Chapter 9 - Quality Systems

Team #2: Cindy Guthrie, Amy Randolph and Robin Tomer

ISO 9000 Series of Standards

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?

Implementation

Senior management commitmentAppoint management repAwarenessAppoint imp. teamTrainingTime scheduleSelect element owners

Review present systemWrite the documentsInstall the new systemInternal auditManagement reviewPreassessmentRegistration

Documentation

Policy - Why, What will be doneProcedure -Who, When, WhereWork instructions - HowRecords - EvidenceDocument development4 tiers of documentation?

ISO/QS 9000 ElementsManagement ResponsibilityThe Quality SystemContract ReviewDesign ControlDocument & Data ControlPurchasingControl of Customer Supplied ProductProduct Identification & TraceabilityProcess ControlInspection & Testing

Control of Inspection, Measuring & Test EquipmentInspection & Test StatusControl of Nonconforming productCorrective & Preventive ActionHandling, Storage, Packaging, Preservation & DeliveryControl of Quality RecordsInternal Quality AuditsTrainingServicingStatistical Techniques

Exercise

Writing the documents

Keep simple and concise - same formatShould include quality policy and statement and distribution listAll 20 elements should be included - just state if not applicable Include forms, contracts, etc..

Internal Audits

Done after policies, procedures and work instructions developed and implementedInternal audit is the system used to make sure systems is being followed and expected results obtainedObjectives of internal audit?

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

Conclusion/Discussion

Benefits of implementing a quality system?