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External Validation of Quality Programs

External Validation of Quality Programs. ISO 9000-2000 There is a new sheriff in town. This will quickly become a widely adopted world standard. Focus is on documenting quality systems (establishing structural measures) and showing that they are followed. ISO 9000 (Redford and Streisand).

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External Validation of Quality Programs

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  1. External Validation of Quality Programs • ISO 9000-2000 • There is a new sheriff in town. • This will quickly become a widely adopted world standard. • Focus is on documenting quality systems (establishing structural measures) and showing that they are followed.

  2. ISO 9000 (Redford and Streisand) • What was ISO 9000: 1994? • A series of three standards (9001, 9002, 9003) and two guidance documents (9000, 9004). • The ISO documents are very cryptic and undetailed. They do not provide a true understanding of ISO requirements. They are open to broad interpretation. • ISO 9000 certification is not presently required for commerce in the EEC. • Can act as a filter for individual companies.

  3. New Standard 9001:2000 • In the past, ISO had three standards: ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. Now there's only one standard: ISO 9001:2000! ISO 9002 and ISO 9003 have been dropped. • So, if you are currently ISO 9002:1994 or ISO 9003:1994 certified, you will now need to become ISO 9001:2000 certified. • And if you're now ISO 9001 certified, you're going to have to update your quality system in order to meet the new ISO 9001:2000 requirements.

  4. New Structure • When you compare ISO 9001:1994 and ISO 9001:2000 you’ll notice that ISO has abandoned the 20-clause structure of the old standard. Instead of 20 sections, the new standard now has 5 sections. • It time to write some new manuals!

  5. ISO 9001 Requirements (old structure): • Management responsibility • Quality system • Contract review • Design control • Document and data control • Purchasing • Control of customer - supplied product • Product identification and traceability • Process control • Inspection and testing • Control of inspection, measuring, and test equipment • Inspection and test status • Control of nonconforming products • Corrective and preventive action • Handling, storage, packaging, preservation, and delivery • Control of quality records • Internal quality audits • Training • Servicing • Statistical techniques

  6. New Definitions ISO 9000-2000 • Suppliers are now organizations. • The term supplier now refers to the organization’s supplier. • Old standard products: software, hardware, services, and processed materials. • New standard: ISO seems to take a more abstract approach. ISO now refers to these four items as generic elements, not types of products.

  7. New Emphasis • New standard is more customer-oriented. More specifically, ISO 9001 now expects you to identify and meet customer needs and expectations. Plus it expects you to communicate with customers and to measure and monitor customer satisfaction. • In addition, the new standard emphasizes the need to make improvements.

  8. New Requirements (old clause numbers) • Communicate with customers (7.2.3). • Identify customer needs and expectations (5.2, 7.2.1). • Meet customer needs and expectations (5.2). • Measure and monitor customer satisfaction (8.2.1). • Meet regulatory requirements (5.1, 5.2). • Meet legal requirements (5.1, 5.2). • Support internal communication (5.5.4). • Provide quality facilities (6.3). • Provide a quality work environment (6.4). • Evaluate the effectiveness of training (6.2.2). • Measure and monitor realization processes (8.2.3). • Evaluate the effectiveness and suitability of quality system (8.4). • Identify quality management system improvements (5.1, 8.4). • Improve quality management system (5.1, 8.5).

  9. New Flexibility • Under the new ISO 9001:2000 standard, you may ignore or exclude some requirements. • Requirements that may be ignored under special circumstances are known as permissible exclusions. • According to ISO, you may ignore or exclude any of the requirements found in Section 7 Product realization if you meet certain conditions.

  10. A Process Approach • 21Processes: • 1. Quality Management Process • 2. Resource Management Process • 3. Regulatory Research Process • 4. Market Research Process • 5. Product Design Process • 6. Purchasing Process • 7. Production Process • 8. Service Process • 9. Product Protection Process • 10. Customer Needs Assessment Process • 11. Customer Communications Process • 12. Internal Communications Process • 13. Document Control Process • 14. Record Keeping Process • 15. Planning Process • 16. Training Process • 17. Internal Audit Process • 18. Management Review Process • 19. Measuring and Monitoring Process • 20. Nonconformance Management Process • 21. Continual Improvement Process

  11. Process Inputs and Outputs • types of inputs/outputs: • Products • Services • Information • Documents • Reports • Records • Results • Needs • Data • Expectations • Requirements • Complaints • Comments • Feedback • Resources • Measurements • Authorizations • Decisions • Plans • Ideas • Solutions • Proposals

