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I S O 13485 I M P L E M E N T A T I O N

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ISO 13485:2003 Implementation Jerome Council, ASQ-CQA, CBA QMS Consultant
What Is The ISO 13485 Standard ,[object Object],[object Object],[object Object]
Core Major Clauses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
TIP: FDA/QSR 21 PART 820- first!!! ,[object Object],[object Object],[object Object],[object Object]
PROCESS -PDCA ,[object Object],MEASUREMENT, ANALYSIS AND IMPROVEMENT COMMITMENT BY M/WEXR PRODUCT REALIZATION QMS RESOURCE MGT
PROCESS APPROACH
Use A Compliance Matrix to Outline Processes
KEEP AFRESH OF THE STD RULES AND WORK CLOSELY WITH YOUR “CUSTOMERS” ,[object Object],[object Object],[object Object],[object Object]
OBTAIN BUY-IN FROM KEY PLAYERS ,[object Object],[object Object],[object Object],[object Object]
PARTICULARITY ,[object Object],[object Object],[object Object],[object Object]
IMPLEMENTATION PROJECT LEADER QUALIFICATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CONCLUSION ,[object Object],[object Object],[object Object],[object Object]
THANKS FOR YOUR ATTENTION/TIME! ,[object Object]

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