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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
RequirementsRequirements
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
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
REQUIREMENTSREQUIREMENTS
STATUTORY & REGULATORYSTATUTORY & REGULATORY
REQUIREMENTSREQUIREMENTS
ORGANIZATIONS INTERNALORGANIZATIONS INTERNAL
REQUIREMENTSREQUIREMENTS
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
RequirementsRequirements
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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
Analysis ofAnalysis of
Product DataProduct Data
Analysis ofAnalysis of
ProcessProcess
TrendsTrends
Analysis ofAnalysis of
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
Action taken toeliminate the
potentialproblems toavoid theiroccurrence
CORRECTIVECORRECTIVEACTIONACTION
Action taken toeliminate the
problems
occurred toavoid theirrecurrence
CORRECTIVECORRECTIVEACTIONACTION
Action taken toeliminate the
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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