Transcript ISO
ISO What is it? • “International Organization of Standards” • 163 Member countries headquartered in Geneva Switzerland • Meet annually for review and revision • Develop and maintain a uniform set of standards for a Quality Management System that meets the needs of a Global Marketplace What is it’s purpose? • To define a QMS structure that reduces variation and ensures consistency of product quality to meet customers’ expectations, specifications, and regulatory requirements. • To develop a culture of Continuous Improvement within your Organization • To provide your Customers with the knowledge that you operate to an Internationally recognized Quality Standard. What does it consist of? • QMS: • General requirements, structure, documentation, revisions, control of records, reporting authority, and Configuration Management: • “A process for establishing and maintaining consistency of a product’s performance, functional and physical attributes, with it’s requirements, design, and operational information throughout it’s life”. Continued: • • • • • • • • Management Responsibility: Organizational Structure Management’s commitment Quality Policy Measureable Quality Objectives Planning Responsibilities and reporting authority Periodic Mgmt. reviews of QMS to ensure it is appropriate for it’s purpose. Continued: • • • • • • • Resource Management: Human Resources Training Records Qualifications Competence and awareness Equipment and infrastructure maintenance Maintaining a controlled environment Continued: • • • • • • • Product Realization: Processing Customer P.O.’s Determine requirements of the product Create internal control documents Schedule the work What IMTE is required Unique and special handling Continued: • • • • • • • • • Control of all related documents Outside services Raw Material Inspection requirements Supply Chain Management Delivery requirements Packaging Hazardous Material handling Calibration records Continued: • • • • Design and Development of Product Measurement, Analysis, and Improvement Internal Audits of the QMS Corrective and Preventive Action for NonConforming product • Continuous Improvement How do I get certified? • Appoint someone in your organization to spearhead the process, or hire a Consultant. • Contact an ISO Registrar for information and quote. • Obtain a copy of the Standard to which your organization would like to be certified to. • Develop a Quality Manual (aligned to the Standard) and a Procedures Manual that defines what, when, and by whom each procedure is done. Continued: • Appoint and train an employee as an Internal Auditor who will audit the QMS to the ISO Standard/Quality Manual/Procedures Manual. • (That Internal Auditor cannot audit their own area of responsibility) • Contact Registrar for Stage I Audit • Close any Corrective Actions from that Audit • Contact Registrar for Stage II Audit • Close any Corrective Actions from that Audit CERTIFIED! QUESTIONS?