Download - Cairo Iso 2000
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ISO 9000:2000
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ISO 9000:1994 Specified Quality System Requirements
Twenty Quality System Elements
1. Management Responsibility2. Quality System3. Contract Review4. Design Control5. Document & Data Control6. Purchasing7. Control Of Customer Supplied Product8. Product Identification & Traceability9. Process Control10. Inspection & Testing
11. Control Of Inspection, Measuring, & Test Equipment12. Inspection And Test Status13. Control Of Nonconforming Product14. Corrective And Preventive Action15. Handling, Storage, Packaging, Preservation, & Delivery16. Control Of Quality Records17. Internal Quality Audits18. Training19. Servicing20. Statistical Techniques
ISO 9001 - All 20 Elements; ISO 9002 - No Design Control; ISO 9003 - No Design Control, Purchasing, Process Control Or Servicing
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ISO 9001: 2000Specified Quality System Requirements
A Process Approach - Four Specific Areas
• Management Responsibility• Resource Management• Product Realization• Measurement Analysis, Improvement
All ISO 9000:1994 Requirements Addressed
New: Continual Improvement Customer SatisfactionCustomer Requirements
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THE EIGHT QUALITY MANAGEMENT PRINCIPLES
• Customer Focus
• Leadership
• Involvement Of People
• Process Approach
• System Approach To Management
• Continual Improvement
• Factual Approach To Decision Making
• Mutually Beneficial Supplier Relationships
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THE PROCESS MODEL IS THE BASIS FOR THE STANDARD
Continual Improvement Of TheQuality Management System
ManagementResponsibility
ResourceManagement
ProductRealization
MeasurementAnalysis,
Improvement
CustomerCustomer
Satisfaction
Requirements Product
Value Added Activities
Information Flow
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QUALITY MANAGEMENT SYSTEM
QUALITY MANAGEMENT SYSTEM
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GENERAL REQUIREMENTS(Paragraph 4.1)
•Identify Processes
• Determine Sequence & Interaction
• Determine Criteria & Methods
• Resources & Information
• Monitor, Measure, & Analyze
• Implement Actions
• Continual Improvement
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DOCUMENTATION REQUIREMENTS(Paragraph 4.2)
Quality Policy & Objectives
Quality Manual
Documented Procedures
Essential Documents
Quality Records
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THE QUALITY MANUAL
Scope
Justification For Exclusions
Documented Procedures Or Reference
Describe Interactions
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DOCUMENTATION REQUIREMENTS
A Procedure To:• Approve Documents• Review, Update, And Re-Approve• Identify Changes & Revision Status • Relevant Versions Available• Legible And Identifiable• External Origin Controlled• Unintended Use Of Obsolete Documents• Identify Retained Obsolete Documents
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CONTROL OF QUALITY RECORDS
Evidence Of Conformity And Effectiveness
Legible, Readily Identifiable And Retrievable
A Documented Procedure• Identification• Legibility• Storage• Retrieval• Protection• Retention Time• Disposition
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MANAGEMENT RESPONSIBILITYMANAGEMENT
RESPONSIBILITY
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MANAGEMENT RESPONSIBILITYParagraph 5.1 - Management Commitment
Evidence Of CommitmentCommunication
Establish Quality Policy
Establish Quality Objectives
Management Reviews
Available Resources
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MANAGEMENT RESPONSIBILITYParagraph 5.2 - Customer Focus
Customer Needs And Expectations
• Determined
• Fulfilled
The Aim Is To Achieve Customer Satisfaction
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MANAGEMENT RESPONSIBILITYParagraph 5.3 - Quality Policy
• Appropriate
• Commitment To Meet Requirements
• Continual Improvement
• Framework For Establishing & Reviewing Quality Objectives
• Communicated & Understood
• Reviewed For Continuing Suitability
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PLANNINGParagraph 5.4.1 - Quality Objectives
Quality Objectives
• Relevant Functions & Levels
• Measurable and Consistent
QMS Planning
• Meet Requirements & Objectives
• Maintain QMS Integrity
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RESPONSIBILITY, AUTHORITY AND COMMUNICATION
(Paragraph 5.5)Responsibilites, Authorities & InterrlationshipsAre Defined & Communicated
