1. Putting ISO 9001:2000 to Work for You Center for Professional Management September 16, 2003

2. 9/16/2003Center for Professional Management Outline ISO 9001:2000 –The WIIFM Factor Overview Details –Transition –Implementation –Use

3. 9/16/2003Center for Professional Management Overview

4. 9/16/2003Center for Professional Management Background There are several standards organizations –SAE, ASTM, ANSI, DIN, BSI –ISO The International Organization for Standardization From the Greek isos – equal or standard ISO 9001:2000 Quality Management Systems - one of many ISO standards Aggregation of Mil and Industry Req’s

5. 9/16/2003Center for Professional Management Definition ISO 9001:2000 is - A series of standards to insure that necessary processes are in place, that the processes identified as necessary are appropriately coordinated, that they are being performed consistently and effectively and that there is objective evidence of same.

6. 9/16/2003Center for Professional Management 8 Quality Principles 1.Customer Focus 2.Leadership 3.Involvement of People 4.Process Approach 5.System Approach to Management 6.Continual Improvement 7.Factual Approach to Decision-Making 8.Mutually Beneficial Supplier Relationships

7. 9/16/2003Center for Professional Management 5 Core Elements (Clauses) Clause 4 – Quality Management System Clause 5 – Management Responsibility Clause 6 – Resource Management Clause 7 – Product Realization Clause 8 – Measurement Analysis and Improvement

8. 9/16/2003Center for Professional Management The “Big 6” Required Procedures 4.2.3 Control of Documents 4.2.4 Control of Records 8.2.2 Internal Audit 8.3 Control of Non Conforming Product 8.5.2 Corrective Action 8.5.3 Preventive Action

9. 9/16/2003Center for Professional Management Transition From 1994 Standard ISO 9001:2000 5 Core Elements 6 Req’d Procedures Business System ISO 9000:1994 20 Core Elements 18 Req’d Procedures Shop Floor Control System

10. 9/16/2003Center for Professional Management 90% + Fall Into 1 0f 4 Groups –Not ISO Registered –Registered to the 1994 Standard –ISO 9001:2000 or QS Customer Requirement Foundation for CE stamp –“Did what we had to do to get ISO in on time”

11. 9/16/2003Center for Professional Management Considerations Beyond ISO As Example – Lean Manufacturing –Error proofing –5Ss Sort Shine Set in Order Standardize Sustain –Employees properly trained –Use Visual Management techniques –Managers are committed to the program’s success –Workplace is well ordered & adheres to procedures –New procedures become a habit How do you keep these initiatives alive and well?

12. 9/16/2003Center for Professional Management...who wish to know about the world must learn about it in its particular details. -- Heraclitus c. 500 B.C.

13. 9/16/2003Center for Professional Management The Details

14. 9/16/2003Center for Professional Management TLAs ABC BPI BPM BRP CIP CIT CMM CPM CQI CRM CRP DRP ERP FBA GMP HMT JAD JIT KPI MBO MRP MES OEE QFD QIT QMS QRP SCM SPC TCO TOC TQM TPP TPM WCM

15. 9/16/2003Center for Professional Management TLAs ABC BPI BPM BRP CIP CIT CMM CPM CQI CRM CRP DRP ERP FBA GMP HMT JAD JIT KPI MBO MRP MES OEE QFD QIT QMS QRP SCM SPC TCO TOC TQM TPP TPM WCM

16. 9/16/2003Center for Professional Management ??? CMMS SCADA CFPR

17. 9/16/2003Center for Professional Management ISO

18. 9/16/2003Center for Professional Management ISO 9001:2000

19. 9/16/2003Center for Professional Management Additional Definition ISO 9001:2000 is also- Model Framework Structure Backbone

20. 9/16/2003Center for Professional Management ISO9001 Company Objectives Company Mission EquipmentMaterial PeopleMethods Mgt. Initiatives Performance Measure ERP System Morale Communications Coaching&Mentoring Training&Devlpmnt Vendor Certification Production Lines Quality Mgt. ISO as ‘Backbone’ Model Company Direction Tooling Computer Network Components Chemicals

