Iso 9001 training
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Transcript of Iso 9001 training
ISO 9001:2008
Awareness Program
Purpose of Program
Awareness of ISO 9001:2008.Self ImprovementImprovements in routine workingTo improve the health of organization’s Quality Management System
FAQ?
What is ISO?From where it comes?How it is helpful for us?How it works?What we have to do?
Contents Of Program
Background of ISOISO FamilyQuality Management PrincipleProcess ApproachISO 9001:2008 OverviewDetail Of Different Clauses Of ISO 9001:2008
What is ISO 9001:2008?
ISO = International Organization for StandardizationISO has representation from 162 countries and has issued many standardsISO 9001:2008 is a model for a quality management system.
Who created the standard?
International Organization for Standardization - GenevaStandards created in 1987
To eliminate country to country differencesTo eliminate terminology confusionTo increase quality awareness
ISO 9000:2005 Consists of 3 AreasISO 9000:2005 Consists of 3 Areas
ISO 9000:2005 Quality Management Systems: fundamentals and vocabularyISO 9001:2008 Quality Management Systems –Requirements (required for certification)
Management responsibilityResource managementProduct/service realizationMeasurement, analysis, improvement
ISO 9004-2009 Quality Management Systems –Guidelines for performance improvement
Generic standards
ISO 9001 is a generic standards.Generic means that the same standards can
be applied: to any organization, large or small, whatever its product or service,in any sector of activity, andwhether it is a business enterprise, a public administration, or a government department.
Generic standards (cont.)
Generic also signifies that no matter what the organization's scope of activityif it wants to establish a quality management system, ISO 9001 gives the essential features
Certification and registration
Certification is known in some countries as registration.It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001).ISO does not carry out certification and does not issue or approve certificates,
Accreditation
Accreditation is like certification of the certification body.It means the formal approval by a specialized body -an accreditation body - that a certification body is competent to carry out ISO 9001:2008 certification in specified business sectors. Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility. ISO does not carry out or approve accreditation.
Certification not a requirement
Certification is not a requirement of ISO 9001.The organization can implement and take benefit from an ISO 9001 system without having it certified. The organization can implement them for the internal benefits without spending money on a certification programme.
Certification is a business decision
Certification is a decision to be taken for business reasons:if it is a contractual, regulatory, or market requirement,If it meets customer preferencesif it will motivate staff by setting a clear goal.
Ten Steps to ISO RegistrationTen Steps to ISO Registration
2. Select the appropriate standard
1. Set the registration objective
3. Develop and implement the quality system
4. Select a third-party registrar and apply
5. Perform self-analysis audit
6. Submit quality manual for approval
7. Pre-assessment by registrar
8. Take corrective actions
9. Final assessment by registrar
10. Registration!
What is a Quality Management System?
A Quality Management System is a web of interconnected processes that are used to manage a business.
Operating Cycle of ISO.
The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's management system standards
Plan – establish objectives and make plans (analyze your organization's situation, establish your overall objectives and set your interim targets, and develop plans to achieve them).Do – implement your plans (do what you planned to).Check – measure your results (measure/monitor how far your actual achievements meet your planned objectives).Act – correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time).
ISO 9001:2008CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEMCONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
Measurement, analysis and improvement
Measurement, analysis and improvement
ProductProductInput Output
Management responsibility
Resource management
Resource management
Clause 5Clause 6
Clause 8
Clause 7
RequirementsProduct
realization
Satisfaction
Value adding activitiesInformation flow
Customers
Customers
Inputs
With What?(Materials / Equipment)
How?(Methods / Procedure)
Measure
WHO?Special Skills? / Competence?
Outputs
Process Linkages
Objectivesand
Targets
Process
PROCESS REQUIREMENTS
Management Principles
A Quality Management Principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all stakeholders.
8 Management Principles
Principle 1 : Customer FocusPrinciple 2 : LeadershipPrinciple 3 : Involvement Of PeoplePrinciple 4 : Process ApproachPrinciple 5 : System approach to managementPrinciple 6 : Continual ImprovementPrinciple 7 : Factual approach to decision makingPrinciple 8 : Mutually beneficial supplier relationships
Principle 1 : Customer Focus
Organizations depend on their customers & therefore should understand current & future customer needs, should meet customer requirements & strive to exceed customer expectations
Principle 2 : Leadership
Leaders establish unity & direction of the organization. They should create & maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
Principle 3 : Involvement Of People
People at all levels are the essence of an organization and their full involvement enables their abilities to be utilized for the organization's mutual benefit.
Principle 4 : Process Approach
The application of a system of processes within an organization, together with the identification and interaction of these processes, and their management to produce the desired outcome, can be called “Process Approach”
Principle 5 : System approach to management
Identifying, understanding & managing interrelated processes as a system contributes to the organization's effectiveness & efficiency in achieving its objectives.
Principle 6 : Continual Improvement
Continual Improvement of the organization's overall performance should be the primary driver of the organization’s Quality Management System.
Continuous Improvement
Continual Improvement
Principle 7 : Factual approach to decision making
Effective decisions are based on the analysis of data & information
Principle 8 : Mutually beneficial supplier relationships
An organization & its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
Clauses of ISO 9001-2008
1.Scope2.Normative References3.Term & Definitions4.Quality Management System5.Management Responsibility.6.Resources Management7.Product Realization8.Measurment,Analysis and Improvement
SCOPE OF STANDARD
1. ScopeGeneral
Application
2. Normative reference
3. Terms and definitione.g., Supplier Organization Customer
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
4.1 General 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 REQUIREMENTS
4.2 Documentation requirementsManagement system documentationQuality ManualControl of documentsControl of records
QUALITY SYSTEMDOCUMENTATION STRUCTURE
1st LevelQuality Manual
2nd LevelProcedures
3rd LevelWork Instructions
Machine instructionsComputer inputsDetailed work instructions
4th LevelTechnical Data
International standardsComputer operating manualsDetailed product specifications
Policy and ObjectivesWhat the company wishes to achieve
How the companyimplements its policyStructured to reflectprocess flow of events
Detailed instructions How to completea job or task
MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.2 Customer focus
5.3 Quality policyMust be documented Must be used for setting objectives
5.4 PlanningDocument objectives- Must be Measurable
Quality management system planning
MANAGEMENT RESPONSIBILITY
5.5 Responsibility, authority and communication
Responsibility and authorityManagement representativeInternal communication
MANAGEMENT RESPONSIBILITY
5.6 Management ReviewGeneralReview inputReview output
RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resourcesGeneralCompetence, awareness and training
6.3 Infrastructure
6.4 Work environment
PRODUCT REALIZATION
7.1 Planning of product realization
7.2 Customer-related processesDetermination of requirements related to the product
Review of requirements related to the product
Customer communication
PRODUCT REALIZATION
7.3 Design and developmentPlanning, inputs, outputs, systematic reviews, verification and validation, control of changes
7.4 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 it’s status Care of customer propertyPreservation of product
Includes constituent parts
PRODUCT REALIZATION
7.6 Control of monitoring and measuring devices
Calibrated or verified where necessaryAdjusted and re-adjusted as necessaryIdentified to enable calibration statusSafeguarded from invalid adjustmentProtected from damage and deterioration
MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.1 General8.2 Monitoring and measurement
Customer satisfactionInternal auditMonitoring and measurement of processesMonitoring and measurement of product
MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement
Continual improvementCorrective actionPreventive action
Any Questions or Query?
ThanksVarinder SandhuAbhived BhardwajBalram Sharma