Appoint A Management Representative• Ensure Processes Needed Are Established• Report On Performance Of QMS• Ensures Promotion Of Awareness
Appropriate Communication Processes• Within Organization• Effectiveness Of The QMS
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MANAGEMENT REVIEWParagraph 5.6 - General
At Planned Intervals
Must Include• Evaluate Need For QMS Improvement• Evaluate Need For QMS Changes
Records Must Be Maintained
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MANAGEMENT REVIEW INPUTS & OUTPUTS
Inputs Include• Audit Results• Customer Feedback• Process Performance• Corrective & Preventive Action Status• Follow-up Of Previous Actions• Recommendations Output• Improvement Of The QMS• Product Improvement• Resource Needs
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RESOURCE MANAGEMENTRESOURCE MANAGEMENT
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PROVISION OF RESOURCES(Paragraph 6.1)
The Organization Must Determine & Provide Resources Needed:
To Implement & Maintain The QMS
To Continually Improve Effectiveness
To Address Customer Satisfaction
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HUMAN RESOURCESParagraph 6.2.1 - General
Competent Personnel
• Education
• Skills
• Experience
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RESOURCE MANAGEMENTParagraph 6.2.2
Competence, Awareness & Training
• Identify Competency Needs
• Provide Training
• Evaluate Effectiveness
• Personnel Know Relevance & Importance
• Personnel Know Contribution
•Maintain Records
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RESOURCE MANAGEMENTParagraph 6.3 - Infrastructure
To Achieve Conformity
Identify,
Provide
Maintain
For Example:• Buildings, Workspace & Utilities• Process Equipment • Supporting Services
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Determine & Manage Conditions
Achieve Conformity To Requirements
RESOURCE MANAGEMENTParagraph 6.4 - Work Environment
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PRODUCT REALIZATIONPRODUCT REALIZATION
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PRODUCT REALIZATION
Paragraph 7.1- Planning of Product Realization
Plan & Develop Consistent Processes
Plan As Appropriate• Product Quality Objectives & Requirements• Product Specific Processes, Documentation & Resources• Verification And Validation Monitoring• Records
Output Must Be Suitable
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CUSTOMER-RELATED PROCESSESParagraph 7.2.1
Determination of Requirements Related to The Product
• Customer Requirements Specified
• Requirements Not Specified By Customer
• Statutory & Regulatory Requirements
• Additional Requirements
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CUSTOMER-RELATED PROCESSESParagraph 7.2.2 -Review Of Product Requirements
Prior To Commitment • Requirements Defined• Differences Must Be Resolved• Ability To Meet Requirements
Records Maintained
Requirements Confirmed
Changes - Amendments, & Personnel Advised
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CUSTOMER-RELATED PROCESSESParagraph 7.2.3 - Customer Communication
• Product Information
• Inquiries, Contracts Or Order Handling (Including Amendments)
• Customer Feedback
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DESIGN AND DEVELOPMENTParagraph 7.3.1 - Design &/or Devlopment Planning
Plan & Control• Stages Of Design Process• Review Of Each Stage• Verification & Validation - Each Stage• Responsibilities & Authorities
Interfaces Must Be Managed
Output Must Be Updated
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DESIGN AND DEVELOPMENTParagraph 7.3.2 - Design &Development Inputs
Must Be Defined & Records Maintained• Function & Performance • Statutory & Regulatory • Previous Designs• Any Other Requirements
Reviewed For Adequacy
Complete , Unambiguous & Not In Conflict
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DESIGN AND DEVELOPMENTParagraph 7.3.3 - Design & Development Outputs
Enables Verification Against Inputs
Approved Prior To Release
Meet Input Requirements
Provide Appropriate Information
Product Acceptance Criteria
Essential Product Characteristics
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DESIGN AND DEVELOPMENTParagraph 7.3.4 - Design & Development Review
• At Suitable Stages
• Systematic Review
• Evaluate Ability To Fulfill Requirements
• Identify Problems
• Include Representatives Of Functions Concerned
• Record Results And Necessary Actions
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DESIGN AND DEVELOPMENTParagraph 7.3.5 - Design & Development Verification
