Implementing ISO 9000 Quality Systems: A Comprehensive Guide
This chapter delves into the ISO 9000 series of standards established by the International Organization for Standardization (ISO) in 1946, focusing on quality systems used globally. It outlines the purpose and implementation of these standards, emphasizing senior management commitment, documentation, and internal audits. Key components include policy formulation, procedures, work instructions, and record-keeping, which are essential for effective quality management. The text also discusses the benefits of adopting these quality systems and the registration process with third-party registrars.
Implementing ISO 9000 Quality Systems: A Comprehensive Guide
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Presentation Transcript
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?
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 Implementation
Documentation • Policy - Why, What will be done • Procedure -Who, When, Where • Work instructions - How • Records - Evidence • Document development • 4 tiers of documentation?
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 ISO/QS 9000 Elements Exercise
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..
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?
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?
