ISO 9001:2000 Awareness Training

The Purpose of this Overview
³What is ISO 9000?´  What will it require from YOU, as a (Company) Employee? 

Things You Should Know

Co 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? 

International Organization for Standardization

3 Major Requirements for ISO 9000 Certification
A standard system for documenting quality practices (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 Audits
Gap Analysis  Self Certification Audit  Registration Audit 

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

Registration 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 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 Nonconformities 

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

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

Your Role During the Audit
Know the Quality Policy When asked ³Who is responsible for Quality?´ the answer is- ³Everyone´  If asked ³How do you know how to do your job?´ the answer is- ³Through Training´ 

Know the Co Management Representative(s)! 

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

ISO 9000 Documentation Structure
Level 1 Quality Manual Level 2 Quality System/Operating Procedures Level 3 Work Instructions Level 4 Quality Documents- Forms, Reports, Records

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

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