Transcript
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What is ISO9001:2000?
ISO 9001:2000 is aninternationalstandard for implementing aquality management system
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ISO 9001:2000 sets out
how a company canestablish an effectivequality management
system to meet itsstakeholders’ needs
ISO 9001:2000 sets out
how a company canestablish an effectivequality management
system to meet itsstakeholders’ needs
Why Use ISO9001:2000?
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ISO 9000:2000 - Fundamentals andVocabulary
Provides an introduction to Quality
Management Systems (QMS) and vocabularyISO 9001:2000 - Requirements
Specifies requirements for a QMS wherecapability to provide product that meets
customer and regulatory requirements needsto be demonstrated
ISO 9004:2000 - Guidelines forPerformance Improvement
Provides guidance on using an establishedQMS to further enhance customer satisfaction
IS0 9000:2000 Series of Standards
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1. Customer focus
2. Leadership
3. Involvement of people4. Process approach
5. System approach to management
6. Continual improvement7. Factual approach to decision making
8. Mutually beneficial supplierrelationship
Eight Quality ManagementPrinciples
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CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
Measurement,analysis and improvement
Measurement,analysis and improvement
Product Product Input Output
Management responsibility
Resourcemanagement
Resourcemanagement
Clause 5
Clause 6 Clause8
Clause 7
Customers
Requirements
Product
realization
Customers
Satisfaction
Value adding activitiesInformation flow
Introduction to ISO 9000:2000
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1. Scope
1.1 General
1.2 Application
2. Normative reference
3. Terms and definitione.g., Supplier OrganizationCustomer
ISO 9001:2000Requirements
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Possibility to reduce scope
No 9002 or 9003
Can reduce the scope of requirementsrelated to “product realization”
May not exclude any requirement thataffects ability to provide product and/orservice that meets customer andregulatory requirements
Permissible Exclusions
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To meet the requirements you must: Document
Implement Maintain Continually improve effectiveness
4 Quality ManagementSystem
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4 Quality ManagementSystem
4.1 General requirements Processes, interaction, improvement
4.2 Documentation requirements General Quality manual Control of document Control of records
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5 Management Responsibility
5.1 Managementcommitment
5.2 Customer focus5.3 Quality policy
5.4 Planning Objectives
Management system
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5.5 Responsibility, authority andcommunication Top management emphasis
Management representative Includes promotion of customer
requirements throughout the organization Internal communication
5.6 Management review Lists of inputs and outputs Recommendation for improvement Action items expected Records
5 Management Responsibility
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6 Resource Management
6.1 Provision of resources to improveprocesses and enhance customersatisfaction
6.2 Human resource Determine competence Provide training or other action Evaluate effectiveness of action
6.3 Infrastructure
Buildings, workspace, utilities Process equipment Support services
6.4 Work environment Manage conditions of environment to
achieve product requirement conformance
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7 Product Realization
7.1 Plan and develop the processes
Include product objectives, relevantprocesses and resource, appropriate testand validation
7.2 Customer related processes
Customer requirement - stated andimplied
Statutory and regulatory
Product requirements and changes Organization ability Communication with customers
7.3 Design and development
Planning, inputs, outputs, systematicreviews, verification and validation,
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7 Product Realization
7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product
7.5 Production and service provision Controlled conditions including product
characteristics, work instructions, suitableequipment, measuring devices, andsystem
Release, delivery and post deliveryactivities Validation of processes when no other
method Identification and traceability of product
and it’s status Care of customer property
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7 Product Realization
7.6 Control of monitoring and measuringdevices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration
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8 Measurement, Analysis,and Improvement
8.1 General Plan and implement Measurement and monitoring processes
To demonstrate product conformity,
system conformity and continuallyimprove the QMS
8.2 Monitoring and measurement Customer satisfaction
Perception of fulfillment
Internal planned audit, etc. Auditors independent of their own work
Processes Demonstrate achievement of planned results
Product
Monitor and measure characteristics Conformity with acceptance criteria
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8 Measurement, Analysis,and Improvement
8.3 Control of nonconforming product Elimination, concession, preclude
intended use
8.4 Analysis of data Customer satisfaction Product and process requirements and
trends Suppliers
8.5 Improvement Continually improve effectiveness
of the system Corrective action
Preventive action
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Next Steps
Phase I: Assess the present situation
Phase II: Plan the implementation /transition
Phase III: Implement plan
Phase IV: Assess and review
Phase V: Consolidate and improve
Phase VI: External assessment
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Next Steps
I mplementation Transition
Assess existing Business
System
Review:
ScopeI.D. Steering Team andImplementation Team
Existing documentation Assessment system Management review
Prepare and coach
teams
Corrective and Preventive
Action Systems Senior management focus Performance since
registration For compliance gaps
Phase I: Assess the PresentSituation
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Next Steps
I mplementation Transition
Develop: Project Plan
Develop: Overall transition plan
Documentation plan Training plan Communication plan Process mapping plan Calibration plan Assessment plan Management review
plan
Plan for those topics
needing attention as aresult of the review
- Documentation(especially if existing
system is not processfocused)
- Transition Measurement and
Improvement plan Registrar selection plan
Plan to implement
processes to fulfill anysystem gaps
Phase II: Plan theImplementation/Transition
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Next Steps
I mplementation Transition
Maintain project plan Provide training identified Process map the business
processes
Gather metrics data I.D. improvement issues Publish improvement
Map processes is notalready Measure processes Train assessors to assess
for business effectiveness Gather metrics data I.D. improvement issues Publish improvement
Phase III: Implement the Plan
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Next Steps
Assess Review
Use internal assessmentto verify compliance andI.D. businesseffectiveness issues
Use internal assessmentto verify compliance andI.D. business effectivenessissues
Share information to gain
improvement momentum
Share information to gain
improvement momentum Start management
reviews
Continue managementreviews (revised)
Phase IV: Assess and Review
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Next Steps
I mplementation Transition
$ Improvement issues(process mapping,assessments, customersatisfaction)
$ Improvement issues(process mapping,assessments, customersatisfaction)
Change the processes Change the processes
Publish gains andsuccess
Publish gains andsuccess
Close gaps withcompliance
Close gaps withcompliance
Phase V: Consolidate and Improve
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Next Steps
I mplementation Transition
Optional pre-assessment
On goingsurveillance(increase scope)
Registrationassessment
Upgrading theexisting registration
Business focus Business focus
Phase VI: External Assessment
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Summary
ISO 9001:2000 is much more project driven
Top management have greater accountability
The organization is required to measurebusiness performance against objectives
If implemented correctly, it will help theorganization to: Be more competitive Improve cycle times Reduce costs Improve morale
top related