putting iso 9001:2000 to work for you center for professional management september 16, 2003

Putting ISO 9001:2000 to Work for You

Center for Professional Management

September 16, 2003

9/16/2003 Center for Professional Management

Outline

• ISO 9001:2000– The WIIFM Factor

• Overview

• Details– Transition– Implementation– Use


Overview


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


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.


8 Quality Principles1. 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


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


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


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


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”


Considerations Beyond ISOAs 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?


...who wish to know about the world must learn about it in its particular details.

-- Heraclitus c. 500 B.C.


The Details


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


???• CMMS

• SCADA

• CFPR


ISO


ISO 9001:2000


Additional Definition

ISO 9001:2000 is also-• Model

• Framework

• Structure

• Backbone


ISO9001Company Objectives

Company Mission

Equipment Material

People Methods 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

ComponentsChemicals


Further Definition

ISO 9001:2000 as Business System outlines the following:

• A Management System– A Process Control System– A Document Control System


Characteristics

ISO 9001:2000• Completeness/Encompassing

• “Closed Loop” System

• Linked Inputs and Outputs

• Internal Audits

• Externally Audited

• Global Recognition


Model of a Process Based QMS

Requirements

Measurement, Analysis &

Improvement

Product Realization

Resource Management

Management

Responsibility

ProductInput Output

Satisfaction

Customers Customers

Continual Improvement of the Quality Management System

Source: ANSI/ASQ/ISO

Key Value-adding activity Information flow


ISO 9001:2000

-- Not a Silver Bullet


“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


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”


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.


Please Note

• It should be Conformance versus Compliance to standards

• ISO 9001:2000 is a Registration as opposed to being a Certification


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


Changing Doctrines

• 1994 Dogma

“Document What You Do and Do What You Document”

• 2000 Dogma

“A Failure to Plan is a Plan to Fail”


Implementation

Implement ISO using the ISO conforming processes


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


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


Selecting the audit firm

• References

• Bench Audit

• Pricing

• Gap Analysis as ‘Test Drive”


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 cast Week 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


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


Process Map Design

R & D

Ops

Finance MIS

Sales

Mrkting

Quality

Mgt

CUSTOMER

CUSTOMER

Satisfaction / Fulfillment

Requirements


Process Map Document Example


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


Training Material ExampleStress Linkage with

Organizational Objectives

Corporate Mission

Statement

Quality Policy

Statement

Dept Mission

Statement

Area Mission

Statement

Functional Quality

Objectives


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


1 2 3 4 5 6 7 8 910

11

12

13

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


4.1 4.2 4.2.1 4.2.2 4.2.1 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1

MANAGEMENT

Strategic Planning X

Operating Committee X 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


Using the System


ISO’s ApproachFamiliar PDCA Cycle

Do

Check

Act

Plan


Juran Approach

Requirement

Plan

Corrective Action

CheckDo Conforms?

Remedial Action

Feedback Loop

No

Yes

Conforming Product / Service


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


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


Good Practice

• Good Companies use Major Events to Provide Improvement in Specific, Usually Predefined, Areas of the Business


Best Practice

• Great Companies Use Major Events as a Place Marker from which to Examine Thinking


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


Near Flawless Execution Requires Robust Policy, Procedures and Practices


Process Map with Board

R & D

Ops

Finance MIS

Sales

Mrkting

Quality

Mgt

CUSTOMER

CUSTOMER

Satisfaction / Fulfillment

Requirements

Board


Maturation

ISO 9001:2000 Evolves


Role of the Individual

• Desire to have a positive impact

• Effort to get ISO up and running

• Diligence

• Change of mindset


Critical Success Factors

• Link Inputs and Outputs

• Include Everyone

• Design Ongoing Involvement

• Promote Institutional Memory


ISO ‘Take-Aways’

• Structured Management• Major Constituents Addressed

– Customers– Employees– Suppliers

• Common Understandings Enforced• Functions Linked• Process Reinforcement• Communications Integrated• Participation at All Levels


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


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


Resources - Web Sites

• ISO - http://www.iso.ch/iso/en/ISOOnline.frontpage

– Magical Demystifying tour - http://www.iso.ch/iso/en/iso9000-14000/tour/magical.html

• ASQ - http://www.asq.org/

– Standards - http://standardsgroup.asq.org/

• BSI - http://www.bsi-global.com/index.xalter

http://www.iso.ch/iso/en/ISOOnline.frontpage

http://www.iso.ch/iso/en/iso9000-14000/tour/magical.html

http://www.iso.ch/iso/en/iso9000-14000/tour/magical.html

http://www.asq.org/

http://standardsgroup.asq.org/



http://www.bsi-global.com/index.xalter


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


Use ISO 9001:2000 As A Resource


Success does not just happen – Success is

caused


Cause Success

Center for Professional Management

Thank You APICS

putting iso 9001:2000 to work for you center for professional management september 16, 2003

Documents

resource management

improvement slide

quality management systems

time slide

standard iso

bsi iso

preventive action slide

industry reqs slide