ISO 13485 Effective Internal Audit Training and Workshops

ISO 13485: 2016 Effective Internal Audit Training and Workshops

Training Total Day & Time: 2 Days (9.00am to 5.00pm)

Objective of the Course:

Understanding of ISO 13485: 2016 audit terminologies, audit methodologies, audit reporting on how to write correct non-conformance statement including proper completion and recording of investigation of causes, correction, corrective action and review effectiveness of corrective action taken.

Who should attend:

Managing Director/ General Manager/ Top Management
Head of Departments/ Sections
Key personnel/ Supervisor
Internal auditors

Training agenda:

Day1	9am~1pm	Audit Terminology and Methodology Audit Terminologies Audit Program / Schedule vs. Audit Plan Audit Preparation Conduct of Audit & Auditor Behavior Audit Reporting Writing of non-compliance statements Investigation of causes Correction vs. Corrective Action Follow-up Audit
	1pm~2pm	Lunch Break
	2pm~5pm	Workshop 1: Prepare Audit Program (40 minutes). What to look for when auditing key areas/ processes in ISO 13485: 2016
Day2	9am~1pm	What to look for when auditing key areas/ processes in ISO 13485: 2016 (continued). Workshop 2: Opening meeting and Live audit (1 hour). Workshop 3: Auditor team discussion (30 minutes).
	1pm~2pm	Lunch Break
	2pm~5pm	Workshop 4: Completing CAR/ NCR report (40 minutes). Workshop 5: Closing meeting and Audit Findings presentation (40 minutes).

Contact us for information

Revision No.: 1 SM Effective Date: 1/8/2025

CI International Certification Sdn Bhd (Co. No. 515984-M)
(FKA CI Certification Malaysia Sdn Bhd)

CIMY International Standards Training (M) Sdn Bhd (Co. No. 806514-D)

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