Introduction to ISO 9001 2000

8/9/2019 Introduction to ISO 9001 2000

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INTRODUCTION TOISO 9001:2000ISO 9001:2000

Packages Limited


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CONTENTS

1 Background

2 Eight Quality Management Principles

3 ISO 9001:2000 Requirements


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BACKGROUNDBACKGROUND

11


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What is ISO 9000?

ISO 9000ISO 9000 is a series of standards

describing the requirements for establishing

and maintaining a quality management

system in an organization

The word iso orInternational Organization for

Standardization

The series allocatedfor

Quality Systemstandards

ISOISO 90009000


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Origin of ISO 9000

MIL-STD-9858(1940s)

AQAP1(NATO)1970s

BS57501979

ISO 9000:87ISO 9000:94ISO 9000:2000


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Revisions of ISO 9000

19871987

19941994

20002000

Originally released asISO 9000:1987

First revision named

as ISO 9000:1994

Second revision named

as ISO 9000:2000

ISO 9000 is revised after five years


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ISO 9000:1994 Models

ISO 9003:1994ISO 9003:1994Applies to organizations that do not design/developand produce their products or services but are onlyinvolved in final inspection and delivery of the finished

product

ISO 9002:1994ISO 9002:1994Applies to organizations that do not design/develop theirproducts or services but are only involved in productionof products/ provision of services and delivery ofproducts/services

ISO 9001:1994ISO 9001:1994Applies to organizations involved in design anddevelopment of products/services, production of

products/provision of services, and delivery ofproducts/services


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Elements of ISO 9000:1994Clause Clause Title 9001:1994 9002:1994 9003:1994

4.1 Management Responsibility A A A

4.2 Quality System A A A

4.3 Contract Review A A A

4.4 Design Control A

4.5 Document and Data Control A A A

4.6 Purchasing A A

4.7 Customer-supplied products A A A

4.8 Identification & Traceability A A A

4.9 Process Control A A

4.10 Inspection and Testing A A A

4.11 Inspection and Test Equipment A A A

4.12 Inspection and Test Status A A A

4.13 Control of Non-conforming Product A A A

4.14 Corrective and Preventive Action A A A

4.15Handling, Storage, Preservation, Packing

and DeliveryA A A

4.16 Control of Records A A A

4.17 Internal Quality Auditing A A A

4.18 Training A A A

4.19 Servicing A A

4.20 Statistical Analysis A A A


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Eight QualityEight Quality

Management PrinciplesManagement Principles

2


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8 QUALITY MANAGEMENT

PRICINIPLES

8 QUALITY8 QUALITY

MANAGEMENTMANAGEMENT

PRINCIPLESPRINCIPLES

Mutuallybeneficial supplier

relationship

Customer-focus

FactualApproach toManagement

Leadership

Involvement ofPeople

ProcessApproach

System approach to

management

ContinualImprovement


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1. CUSTOMER FOCUSED

Organizations depend ontheir customers and

therefore should: understand current and future

customer needs,

meet customer requirements, and

strive to exceed customerexpectations.


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2. LEADERSHIP

Leaders should:

establish unity of purpose (vision and mission) provide direction to the organization (policy and objectives) provide resources to achieve organizations objectives

Corporate

Goal


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3. INVOLVEMENT OF PEOPLE

People at all levels are the essence of an organization.Therefore, their full involvement enables their abilities to be used for the

organizations benefit


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4. PROCESS APPROACH

Organizations need to do more than simply monitor process outputs,(typically through inspection activities)

they must also control all process inputs, (people, facilities/equipment, material and methods)

and, they must establish appropriate controls over the transformation activities, (if desired results are to be achieved consistently and efficiently)

TransformationInputs Outputs

Resources


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5. SYSTEM APPROACH TO

MANAGEMENT

Organizations must understand a system is a set of interrelated processes, and the output of one process is the input to one or more subsequent processes, so

It is critical to manage the white space (or interface) between processes to ensure that the overall system is effective


