ISO13485:2016 Medical Devices - Quality Management Systems – Internal Auditor (2-Day) Training

Duration

2-day

Training Venue

WCCQ training centre in Kowloon Bay  (Hong Kong)

Language

Cantonese with Chinese / English materials

Description

To meet regulatory requirements and customer expectations: national regulatory authorities usually strongly recommend the manufacturer’s medical devices have a third-party audited and certified management system in place or even become mandatory requirement. This is a two-day medical device - quality management system training course, to equip delegates with in-depth understanding of the application of ISO13485 and also an understanding of how to start planning of ISO13485.

Learning Outcomes

- Understand the ISO 13485 standard;

- Plan an audit against a set of audit criteria;

- Successfully execute a medical device industry audit; and

- Create clear, concise and relevant audit reports

Agenda / Content

- Overview of ISO 13485;

- What to look for in Policy and Planning;

- Audit Techniques;

- What to look for in Implementation and Operation;

- What to look for in Checking and Corrective Action;

- Report writing workshop; and

- Practical Exercises and Feedback

Participants

Person in charge of establishing and implementing ISO 13485;

Person is responsible for auditing;

Person wishes be trained as ISO 13485:2016 internal auditors; and/or

Person is seeking for learning essential knowledge in quality management control in medical device industry

Pre-requisites

Familiarity with the structure and requirements in ISO 9001 is the ideal prerequisite would be beneficial.

Learning Method

Lecture, case studies and assignment

Contact information

For further information or discussion on analyzing and meeting your training needs please contact us at certificates@wccq.org or (852) 2110 8492.

Remarks

# Onsite training quotation is available: please contact us for an on-site proposal. We respond to inquiries on the same day.