In collaboration with:
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.
Introduction to SS 620:2016 (GDPMDS)
SS620:2016 requirements versus TS-01: R 2.1 requirements
SS620:2016 standards requirements - with evidence of clause reference for the audit purposes
Planning and performing an audit
Reporting the audit
Handling post-audit follow-up activities
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.
Planning and performing an internal audit using the audit schedule and checklist
Who Should Attend?
Decision makers on management system strategy
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)
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.
Date: 22 - 23 October 2018
Time: 9:00am - 5.00pm
Venue: SQI, No 1 Sophia Road #05-06/07, Peace Centre, Singapore 228149
SQI Member: S$500/pax
Course fees include training materials, certificates and light refreshments
Funding availability (to be announced soon)