ImplementingISO 9001:2000

• Compressed ProjectDrop Dead DateHigh Priority Project Management ApproachInitiate high level management involvement

• Business As UsualLow stressLow Priority Project Management ApproachSlipping schedule not criticalIrregular Meetings

• MeanderingSlipping schedule not importantLow level management support / involvementIrregular meetingsProject tends to “Fade Away”

Implementation Strategies

• 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.

Implementation Commandments

• Single LocationCurrent company / facility statusScope of registrationTraining needsImplementation strategyResource allotment

• Multiple LocationsSingle or shared certificateDegree of shared documentationDegree of shared data / information systemsNetwork Capacity /Capability

Note: Single location considerations all apply to multiple location projects

Project Scope Considerations

• “Full Service”On-site full-time for the duration of the project

• Two or Three Week VisitsTrack progress through interview (meetings) and “Internal audits”

• Internet / PhoneVerify systems documentsDiscuss interpretations and systemsAnswer general questions

NOTE: Training can be applied to any of the above but is on-site. Internet / Phone is always available

Role of Consultant – Piano Teacher?

• Dependent Upon The Client’s Needs and Expectations• Must Be Agreed To In Advance• May Change During Project• May Include:

Project ManagementSystems DesignSystems DocumentationTrainingInternal Auditing

Deliverables

• 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”

Implementation Guarantees

8-Step Guaranteed Registration PlanPIC 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:1. ISO/QS Introduction Seminar – Training2. ISO/QS Awareness Sessions – Training3. ISO/QS Needs Assessment – Consulting4. ISO/QS Implementation/Documentation – Training5. ISO/QS System Development, Consulting, Coaching, Training6. Choosing a Registrar Consulting7. Part A: ISO/QS Internal Auditor Training

Part B: Internal Auditor Site Coaching – Training8. Part A: Pre-Assessment Audit – Consulting

Part B: Registration Audit - Consulting

Example Guarantee Program

Task ID Project Elements Days Start Finish SEP.99 OCT.99 NOV.99 DEC.99 JAN.00

1 Define Scope of Assessment 25d Mon 9/20/99 Fri 10/22/99

2

3 Kick-off Meeting 1d Thu 10/7/99 Thu 10/7/99

4

5 Project Set-Ups 73d Thu 10/7/99 Mon 1/17/99

6 Establish Master Binders 43d Thu 10/7/99 Mon 12/6/99

7 Procedures History Binder(Scott) 1d Thu 10/7/99 Thu 10/7/99

8 Project Master Binder(Scott) 1d Thu 10/7/99 Thu 10/7/99

9 Define Documentation Systems 25d Tue 11/2/99 Mon 12/6/99

10 Document Company Quality Policy 35d Tue 11/2/99 Mon 12/20/99

11 Tailor Company Quality Systems Manual 30d Tue 11/2/99 Mon 1/17/00

12

13 Registrar Selection 110d Mon 10/11/99 Fri 3/10/00

14 Preparation, Initial Selection 35d Mon 10/11/99 Fri 11/26/99

15 Contact, Complete Rating Sheet 30d Mon 11/29/99 Fri 1/7/00

16 Interviews ( 2 to 4) 15d Mon 1/10/00 Fri 1/28/00

17 Agree on Scope, Fee, Audit Dates 30d Mon 1/31/00 Fri 2/10/00

18

19 Awareness & Mapping Meeting – Management 94d Wed 10/27/99 Mon 3/6/00

20 ISO Overview 1d Wed 10/27/99 Wed 10/27/99

21 Process Mapping 1d Wed 10/27/99 Wed 10/27/99

Example Project Plan

• 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

General Registration Path

• 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

Typical Failure Modes

• 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

Critical Success Factors

• IRS Revenue Ruling 2000-4Implementation 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

Implementation Costs

Some Thoughts

Corporate Manual

Tier 2 Flow Charts & Procedures Department & Location Specific

Department & Location Specific

Situation Specific

Tier 1Quality

Systems ManualTier 2

Policies & Gen. Op. Procedures

Tier 3Inter- Departmental

proceduresProduct & Process

DocumentsTier 4

Forms & TagsObjective Evidence Records

Tier 5Ad Hoc. Temporary

Documents

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

“Standard” Documentation Pyramid

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

Documentation

• Documentation Is Meant To Be Easily

Changed

• The Less Documentation , The Better

Myths vs. Truths

• Your Job & DocumentationSAY What You Do

Documentation

DO What You Say You DoActions

• If It’s Not WRITTEN Down, It DIDN’T Happen

Basic Rules

What QS/ISO 9000 Means To You

• You MUST:Know Your Job DutiesKnow What Training Your Job RequiresBe Able To Tell About How You Were TrainedKnow What Documentation Involves YOU!Know How To Find Out What The “Latest”

Version IsKnow What The Documentation SaysKnow How The Documentation Applies To

You !Know What The INTENT of the Documentation

Real Life