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International Organization for Standardization International Organization for Standardization Guidelines on how to document the
processes in specific industriesprocesses in specific industries The goal:
Consistency◦ Consistency◦ Set of complete, easy to follow instructions
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ISO standards are really a Quality ISO standards are really a Quality Management System
With specific rules on documentation and With specific rules on documentation and record-keeping
Is not a replacement for Is not a replacement for Total Quality Management (TQM)(TQM)
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They can co-exist They can co-exist ISO focuses on consistency and record-
keepingkeeping TQM focuses on employee involvement &
product improvementproduct improvement
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ISO is methodical and rigorous ISO is methodical and rigorous Break production process down into key steps
Each process is then analyzed Each process is then analyzed
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Measure each process to meet quality Measure each process to meet quality standard
Document the process to Standard Operating Document the process to Standard Operating Procedure
Performs audits Performs audits
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Review 21 elements for each key process Review 21 elements for each key process Detailed plan for applied elements
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Employee training Employee training Written standard operating procedures
Management buy in Management buy-in Tool calibrations and records
I l & l di i Internal & external auditing Document control Input material quality verification Plans for handling non-conforming product
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Ensure the production follow the procedure Ensure the production follow the procedure Ensure the product is consistent
Assures consistency not quality Assures consistency, not quality
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ISO is a rigorous method of ensuring QMS ISO is a rigorous method of ensuring QMS ISO certification proves quality control
Important for other businesses and Important for other businesses and customers
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