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6. CONTINUAL IMPROVEMENT

Continual improvement should bea permanent objective of the

organization

QMS

Measure/Monitor Results

against Objectives Improve Process, and

Change QMS as needed to

achieve and sustain Desired

Results

Plan

DoCheck

Act

Baseline Performance

Continual

Improvement

Results


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7. FACTUAL APPROACH TO

DECISION MAKING Effective decisions should be

based on: the analysis of data and information

COLLECTIONCOLLECTION

OF DATAOF DATAANALYSISANALYSIS DECISIONDECISION


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8. MUTUALLY BENEFICIAL

SUPPLIER RELATIONSHIPS

An organization and itssuppliers are interdependent.Therefore: a mutually beneficial relationship should be established between them to enhance the

ability of both to create value

PRODUCTPRODUCT

OROR

SERVICESERVICE

PRODUCTPRODUCT

OROR

SERVICESERVICE

VENDORSVENDORS

ORGANIZATIONORGANIZATION

+


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ISO 9001:2000ISO 9001:2000

RequirementsRequirements

3


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ISO 9000:2000

ISO 9002:1994 & ISO 9003:1994 dropped and merged into a singleISO 9001:2000 standardISO 9001:2000 standard

New StandardsNew Standards

ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS RequirementsISO 9001:2000 QMS Requirements

ISO 9004:2000 Guidelines for PerformanceImprovement

New StandardsNew Standards

ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS RequirementsISO 9001:2000 QMS Requirements

ISO 9004:2000 Guidelines for PerformanceImprovement


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NEW STRUCTURE

20 Clauses20 Clauses have been abandoned and merged into 55

sectionssections with additional requirements

Permissible Exclusions from Clause 7Clause 7 only if it does notapply

Clause 6:Clause 6:Resource

Management

Clause 7:Clause 7:Product Realization

Clause 4:Clause 4:Quality System

Clause 5:Clause 5:ManagementResponsibility

Clause 8:Clause 8:Measurement,

Analysis &Improvement


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Contents

Scope 1.1 General1.2 Application

1

Terms and Definitions3

NormativeReference2


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Contents (cont.)

QualityManagementSystem

4.1 General Requirements4.2 Documentation Requirements

4ManagementResponsibility

5.1 Management Commitment5.2 Customer focus5.3 Quality Policy

5.4 Planning5.5 Responsibility, authority andcommunication5.6 Management Review

5

Resource Management6.1 Provision of resources6.2 Human resources6.3 Infrastructure

6.4 Work environment

6

Product Realization7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision

7.6 Control of monitoring and measuringdevices

7


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Contents (cont.)

