Implementing ISO 9001: 2000

1. Implementing ISO 9001:2000

2. Implementation Strategies • Compressed Project • Drop Dead Date • High Priority Project Management Approach • Initiate high level management involvement • Business As Usual • Low stress • Low Priority Project Management Approach • Slipping schedule not critical • Irregular Meetings • Meandering • Slipping schedule not important • Low level management support / involvement • Irregular meetings • Project tends to “Fade Away”

3. Implementation Commandments • You cannot give someone a responsibility without publicly conferring authority to act • If top management doesn’t care, no one else will care • If planned meetings are not attended, “someone” isn’t serious about their part in the project • Track the project publicly. Publicize status weekly or bi-weekly. • Communication may not be everything, but it is the largest single stumbling block. No camps with walls.

4. Project Scope Considerations • Single Location • Current company / facility status • Scope of registration • Training needs • Implementation strategy • Resource allotment • Multiple Locations • Single or shared certificate • Degree of shared documentation • Degree of shared data / information systems • Network Capacity /Capability • Note: Single location considerations all apply to multiple location projects

5. Role of Consultant –Piano Teacher? • “Full Service” • On-site full-time for the duration of the project • Two or Three Week Visits • Track progress through interview (meetings) • and “Internal audits” • Internet / Phone • Verify systems documents • Discuss interpretations and systems • Answer general questions • NOTE: Training can be applied to any of the above but is on-site. • Internet / Phone is always available

6. Deliverables • Dependent Upon The Client’s Needs and Expectations • Must Be Agreed To In Advance • May Change During Project • May Include: • Project Management • Systems Design • Systems Documentation • Training • Internal Auditing

7. Implementation Guarantees • Some companies offer “guarantees”. Consider the details / requirements carefully. • Typical Disclaimer • “The ISO 9000 Network guarantees that your company will achieve ISO 9000, QS 9000, or ISO 14000 certification if you follow our program.”– From http://www.isonet.com/Gaurantee.htm • The time it takes to implement a systems is inversely prioritization to the company’s involvement and prioritization. As involvement and/or priority increases, time decreases. Pretty much a “no brainer”

8. Example Guarantee Program • 8-Step Guaranteed Registration Plan • PIC has now designed a cost effective training and consulting package to help your organization achieve registration – GUARANTEED! • Our philosophy is to assist your company in developing and applying the skills necessary to plan, implement and achieve registration. • Our 8-Step Guaranteed Registration Plan Includes: • ISO/QS Introduction Seminar – Training • ISO/QS Awareness Sessions – Training • ISO/QS Needs Assessment – Consulting • ISO/QS Implementation/Documentation – Training • ISO/QS System Development, Consulting, Coaching, Training • Choosing a Registrar Consulting • Part A: ISO/QS Internal Auditor Training • Part B: Internal Auditor Site Coaching – Training • 8. Part A: Pre-Assessment Audit – Consulting • Part B: Registration Audit - Consulting

9. Example Project Plan

10. General Registration Path • Assess your situation(Pre-assessment) • Also called Gap Analysis • Define a plan with time line & begin • Interview and choose registrar • Documentation processes • Manager transitional activities • Registrar document review • Registrar document review • Registrar pre-assessment • Corrective actions • Registration audit • Implementation time frame: 3month to 2years

11. Typical Failure Modes • Can’t explain systems and/or documentation • Lack of management involvement • Personnel not following documentation • Poor communication and/or training • Lack of documentation • No or inadequate document control • Poor record keeping and systems

12. Critical Success Factors • Dedicated “Company Knowledgebase” • (Coordinator and/or Management Representative) • Pre-assessment(document and interview) • Involved, supportive top management • Receptive culture • Focus on business rather than functional areas • Prioritize processes based on customer needs, • anticipated benefits, and potential for success

13. Implementation Costs • IRS Revenue Ruling 2000-4 • Implementation costs are tax deductible in the same year. • Registration costs and registration upkeep costs are tax deductible in the same year. • Internal map hours • Internal capital expenses • Consultant fees

14. Some Thoughts

15. “Standard” Documentation Pyramid Tier 1 Quality Systems Manual Tier 2 Policies & Gen. Op. Procedures Tier 3 Inter- Departmental procedures Product & Process Documents Tier 4 Forms & Tags Objective Evidence Records Tier 5 Ad Hoc. Temporary Documents Corporate Manual Tier 2 Flow Charts & Procedures Department & Location Specific Department & Location Specific Situation Specific Define Approach Through Policies Defines Who,What and When “Things” Happen These describe Tier 3 Sub-Systems Answer How Things Happen- The Individual Steps. These describe Tier 4 Elements. Three Result –Evidence of Occurrence such as SPC Data Sheets These are typically temporary Investigative documents

16. Documentation • Organization Charts • Procedures • Forums • Tags • Prints • Specifications • Statistical Data • Inspection & Test Results

17. Myths vs. Truths • Documentation Is Meant To Be Easily Changed • The Less Documentation , The Better

18. Basic Rules • Your Job & Documentation • SAY What You Do • Documentation • DO What You Say You Do • Actions • If It’s Not WRITTEN Down, It DIDN’T Happen

19. Real Life • What QS/ISO 9000 Means To You • You MUST: • Know Your Job Duties • Know What Training Your Job Requires • Be Able To Tell About How You Were Trained • Know What Documentation Involves YOU! • Know How To Find Out What The“Latest” Version Is • Know What The Documentation Says • Know How The Documentation Applies To You ! • Know What The INTENT of the Documentation