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) 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.

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.

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!

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

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.

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.

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).

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.

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

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

Section 4 4 Systemic requirements 4.1 Develop your quality system Design your quality management system Implement your quality management system 4.2 Document your quality system Use documents to manage your quality system Use documents that meet your system's needs

Section 5 5 Management requirements 5.1 Support quality Promote the importance of quality Develop a quality management system Improve your quality management system 5.2 Satisfy your customers Identify customer needs and expectations Turn customer needs into requirements Meet your customers' requirements 5.3 Establish a quality policy Define your organization's quality policy Manage your organization's quality policy 5.4 Carry out quality planning 5.4.1 Formulate your quality objectives 5.4.2 Plan to achieve your quality objectives 5.5 Manage your quality system 5.5.1 Control quality management system 5.5.2 Define responsibilities and authorities 5.5.3 Appoint management representative 5.5.4 Support internal communications 5.5.5 Prepare quality system manual 5.5.6 Control quality documents 5.5.7 Maintain quality records 5.6 Perform management reviews 5.6.1 Review quality management system 5.6.2 Examine management review inputs 5.6.3 Generate management review outputs

Section 6 6 Resource requirements 6.1 Provide quality resources Identify quality resource requirements Provide quality system resources 6.2 Provide quality personnel 6.2.1 Assign competent personnel 6.2.2 Educate your personnel 6.3 Provide quality facilities Identify facility needs Provide needed facilities Maintain your facilities 6.4 Provide quality environment Identify work environment Manage work environment

Section 7 7 Realization requirements 7.1 Control realization planning Plan product realization processes Document product realization processes 7.2 Control customer processes 7.2.1 Identify product requirements 7.2.2 Review product requirements 7.2.3 Communicate with customers 7.3 Control product development 7.3.1 Control design and development 7.3.2 Control design and development inputs 7.3.3 Control design and development outputs 7.3.4 Control design and development reviews 7.3.5 Control design and development verifications 7.3.6 Control design and development validations 7.3.7 Control design and development changes 7.4 Control purchasing function 7.4.1 Control purchasing processes 7.4.2 Document product purchases 7.4.3 Verify purchased products 7.5 Control operational activities 7.5.1 Control production and service 7.5.2 Identify and track your products 7.5.3 Protect property supplied by customers 7.5.4 Preserve your products and components 7.5.5 Validate special process operations 7.6 Control measurement devices Identify measuring and monitoring needs Use measuring and monitoring devices Calibrate measuring and monitoring devices Protect measuring and monitoring devices Validate measuring and monitoring software

Section 8 8 Analytical requirements 8.1 Plan measurement activities Define quality measuring and monitoring needs Meet quality measuring and monitoring needs 8.2 Measure and monitor quality 8.2.1 Measure and monitor customer satisfaction 8.2.2 Plan and perform periodic internal audits 8.2.3 Measure and monitor realization processes 8.2.4 Measure and monitor product characteristics 8.3 Control nonconforming products Control nonconforming product before delivery Control nonconforming product after delivery 8.4 Analyze quality information Collect quality management system data Analyze quality management system data Identify quality improvement opportunities 8.5 Make quality improvements 8.5.1 Plan continual improvement 8.5.2 Correct actual nonconformities 8.5.3 Prevent potential nonconformities

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

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.

Choosing a Registrar Factors to consider in 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

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