1. Chapter 9 - Quality Systems Team #2: Cindy Guthrie, Amy Randolph and Robin Tomer

2. ISO 9000 Series of Standards –International Organization for Standardization (ISO) formed in 1946 in Geneva, Switzerland –International standards of quality used by more than 60 countries –ISO 9000, 9001, 9002, 9003 and 9004 Purpose of a quality system?

3. Implementation Senior management commitment Appoint management rep Awareness Appoint imp. team Training Time schedule Select element owners Review present system Write the documents Install the new system Internal audit Management review Preassessment Registration

4. Documentation Policy - Why, What will be done Procedure -Who, When, Where Work instructions - How Records - Evidence Document development 4 tiers of documentation?

5. ISO/QS 9000 Elements Management Responsibility The Quality System Contract Review Design Control Document & Data Control Purchasing Control of Customer Supplied Product Product Identification & Traceability Process Control Inspection & Testing Control of Inspection, Measuring & Test Equipment Inspection & Test Status Control of Nonconforming product Corrective & Preventive Action Handling, Storage, Packaging, Preservation & Delivery Control of Quality Records Internal Quality Audits Training Servicing Statistical Techniques Exercise

6. Writing the documents Keep simple and concise - same format Should include quality policy and statement and distribution list All 20 elements should be included - just state if not applicable Include forms, contracts, etc..

7. Internal Audits Done after policies, procedures and work instructions developed and implemented Internal audit is the system used to make sure systems is being followed and expected results obtained Objectives of internal audit?

8. Registration Assessment of a quality system by a third party, a registrar. 2 Parts: –Selecting a registrar Registrar Accreditation Board (RAB) –Registration process Six basic steps

9. Conclusion/Discussion Benefits of implementing a quality system?