Measurement,Analysis andImprovement

8.1 General8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement

8


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DEMINGS CYCLE

DEMINGSCYCLE

PLANPLAN

DODOCHECKCHECK

ACTACT

Define Policy Set Objectives &Targets

Assign Responsibilities Provide Resources

Implement accordingto plannedarrangements

Monitor and Measurethe actualimplementationagainst the planned

Identify the Gaps

Analyze the GapsTake corrective and

preventive actions tofill the gap


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Process Model

ManagemeManageme

ntnt

responsibiliresponsibili

tyty MeasuremeMeasurement, analysisnt, analysis

andandimprovemenimprovemen

tt

ResourceResource

managememanageme

ntnt

ProductProduct

realizatirealizati

onon

Output

Input

ProducProduc

tt

CONTINUAL IMPROVEMENT OFTHE QUALITY MANAGEMENT

SYSTEM

CUST

OMER

CUST

OMER

Satisfac

tion

Satisfac

tion

CUST

OMER

CUST

OMER

Requirem

ents

Requirem

ents


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Scope

ConsistencyConsistency of products/services

Compliance with requirements including

customer and regulatory requirementscustomer and regulatory requirements

Enhanced Customer SatisfactionCustomer Satisfaction

Continual ImprovementContinual Improvement


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4 QUALITY SYSTEM

Policy/Objectives

QualityManual

Quality System Procedures

Process Procedures, Plans

Records/Reports/Logs

4.2: Documentation4.2: Documentation


4.2.3 Control ofDocuments

4.2.4 Control of Records

4.1: General Requirements4.1: General Requirements


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4.4.5 DOCUMENT CONTROL

DOCUMENTDOCUMENT

CONTROLCONTROL

Review & Approval

DistributionControl

Change ControlExternal DocumentControl

Obsolete DocumentControl


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4.5.3 CONTROL OF RECORDS

RECORDSRECORDS

CONTROLCONTROL

Identification

Retrieval

Disposition

Indexing

Retention

Filing

Storage

Maintenance


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5 MANAGEMENT

RESPONSIBLITY

5.1: ManagementCommitment

5.2: Customer Focus

5.3: Quality Policy

5.4: Quality Objective &Planning

5.5.2: Management Representative

5.5.3: Internal Communication

5.6: Management Review

5.5: Responsibility, Authority and Communication5.5: Responsibility, Authority and Communication

New

New

New

5.5.1: Responsibility & Authority

5 1 MANAGEMENT


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5.1 MANAGEMENT

COMMITMENT

Setting Quality

Policy

Establishing

Quality

Objectives

Supporting

Quality Initiatives

& Programs

Participating in

Quality Reviews

& Meetings

Providing

ResourcesMotivating &

Involving people


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5.2 CUSTOMER FOCUS

OrganizatioOrganizatio

nsns

ProcessesProcesses

OrganizatioOrganizatio

nsns

ProcessesProcesses

Inputs

ProducProduc

tt

ProducProduc

tt

CU

S

T

OM

E

R

CU

S

T

OM

E

R

Sa

t

i

s

f

a

c

t

i

o

n

S

at

i

s

f

a

c

t

io

n

CU

S

T

O

M

E

R

C

U

S

T

O

ME

R

RR

ee

qq

uu

ii

rr

ee

mm

ee

nn

tt

ss

RR

eeqq

uu

ii

rr

ee

mm

ee

nntt

ss

Complaints

Feedback

IDENTIFY &

REVIEWMONITOR &

MEASURE


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5.3 QUALITY POLICY

COMMITMENT

M

EETING

REQU

IREMENTS

CO

NT

INUA

L

IMPROVEM

ENT

QUALITY

POLICY


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5.4 PLANNING

SPECIF

IC

MEASUR

ABLE

ACHIEV

ABLE

REALIS

TIC

TIME

-BO

UN

D

QUALITY

OBJECTIVES

Rejection Rate = ??Rework rate = ??Failure rate = ??

On-time delivery = ??Response time = ??Complaints = ??

5 5 R ibilit


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5.5 Responsibility,

Authority & Communication

Defining responsibilities & authorities

in the form of:

Organizational Charts

Job Descriptions

Appointing the ISO 9000 Project

Coordinator, called Management

Representative (MR)

Establishing Internal Communication

Channels, which may include:

intranet, memos, internal

meetings, emails, phones, etc.


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5.6 MANAGEMENT REVIEW

TopTop

ManagemenManagemen

t Reviewt Review

MeetingMeeting

TopTop

ManagemenManagemen

t Reviewt Review

MeetingMeeting

Results of Audits

Complaints/Feedback

Product Quality Status

Pending Actions

External Market Status

Improvement Suggestions

Revision of policy

Revision of objectives

Corrective Actions

Improvement Actions

Resource needs

INPUTSINPUTS OUTPUTSOUTPUTS


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6 RESOURCE MANAGEMENT

6.2: Human Resources6.2: Human Resources

6.2.1: General

6.2.2: Awareness & Training

6.3: Infrastructure6.3: Infrastructure

6.4: Work Environment6.4: Work Environment

New

New

New

6.1: General6.1: General


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6.2 HUMAN RESOURCES

TrainingTrainingSkillsSkillsExperienceExperienceEducationEducation

Identify training needs

Provide training

Evaluate the

effectiveness of training

Maintain records of

training

COMPETENCOMPETEN

CECE

TRAININGTRAINING

&&

AWARENESAWARENESSS


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6.3/6.4 INFRASTRUCTURE &

WORK ENVIRONMENT

INFRASTRUCTUREINFRASTRUCTURE

EquipmentEquipment

(hardware, software)(hardware, software)

