ISO 9000 OverviewISO 9000 Overview

The Purpose of this OverviewThe Purpose of this Overview

“What is ISO 9000?” What will it require from YOU, as a (Company)

Employee?

Things You Should KnowThings You Should Know

Corporate Objective How do you know how to do your job? What do you do if you find a defect? Are there written instructions for your job?

What is ISO?What is ISO?

International Organization for Standardization

Development of Quality Development of Quality StandardsStandards

Prior to WWII, Quality Standards were driven by the Military

Britain used the ‘BS’ Standards United States used the ‘MIL’ Standards

Development of Quality Development of Quality StandardsStandards

Europe- Government Driven BS-5750, EN 29000

USA- Quality DrivenFord’s Q1GM’s Targets for Excellence

ISO 9000 Quality Management ISO 9000 Quality Management StandardStandard

Adopted 1987; current version is 1994 Practical collection of well recognized and

universal business practices Applies to any type of facility Emphasizes the system a facility uses to assure

quality

ISO 9000 Quality Management ISO 9000 Quality Management StandardStandard ISO 9000 ISO 9001 ISO 9002 ISO 9003 ISO 9004

Elements of ISO 9002Elements of ISO 9002

4.1 Management Responsibility 4.2 Quality System 4.3 Contract Review 4.4 Design Control 4.5 Document and Data Control 4.6 Purchasing 4.7 Control of Customer Supplied Product

Elements of ISO 9002Elements of ISO 9002

4.8 Product Identification and Traceability 4.9 Process Control 4.10 Inspection and Testing 4.11 Control of Inspection,Measuring, and Test

Equipment 4.12 Inspection and Test Status 4.13 Control of Nonconforming Product

Elements of ISO 9002Elements of ISO 9002

4.14 Corrective and Preventive Action 4.15 Handling, Storage, Packaging,

Preservation, and Delivery 4.16 Control of Quality Records 4.17 Internal Quality Audits 4.18 Training 4.19 Servicing 4.20 Statistical Techniques

3 Major Requirements for ISO 3 Major Requirements for ISO 9000 Certification9000 Certification

A standard system for documenting qualitypractices (i.e. a Quality Manual)

A system to track that the quality practices are in place and effective (Audits)

A third party (Registrar), whose function is to audit, certify and maintain certifications of

organizations

Types of ISO 9000 AuditsTypes of ISO 9000 Audits

Gap Analysis Self Certification Audit Registration Audit

Self Certification AuditSelf Certification Audit

Perform Gap Analysis Action Plan Developed from Gap Analysis Action Plan Implemented Perform Internal Audit Corrective Action Perform Self Certification Audit

Registration AuditRegistration Audit

Select Registrar Registrar performs Gap Analysis Action Plan developed from Gap Analysis Action Plan implemented Perform Internal Audit Corrective Action Registrar performs Registration Audit Registration complete or corrective action

Audit ResultsAudit Results

Observation: Statement of fact made during a quality audit and substantiated through

objective evidence Conforming: Meets the intent of the standard Nonconforming: Non-fulfillment of a specified

requirement

Types of NonconformitiesTypes of Nonconformities

Major Nonconformity: Absence of a requiredprocedure or the total breakdown of a

procedure

Minor Nonconformity: Single observed lapse in a procedure

Registration CycleRegistration Cycle

Registration is valid for three years Surveillance Audits (Maintenance Audits)

* Mini Audit; covers only a portion of the Registration Audit

* Required to be conducted at a minimum, annually

Your Role During the AuditYour Role During the Audit

Know the Quality Policy- “To produce the highest quality widget sold in North America”

When asked “Who is responsible for Quality?”the answer is- “Everyone”

If asked “How do you know how to do your job?” the answer is- “Through Training”

Know the Plant’s Management Know the Plant’s Management Representative(s)!Representative(s)!

They are the key contact for the ISO 9000 program; they are responsible for your plant’s Quality Manual; they will notify your Area Manager of upcoming audits.

Management RepresentativesManagement Representatives

Typically, each major area will have a representative

ISO 9000ISO 9000Documentation StructureDocumentation Structure

L ev e l 4Q u a li ty D o cu m en ts - F orm s,

R e po r ts ( ILU s)

L ev e l 3W o rk In stru ctio ns

L ev e l 2Q u a li ty S ys tem P ro ce d ures

L ev e l 1Q ua li ty M a nu a l

ISO 9000 is not ISO 14000ISO 9000 is not ISO 14000

Both standards written by the same organization* ISO 9000: Quality Management

Standard* ISO 14000:

Environmental Management Standard

ISO 9000 Quick DefinitionISO 9000 Quick Definition

Document what you do

(Quality Manual)

Do what you Document (Audits)

Prove it!

(Records)