ISO 13485 Implementation Consulting Plan

ITVC GLOBAL · BUSINESS SERVICES

ISO 13485 Implementation Consulting Plan

Example six-month implementation plan with seven activities. Confirm the applicable ISO 13485 edition and 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 indicate weeks. Blank cells contain no specified information. Confirm the unit of the figures in the total column before using the table as a project plan.

ISO13485:2016

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