Putting ISO 9001:2000 to Work for You

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

Outline • ISO 9001:2000 • The WIIFM Factor • Overview • Details • Transition • Implementation • Use Center for Professional Management

Overview Center 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 Center 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. Center for Professional Management

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 Center 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 Center 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 Center for Professional Management

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 Transition From 1994 Standard Center 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” Center 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? Center for Professional Management

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

The Details Center for Professional Management

TLAs Center for Professional Management

??? • CMMS • SCADA • CFPR Center for Professional Management

ISO Center for Professional Management

ISO 9001:2000 Center for Professional Management

Additional Definition ISO 9001:2000 is also- • Model • Framework • Structure • Backbone Center for Professional Management

ISO as ‘Backbone’ Model People Methods Mgt. Initiatives Morale Communications Performance Measure Quality Mgt. Coaching&Mentoring ERP System Company Training&Devlpmnt Company Objectives Company Mission ISO9001 Direction Tooling Production Lines Vendor Certification Computer Network Chemicals Components Equipment Material Center 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 Center for Professional Management

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

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 Center for Professional Management

ISO 9001:2000 -- Not a Silver Bullet Center 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 Center 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” Center 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. Center 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 Center 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 Center 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” Center for Professional Management

Implementation Implement ISO using the ISO conforming processes Center for Professional Management

Project Mgt 101 • Identify Major Tasks & Activities • Categorize Work Content • Calculate Effort & Duration • Effort =Unit of work by categoryXthe volume required Xthe periodicityXthe frequency • Duration accounts for availability of resources • Forecast variability using MVIs • Plan Backward from Finish Date Center for Professional Management

Implementation Center for Professional Management

Selecting the audit firm • References • Bench Audit • Pricing • Gap Analysis as ‘Test Drive” Center for Professional Management

Process Map Design Requirements Center for Professional Management

Process Map Document Example Center for Professional Management

Center for Professional Management

Training Material ExampleStress Linkage with Organizational Objectives Corporate Mission Statement Quality Policy Statement Dept Mission Statement Area Mission Statement Functional Quality Objectives Center for Professional Management

Week of Audit Schedule/Layout – Bad Example Center for Professional Management

Audit Schedule/Layout – Good Example Center for Professional Management

Using the System Center for Professional Management

ISO’s ApproachFamiliar PDCA Cycle Plan Act Do Check Center for Professional Management

Juran Approach Requirement Conforming Product / Service Yes Plan Do Check Conforms? No Feedback Loop Corrective Action Remedial Action Center for Professional Management

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) Do (5.5.1,5.6,6,7.2,7.3.2-7,7.4,7.5) Check (7.6,8.2) Conforms? (8.1) No Feedback Loop Corrective Action (8.5.2) Remedial Action (8.3) Center 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 Center for Professional Management

Good Practice • Good Companies use Major Events to Provide Improvement in Specific, Usually Predefined, Areas of the Business Center for Professional Management

Putting ISO 9001:2000 to Work for You