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