Output Meets Input Requirements
Record Results And Follow-up Actions
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DESIGN AND DEVELOPMENTParagraph 7.3.6 - Design & Development Validation
Confirm Product Is Capable
If Practical - Prior To Delivery OrImplementation
Record Results And Necessary Actions
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DESIGN AND DEVELOPMENTParagraph 7.3.7
Control of Design & Development Changes
Changes Identified & Records Maintained
Must Be Reviewed, Verified & Validated As Appropriate
Approved Prior To Implementation
Include Evaluation Of Effect
Record Results Of Review & Necessary Actions
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PURCHASINGParagraph 7.4.1: The Purchasing Process • Conforms To Requirements
• Control Dependent Upon Effect On Processes & Product
• Evaluate & Select Suppliers - Ability To Supply Product
• Define Criteria - Selection , Evaluation & Re-evaluation
• Record Results Of Evaluations & Resultant Actions
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PURCHASINGParagraph 7.4.2: Purchasing Information
Describe Product To Be Purchased
• Requirements For Approval
• Personnel Qualification Requirements
• Quality Management Requirements
Ensure Adequacy Of Requirements Prior To Communication To Supplier
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PURCHASINGParagraph 7.4.3
Verification of Purchased Product
Ensure Purchased Product Meets Specified Purchase Requirements
Verification On Supplier’s Premises? • State Requirements • Methods Of Product Release
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PRODUCTION & SERVICE PROVISIONParagraph 7.5.1 - Control of Production & Service
Controlled Conditions
• Availability Of Info • Work Instructions• Suitable Equipment• Measuring & Monitoring Devices• Monitoring & Measurement Implementation• Release, Delivery & Post Delivery Activities
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PRODUCTION & SERVICE PROVISIONParagraph 7.5.2
Validation Of Processes For Production And Service
Output Not Verified
Deficiencies Apparent Later
Demonstrate Ability
Establish Arrangements (As Appropriate)• Defined Criteria • Approval Of Equipment & Personnel• Use Of Specific Methods & Procedures• Requirements For Records
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PRODUCTION & SERVICE PROVISIONParagraph 7.5.3 - Identification & Traceability
Identify by Suitable Means
Product Status - Monitoring & Measurement Requirements
Traceability Requirement • Control • Record Unique Identification
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PRODUCTION & SERVICE PROVISIONParagraph 7.5.4 Customer Property
Exercise Care
Identify, Verify, Protect & Safeguard
Record & Report • Lost, • Damaged • Unsuitable Property
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PRODUCTION & SERVICE PROVISIONParagraph 7.5.4 Preservation Of Product
Preserve Conformity
Identification, Handling,
Packaging Storage & Protection
Preservation - Product
Components
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PRODUCTION & SERVICE PROVISIONControl of Measuring & Monitoring Devices
Identify Devices
Establish Processes
Ensure Measurement Capability
Where Applicable• Calibrated or Verified• Adjusted Where & When Necessary• Identify Calibration Status• Safeguard• Protected From Damage
Out of Calibration -Validate Previous Results
Maintain Records
Validate Software
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MEASUREMENT, ANALYSIS
AND IMPROVEMENT
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
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MEASUREMENT ANALYSIS & IMPROVEMENTParagraph 8.1 General
Plan And Implement
• Demonstrate Conformity
• Ensure Conformity Of QMS
• Continually Improve QMS Effectiveness
• Determination Of Applicable Methods
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MONITORING AND MEASUREMENTParagraph 8.2.1 Customer Satisfaction
Monitor Customer Perceptions
Measurement of These Perceptions - Effectiveness Of QMS
Methods of Obtaining & Using Must Be Determined
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MONITORING AND MEASUREMENTParagraph 8.2.2 Internal Audit
Planned Intervals • Conformity to Plans• Conformity to Requirements• Implemented and Maintained
Processes Status & Importance
Define Criteria , Scope & Frequency
Objectivity & Impartiality
Documented Procedure
Actions Taken Without Delay
Follow-up Include Corrective Action Verification
