ISO 9000:2000

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

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

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

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

QUALITY MANAGEMENT SYSTEM

QUALITY MANAGEMENT SYSTEM

GENERAL REQUIREMENTS(Paragraph 4.1)

•Identify Processes

• Determine Sequence & Interaction

• Determine Criteria & Methods

• Resources & Information

• Monitor, Measure, & Analyze

• Implement Actions

• Continual Improvement

DOCUMENTATION REQUIREMENTS(Paragraph 4.2)

Quality Policy & Objectives

Quality Manual

Documented Procedures

Essential Documents

Quality Records

THE QUALITY MANUAL

Scope

Justification For Exclusions

Documented Procedures Or Reference

Describe Interactions

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

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

MANAGEMENT RESPONSIBILITYMANAGEMENT

RESPONSIBILITY

MANAGEMENT RESPONSIBILITYParagraph 5.1 - Management Commitment

Evidence Of CommitmentCommunication

Establish Quality Policy

Establish Quality Objectives

Management Reviews

Available Resources

MANAGEMENT RESPONSIBILITYParagraph 5.2 - Customer Focus

Customer Needs And Expectations

• Determined

• Fulfilled

The Aim Is To Achieve Customer Satisfaction

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

PLANNINGParagraph 5.4.1 - Quality Objectives

Quality Objectives

• Relevant Functions & Levels

• Measurable and Consistent

QMS Planning

• Meet Requirements & Objectives

• Maintain QMS Integrity

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

MANAGEMENT REVIEWParagraph 5.6 - General

At Planned Intervals

Must Include• Evaluate Need For QMS Improvement• Evaluate Need For QMS Changes

Records Must Be Maintained

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

RESOURCE MANAGEMENTRESOURCE MANAGEMENT

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

HUMAN RESOURCESParagraph 6.2.1 - General

Competent Personnel

• Education

• Skills

• Experience

RESOURCE MANAGEMENTParagraph 6.2.2

Competence, Awareness & Training

• Identify Competency Needs

• Provide Training

• Evaluate Effectiveness

• Personnel Know Relevance & Importance

• Personnel Know Contribution

•Maintain Records

RESOURCE MANAGEMENTParagraph 6.3 - Infrastructure

To Achieve Conformity

Identify,

Provide

Maintain

For Example:• Buildings, Workspace & Utilities• Process Equipment • Supporting Services

Determine & Manage Conditions

Achieve Conformity To Requirements

RESOURCE MANAGEMENTParagraph 6.4 - Work Environment

PRODUCT REALIZATIONPRODUCT REALIZATION

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

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

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

CUSTOMER-RELATED PROCESSESParagraph 7.2.3 - Customer Communication

• Product Information

• Inquiries, Contracts Or Order Handling (Including Amendments)

• Customer Feedback

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

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

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

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

DESIGN AND DEVELOPMENTParagraph 7.3.5 - Design & Development Verification

Output Meets Input Requirements

Record Results And Follow-up Actions

DESIGN AND DEVELOPMENTParagraph 7.3.6 - Design & Development Validation

Confirm Product Is Capable

If Practical - Prior To Delivery OrImplementation

Record Results And Necessary Actions

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

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

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

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

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

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

PRODUCTION & SERVICE PROVISIONParagraph 7.5.3 - Identification & Traceability

Identify by Suitable Means

Product Status - Monitoring & Measurement Requirements

Traceability Requirement • Control • Record Unique Identification

PRODUCTION & SERVICE PROVISIONParagraph 7.5.4 Customer Property

Exercise Care

Identify, Verify, Protect & Safeguard

Record & Report • Lost, • Damaged • Unsuitable Property

PRODUCTION & SERVICE PROVISIONParagraph 7.5.4 Preservation Of Product

Preserve Conformity

Identification, Handling,

Packaging Storage & Protection

Preservation - Product

Components

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

MEASUREMENT, ANALYSIS

AND IMPROVEMENT

MEASUREMENT, ANALYSIS

AND IMPROVEMENT

MEASUREMENT ANALYSIS & IMPROVEMENTParagraph 8.1 General

Plan And Implement

• Demonstrate Conformity

• Ensure Conformity Of QMS

• Continually Improve QMS Effectiveness

• Determination Of Applicable Methods

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

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

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

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

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

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

IMPROVEMENTParagraph 8.5.1 Continual Improvement

Continually Improve Effectiveness Of QMS

• Quality Policy

• Objectives

• Audit Results

• Analysis Of Data

• Corrective & Preventive Action

• Management Review

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

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

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:

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:

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

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?

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:

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,