| Understanding and
Implementing An ISO 9001:2000 or Related QMS (Quality Management System) |
| Implementing An ISO 9001:2000 Quality Management System |
| An Open Source Document |
| Files Included in this Package |
| About This Document - Contents |
| Sample Flow Charts |
| Introduction |
| Implementation Considerations |
| Quality Systems |
| ISO 9000 Family of Documents |
| ISO9001:2000 DIS Structure |
| ISO 9001:2000 Vs Baldrige |
| Malcolm Baldrige National Quality Award Criteria Circa 4/2001 |
| ISO 9000 |
| Where Did It Come From? |
| Liability |
| Origins |
| ISO 9001 and Quality |
| The Main ISO 900x Documents |
| The Stated Intent of ISO 9001 |
| Differences In Sectors |
| Service As A Product |
| Why Do It? |
| Why Do It? |
| Project Duration |
| Simple Schedule |
| Typical Costs |
| Payback |
| Who’s Doing It & General Issues |
| A Quality Management System? |
| System vs. Process |
| What is a System? |
| Trade Relationships |
| The Organization as a System, Subsystems, and Processes |
| Systems and Subsystems |
| Organization As An Extended System |
| Organization As An Extended System |
| Extending Outside the Organization |
| An Extended System |
| Measures In The Extended System |
| Quality Through Process Improvement |
| What is a Process? |
| Examples of Processes |
| Significant and Critical Processes |
| Special Characteristics |
| Characteristics I |
| Characteristics II |
| Characteristics III |
| Characteristics IV |
| Characteristics V |
| Critical Characteristics Matrix |
| What Is A Quality Management System? |
| What is a QMS? |
| ISO 9001:2000 QMS ‘Process Model’ |
| ISO 9001:2000 QMS ‘Process Model’ |
| ISO 14001:1996 EMS ‘Process Model’ |
| The ISO Standards |
| Required Level II Flow Charts (Procedures) |
| Some Other Expected Process Maps |
| ISO 9001 Distilled - 4 |
| ISO 9000 Distilled - 4.2 |
| ISO 9000 Distilled - 4.2.3 |
| ISO 9000 Distilled - 5 |
| ISO 9000 Distilled - 5.2 |
| ISO 9000 Distilled - 5.3 |
| ISO 9000 Distilled - 5.4 |
| ISO 9000 Distilled - 5.5 |
| ISO 9000 Distilled - 5.5.3 |
| ISO 9000 Distilled - 5.6.2 |
| ISO 9000 Distilled - 6 |
| ISO 9000 Distilled - 6.2.1 |
| ISO 9000 Distilled - 6.3 |
| ISO 9000 Distilled - 6.3 |
| ISO 9000 Distilled - 6.3 |
| ISO 9000 Distilled - 6.4 |
| ISO 9000 Distilled - 7 |
| ISO 9000 Distilled - 7.2 |
| ISO 9000 Distilled - 7.2.3 |
| ISO 9000 Distilled - 7.3.2 |
| ISO 9000 Distilled - 7.3.4 |
| ISO 9000 Distilled - 7.3.7 |
| ISO 9000 Distilled - 7.4 |
| ISO 9000 Distilled - 7.4.3 |
| ISO 9000 Distilled - 7.5 |
| ISO 9000 Distilled - 7.5.2 |
| ISO 9000 Distilled - 7.5.4 |
| ISO 9000 Distilled - 7.6 |
| ISO 9000 Distilled - 8 |
| ISO 9000 Distilled - 8.2 |
| ISO 9000 Distilled - 8.2.2 |
| ISO 9000 Distilled - 8.2.3 |
| ISO 9000 Distilled - 8.3 |
| ISO 9000 Distilled - 8.4 |
| ISO 9000 Distilled - 8.5 |
| ISO 9000 Distilled - 8.5.2 |
| ISO 9000 Distilled - 8.5.3 |
| Implementation |
| Implementing ISO 9001:2000 |
| The Fed Ex Registration |
| A Consultant? |
| Basic Reasons To Consider A Consultant |
| Role of Consultant - Piano Teacher? |
| Deliverables |
| Implementation Guarantees |
| Example Guarantee Program |
| A Consultant? Some Last Thoughts... |
| Implementation - The Process |
| Implementation Strategies |
| Project Scope Considerations |
| Implementation Commandments |
| Initial Basic Suggestions |
| ‘Standard’ General Registration Path |
| Top Level Project Flow |
| ‘Typical’ Detailed Implementation Steps Example |
| Project Definition |
| Defining Responsibilities |
| Example Organizational Chart |
| Top Management |
| Responsibilities |
| Other Responsibilities |
| An Example Area ‘Element Responsibility’ Chart |
| Department Specific Responsibility Tracking |
| Department Specific Responsibility Tracking |
| Department Specific Responsibility Tracking |
| Department Specific Responsibility Tracking |