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MONITORING AND MEASUREMENTParagraph 8.2.3 Monitoring & Measurement of Processes
Apply Suitable Methods For Monitoring & Measurement Of QMS Process
Confirm Ability Of Processes - Planned Results
Results Not Achieved - Corrective Action Must Be Taken
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MONITORING AND MEASUREMENTParagraph 8.2.4 Monitoring & Measurement of Product
Monitor & Measure Characteristics Of Product
Taken At Appropriate Stages
Evidence Of Conformity
Records - Authority Responsible For Release
No Product Release & Service Until All ActivitiesCompleted
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CONTROL OF NONCONFORMING PRODUCT
(Paragraph 8.3)Identify & Control
Documented Procedure• Control• Responsibilities & Authorities
Deal With nonconforming Product• Take Actions • Authorize Use, Release or Acceptance• Preclude Original Use
Records Maintained
Reverification
After Delivery - Take Appropriate Action
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ANALYSIS OF DATA(Paragraph 8.4)
Collect & Analyze
Demonstrate QMS Suitability & Effectiveness
Continual Improvement Indications
Measuring & Monitoring Activities & Other Sources
Provide Information On• Customer Satisfaction• Conformance To Requirements• Characteristics & Trends Of Products & Processes• Opportunities For Preventive Action• Suppliers
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IMPROVEMENTParagraph 8.5.1 Continual Improvement
Continually Improve Effectiveness Of QMS
• Quality Policy
• Objectives
• Audit Results
• Analysis Of Data
• Corrective & Preventive Action
• Management Review
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IMPROVEMENTParagraph 8.5.2 Corrective Action
Eliminate Cause
Prevent Recurrence
Appropriate
Documented Procedure • Identifying Non-conformances• Determining Causes• Evaluating Need For Preventive Actions • Determining & Implementing Corrective Action• Recording Results • Reviewing Corrective Action
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IMPROVEMENTParagraph 8.5.3 Preventive Action
Identify Preventive Action to Eliminate Potential Non-conformities
Prevent Occurrence
Appropriate
Documented Procedure• Identifying Potential Problems• Identifying Need for Action• Determining & Implementing Action Needed• Recording Results of Action Taken• Review of Preventive Action Taken
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THE PROCESS CENTERED ENTERPRISE
(or the end of the organization chart)
Tight Job Definition and Narrow FocusClose SupervisionIgnorance of the Big PictureIncongruent GoalsInformation AttenuationLack of Ownership, Accountability,
ResponsibilityAlienation, Boredom, Discontent
Life in the Functional Organization:
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THE PROCESS CENTERED ENTERPRISE
Everyone Knows the Organization’s ProcessesEveryone Knows where he or she fits inEveryone Knows who’s responsible for the ProcessesEveryone Knows what the Customers NeedEveryone Knows the Real EnemyEveryone is Measured on ProcessesEveryone's Head is Turned 90 Degrees
Recognizing a Process Centered Organization:
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THE PROCESS CENTERED ENTERPRISE
The Process Payoff:
Order Cycle - Standard
Order Cycle - Premium
Order Cycle - Custom
Production Cycle
Submittal Cycle
Inventory Turns
Sales
30-40 days
10-13 days
40-50 days
8-15 days
3-5 weeks
8
$108M
10 days
1-5 days
23 days
<3 days
5 minutes
20
$159M
Functional Process
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THE PROCESS CENTERED ENTERPRISE
Identify Processes
Document and Standardize Processes
Rewrite Job Descriptions
Realign Measurement and Reward Systems
Redefine Management/Leadership Roles
Reorganize Around Processes
Reshape Language, Culture, and Customs
How Do We Get There?
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THE PROCESS CENTERED ENTERPRISE
Leader– Creating a Common Vision– Deploying Holistic Measurement and Reward
Process Sponsor– Process Advocate– Process Guidance
Process Owner– Process Design/Redesign– Process Measurement
Roles and Responsibilities:
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THE PROCESS CENTERED ENTERPRISE
Introducing the Process Owner:
“A process owner is someone who spends their time thinking about work and processes. My job is linking tasks into one body of work and then looking at the complete process and making sure that it all works together”
Charles DunaganProcess OwnerCustomer Order and Inquiry FulfillmentShell Chemical Co,