS OF ISO 9000 IMPLEMENTATION For the company:-- Well defined organization and responsibilities,i.e., minimize grey areas and possibleresources wastage.- Standardize practice and establishmentof proper communication channel, i.e.maximize productivity andcommunication efficiency.
10 BENEFITS OF ISO 9000 IMPLEMENTATION For the company:-- A greater degree of internal control.- Ultimately, increase profitability andmarket share, improve competitive position.For the customer:-- Increase satisfaction and growth in confidence.
11 QUALITY MANAGEMENT SYSTEM – ISO 9001:2000 Set of comprehensive and fundamentals rules or beliefs for leading and operating an organization. The aim is to improve performance continually , by focusing on customers while addressing the needs of all stakeholders.
12 ISOQMS- |Fundamentals and vocabularyProvides fundamentals of QMS and specifies QM terms and definitionsISOQMS- RequirementsSpecifies requirements for a QMS where an organization needs to demonstrate its capability to meet customer requirement for product/service and its assessmentISOQMS- Guidance for performance improvementsProvides guidance on QMS as a mean of continual improvement of processes that contribute to the satisfaction of customers
13 Eight Quality Management Principles which can facilitate any organization in creating quality work cultureCustomer - focused organizationLeadershipInvolvement of peopleProcess approachSystem approach to managementContinual improvementFactual approach to decision makingMutually beneficial supplier relationship
14 Customer focused organization Identify customer needsDesign a product that respond to customer needsProduce and deliver the product as per the designEnhance after sales serviceMeasure customer satisfactionImprove quality to delight the customer
15 LeadershipSenior leaders set directions and create customer orientation.Values, directions and expectations must address all stakeholders.Leaders needs to ensure the creation of strategies, systems and methods for achieving excellence.Should encourage participation, learning innovation and creativity.Serve as role models who reinforce values and expectations.
16 Involvement of peopleInvolvement of all people is one way of improving quality and productivity.Involvement of people at all levels by providing a good corporate cultureproviding an interesting environment, and building the capability to perform tasks in the organization
17 Process ApproachA desired result is achieved more efficiently when related resources and activities are managed as a process.
18 System approach to Management Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization
19 Continuous Improvement Continually improve the performance by addressing the needs of all the interested parties is the permanent objective of the organization
20 Factual approach to Decision-making Effective decisions are based on the logical or intuitive analysis of data and information
21 Mutually Beneficial Supplier Relationship To create value mutual beneficial relationship between the organization and supplier in necessary
22 Structure of the ISO 9001:2000 standard 20 elements of ISO 9001:1994 still there but inthe context of a model based on organizationalprocessesCore organizational processes covered under:Clause 4. QUALITY MANAGEMENT SYSTEMClause 5. MANAGEMENT RESPONSIBILITYClause 6. RESOURCE MANAGEMENTClause 7. PRODUCT REALISATIONClause 8. MEASUREMENT, ANALYSIS ANDIMPROVEMENT
23 Structure of the new ISO 9001:2000 standard - Process-oriented structure and a more logicalsequence of contents- Allows for more flexibility on amount ofdocumentation- Changes in terminology for easierinterpretation by all sectors.
24 QUALITY MANAGEMENT SYSTEM Continual improvement of theQuality management systemManagementresponsibilityCustomersCustomersMeasurement,analysis andimprovementResourcemanagementSatisfactionRequirementsThe ISO 9001:2000 Requirements:ScopeGeneralApplicationNormative referenceTerms and definitionsQuality management systemGeneral requirementsDocumentation requirementsQuality manualControl of documentsControl of recordsManagement responsibilityManagement commitmentCustomer focusQuality policyPlanningQuality objectivesQuality management system planningOutputInputProductrealizationProductInformation flowValue-adding activitiesReference: ISO 9001:2000
25 The ISO 9001:2000 standard has new more clearly defined requirements relating to : 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 as a measure of system performance;
26 The ISO 9001:2000 standard has new more clearly defined requirements relating to : (contd.)Increased attention to resourceavailability;Determination of training effectiveness;Measurements extended to systems, process and product;Analysis of collected data on the performance ofthe QMS;Control of outsourced processes .
27 ISO 9001: 20011. Scope2. Normative reference3. Definitions4. Quality system requirements4.1 General requirementsOrganization shall establish document implement and maintain a QMS and continually improve4.2 Documentation RequirementIt includesQuality policyQuality objectivesQuality manualDocumented proceduresDocuments to ensure effective planningOperation and control of processes and records required by the international standard
28 5. Management Responsibility 5.1 Management Commitmentdevelopment and implementation of QMSContinuous Improvement in its effectiveness5.2 Customer FocusConstantly endeavor to enhance customer satisfaction5.3 Quality PolicyThe quality policyis appropriate to the purpose of the organizationincludes the commitment to comply with requiremtns and continually improve QMSframework for reviewing quality objectivesunderstood in the organizationreviewed for continuing stability5.4 PlanningQuality ObjectivesQMS Planning
29 5.5 Responsibility, Authority and Communication define the responsibilities and authority of the key personnel and ensure they are known throughout the organization.5.6 Management ReviewReview of the QMS at regular intervals6. Resource Management6.1 Organization shall determine and provide needed resources6.2 Workers will be provided necessary education, training skills and experience6.3 organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirement7. Product or Service Realization7.1 Planning of processes needed for Product/Service realization7.2 Customer Related Processes
30 7.3 Design and development Design and development planningDesign and development inputsDesign and development outputsDesign and developmentDesign and development verificationDesign and development validationControl of design and development changes7.4 PurchasingPurchasing processPurchasing informationVerification of purchased product7.5 Production and service provisionControl of production and service provisionValidation of processes for production and service provisionIdentification and traceabilityCustomer propertyPreservation of product
31 7.6 Control of monitoring and measuring devices 8. Measurement, analysis and improvement (title only)8.1 General8.2 Monitoring and measurement (title only)Customer satisfactionInternal auditMonitoring and measurement of processesMonitoring and measurement of product8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement (title only)Continual improvementCorrective actionPreventive action
32 DOCUMENTING THE SYSTEM BASED ON ISO 9001:2000 STANDARD
33 Quality Management System Documentation The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.(Clause 4.1, ISO 9001:2000)Documentation is a set of documents, for example specifications and records.Document is information (meaningful data) and its supporting medium.Quality management system is a management system to direct and control an organization with regard to quality.Quality manual is the document specifying the quality management system of an organization.
35 LEVEL 1: QUALITY MANUALThe quality manual as a highest level document at the peak of a pyramid outlining the quality system and acting as a directory for the documents and procedures below. It will outline the company’s policy and commitment to quality.
36 WHY NEED QUALITY MANUAL? Communicating the organization’s quality policy, procedures and requirements;Describing and implementing an effective quality system;Providing improved control of practices and facilitating assurance activities;Providing the documented bases for auditing the quality system;Providing continuity of the quality system and its requirements during changing circumstances;Training personnel;Presenting quality system for external purposes;Demonstrating compliance of the quality system with quality requirements
37 Quality PolicyClause 5.3The overall quality intentions and direction of an organization related to quality, as formally expressed by top management