ISO 13485 Internal Auditor  training

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ISO 13485 Internal Auditor training Objectives

ISO 13485 Internal Auditor  training suitable for those wishing to conduct internal audits to ISO 13485. This 3-day ISO 13485 Internal Auditor training enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective audits and produce audit findings.

Delegates completing the ISO 13485 internal auditing training will be able to audit their quality management system for conformity to ISO 13485, the effectiveness of their business processes, and to identify opportunities for improvement. Improving Medical Devices-QMS performance and continual improvement are key elements of this ISO 13485 Internal Auditor  training.

ISO 13485 Internal Auditor  training will help you understand the underlying philosophy, principles, concepts, and requirements of the ISO 13485 Standard, the application of this International Standard within your organization and the skills necessary to conduct an ISO 13485 management system audit.

 

ISO 13485 Internal Auditor  training Course Content Outline

Audit Fundamentals

Definitions, purpose, types

Quality Management Systems (Medical Devices)

In-depth discussion on ISO 13485:2003 Standard requirements

GMP background and FDA requirements

What is auditing. Audits: Definition, Principles

Defining an Internal audit process Audit Planning & Preparation

Conducting the Audit & Audit Review

Audit Reporting and Follow-Up

Types of audits – 1st, 2nd & 3rd party audits?

3rd party auditing process and certification requirements

Definitions of key words in ISO 13485 and GMP Standards

Review of Standard Requirements and Summary of Key Points

General requirements

Changes from old Standard and newly emphasized points

General review of 5 major categories

Quality Management System

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis and Improvement

Type of Findings

Minor non-compliances

Major non-compliances

Recommendations

Corrective actions/follow-up

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ISO 13485 Internal Auditor  training Course Format

The format of the ISO 13485 Internal Auditor utilises accelerated learning techniques and is therefore highly interactive, with tutor-led sessions interspersed with individual and group exercises. A realistic case study and role-play activities provide an excellent opportunity to practice ISO 13485 auditing skills.

 

Who should attend ISO 13485 Internal Auditor  training

ISO 13485 Internal Auditor  training is valuable for delegates involved in the planning and implementation of ISO 13485:2003 based quality management systems as well as for personnel who will manage, conduct or participate in ISO 13485:2003 audits.

 

ISO 13485 Internal Auditor  training Achievement

Upon SUCCESSFUL completion of the ISO 13485 Internal Auditor  training a Certificate of “ISO 13485 Certified Lead Auditor Training” will be issued.

CPD-16

CEU-1.6

 

ISO 13485 Internal Auditor  training Duration-   02 days                  

 

Value added ISO 13485 Internal Auditor  training

Accelerate learning with the expert faculty Lead Auditors and Principal Trainers from the Industry. ISO 13485 Internal Auditor  training from the "Specialist Expert" has many advantages:-

 

• It will drastically change the way of thinking and basic approach towards the Management System Standards.

• You would cherish & Benchmark our training for a very long time to come.

• No fictitious case studies you can not connect with.

• Real time examples, real time scenarios you can quickly relate to.

• Complete Focus on your systems, processes and line of businesses.

• 100% involvement and engagement of the participants

• Learn to make the ISO Standard sweat to:-

A). Improve the profits.

B). Reduce rework, defects, customer rejections, wastage,& cost of operation

C). Enhance customer delight

D). Reduce attrition of customers and employees

E). Enhance confidence of all stakeholders