ISO 13485 Implementation Consulting Plan

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ISO 13485 Implementation Consulting Plan

This six-month example retains the seven activities listed in the original article. The source referred to a 2012 edition; determine the applicable ISO 13485 edition before using the plan. Agree the schedule, resources and scope for each organization.

Example implementation schedule

Illustrative six-month plan
No.	Activity	Responsible parties	Implementation schedule																								Total
			Month 1				Month 2				Month 3				Month 4				Month 5				Month 6
			1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4
1	Factory gap assessment	Consultant and ISO team																									1
2	ISO 13485 awareness training	Consultant and ISO team																									2
3	Documentation planning and assignment of responsibilities	Consultant and ISO team																									1
4	Develop documentation to meet the applicable ISO 13485 requirements	Consultant and ISO team																									8
5	Issue the documentation system	Consultant and ISO team																									1
6	Communicate the policy and general requirements to all employees	Consultant and ISO team																									1
7	Internal auditor training	Consultant and ISO team

Numbers 1–4 under each month are the original weekly markers. Blank cells indicate information not provided. The total column retains the original figures, whose unit was not stated; clarify these before using the table as a project plan.

ISO13485:2016

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