  12. Section 4 • 4 Systemic requirements • 4.1 Develop your quality systemDesign your quality management systemImplement your quality management system • 4.2 Document your quality systemUse documents to manage your quality systemUse documents that meet your system's needs

  13. Section 5 • 5 Management requirements • 5.1 Support qualityPromote the importance of qualityDevelop a quality management systemImprove your quality management system • 5.2 Satisfy your customersIdentify customer needs and expectationsTurn customer needs into requirementsMeet your customers' requirements • 5.3 Establish a quality policyDefine your organization's quality policyManage your organization's quality policy • 5.4 Carry out quality planning5.4.1 Formulate your quality objectives5.4.2 Plan to achieve your quality objectives • 5.5 Manage your quality system5.5.1 Control quality management system5.5.2 Define responsibilities and authorities5.5.3 Appoint management representative5.5.4 Support internal communications5.5.5 Prepare quality system manual5.5.6 Control quality documents5.5.7 Maintain quality records • 5.6 Perform management reviews5.6.1 Review quality management system5.6.2 Examine management review inputs5.6.3 Generate management review outputs

  14. Section 6 • 6 Resource requirements • 6.1 Provide quality resourcesIdentify quality resource requirementsProvide quality system resources • 6.2 Provide quality personnel6.2.1 Assign competent personnel6.2.2 Educate your personnel • 6.3 Provide quality facilitiesIdentify facility needsProvide needed facilitiesMaintain your facilities • 6.4 Provide quality environmentIdentify work environmentManage work environment

  15. Section 7 • 7 Realization requirements • 7.1 Control realization planningPlan product realization processesDocument product realization processes • 7.2 Control customer processes7.2.1 Identify product requirements7.2.2 Review product requirements7.2.3 Communicate with customers • 7.3 Control product development7.3.1 Control design and development7.3.2 Control design and development inputs7.3.3 Control design and development outputs7.3.4 Control design and development reviews7.3.5 Control design and development verifications7.3.6 Control design and development validations7.3.7 Control design and development changes • 7.4 Control purchasing function7.4.1 Control purchasing processes7.4.2 Document product purchases7.4.3 Verify purchased products • 7.5 Control operational activities7.5.1 Control production and service7.5.2 Identify and track your products7.5.3 Protect property supplied by customers7.5.4 Preserve your products and components7.5.5 Validate special process operations • 7.6 Control measurement devicesIdentify measuring and monitoring needsUse measuring and monitoring devicesCalibrate measuring and monitoring devicesProtect measuring and monitoring devicesValidate measuring and monitoring software

  16. Section 8 • 8 Analytical requirements • 8.1 Plan measurement activitiesDefine quality measuring and monitoring needsMeet quality measuring and monitoring needs • 8.2 Measure and monitor quality8.2.1 Measure and monitor customer satisfaction8.2.2 Plan and perform periodic internal audits8.2.3 Measure and monitor realization processes8.2.4 Measure and monitor product characteristics • 8.3 Control nonconforming productsControl nonconforming product before deliveryControl nonconforming product after delivery • 8.4 Analyze quality informationCollect quality management system dataAnalyze quality management system dataIdentify quality improvement opportunities • 8.5 Make quality improvements8.5.1 Plan continual improvement8.5.2 Correct actual nonconformities8.5.3 Prevent potential nonconformities

  17. How To Get Registered • Select a standard - 9001, 9002 or 9003 • Learn about ISO 9000, talk to other companies who have registered • Establish an organizational structure • Prepare detailed operational standards and procedures • Implement the quality program • Perform internal audits • Select a registrar • Schedule an assessment

  18. Selecting a Registrar • This is difficult due to the large number of companies offering services. • Talk to your customers. • Some have official ties to one of the 12 EU or 7 European Free Trade Association (EFTA) countries. • Some have a memorandum of understanding with an EU member country registrar.

  19. Choosing a Registrar Number of orgs. certified Industry experience Standards experience Surveillance visits Factors to consider in choosing a registrar Auditor’s background References Size of audit team Audit style Fees, terms, and conditions Contact the ASQC for more information on ISO 9000/ASQ90

  20. Historical Problems with ISO 9000 • Some maintain that ISO 9000: • is mainly for exporting firms • is a barrier to trade • is time consuming • is costly • is difficult for small firms to afford • eats up human resources • discourages free thinking and employee empowerment • is limited because not all countries are accepting of all ISO registrars • registrars are poorly regulated • is a symptom of standard proliferation

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