*Quality Management Standards

*THE ISO 9000 FAMILY ISO 9000: 2005Identifies the fundamentals and vocabulary for Quality Management Systems (QMS)ISO 9001:2008Specifies requirements for a QMS where capability to provide product that meets customer and regulatory requirements needs to be demonstratedISO 9004:2009Provides guidance on QMS that contributes to the satisfaction of customers and other interested parties

*ISO 9000 : 2008Eight quality management principles1.Customer focus2.Leadership3.Involvement of people4.Process approach5.System approach to management6.Continual improvement7.Factual approach to decision making8.Mutually beneficial supplier relationships

ISO 9001:2008CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEMInputOutputClause 5 Clause 6Clause 8Clause 7

Requirements

Satisfaction

Value adding activitiesInformation flowCustomersCustomers

*Source: AIAG ISO/TS 16949:2002 Implementation GuidePROCESS REQUIREMENTS

*SCOPE OF STANDARD1.ScopeGeneralApplication2.Normative reference3.Terms and definition e.g., Supplier Organization Customer

*QUALITY MANAGEMENT SYSTEM REQUIREMENTS4.1General requirementsDocument, implement, maintain and continually improveIdentify and determine sequence and interaction of processesDetermine criteria and methods neededEnsure availability of resourcesMonitor, measure and analyze processesImplement actions to achieve planned results

*QUALITY MANAGEMENT SYSTEM REQUIREMENTS4.2 Documentation requirementsManagement system documentationQuality ManualControl of documentsControl of records

*MANAGEMENT RESPONSIBILITY5.1Management commitment5.2Customer focus5.3Quality policyMust be documented Must be used for setting objectives5.4PlanningDocument objectives- Must be MeasurableQuality management system planning

*MANAGEMENT RESPONSIBILITY5.5Responsibility, authority and communicationResponsibility and authorityManagement representativeInternal communication

*MANAGEMENT RESPONSIBILITY5.6Management ReviewGeneralReview inputReview output

*RESOURCE MANAGEMENT 6.1Provision of resources6.2Human resourcesGeneralCompetence, awareness and training6.3Infrastructure6.4Work environment

*PRODUCT REALIZATION 7.1 Planning of product realization7.2 Customer-related processesDetermination of requirements related to the productReview of requirements related to the productCustomer communication

*PRODUCT REALIZATION 7.3 Design and developmentPlanning, inputs, outputs, systematic reviews, verification and validation, control of changes7.4 PurchasingSupplier evaluation and selectionRelevant purchasing informationVerification of purchased product - receiving, source

*PRODUCT REALIZATION 7.5 Production and service provisionControlled conditions including product characteristics, work instructions (as necessary), suitable equipment, monitoring and measuring devices, monitoring and measurement, and release, delivery and post- delivery activitiesValidation of processes when no other methodIdentification and traceability of product and its status Care of customer propertyPreservation of productIncludes constituent parts

*PRODUCT REALIZATION 7.6 Control of monitoring and measuring devicesCalibrated or verified where necessaryAdjusted and re-adjusted as necessaryIdentified to enable calibration statusSafeguarded from invalid adjustmentProtected from damage and deterioration

*MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.1General8.2Monitoring and measurementCustomer satisfactionInternal auditMonitoring and measurement of processesMonitoring and measurement of product

*MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.3Control of nonconforming product8.4Analysis of data8.5ImprovementContinual improvementCorrective actionPreventive action

*ISO 9001:2008A Structured Approach to Quality Management

*

Documented Systems

Diaco Inc. asahi515874@comcast.net 505 780-3185*QUALITY SYSTEM DOCUMENTATION STRUCTURE1st Level Quality Manual3rd Level Work InstructionsMachine instructionsComputer inputsDetailed work instructions4th Level Technical DataInternational standardsComputer operating manualsDetailed product specificationsPolicy and Objectives What the company wishes to achieve How the company implements its policy Structured to reflect process flow of eventsDetailed instructions How to complete a job or task

Diaco Inc. asahi515874@comcast.net 505 780-3185

TQM

TOTAL QUALITY MANAGEMENT

Total quality management is a systemic approach to productivity improvement using qualitative and quantitative methods and involving all stakeholders to continuously improve the quality of all products and services. TQM

TQMIS THE SET OF MANAGEMENT PROCESSES AND SYSTEMS THAT CREATE DELIGHTED CUSTOMERS THROUGH EMPOWERED EMPLOYEES, LEADING TO HIGHER REVENUES & LOWER COST

THE JURAN INSTITUTE, Inc.

TQMIt is the process of individual & organizational development the purpose of which is to increase the level of satisfaction of all the stakeholders

PIKE, R J BARNES

WHY TQM?

B/C IT IS FOR BENEFIT OF ALL STAKEHOLDERS

INTERNAL SATKEHOLDER

EXTERNAL STAKEHOLDER

COMPONENTS OF TQM

PRICE REDUCTIONCUSTOMER SATISFACTIONINVOLVEMENT OF EVERYONECONTINUOUS QUALITY IMPROVEMENTLEADERSHIP

PRICE REDUCTIONCOST AN ESSENTIAL ELEMENT OF TQMCROSBY PHILOSPHY QUALITY IS FREE QLTY IS THE RIGHT OF CUSTOMER

Who determines quality?

THE CUSTOMER

If the customer does not perceive you as offering quality service you are not.

INVOLVEMENT OF EVERYONE

CONTINUOUS IMPROVEMENTImprove each and everyday - Do not focus on problems, focus on improvements.

IF YOURE NOT PART OF THE SOLUTION, YOURE PART OF THE PROBLEM.

CONTINUOUS IMPROVEMENTCustomers are not interested in excuses, theyre interested in results.Be proactive - because if you dont someone else will.Ishikawa Says The organization which does not make a change in the 06 months is a dead organizations

LEADERSHIPNO EFFORT FOR QUALITY IMPROVEMENT CAN SUCCEED WITHOUT COMMITMENT OF TOP MANAGEMENT

LEADERSHIPA NATION WITHOUT LEADERSHIP IS THE HERD OF SWINE EINSTEIN

Steps to use the tools:1. Enter the name of the business process.2. Enter the details of the actual output which may be a product, a document, etc. It should be what is expected from the process. This should reflect process effectiveness and efficiency measurements.3. Enter the details of the equipment, materials, (including measuring and monitoring equipment) computer systems, software used in the process. Include any safety equipment needed.4. Enter the resource requirements, paying particular attention to the required skills and competence requirements.5. Enter the details for any process controls, instructions, diagrams, work instructions, etc.6. Enter the measurements that would be used to determine process effectiveness.7. Enter the details of the actual inputs which may be a document, materials, schedules, tooling, results or output of a previous process. 8. Enter the other key supporting business processes that enable the successful performance of this process. ***