ISO 9000 Overview

The Purpose of this Overview l “What is ISO 9000?” l What will it require from YOU, as a (Company) Employee?

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

What is ISO? l International Organization for Standardization

Development of Quality Standards l Prior to WWII, Quality Standards were driven by the Military l Britain used the ‘BS’ Standards l United States used the ‘MIL’ Standards

Development of Quality Standards l Europe- Government Driven BS-5750, EN l USA- Quality Driven Ford’s Q1 GM’s Targets for Excellence

ISO 9000 Quality Management Standard l Adopted 1987; current version is 1994 l Practical collection of well recognized and universal business practices l Applies to any type of facility l Emphasizes the system a facility uses to assure quality

ISO 9000 Quality Management Standard l ISO 9000 l ISO 9001 l ISO 9002 l ISO 9003 l ISO 9004

Elements of ISO 9002 l 4.1 Management Responsibility l 4.2 Quality System l 4.3 Contract Review l 4.4 Design Control l 4.5 Document and Data Control l 4.6 Purchasing l 4.7 Control of Customer Supplied Product

Elements of ISO 9002 l 4.8 Product Identification and Traceability l 4.9 Process Control l 4.10 Inspection and Testing l 4.11 Control of Inspection,Measuring, and Test Equipment l 4.12 Inspection and Test Status l 4.13 Control of Nonconforming Product

Elements of ISO 9002 l 4.14 Corrective and Preventive Action l 4.15 Handling, Storage, Packaging, Preservation, and Delivery l 4.16 Control of Quality Records l 4.17 Internal Quality Audits l 4.18 Training l 4.19 Servicing l 4.20 Statistical Techniques

3 Major Requirements for ISO 9000 Certification l A standard system for documenting quality practices (i.e. a Quality Manual) l A system to track that the quality practices are inplace and effective (Audits) l A third party (Registrar), whose function is to audit, certify and maintain certifications of organizations

Types of ISO 9000 Audits l Gap Analysis l Self Certification Audit l Registration Audit

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

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

Audit Results l Observation: Statement of fact made during a quality audit and substantiated through objective evidence l Conforming: Meets the intent of the standard l Nonconforming: Non-fulfillment of a specified requirement

Types of Nonconformities l Major Nonconformity: Absence of a required procedure or the total breakdown of a procedure l Minor Nonconformity: Single observed lapse in a procedure

Registration Cycle l Registration is valid for three years l 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 Audit l Know the Quality Policy- “To produce the highest quality widget sold in North America” l When asked “Who is responsible for Quality?” the answer is- “Everyone” l If asked “How do you know how to do your job?” the answer is- “Through Training”

Know the Plant’s Management Representative(s)! l 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 Representatives l Typically, each major area will have a representative

ISO 9000 Documentation Structure

ISO 9000 is not ISO l Both standards written by the same organization * ISO 9000: Quality Management Standard * ISO 14000: Environmental Management Standard

ISO 9000 Quick Definition Document what you do (Quality Manual) Do what you Document (Audits) Prove it! (Records)