Build

ing&Facilities

Build

ing&Facilities

Sup

port

Facil

itates

Sup

port

Facil

itates

(Com

m.,tran

sport)

(Com

m.,tran

sport)

NoiseNoise DustDust

VentilationVentilation

Health &

Safety

Health &

Safety

Work

Space

Work

Space

CleanlinessCleanliness

TemperatureTemperature HumidityHumidity

WORKWORK

ENVIRONMENTENVIRONMENT


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7 PRODUCT REALIZATION

7.1: Planning ofRealization

Processes

7.2: Customer-related7.2: Customer-relatedprocessesprocesses7.2.1 Determination ofrequirements7.2.2 Review of requirements

7.2.3 Customer Communication

7.3: Design &Development

7.4: Purchasing

7.6: Control ofMonitoring &

Measurement

Equip.

7.5.1 Control of Production

7.5.2 Validation of Processes

7.5.3 Identification andTraceability7.5.4 Customer Property

7.5.5 Preservation

7.5: Production7.5: Production

New

New


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7.1 PLANNING OF

REALIZATION PROCESSES

Inspection and test stages Inspection and test stages

Reference standards Reference standards

Related records Related records

Process stages Process stages

QUALITY PLANQUALITY PLAN

Responsible persons Responsible persons

Parameters to be controlled/checked Parameters to be controlled/checked


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7.2 CUSTOMER-RELATED

PROCESSES

CUSTOMERS SPECIFIEDCUSTOMERS SPECIFIED

REQUIREMENTSREQUIREMENTS

CUSTOMERS INTENDEDCUSTOMERS INTENDED


STATUTORY & REGULATORYSTATUTORY & REGULATORY


ORGANIZATIONS INTERNALORGANIZATIONS INTERNAL


7 2 2 REVIEW OF


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7.2.2 REVIEW OF

REQUIREMENTS

Product requirements are defined

Differences/ conflicts

are resolved

Organization has the ability to

meet the requirements

Records of review are

maintained Review ofReview of



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7.3 DESIGN & DEVELOPMENT

INPUTINPUTDesign &

DevelopmentOUTPUT

VERIFICATIONVERIFICATION

VALIDATIONVALIDATION

DESIGN REVIEWDESIGN REVIEW

Requirements

- Customer

- Technical

- Legal

DESIGN & DEVELOPMENT PLAN


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7.4 PURCHASING

RecordsRecords

Purchasing Process(Evaluation and selection

of suppliers)

Purchasing Process(Evaluation and selection

of suppliers)

ProcedureProcedure

Verificationof PurchasedProduct

Verificationof PurchasedProduct

Purchasing InformationComplete product specs.Personnel qualificationsApproval of purchase

documents

Purchasing InformationComplete product specs.Personnel qualificationsApproval of purchase

