ISO 9000ISO 9000ImplementationImplementation

Imran HussainImran Hussain

ISO 9000: 1994 ClausesISO 9000: 1994 Clauses

1.1. Management ResponsibilityManagement Responsibility2.2. Quality SystemQuality System3.3. Contract ReviewContract Review4.4. Design ControlDesign Control5.5. Document ControlDocument Control6.6. PurchasingPurchasing7.7. Purchaser Supplied ProductPurchaser Supplied Product8.8. Product Identification and TraceabilityProduct Identification and Traceability9.9. Process ControlProcess Control10.10. Inspection and TestingInspection and Testing

ISO 9000: 1994 ClausesISO 9000: 1994 Clauses

11.11. Inspection Measuring and Test EquipmentInspection Measuring and Test Equipment12.12. Inspection and Test StatusInspection and Test Status13.13. Control of Non-Conforming ProductControl of Non-Conforming Product14.14. Corrective ActionCorrective Action15.15. Handling, Storage, Packaging and DeliveryHandling, Storage, Packaging and Delivery16.16. Quality RecordsQuality Records17.17. Internal Quality AuditsInternal Quality Audits18.18. TrainingTraining19.19. ServicingServicing20.20. Statistical TechniquesStatistical Techniques

ISO 9000:2000 ClausesISO 9000:2000 Clauses

1.1. Quality Management SystemQuality Management System

2.2. Resource ManagementResource Management

3.3. Product or Service RealizationProduct or Service Realization

4.4. Management ResponsibilityManagement Responsibility

5.5. Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

ISO 9000: 2000ISO 9000: 2000Quality Management Quality Management

SystemSystem

Quality Management Quality Management SystemSystem

DocumentationDocumentationStandardISO 9000

Quality Manual

Quality System Procedures

Work Instructions

Forms

LEVEL 1

LEVEL 2

LEVEL 3

LEVEL 4

Policy Statement, Commitment, Organisation,

Responsibilities

Company Practices, Interfaces

Written Instructions to Control Tasks

Quality Records

Sales Design

Purchasing

Manufacturing

Accounts Personnel

After Sales

Why have a Quality Why have a Quality Policy?Policy?

Need for Quality PolicyNeed for Quality Policy

All organizations have in mind some All organizations have in mind some principles, beliefs which are their principles, beliefs which are their broad guides to managerial conductbroad guides to managerial conduct

These guides rest on a philosophical These guides rest on a philosophical and ethical baseand ethical base

They concern important issues and They concern important issues and are intended to have a long life, i.e. to are intended to have a long life, i.e. to act as a stabilizeract as a stabilizer

Such principles and beliefs are Such principles and beliefs are referred to as a referred to as a Quality PolicyQuality Policy

Need for Quality PolicyNeed for Quality Policy

When organizations grow, there are When organizations grow, there are different managers working under which different managers working under which various employees are workingvarious employees are working

Things need to be defined at that stage as Things need to be defined at that stage as things start becoming ambiguousthings start becoming ambiguous

As the unwelcome incidents accumulate, As the unwelcome incidents accumulate, there arises a growing urge to think there arises a growing urge to think through, write out, and publish quality through, write out, and publish quality policies to serve as guides to managerial policies to serve as guides to managerial actionaction

Advantages of PoliciesAdvantages of Policies

It provides insiders and outsiders with a It provides insiders and outsiders with a new, superior form of predictability, i.e. a new, superior form of predictability, i.e. a written guide to managerial actionwritten guide to managerial action

It forces the organization to think about It forces the organization to think about quality problems to a depth never before quality problems to a depth never before achieved. “before you write it down, you achieved. “before you write it down, you must think it out”must think it out”

It establishes legitimacy and can be It establishes legitimacy and can be communicated in an authoritative, communicated in an authoritative, uniform manneruniform manner

It permits practices to be audited against It permits practices to be audited against that policythat policy

Disadvantages of PoliciesDisadvantages of Policies

Major disadvantage is work involvedMajor disadvantage is work involved Some managers think that written Some managers think that written

policies tend to restrict innovation policies tend to restrict innovation and to narrow the range of action and to narrow the range of action available to adapt to changing available to adapt to changing conditionsconditions

