Classroom 2 days
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Description
MDIA
This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognised Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognised by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognised by the Hong Kong Medical Device Control Office.
Objectives
The objective of this course is to provide delegates with the skills required to conduct internal audits as required by ISO 13485.
Upon completion of this course delegates will be able to :
- Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
- Know how to conduct internal quality system audits :
- understand the role of internal audit in the maintenance and improvement of management systems
- plan and prepare for an internal audit
- learn to gather evidence by observation, questioning & sampling
- write factual reports on the compliance of the management system against the audit standards
- participate in the corrective action process
Audience
This course is designed to familiarise quality and regulatory professionals, engineers, designers and management with the requirements for internal auditing of ISO 13485 quality systems.
To gain the most from this training, delegates will require a copy of ISO 13485 as it will be reviewed and referred to during the training.
Copies of the Standard are provided for the learner’s use during this course. If participants would like to purchase their own copy of the Standard to familiarise themselves with the vocabulary and clauses, the documents are available to order here: Standard - ISO 13485:2016 Medical Devices
Classroom 2 days
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