documents


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7.5.1 CONTROL OF PRODUCTION

CONTROL OFCONTROL OF

PRODUCTIONPRODUCTION

Product Specifications

Use of suitableEquipment

In-processmonitoring &measurement

Availability ofwork Instructions

Availability of

monitoring equipment

Maintenance ofequipment

Productionrecords

Production planning

7 5 3 IDENTIFICATION &


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7.5.3 IDENTIFICATION &

TRACEABILITY

INSPECTIONINSPECTION

& TEST STATUS& TEST STATUSTRACEABILITYTRACEABILITYIDENTIFICATIONIDENTIFICATION

Article #/Model #/Item #/Design #

Lot #/Batch #/Serial #/Mfg. date

Tags/Stickers/Trays forrejected/reworked

items


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7.5.4 CUSTOMER PROPERTY

CUSTOMERCUSTOMER

PROPERTYPROPERTY

Segregation & MaintenanceSegregation & Maintenance

Verificatio

n

Verificatio

n

Rep

ortin

gof

dam

age/l

oss

Rep

ortin

gof

dam

age/l

oss


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7.5.5 PRESERVATION

PRESERVATIONPRESERVATION

Handling

Storage

PackingProtection

Delivery

8 MEASUREMENT ANALYSIS


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8 MEASUREMENT, ANALYSIS

& IMPROVEMENT

8.2.1: Customer Satisfaction

8.2.2: Internal Audit

8.2.3: Measurement ofProcesses

8.2.4: Measurement of Products

8.2: Monitoring and8.2: Monitoring and

MeasurementMeasurement

8.3: Control ofNonconformity

8.4: Analysis of Data

Customer feedback

Product Performance

Product & ProcessTrends

Suppliers

8.5: Improvement

8.5.1: Continual Improvement

8.5.2: Corrective Action

8.5.3: Preventive Action

New

New

New

New

8.1: General8.1: General


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8.2.2 QUALITY AUDITS

RecordsRecordsRecordsRecords

ProcedureProcedureProcedureProcedure

AUDITEXECUTION

AUDITPLANNING

CORRECTIVEACTION &

FOLLOW UP

AUDITREPORTING

8 2 3/8 2 4 M it i f P


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8.2.3/8.2.4 Monitoring of Processes

& Products

Quality Plan or Inspection/Test Plans

Availability of

specifications

Inspection and Test Methods

Test records

INSPECTION &INSPECTION &

TESTINGTESTING

ReceivingIn-process

Final

8 3 CONTROL OF


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8.3 CONTROL OF

NONCONFORMITY

Controlof non-

conformity

Reject/Rework

Re-gradeAccept-as-is

Alternativeuse

RecordsRecordsRecordsRecords

ProcedureProcedureProcedureProcedure


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8.4 ANALYSIS OF DATA

Analysis ofAnalysis of

CustomerCustomer

DataData


Product DataProduct Data


ProcessProcess

TrendsTrends


SuppliersSuppliers

DataData


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8.5.1 CONTINUAL IMPROVEMENT

CONTINUALCONTINUAL

IMRPROVEMENTIMRPROVEMENT

QualityObjectives

Data Analysis

Quality AuditsCorrective/

Preventive

ManagementReview

8 5 CORRECTIVE &


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8.5 CORRECTIVE &

PREVENTIVE ACTION

PREVENTIVEPREVENTIVEACTIONACTION

Action taken toeliminate the

potential

problems toavoid theiroccurrence

PREVENTIVEPREVENTIVEACTIONACTION


potentialproblems toavoid theiroccurrence

CORRECTIVECORRECTIVEACTIONACTION


problems

occurred toavoid theirrecurrence

CORRECTIVECORRECTIVEACTIONACTION


problems

occurred toavoid theirrecurrence

Identify the problem

Investigate the root

causes

Propose solutions

Implement solution

Evaluate theeffectiveness of

solution

SUMMARY OF NEW


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SUMMARY OF NEW

REQUIREMENTS

Defining function-wise and level-wise Quality ObjectivesQuality Objectives Defining internal communicationinternal communication Defining competencecompetence based on education, training,

experience and/or skill Evaluating effectiveness of Trainingeffectiveness of Training Identification and provision ofinfrastructure and workinfrastructure and work

environmentenvironment Compliance with legal and regulatory requirementslegal and regulatory requirements

Defining external communicationexternal communication with customers Monitoring and Measurement ofcustomer satisfactioncustomer satisfaction Defining mechanism for identifying continual improvementcontinual improvement

opportunities


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Introduction to ISO 9001 2000

Documents

Transcript of Introduction to ISO 9001 2000