ISO 13485 – Medical Devices
Quality Management Systems – Requirements for Regulatory Purposes
ISO 13485 is a quality management system designed specifically for the Medical Devices industry.
The ISO 13485 standard follows the ISO 9001:2008 standard and adds additional requirements (such as compliance with statutory and regulatory requirements) for those companies involved in the medical and pharmaceutical supply chain at any level/tier.
ISO 13485 Internal Auditor Course
2 Day Course – £995
The Batalas ISO 13845 Internal Auditing training course is aimed at professionals wanting to conduct internal audits to the ISO 13845 standard. This very intensive 2 day course will help you to evaluate the effectiveness of your organisations management system.
ISO 13485 Auditor / Lead Auditor Course
5 Day Course – £1795
The Batalas ISO 13845 Lead Auditing training course covers 2 main aspects of auditing
a) the requirements of the ISO 13485 including regulatory and legislative controls
b) using ISO 19011 we will teach you how to plan, conduct, lead and report audits within their own organisation and their suppliers for conformity to the ISO 13845 standard.
Need help - get in touch now
Contact us for help with transitioning to the new standard – call one of our friendly team on 0333 700 9001