Professional Documents
Culture Documents
EmergoGroup.com
Presentation Objectives
Initiating the steps of an ISO 13485 implementation project Establishing your QMS criteria Determining training requirements Defining your business processes Implementing your quality system Generating records Conducting Readiness Reviews
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EmergoGroup.com
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EmergoGroup.com
Conduct gap analysis What does your current quality system look like? How are your key business systems handled? How much documentation do you have in place?
EmergoGroup.com
EmergoGroup.com
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EmergoGroup.com
Quality policy reflects essence of company Generated by senior management Apply to the needs of the company
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EmergoGroup.com
EmergoGroup.com
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Educate Employees
Train all employees on what ISO 13485 means to the company Train employees on what ISO 13485 means to them Need awareness from everyone Also serves as communication of project Train champion(s) one-on-one/group
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EmergoGroup.com
EmergoGroup.com
Develop Documentation
Quality manual
(why)
Procedures
(who, what, when, where)
LEVEL 2
Work instructions
(how)
LEVEL 3
LEVEL 4
EmergoGroup.com
EmergoGroup.com
Implementation Process
Follow the ISO Standard Chapter 4 -> 5 -> 6 -> 7 -> 8 -> others Or Chapter 4 -> 5 -> 6 -> 8 -> 7 -> others Prioritize development as needed Utilize a checklist to gauge process Roll out in phases, implement, then train Start generating quality records ASAP Need to show evidence of utilization Have periodic (weekly) review meetings
EmergoGroup.com
EmergoGroup.com
EmergoGroup.com
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EmergoGroup.com
Chapter 8 Improvement
Customer Feedback Customer complaint handling (returns) Post market activities (next slide) Internal Audits Control of Non-Conforming product Corrective and Preventive Actions
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EmergoGroup.com
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Conclusion Take Away Info Management must take charge Develop an Implementation Plan Educate the employees Develop the procedures Review the process frequently End objective may be certification
EmergoGroup.com
EmergoGroup.com