| Department Specific Responsibility Tracking |
| Department Specific Responsibility Tracking |
| Department Specific Responsibility Tracking |
| Typical Failure Modes |
| Critical Success Factors |
| United States - IRS Deduction Ruling |
| A Plan - Think Project |
| Example Project Plan Snippet |
| Support of Upper Management? |
| A Management Committee |
| Project Kickoff |
| What Does This Mean To YOU? |
| Premise |
| Discovery! The Sweeps! |
| Success Based Upon |
| Old and New |
| Remember -- The Idea is NOT.... |
| The Basics |
| Things to Know |
| Organization and Friendliness |
| Managers Should Think About... |
| Last Things to Think About |
| A “War Room” (Status and Tracking) |
| Discovery and Classification |
| Define Document Types (Classifications) |
| More on Documentation |
| Interviewing A Registrar |
| Basics |
| Inform & Discuss |
| About The Auditors |
| Questions & Thoughts 1 |
| Questions & Thoughts 2 |
| Questions & Thoughts 3 |
| The Audits |
| Communications |
| Specification Interpretations |
| What’s In A Contract Anyway? |
| Audit Nonconformance Questions |
| Project Actions |
| Sweeps - The Discovery Phase |
| Sweeps |
| Where to Start - Documentation |
| Identification |
| Sweeping An Area - I |
| Sweeping An Area - II |
| Some Things To Think About... |
| More(!) Things to Think About |
| Organization and Friendliness |
| Discovery Phase (Sweeps) Check List |
| Discovery Phase Check List |
| Documentation - The Details |
| Why the Stress on Documentation? |
| What is Documentation? |
| An Everyday Work Instruction |
| What is Controlled Documentation? |
| ‘Standard’ Documentation Pyramid |
| Documentation |
| Myths vs. Truths |
| Basic Rules |
| Quality Records |
| What Are Quality Records? |
| Typical Types of Records |
| Records Management Activities |
| Records Required By ISO 9001:2000 |
| Document Mapping |
| Document Mapping |
| Mapping Aspects |
| Document Tiers & Classes |
| High Level Documentation Structure |
| Local Documentation Tiers |
| Typical Documentation Tiers |
| Flow Up vs Flow Down |
| Documentation Compliance Considerations |
| Mapping - Two Aspects |
| Line Item Matrix Mapping |
| Determination of Required Documents |
| Summary |
| Process Mapping |
| Why Process Maps? |
| Typical Top Level Operations Flowchart |
| Business As A System (Process) |
| Use a Process Flow Chart! |
| Creating a Process Flow Chart |
| Creating a Process Flow Chart |
| Early Process Flow Diagram |
| Flowchart |
| Symbols Used In Flowcharts |
| Basic Flow Chart Example - High Level |
| Basic Flow Chart Example - High Level |
| Flow Chart Example - Low Level |
| Process Map Elements |
| Process Map Elements |
| Process Map Elements |
| 7 Steps to Process Mapping |
| Process Mapping Worksheets |
| Process Mapping Steps 1 and 2 |
| Process Mapping Step 3 |
| Process Mapping Step 4 |
| Process Mapping Step 4 |
| Job Descriptions |
| Process Mapping Step 4 |
| Process Mapping Step 5 |
| Process Mapping Step 6 |
| Internal Audits |
| Internal Audits |
| The Internal Audit |
| A Typical Audit Process |
| Internal Audit Goal |
| Objective Evidence |
| Many Requirements |
| Internal Audits |
| Schedule Example |
| Outsourcing Internal Audits |
| Project Fulfillment |
| Enter The Registrar |
| The Registrar’s Document Review |
| Pre-Assessment Audit |
| Assessment Audit |
| Reasons For Third Party Audits |
| Reasons For Third Party Audits 2 |
| What is an Auditor? |
| Auditors Are Not!!! |
| What Will The Auditors Do? |
| Who Will Be Audited? |
| The Audit Team |
| Types of Audits |
| What Will Happen If... |
| Things to Know |
| Things to Do |
| Things NOT to Do |
| General Things To Know and Do |
| Typical Audit Questions to Expect |
| Supervisors Should Think About... |
| Last Things to Think About |
| QS-9000 / ISO 9001 Reminders |
| Real Life |
| Good Luck! |