Corporate Quality Corporate Quality PoliciesPolicies

As a company grows, it becomes evident As a company grows, it becomes evident that no one set of quality policies can fit all that no one set of quality policies can fit all company activitiescompany activities

This problem is solved by creating several This problem is solved by creating several levels of quality policy out of which one is levels of quality policy out of which one is corporate policy which usually consists ofcorporate policy which usually consists of The purpose of writing and publishing quality The purpose of writing and publishing quality

policiespolicies A brief statement of corporate intentA brief statement of corporate intent The minimal actions to be taken by the company The minimal actions to be taken by the company

divisions with respect to qualitydivisions with respect to quality Interdivisional relationships concerning qualityInterdivisional relationships concerning quality Relationship of quality policies to other company Relationship of quality policies to other company

policiespolicies

Corporate Quality Corporate Quality PoliciesPolicies

A delegation of authority to subordinate A delegation of authority to subordinate company organization units to establish company organization units to establish subsidiary quality policies appropriate to subsidiary quality policies appropriate to their needstheir needs

Summary statementSummary statement It is the policy of the company to provide It is the policy of the company to provide

products and services of a quality that meet the products and services of a quality that meet the initial and continuing needs and expectations of initial and continuing needs and expectations of customers in relation to the price paid and to customers in relation to the price paid and to the nature of competitive offerings, and in doing the nature of competitive offerings, and in doing so, to be the leader in product quality reputationso, to be the leader in product quality reputation

Corporate Quality Corporate Quality PoliciesPolicies

Importance of qualityImportance of quality Leadership in quality has top priorityLeadership in quality has top priority Quality shall be given equal priority to costs Quality shall be given equal priority to costs

and deliveryand delivery Quality competitivenessQuality competitiveness

Equal or exceed competitive qualityEqual or exceed competitive quality Be of the highest qualityBe of the highest quality

Customer relationsCustomer relations Provide customer satisfactionProvide customer satisfaction Meet customer perception of good qualityMeet customer perception of good quality

Corporate Quality Corporate Quality PoliciesPolicies

Internal CustomersInternal Customers We regard the receivers of our work results as We regard the receivers of our work results as

“customers” whose needs are important to “customers” whose needs are important to understand and satisfyunderstand and satisfy

Work Force InvolvementWork Force Involvement Our policy is to foster a spirit of pride among Our policy is to foster a spirit of pride among

employees regarding the company’s quality employees regarding the company’s quality performanceperformance

Quality improvementQuality improvement Resources will be allocated primarily to the Resources will be allocated primarily to the

prevention of defects and corrective action will be prevention of defects and corrective action will be focused on rot-cause identification and eliminationfocused on rot-cause identification and elimination

Divisional Quality Divisional Quality PoliciesPolicies

The same design shall be used in all The same design shall be used in all factories making a specific product.factories making a specific product.

Quality of design shall be used in all Quality of design shall be used in all factories making a specific productfactories making a specific product

Quality Policies for Quality Policies for Functional AreasFunctional Areas

Many of the policies are prepared to provide Many of the policies are prepared to provide guidance to managers in specific functional guidance to managers in specific functional departments such as product development, departments such as product development, manufacturing and marketingmanufacturing and marketing

New product introductionNew product introduction Design reviews shall be conducted with customer, Design reviews shall be conducted with customer,

market and regulatory bodies in order to ensure market and regulatory bodies in order to ensure the compliance of the design for qualitythe compliance of the design for quality

SuppliersSuppliers We seek to establish long-term, open relations We seek to establish long-term, open relations

with our supplierswith our suppliers

Quality Policies for Quality Policies for Functional AreasFunctional Areas

ManufacturingManufacturing Manufacturing process capability must be Manufacturing process capability must be

verified during the product development cycleverified during the product development cycle ProductionProduction

Involvement and a spirit of pride will be Involvement and a spirit of pride will be fostered among employees by encouraging fostered among employees by encouraging ideas and resolutions regarding the company’s ideas and resolutions regarding the company’s quality performancequality performance

Customer serviceCustomer service Service operations shall be conducted so as to Service operations shall be conducted so as to

minimize customers’ shutdownsminimize customers’ shutdowns

Quality ObjectivesQuality Objectives

An objective is an aimed-at-target– An objective is an aimed-at-target– an achievement toward which effort an achievement toward which effort is extended. is extended.

