ISO 9001:2000 Awareness Training 5/20/2019 ISO 9001:2000 Awareness Training

The Purpose of this Overview “What 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?

International Organization for Standardization 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 “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 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

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