Putting ISO 9001:2000 to Work for You

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Putting ISO 90012000 to Work for You

• Center for Professional Management
• September 16, 2003

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Outline

• ISO 90012000
• The WIIFM Factor
• Overview
• Details
• Transition
• Implementation
• Use

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• Overview

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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 90012000 Quality Management Systems - one of
  many ISO standards
• Aggregation of Mil and Industry Reqs

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Definition
ISO 90012000 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.
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8 Quality Principles

• Customer Focus
• Leadership
• Involvement of People
• Process Approach
• System Approach to Management
• Continual Improvement
• Factual Approach to Decision-Making
• Mutually Beneficial Supplier Relationships

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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

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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

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Transition From 1994 Standard

• ISO 90012000
• 5 Core Elements
• 6 Reqd Procedures
• Business System

• ISO 90001994
• 20 Core Elements
• 18 Reqd Procedures
• Shop Floor Control System

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• 90 Fall Into 1 0f 4 Groups
• Not ISO Registered
• Registered to the 1994 Standard
• ISO 90012000 or QS
• Customer Requirement
• Foundation for CE stamp
• Did what we had to do to get ISO in on time

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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 programs success
• Workplace is well ordered adheres to procedures
• New procedures become a habit
• How do you keep these initiatives alive and well?

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• ...who wish to know about the world must learn
  about it in its particular details.
• -- Heraclitus c. 500 B.C.

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• The Details

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TLAs
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TLAs
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???

• CMMS
• SCADA
• CFPR

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• ISO

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• ISO 90012000

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Additional Definition

• ISO 90012000 is also-
• Model
• Framework
• Structure
• Backbone

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ISO as Backbone Model
People
Methods
Mgt. Initiatives
Morale
Performance Measure
Communications
Quality Mgt.
ERP System
CoachingMentoring
Company
TrainingDevlpmnt
Company Objectives
Company Mission
ISO9001
Direction
Tooling
Production Lines
Vendor Certification
Computer Network
Chemicals
Components
Equipment
Material
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Further Definition

• ISO 90012000 as Business System outlines the
  following
• A Management System
• A Process Control System
• A Document Control System

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Characteristics

• ISO 90012000
• Completeness/Encompassing
• Closed Loop System
• Linked Inputs and Outputs
• Internal Audits
• Externally Audited
• Global Recognition

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Model of a Process Based QMS
Continual Improvement of the Quality Management
System
Customers
Customers
Satisfaction
Requirements
Key Value-adding activity
Information flow
Source ANSI/ASQ/ISO
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ISO 90012000 -- Not a
Silver Bullet
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• 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

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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

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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 customers perception
  of the degree to which the customers
  requirements have been fulfilled.

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Please Note

• It should be Conformance versus Compliance to
  standards
• ISO 90012000 is a Registration as opposed to
  being a Certification

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Transition

• ISO 90012000 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

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Changing Doctrines

• 1994 Dogma
• Document What You Do and Do What You Document
• 2000 Dogma
• A Failure to Plan is a Plan to Fail

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Implementation

• Implement ISO using the ISO conforming
  processes

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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

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Implementation
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Selecting the audit firm

• References
• Bench Audit
• Pricing
• Gap Analysis as Test Drive

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Implementation
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Implementation
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Process Map Design
Requirements
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Process Map Document Example
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(No Transcript)
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Implementation
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Training Material ExampleStress Linkage with
Organizational Objectives
Corporate Mission Statement
Quality Policy Statement
Dept Mission Statement
Area Mission Statement
Functional Quality Objectives
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Implementation
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Week of
Audit Schedule/Layout Bad Example
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Audit Schedule/Layout Good Example
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• Using the System

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ISOs ApproachFamiliar PDCA Cycle
Plan
Do
Act
Check
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Juran Approach
Requirement
Conforming Product / Service
Yes
Plan
Check
Do
Conforms?
No
Feedback Loop
Corrective Action
Remedial Action
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ISO Overlay
Requirement (1.1,4.1,7.2.2)
Conforming Product / Service
Yes
Plan (5.4,7.1,7.3.1, 8.5.3)
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)
No
Feedback Loop
Corrective Action (8.5.2)
Remedial Action (8.3)
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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

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Good Practice

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

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Best Practice

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

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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

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• Near Flawless Execution Requires Robust Policy,
  Procedures and Practices

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Process Map with Board
Board
Requirements
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Maturation

• ISO 90012000 Evolves

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Role of the Individual

• Desire to have a positive impact
• Effort to get ISO up and running
• Diligence
• Change of mindset

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Critical Success Factors

• Link Inputs and Outputs
• Include Everyone
• Design Ongoing Involvement
• Promote Institutional Memory

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ISO Take-Aways

• Structured Management
• Major Constituents Addressed
• Customers
• Employees
• Suppliers
• Common Understandings Enforced
• Functions Linked
• Process Reinforcement
• Communications Integrated
• Participation at All Levels

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Resources - Pocket Guides

• Goal/QPC Memory Joggers
• 90002000
• 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 90012000 for Service
  Cianfrani, West
• Cracking the Case of ISO 90012000 for
  Manufacturing - Cianfrani,
  West
• ISO 90012000 Revision Highlights - Graebig

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Resources - Books

• American National Standard Quality Management
  Systems-Requirements ANSI/ISO/ASQ Q9001-2000 -
  ASQ
• Demystifying ISO 90012000 Paradis, Trubiano
• The Route to Registration BSI, CEEM
• ISO 9000 Requirements Kanholm
• ISO 90012000 Standard Paraphrased Peach,
  Wilson

• The Management Review Handbook Robitalle
• The Painless ISO 90012000 Transition Robitalle
• Quality Audits for ISO 90012000 OHanlon
• How to Audit the Process-Based QMS Arter,
  Cianfrani, West
• ISO 90012000 Explained Cianfrani, Tsiakals,
  West
• ISO 9000 - Johnson

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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

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ISO as Resource

• ISO 90012000 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

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• Use ISO 90012000 As A Resource

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• Success does not just happen Success is caused

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• Cause Success

Thank You APICS
Center for Professional Management