As is widely known, Deming Certification Services Pvt Ltd is conducting various technical courses inviting interested personnel/technocrats for enhancing & fine-tuning of the skill. Deming Certification Services Pvt Ltd organizing Internal Auditor Classroom & online Training course for ISO 13485:2016 Medical Devices — Quality Management Systems  2 day internal auditor training 

 

1. Introduction of ISO 13485:2016

 The Standards Published By Iso Undergo Changes Periodically, To Reflect The Best-Suited Practices Over The Changing Times. Iso Series Of Standards For A Business Unit To Successfully Set Up An ISO 13485:2016 MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS  2 day internal auditor training   Or Get Maximum Benefits From An Established Management System, Auditors Within The Organization Have To Be Trained To Assess The System Against For ISO 13485:2016 MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS  2 day internal auditor training    Requirements.

They Must Also Be Able To Assess Their Suppliers Required Management System To Support Own Quality Initiative. To Increase Professionalism, Quality Auditors Also Seek Formal Registration With The UKJAS (UK) One Of The Prerequisites For Such Registration Requires The Quality Auditors And Practitioners To Successfully Complete An UKJAS (UK) Approved Auditor Training.

 

2. Objective Of The Course of ISO 13485:2016

 

The objective of the course is to illustrate the importance of the Internal Auditors role, skills and competency in bearing the ultimate responsibility for the effective performance of the audit team. A practical and intensive course for Training quality professionals to External, Internal and manage third and second party audits of an for ISO 13485:2016 MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS  2 day internal auditor training Course Describes How To Plan And Perform An Audit, Report Findings, Conduct Opening And Closing Meetings And Establish Follow-Up Action.

You Will Understand By The End Of The Course How Regular Auditing By An Audit Team Directed By A Competent Internal Auditor Is The Foundation Of An Effective For ISO 13485:2016 Medical Devices — Quality Management Systems  2 day internal auditor training  . On Completion Of The Course You Will Have The Necessary Skills And The Experience To Internal Audit And Manage Your Own Audits. The Learning Process Will Include A Series Of Tutorials, Exercises, Culminating In Both Practical And Written Examination. Delegates Will Be Supplied With A Bound Set Of Comprehensive Course Notes.

3. COURSE CONTENTS:

• Introduction For ISO 13485:2016 Medical Devices — Quality Management Systems 2 day internal auditor training  Vocabulary & understanding definitions
• Introduction to For ISO 13485:2016 Medical Devices — Quality Management Systems 2 day internal auditor training  Management System Requirements
• Need for Internal Quality Audits
• Auditing Techniques
• Conducting Internal Quality Audits
• Course Examination

For detail of contents refer our website at www.Demingcert.com

 

4. WHO SHOULD ATTEND:

• All Employees Whose Work Responsibility Directly Affects For ISO 13485:2016 Medical Devices — Quality Management Systems 2 day internal auditor training  Those Individuals Willing To Take Up External Auditing As A Future Profession By Becoming An Independent Auditor.
• Those Who Intend To Enroll Themselves To UKJAS (UK & IND) Registration Schemes Of For ISO 13485:2016 Medical Devices — Quality Management Systems 2 day internal auditor training   2 day internal auditor training 
• Management Representatives Responsible For Effective Implementation And Execution Of ISO 13485:2016 Medical Devices — Quality Management Systems 2 day internal auditor training 

 

Day 1: ISO 13485:2016 & Internal Auditing Fundamentals

1. Introduction to Medical Device Quality Management Systems
2. Overview and Structure of ISO 13485:2016
3. Key Differences Between ISO 9001 and ISO 13485
4. Regulatory and Quality Requirements for Medical Devices
5. Quality Management System Requirements
6. Management Responsibility and Quality Objectives
7. Resource Management and Competence
8. Product Realization and Process Controls
9. Risk Management Principles for Medical Devices
10. Documentation and Record Control
11. Nonconformity, Corrective Action, and Preventive Action
12. Introduction to Internal Audit Principles
13. Audit Planning and Audit Programme
14. Preparation of Audit Checklists
15. Practical Case Study and Interactive Exercises

Day 2: Conducting & Reporting ISO 13485 Internal Audits

1. Audit Preparation and Opening Meeting
2. Process-Based Auditing Approach
3. Collecting and Verifying Objective Evidence
4. Interviewing Techniques for Auditors
5. Auditing Medical Device Processes
6. Identification and Classification of Nonconformities
7. Root Cause Analysis and Corrective Action Evaluation
8. Audit Findings and Audit Evidence
9. Preparation of Internal Audit Reports
10. Closing Meeting and Follow-up Audits
11. Audit Effectiveness and Continual Improvement
12. Practical Internal Audit Simulation
13. Group Exercise: Audit Checklist and Report Preparation
14. Final Assessment and Feedback
15. Certificate Distribution

5. FACILITIES:

All facility for delegates covering lecture hall, tea and lunch will be arranged by Client or if you are attending the course at Deming Certification Services. Deming Certification institute will arrange the above facility.

 

6. COURSE DETAILS:

Detail program of every days Training course will be sent / given on the first day to the delegates on registration.

 

7. DURATION:

 ISO 13485:2016 MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS  2 day internal auditor training  [Timings: 10.00 am to 6.00 pm]

 

8. FEES:

 ISO 13485:2016 MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS 2 day internal auditor training  Is Rs 8,500 +18%GST Payment should be made by Cheque / DD in favor of “Deming Certification Services Pvt Ltd, Mumbai”

 

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