Quality objective is an aimed-at-Quality objective is an aimed-at-quality targetquality target

Quality objectives should be Quality objectives should be quantifiable in nature (measurable) - quantifiable in nature (measurable) - SMARTSMART

Objectives vs. PoliciesObjectives vs. Policies

Objectives vs. StandardsObjectives vs. Standards

Implementing ISO Implementing ISO 9000:20009000:2000

Awareness TrainingAwareness Training Establish a TeamEstablish a Team Establish ISO 9000 StatusEstablish ISO 9000 Status Prepare Action PlanPrepare Action Plan Track Action PlanTrack Action Plan Present Status of Action PlanPresent Status of Action Plan ISO 9000 Readiness AssessmentISO 9000 Readiness Assessment Contact Registrar (Certification Body)Contact Registrar (Certification Body) Official ISO 9000 AuditOfficial ISO 9000 Audit Continuous ImprovementContinuous Improvement Celebrate!Celebrate!

ISO 9000:2000 ClausesISO 9000:2000 Clauses

1.1. Quality Management SystemQuality Management System

2.2. Resource ManagementResource Management

3.3. Product or Service RealizationProduct or Service Realization

4.4. Management ResponsibilityManagement Responsibility

5.5. Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

Quality Management Quality Management System (QMS)System (QMS)

Concerned with the documentation Concerned with the documentation and management of the QMSand management of the QMS

Sub-clauses:Sub-clauses: Quality ManualQuality Manual Control of documentsControl of documents Control of recordsControl of records

Management Management ResponsibilityResponsibility

Concerned with the responsibility of Concerned with the responsibility of management in the implementation of the management in the implementation of the quality systemquality system

Sub-clauses:Sub-clauses: Management commitmentManagement commitment Customer focusCustomer focus Quality policyQuality policy PlanningPlanning Responsibility, authority, and communicationResponsibility, authority, and communication Management reviewManagement review

Resource ManagementResource Management

Concerned with the provision of Concerned with the provision of resources needed to implement the resources needed to implement the QMSQMS

Sub-clauses:Sub-clauses: Provision of resourcesProvision of resources Human resourcesHuman resources InfrastructureInfrastructure Work environmentWork environment

Product or Service Product or Service RealizationRealization

Concerned with the provision of processes to implement Concerned with the provision of processes to implement the product or servicethe product or service

Sub-clauses:Sub-clauses: Planning of product realizationPlanning of product realization Customer related processesCustomer related processes Customer requirementsCustomer requirements Customer communicationCustomer communication Design and developmentDesign and development Control of changesControl of changes Purchasing processPurchasing process Production and service provisionProduction and service provision Validation of processesValidation of processes Identification and traceabilityIdentification and traceability Customer propertyCustomer property Preservation of productPreservation of product Control of measuring and monitoring devicesControl of measuring and monitoring devices

Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

Concerned with the establishment of a Concerned with the establishment of a measurement program to measure QMS measurement program to measure QMS performance and to identify problemsperformance and to identify problems

Sub-clauses:Sub-clauses: Measurement of customer satisfactionMeasurement of customer satisfaction Internal auditsInternal audits Measurement and monitoring of processesMeasurement and monitoring of processes Measurement and monitoring of productMeasurement and monitoring of product Control of nonconformityControl of nonconformity Analysis of dataAnalysis of data Continual improvementContinual improvement Corrective actionCorrective action Preventive actionPreventive action

ReferencesReferences

Software Quality Management and Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, ISO 9001, by Michael Jenner, Ch. 1, 22

A Practical Approach to Software A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3Quality, by Gerard O’Regan, Ch. 3