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ISO 13485 Internal Auditor Training

Language : Material in English, Lecturing in Chinese

Location Price
Hong Kong
On demand
Hong Kong On demand Re­gister


Price and confirmation:

  • The price is in HKD 4,500 (or USD 600) per person.
  • The course is subject to confirmation by email, with condition of 3 to 6 participants in total.
  • If the dates are not suitable to you, you can propose other dates for confirmation with us.

Language:

  • Lecturing in Chinese with training materials in English, unless otherwise agreed in writing.

Target

  • To understand the development of and primary changes to ISO 13485:2016
  • To understand ISO 13485:2016 standard requirements
  • To have basic awareness about MDSAP, FDA and CE Approvals
  • To develop the basic expertise to implement a QMS according to ISO 13485:2016
  • To develop the basic expertise for internal audits based on ISO 13485:2016

Note:

  • Since ISO 13485:2016 is based on ISO 9001:2008, this training course does NOT automatically cover ISO 9001:2015.

Agenda

  • General introduction to ISO 13485:2016
  • Key changes to the new standard
  • Standard Requirements Understanding
  • Discussions / Exercises
  • Q&A
  • Basic Introduction of FDA & CE approvals for Medical Devices
  • Basic Introduction of MDSAP
  • Internal Audit
  • Workshops
  • Q&A
  • Evaluation

Content

  • Lecturing
  • Exercises (individual or by team)
  • Workshops
  • Lecturing and training materials in Chinese, unless otherwise specified
  • Tutor: Experienced Trainer with QMS Auditor Qualification

Course Brochure in pdf

Auditors

Course Lecturer of DQS HK

Moderator
Lecturer with solid experience in audits and training.

ISO 13485 Internal Auditor Training

Language : Material in English, Lecturing in Chinese

Location Price
Hong Kong
On demand
Hong Kong On demand Re­gister
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