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ISO 13485 Internal Auditor Training

Medical Devices internal auditor


SGS Academy

Summary

Price
£1,000 inc VAT
Study method
Online, self-paced
Duration
2 days
Qualification
No formal qualification
Additional info
  • Exam(s) / assessment(s) is included in price
  • Tutor is available to students
  • Certificate of completion available and is included in the price

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Overview

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.

Description

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

Who is this course for?

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



View Details
Identifier:
{30D7E806-AA66-40CC-80EA-EAE9FA5F78E2}

Duration:
2 days

Additional Details
Course Number:
MDIA

Course Type:
SGS Controlled

Payment Policy:
This course will be reviewed 15 working days prior to the start date and you will be notified of confirmation or cancellation at that time. SGS shall issue an invoice or proforma invoice at the point of Course Confirmation.

Categories
Industry Based Training

Industry Based Training/Medical & Health Care

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Requirements

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.

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