ISO 13485 2016 Internal Auditor Training Course

ISO 13485 Internal Auditor Training Courses, Classroom based ISO 13485 Internal Auditor Training Courses, Training for ISO 13485 - Medical Device Industry, Medical Device Internal Auditor Training for ISO 13485

Eurotech comprehensive ISO 13485 2016 and regulatory support program for the Medical Device Industry enables your organization to implement an effective ISO 13485 2016 quality management system and meet domestic and international regulations for medical

ISO 13485 | Internal Auditor: ISO 13485:2016

device, while achieving overall business improvement. 

Eurotech ISO 13485 2016 Internal Auditor competency- based 3-day course teaches a general understanding of the concepts of the ISO 13485 2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011 2011, Guidelines on Auditing Management Systems. Experienced instructors explain the clauses of ISO 13485 2016 in detail and guide candidates through internal audits that are required for a quality management system based on ISO 13485 2016. Candidates gain necessary auditing skills through a balance of formal seminar tutorials, practical role-playing, group workshops, and open forum discussions.

You need ISO 13485 Internal Auditor Training Courses if...

You want to understand the best practices to conduct an effective internal Quality Management Systems audit in accordance with the requirements of EN ISO 13485 2016 and ISO 19011 2011

You want to add value to your organization and improve the effectiveness of the Quality Management Systems

What is an ISO 13485 Internal Auditor?

A highly interactive 2 day ISO 13485 internal auditor training course that enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective audits and produce audit findings.

What will you learn from ISO 13485:2016 Internal Auditor Training Course?

A detailed understanding of:

• An overview of the ISO 13485 requirements
• Auditing skills
• The role management systems and internal audits play in helping businesses manage their risks
• Planning, preparation and management of audits
• The roles and responsibilities of an Internal Auditor
• How to plan your audits and how to develop the effective checklists
• Checklist development
• How to carry out effective audits using LRQA's 6 Stage Approach
• To gather objective evidence through observation, interviewing and sampling of documents
• Conducting process audits
• To evaluate audit findings and determine conformity, nonconformity and effectiveness
• To report findings accurately, adding value to the business
• Reporting audit findings
• What is corrective action and who is responsible for implementation
• Verifying corrective action
• How to follow up and verify the effectiveness of corrective action taken
• Interviewing skills
• How to address common internal audit weaknesses within the medical device industry
• Medical devices, quality and auditing terminology
• Structure & intent of the medical devices standard ISO 13485 :2016
• Types of audit
• Internal audit objectives
• Internal audit scope and criteria
• The audit process
• Roles and responsibilities of the internal auditor

Learning Objectives of ISO 13485:2016 Internal Auditor Training Course:

• Understand the Quality Management Principles in the context of ISO 13485:2003.
• Relate the quality management system to the organization’s medical devices
• Understand the application of the principles, procedures and techniques of auditing.
• Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
• Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
• Practice personal attributes necessary for the effective and efficient conduct of a management system audit.

Who should attend ISO 13485:2016 Internal Auditor Training Course?

• Quality Consultants
• Quality and Production Directors
• People new to auditing and have been asked to conduct internal audits
• Anyone involved in planning, managing and implementation of internal audit systems
• Those needing to identify gaps in the effectiveness of your MS
• Those wanting to achieve continual business process improvement
• ISO 13485 specifically requires that staff is trained and that auditors are competent, this course satisfies this requirement.
• Individuals interested in conducting second- or third-party audits of QMS management systems based on ISO 13485
• Quality Management Representatives
• Cross-functional team members of a QMS implementation project
• Individuals who want to become an IRCA or RABQSA International Certified Provisional Auditor, Auditor, Principal Auditor, or Internal Auditor

ISO 13485 2016 Internal Auditor Training Course gives an introduction to the most widely used standard for Quality Management in the world. Enquiry today!

Interested Candidates Can write or call Us for More Information 

Puneet Sharma | Call : 08196980555 | E-Mail  ISO.Training.Eurotech@gmail.com

If You Want to Attend Our ISO 13485 2016 Internal Auditor Training Seminar, Please fill out the Enquiry Form: