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Course Objective

The SS 620:2016 (GDPMDS) serves as a guide on the quality management system for organisations involved in handling, storage, delivery, installation, servicing, secondary assembly and other related activities of medical devices and IVDs. The purpose of this course is to allow business owners, management representatives, internal auditors and any relevant personnel to have a good understanding of the new SS 620:2016 requirements as well as learning how to perform an internal audit.

For wholesalers and importers of medical devices in Singapore, it is a requirement to complete a 3rd party audit and attain the SS 620:2016 GDPMDS certification before applying for the dealers’ license issued by the Health Sciences Authority (HSA) of Singapore.

In this course, attendees would also be able to experience the use of a software tool to set up and customise a set of documents that are relevant to their organisation.

seminar

Learning Outcomes

  1. Introduction to SS 620:2016 (GDPMDS)

  2. SS620:2016 requirements versus TS-01: R 2.1 requirements

  3. SS620:2016 standards requirements - with evidence of clause reference for the audit purposes

  4. Planning and performing an audit

  5. Reporting the audit

  6. Handling post-audit follow-up activities

  7. Application of software tool to set up and customise a set of QMS documents based on the SS 620:2016 requirements, and learning how to implement the processes.

  8. Planning and performing an internal audit using the audit schedule and checklist

Who Should Attend?

  1. Decision makers on management system strategy

  2. Quality managers, executives, management representatives or any person within an organisation who wants to set up and implement business processes based on the new SS 620:2016 for the first time, or transiting from the existing HSA TS-01 (GDPMDS)

  3. Personnel who are involved in organising and conducting internal audits for SS 620:2016 GDPMDS

How to sign up?

Click on “I’m interested!” button on the right, input your information and we will contact you shortly to complete the payment process.

Note: Due to course popularity, we recommend that you express your interest as soon as possible so that our team can be in touch and to complete the registration process in order to ensure sufficient seats for your organisation.

Course Information

 

Date: 22 - 23 October 2018

Time: 9:00am - 5.00pm

Venue: SQI, No 1 Sophia Road #05-06/07, Peace Centre, Singapore 228149

Course Fee

SQI Member: S$500/pax

Non-member: S$530/pax

Course fees include training materials, certificates and light refreshments

Funding availability (to be announced soon)