21. 9/16/2003Center for Professional Management Further Definition ISO 9001:2000 as Business System outlines the following: A Management System –A Process Control System –A Document Control System

22. 9/16/2003Center for Professional Management Characteristics ISO 9001:2000 Completeness/Encompassing “Closed Loop” System Linked Inputs and Outputs Internal Audits Externally Audited Global Recognition

23. 9/16/2003Center for Professional Management Model of a Process Based QMS Requirements Measurement, Analysis & Improvement Product Realization Resource Management Management Responsibility Product Input Output Satisfaction Customers Continual Improvement of the Quality Management System Source: ANSI/ASQ/ISO Key Value-adding activity Information flow

24. 9/16/2003Center for Professional Management ISO 9001:2000 -- Not a Silver Bullet

25. 9/16/2003Center for Professional Management “All good tools can be used poorly… and often are. A lot of companies that have to do ISO misuse ISO. They cause more instead of less work, paperwork, training, meetings, etc.” -- Lestie Carey

26. 9/16/2003Center for Professional Management Resource versus Requirement “ISO tells what to do to run a good company – To improve your business you have to fill-in the how.” “They should be business requirements – if they are not business requirements, they should not be ISO requirements”

27. 9/16/2003Center for Professional Management Terms Quality – the degree to which a set of inherent characteristics fulfills requirements. Effective – Plan-to-Actual performance Efficiency – amount of resources ut takes to complete a task Conformance – fulfillment of a requirement. Customer Satisfaction – the customer’s perception of the degree to which the customer’s requirements have been fulfilled.

28. 9/16/2003Center for Professional Management Please Note It should be Conformance versus Compliance to standards ISO 9001:2000 is a Registration as opposed to being a Certification

29. 9/16/2003Center for Professional Management Transition ISO 9001:2000 is Less Prescriptive Focus Shifted From Documentation to Objective Evidence From Shop Floor Control to Mgt System – with Emphasis on: –Planning –Process –Being Effective –Visibility to Management –Customer Perspective Causing Success & Insuring Success

30. 9/16/2003Center for Professional Management Changing Doctrines 1994 Dogma “ Document What You Do and Do What You Document” 2000 Dogma “ A Failure to Plan is a Plan to Fail”

31. 9/16/2003Center for Professional Management Implementation Implement ISO using the ISO conforming processes

32. 9/16/2003Center for Professional Management Project Mgt 101 Identify Major Tasks & Activities Categorize Work Content Calculate Effort & Duration –Effort = Unit of work by category X the volume required X the periodicity X the frequency –Duration accounts for availability of resources –Forecast variability using MVIs Plan Backward from Finish Date

33. 9/16/2003Center for Professional Management Implementation Build Nucleus of Support “Recruit’” Senior Sponsor ID Peers Open Develop Resource Estimates Cost Effort Staff Requirments Pre Establish Implementation Project Management Select/Appoint Implementation Project Manager Draft Project Outline Establish Project Timeline Weeks 1 - 6 ID Registrar/Prime Resource 6 wks Gap Analysis Week 7 Presentation to Sr. Mgt. Prelium timeline Resource Req’s Major content Features and Benefits- What will be different Week 8 Establish Terminology Open a Glossary of Terms Review Terms in Standards Review & Training Week 9

34. 9/16/2003Center for Professional Management Selecting the audit firm References Bench Audit Pricing Gap Analysis as ‘Test Drive”

35. 9/16/2003Center for Professional Management Implementation Review CAP Review Corrective Action Procedure 8.5.2 Design Implementation Efforts to Insure that CAP is Used Week 9 Define Individual Roles ID probable castWeek 9 SR Mgt Approval Week 10 Schedule Dates Gap analysis Interim Final Audit Registration audit Week 11 Lock-in timeline Week 12 Develop Promotions Promotional Campaign Materials Negotiate Assignments Recruit identified ‘volunteers’ Clear ‘volunteer’ participation with area sprv/mgt Review understanding of commitment (roles & responsibilities) w/’volunteers’ Kick-off

