Medical Device Auditing To ISO 13485
A Course Specially Designed for Medical Device Company and its suppliers
J E M O Limited
Established since 1984
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Pharmaceutical Internal Auditor Training
Pharmaceutical Auditor/lead auditor Training
Pharmaceutical Course
The course is structured in a series of build-up modules which provide a sound understanding of:

• ISO 9001: 2015 – the baseline quality management system
• ISO 9000: 2005 – the terminology and principles underpinning ISO 9001
• ISO 13485: 2003 and CFR 820 – the requirements for medical devices to comply with EU and US statutes applicable to medical devices
• How to perform compliance audits in a constructive and value-adding manner

An optional extra is the inclusion of a module on ISO 9004: 2009– which provides guidance on business sustantiality based on your Quality Management System – not considered a part of a regulated system, but which can provide substantial cost savings and other business benefits.
Book the course or get a quote
“It opened my eyes to what professional supplier auditing is about”

“Superb explanation of the PS 9000 series of GMP standards and how to audit against them”

“Fulfilled my requirements completely”

“Illustrated throughout with pharmaceutical industry examples”

All of our courses can be customerised to your needs nomally with no extra cost.  Please feel free to contact us for more details and/or request a competitive quote.  Please contact us or complete our Enquiry form
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PS...Britain's best kept secret
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Hot off the press
PS 9000: 2011
Download the latest PS9000:2011 standard from PQG for free
Course Structure
Good Distribution Practice (GDP)
GMP For Pharmaceutical Packaging Awareness Workshop
Medical Device Auditing to ISO 13485
CQI Introduces a new Grade
This in-house course is designed for existing auditors who require some refresher training and for people new to internal auditing and provides:
  • Understanding of the requirements of ISO 9001: 2015
  • Understanding of ISO 13485:2003 and CFR 820
  • Instruction and practice in auditing to these standards using the guidance provided in ISO 19011: 2011 – Guidelines for quality and/ or environmental management systems auditing
  • The course includes live auditing of your existing management systems.
    Introduction to latest PS9000:2011
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    Auditor Training, Assessment & Consultancy
    ISO 9001:2015 Gap Analysis
    Auditing & Implementation Tools