ISO 13485:2016 Training Course

ISO 13485:2016 Medical Devices Quality Management System

Requirements, Lead Auditor & Internal Auditor training courses

ISO 13485 is an international standard that specifies requirements for quality management systems for the medical device manufacturing industry. Our Extensive ISO 13485 training courses can help any organization involved in the design, production, installation, and servicing of medical devices understand and apply quality management standards.

ISO 13485:2016 Lead Auditor Course duration- 5 Days

The ISO 13485 lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques.

ISO 13485:2016 Standard requirements- 2 Days

This course will give you a detailed understanding  of Medical Devices quality management system requirements, the knowledge of ISO 13485 impacts the design, development and production of medical devices and Learn why ISO 13485 compliance is essential to meeting customer and legal requirements

ISO 13485:2016 Internal Auditor Course- 3 Days

The ISO 13485 Internal Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques.

Who Should Attend?

  • Anyone involved in the auditing, maintaining or supervising of an ISO 13485:2016 (MDQMS)
  • Management Representatives, Medical Representative, Authorized Representative
  • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
  • Staff responsible for conducting ISO 13485 or Quality audits
  • Candidate who are looking a career in Medical Devices quality Management, Consultants

Training Course Content

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485 standard requirements and sub clauses
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Application of auditing guidelines to ISO 13485:2016
  • An overview of the ISO 13485 requirements and Risk Assessment
  • The management systems and internal audits roles
  • The roles and responsibilities of an Internal Auditor
  • Plan your audits and how to develop the effective checklists
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011 and in accordance with ISO 13485
  • Write factual audit reports that help to improve the effectiveness of the Medical Devices management system by the implementation of appropriate corrective action

ISO 9001:2015 Quality Management system Requirements, Lead

Auditor & Internal Auditor training courses

The ISO 9000:2015 and ISO 9001:2015 standard is based on the following seven principles of Quality management.

  • Customer Focus.
  • Leadership.
  • Engagement of People.
  • Process Approach.
  • Improvement.
  • Evidence-based Decision Making.
  • Relationship Management.

ISO 9001:2015- Lead Auditor Course duration- 5 Days

The ISO 9001 Lead Auditor training enables you to develop the necessary expertise to perform a Quality Management System (QMS) audit by applying widely recognized audit principles, procedures and techniques.

ISO 9001:2015- Internal Auditor Course Duration- 2 Days

Attending this two day internal auditor course enables you to demonstrate you have the necessary skills to conduct internal audits against ISO 9001:2015 requirements

ISO 9001:2015- Standard Requirements Course Duration- 2 Days

If you’re thinking about implementing a quality management system (QMS) and want to find out more, this ISO 9001:2015- Standard Requirements training provides you with an understanding of the 7 key management principles and key requirements of the ISO 9001:2015 standard.

It explains how these relate to each other so you can meet organizational objectives and improve business performance.

Who Should Attend?

  • Quality Managers, QES managers, Sustainability Managers, Executives & professionals engaged in the development or preparing for the upgrade of existing Management Systems.
  • Trainers and consultants who search for basic knowledge related to the changes expected in the revised ISO 9001.
  • Anyone new to quality management systems and ISO 9001:2015 tasked with implementing and/or managing an organization’s QMS

Training Course Content

  • The fundamental and value of an effective QMS and its contribution to your business
  • The purpose and intent of the ISO 9001 series of standards & Key requirements of ISO 9001 and how they relate to each other to form a robust system.
  • Principles and the “Deming’s Cycle” Plan Do, Check, Act cycle.
  • What needs to be considered when developing or upgrading your existing Management Systems to meet the High Level Structure (HLS) requirements?
  • Types of emerging stake-holder (interested parties) pressures on your business.
  • Risk based thinking – types of risks linked to your business processes.
  • The new versions of the standards as enablers for sustainable business performance.
  • Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021, as appropriate
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