36. 9/16/2003Center for Professional Management Implementation Prelim Internal Audit Activities ID ‘Lead” Internal Auditor(s) Schedule Certification Classes ID Resource to Assist Initial Internal Audit Efforts Institute Document Control Appoint administrator Enter into vendor selection – Resource/Software Define Controlled Document & Protocol Establish Quality Record Listing Format Mark Non cntrl’d process maps “for reference only” Schedule Standards Review Publish Resource Names Draft Quality Policy Statement Draft Quality Objectives Identify Key Processes Develop Process Formats Establish Map Design Develop Process Database

37. 9/16/2003Center for Professional Management Process Map Design CUSTOMERCUSTOMER CUSTOMERCUSTOMER Satisfaction / Fulfillment Requirements

38. 9/16/2003Center for Professional Management Process Map Document Example

39. 9/16/2003Center for Professional Management

40. 9/16/2003Center for Professional Management Implementation Process Map Process Gap Analysis Impanel Mgt Board Select/Appoint Mgt Rep Devlelop Mgt Review Protocols Big 6 Procedures Draft Quality Manual Quality Record Database Develop Training Program Develop Training modules Create Handouts Determine Time Requirements Schedule Training/Set Training Timeline Review Work Instructions Initiate Training

41. 9/16/2003Center for Professional Management Training Material Example Stress Linkage with Organizational Objectives Corporate Mission Statement Quality Policy Statement Dept Mission Statement Area Mission Statement Functional Quality Objectives

42. 9/16/2003Center for Professional Management Implementation Initiate Internal Audits “Initialize” System First Interim External Audit Make Necessary Adjustments Communications Process 5.5.3 Draft Letters Introduction letter ID all communications Have communication meetins post minutes Use System Continue audits, Training, Promotions Second Interim Audit Fill-in Gaps Registration Audit Celebrate

43. 9/16/2003Center for Professional Management Week of ISO-9001:2000 QUALITY SYSTEM ELEMENTS 123456789 10101 1212 1313 4 - QUALITY MANAGEMENT SYSTEM 4.1 General requirements X X 4.2 Documentation requirements 4.2.1 General X X 4.2.2 Quality manual X X 4.2.3 Control of documents X X 4.2.4 Control of records X X 5 - MANAGEMENT RESPONSIBILITY 5.1 Management commitment X X 5.2 Customer focus X X 5.3 Quality policy X X 5.4 Planning 5.4.1 Quality objectives X X 5.4.2 Quality management system planning X X 5.5.1 Responsibility and authority X X 5.5.2 Management representative X X 5.5.3 Internal communication X X Audit Schedule/Layout – Bad Example

44. 9/16/2003Center for Professional Management 4.14.24.2.14.2.24.2.14.2.34.2.45.15.25.35.4.1 MANAGEMENT Strategic Planning X Operating CommitteeX X QUALITY SYSTEMS Quality Systems Management X X Quality Control Management - Line Inpection - Receiving Inspection - Analytical Lab Quality Assurance X Regulatory Affairs OPERATIONS Manufacturing Management X X Production Management - Production Line Operation - Maintenance - Material Handling Audit Schedule/Layout – Good Example

45. 9/16/2003Center for Professional Management Using the System

46. 9/16/2003Center for Professional Management ISO’s Approach Familiar PDCA Cycle Do Check Act Plan

47. 9/16/2003Center for Professional Management Juran Approach Requirement Plan Corrective Action CheckDo Conforms? Remedial Action Feedback Loop No Yes Conforming Product / Service

48. 9/16/2003Center for Professional Management ISO Overlay Requirement (1.1,4.1,7.2.2) Plan (5.4,7.1,7.3.1, 8.5.3) Corrective Action (8.5.2) Check (7.6,8.2) Do (5.5.1,5.6,6,7.2, 7.3.2-7,7.4,7.5) Conforms? (8.1) Remedial Action (8.3) Feedback Loop No Yes Conforming Product / Service

