Full program description
ISO 13485: 2016 Internal Auditor Training
What's In It For Me
This course is specially designed to equip participants with comprehensive understanding :
requirements of the ISO 13485: 2016 standards.
- Common medical
device related risk.
- Practical knowledge
in planning and conducting Internal Audit within the company premise,
encouraging live-interaction with department staff.
- Skills necessary to write effective "Corrective
Action Request" statements and to prepare audit reports for management
To express your interest for enrolment in this course, please fill up this form at www.surveymonkey.com/r/WSHdemandform. We will contact you when the class schedule is released. Thank you!
ISO 13485:2016 specifies requirements for a quality management system where organisations needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities (e.g. technical support).
ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.
Who Should Attend
- Appointed lead
auditors/auditors and any personnel who wish to gain an in-depth understanding
of internal auditing.
- Personnel who are
appointed as representatives in the ISO 13485 committee and wish to understand
how auditors approach an audit are also encouraged to attend.
- This training is
designed for personnel from organisations which are implementing or certified
to ISO 13485.
to ISO 9001: 2015 & ISO 13485: 2016
between ISO 9001: 2015 and ISO 13485: 2016
- ISO 13485
reference to ISO 14971: 2007 (Application of risk management to medical
analysis and improvement
ISO 13485:2016 auditing requirements
Phase (Case Discussion)
- Follow-up Phase
Certification Obtained and Conferred by
Certificate of Competency from NTUC Learninghub
Note: Due date for all companies to transit to ISO 13485 : 2016 is February 2019.
Persons with some industrial, business and/or service sector experience.