ISO 13485:2016 Internal Auditor Training

Language : Material in English, Lecturing in Chinese

Please choose a date from the options below					Please choose a date from the options below	Location	Price
On demand Hong Kong 4500 HK$	Hong Kong	4500 HK$	Book or Inquire

# Medical devices

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.

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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

Moderator

Course Lecturer of DQS HK

Moderator

Lecturer with solid experience in audits and training.

ISO 13485:2016 Internal Auditor Training

Language : Material in English, Lecturing in Chinese

Please choose a date from the options below					Please choose a date from the options below	Location	Price
On demand Hong Kong 4500 HK$	Hong Kong	4500 HK$	Book or Inquire

# Medical devices

Any Questions?

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