49. 9/16/2003Center for Professional Management Signs ISO IS Sub Optimized “ISO requires us to do this.” People with ISO in their job titles Activities that were ‘done for ISO’ (e.g., flowcharts, work instructions, etc.) but are not referred to or used otherwise

50. 9/16/2003Center for Professional Management Good Practice Good Companies use Major Events to Provide Improvement in Specific, Usually Predefined, Areas of the Business

51. 9/16/2003Center for Professional Management Best Practice Great Companies Use Major Events as a Place Marker from which to Examine Thinking

52. 9/16/2003Center for Professional Management Selling ISO to Senior Management –ISO as a Resource NOT a Requirement –Major part of ROI comes from all the other projects working as they should –Sarbanes - Oxley

53. 9/16/2003Center for Professional Management Near Flawless Execution Requires Robust Policy, Procedures and Practices

54. 9/16/2003Center for Professional Management Process Map with Board CUSTOMERCUSTOMER CUSTOMERCUSTOMER Satisfaction / Fulfillment Requirements Board

55. 9/16/2003Center for Professional Management Maturation ISO 9001:2000 Evolves

56. 9/16/2003Center for Professional Management Role of the Individual Desire to have a positive impact Effort to get ISO up and running Diligence Change of mindset

57. 9/16/2003Center for Professional Management Critical Success Factors Link Inputs and Outputs Include Everyone Design Ongoing Involvement Promote Institutional Memory

58. 9/16/2003Center for Professional Management ISO ‘Take-Aways’ Structured Management Major Constituents Addressed –Customers –Employees –Suppliers Common Understandings Enforced Functions Linked Process Reinforcement Communications Integrated Participation at All Levels

59. 9/16/2003Center for Professional Management Resources - Pocket Guides Goal/QPC Memory Joggers –9000:2000 –Memory Jogger –Project Management –Creativity Tools ASQ/J.P. Russell –Process Auditing Techniques –Internal Auditing Pocket Guide –ISO 2000 Lesson Guide An Audit of the System, not the People – Quality Pursuit, Inc. Cracking the Case of ISO 9001:2000 for Service – Cianfrani, West Cracking the Case of ISO 9001:2000 for Manufacturing - Cianfrani, West ISO 9001:2000 Revision Highlights - Graebig

60. 9/16/2003Center for Professional Management Resources - Books American National Standard Quality Management Systems-Requirements – ANSI/ISO/ASQ Q9001-2000 - ASQ Demystifying ISO 9001:2000 – Paradis, Trubiano The Route to Registration – BSI, CEEM ISO 9000 Requirements – Kanholm ISO 9001:2000 Standard Paraphrased – Peach, Wilson The Management Review Handbook – Robitalle The Painless ISO 9001:2000 Transition – Robitalle Quality Audits for ISO 9001:2000 – O’Hanlon How to Audit the Process- Based QMS – Arter, Cianfrani, West ISO 9001:2000 Explained – Cianfrani, Tsiakals, West ISO 9000 - Johnson

61. 9/16/2003Center for Professional Management Resources - Web Sites ISO - http://www.iso.ch/iso/en/ISOOnline.frontpage http://www.iso.ch/iso/en/ISOOnline.frontpage –Magical Demystifying tour - http://www.iso.ch/iso/en/iso9000- 14000/tour/magical.html http://www.iso.ch/iso/en/iso9000- 14000/tour/magical.html ASQ - http://www.asq.org/ http://www.asq.org/ –Standards - http://standardsgroup.asq.org/http://standardsgroup.asq.org/ BSI - http://www.bsi-global.com/index.xalter http://www.bsi-global.com/index.xalter

62. 9/16/2003Center for Professional Management ISO as Resource ISO 9001:2000 is a business management system that can be used by managers: As a robust outline of ‘good practice’ coordinated procedures As a means for insuring consistent inter- departmental cross-functional support As a way to maintain management oversight and participation – at ALL levels

63. 9/16/2003Center for Professional Management Use ISO 9001:2000 As A Resource

64. 9/16/2003Center for Professional Management Success does not just happen – Success is caused

65. 9/16/2003Center for Professional Management Cause Success Center for Professional Management Thank You APICS