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How to Get Certified with ISO 13485 Auditor Training ?

Punyam Academy's this publication is fulfilling the needs of people who want to audit Quality management system for medical devices. The content of this online ISO 13485 auditor training can be presented in an interactive way, including presentation, hand-outs, and responsive questions and answers.For more information visit our web portal at https://www.punyamacademy.com/ <br>

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How to Get Certified with ISO 13485 Auditor Training ?

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  1. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Chapter - 1: CONTENTS OF ISO 13485:2016 CERTIFIED INTERNAL AUDITOR TRAINING Sr. No. The entire e-learning course has 8 main parts as below Details Lectures No. of slides 1. Session - 1 : Overview of ISO 13485:2016 12 2. Session - 2 : ISO 13485:2016 Principles 10 3. Session - 3 : ISO 13485:2016 Requirements 40 4. Session - 4 : Control of Documents and Records 11 Session - 5 : ISO 13485:2016 Quality Management System Internal Audit 1. 5 40 6 Session - 6 : ISO 13485:2016 Internal Audit Records 9 7 Session - 7 : Risk Management 6 Session - 8 : Steps for ISO 13485:2016 QMS Installation & Certification 8 6 Total no. of slides (with Audio lectures)   134 Hand-outs (each session detail document is given in PDF and participant can download, print, or save it for future reference) 2. Approx. 161 Pages in PDF 3. Session Exams at end of each session and Final Exam Total 9 Exams Approx. 200 audit questions 4. Audit Checklist as per Department-wise and Clause-wise 5. ISO 13485:2016 Certified Internal Auditor training certificate Award Certificate For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 1 of 10

  2. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Part – 1 Lectures: Under this part total four sessions are given as Presentations with explanatory audio to understand the subject. Session - 1 : In this session, participants will learn about ISO 13485:2016 standards in detail. It covers total 12 slides on below topics: 1.Session - 1 : Overview of ISO 13485:2016 2.ISO Facts 3.Messages from ISO 13485:2016 Standard 4.Introduction to ISO 13485:2016 5.Key Changes in ISO13485:2016 6.Benefits of ISO 13485:2016 Quality Management System 7.ISO 13485: 2016 Quality Management Principles 8.Summarizing Seven Principles of ISO 13485:2016 9.Basic Process Model 10.Schematic Representation of Process Approach 11.Connectivity of System and Confirmative Assessment as per ISO 13485:2016 12.End of Session Session - 2 : In this session, participants will learn about the principles of ISO 13485:2016 in detail. It covers 10 slides: 1.Session- 2 ISO 13485 Principle 2.ISO 13485 quality management principles 3.Principle-1: Customer Focus 4.Principle-2: Leadership 5.Principle-3: Engagement (involvement) of People 6.Principle-4: Process Approach 7.Principle-5: Improvement 8.Principle-6: Evidence-based Decision Making 9.Principle-7: Relationship Management 10.Summarizing Seven Principles of ISO 13485 For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 2 of 10

  3. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Session - 3 : In this session, participants will learn about ISO 13485:2016 requirements. It covers 40 slides: 1.Session – 3 ISO 13485:2016 Requirements (Clause - 4.0 to 8.0) 2.Overview of the ISO 13485 Standard 3.Clauses - : 1, 2 and 3 4.Clause 4.0 -: Quality management system 5.clause 4.1 - : General requirements 6.4.1 - : General requirements (Continued…) 7.4.2 - : Documentation requirements 8.4.2 - : Documentation requirements (Continued…) 9.Clause 5.0 - : Management Responsibility 10.Clause 5.1 - : Management commitment 11.Clause 5.2 - : Customer focus 12.Sample Quality Policy 13.Clause 5.4 - : Planning 14.Clause 5.5 - : Responsibility, authority and communication 15.Clause 5.6 - : Management review 16.Clause 6.0 - : Resource Management 17.Clause 6.1 - : Provision of resources 18.Clause 6.3 - : Infrastructure 19.Clause 6.4 - : Work environment and contamination control 20.Clause 7.0 - : Product Realization 21.Clause 7.1 - : Planning of product realization 22.Clause 7.2 - : Customer-related processes 23.Clause 7.3 - : Design and development 24.Clause 7.3 - : Design and development (Continued…) 25.Clause 7.3 - : Design and development (Continued…) 26.Clause 7.3 - : Design and development (Continued…) 27.Clause 7.4 - : Purchasing 28.Clause 7.5 : Production and service provision 29.Clause 7.5 - : Production and service provision (Continued…) 30.Clause 7.5 - : Production and service provision (Continued…) 31.Clause 7.6 - : Control of monitoring and measuring equipment For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 3 of 10

  4. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com 32.Clause 8.0 - : Measurement, analysis and improvement 33.Clause 8.1 - : General 34.Clause 8.2 - : Monitoring and measurement 35.Clause 8.2 - : Monitoring and measurement (Continued...) 36.Clause 8.2 - : Monitoring and measurement (Continued...) 37.Clause 8.3 - : Control of nonconforming product 38.Clause 8.3: Control of nonconforming product (Continued...) 39.Clause 8.4 - : Analysis of data 40.Clause 8.5 - : Improvement Session - 4 : In this session, participants will learn ISO 13485:2016 Documented Information. It covers 11 total slides on below topics: 1.Session - 4 :control of documents and records 2.What is Documents and record? 3.Control of Documents and records 4.Documents structure for ISO 13485 5.ISO 13485 in Four-tier Document Structure 6.Tier-1: Quality Manual 7.Tier-2: Quality Procedures 8.Tier-3: SOP / Work Instruction / Exhibit (It is required to make a good system) 9.Tier-4: Format / Record / Register (It is required to make a good system) 10.List of Required Documents as per ISO 13485 11.List of Required Records as per ISO 13485 Session - 5 : In this session, participants will learn about ISO 13485:2016 System Internal Audit. It covers total 40 slides on below topics: 1.Session – 5 : ISO 13485:2016 Internal Audit Process 2.Outline of this topic 3.Audit Definition 4.What is an Audit? 5.Why Audit? 6.What is Internal Audit? For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 4 of 10

  5. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com 7.Overview of Internal Management System Audit 8.Key Elements of Internal Audit 9.Requirements for Internal Audit 10.Tips for Trained Internal Auditors 11.Principles of Auditing 12.Types of Audit 13.Management System Internal Audit Techniques 14.Steps Involved in Management System Audit 15.Implementing the Audit Program 16.Seven Steps of Implementation of Audit Program 17.Step no. 1- Audit Planning 18.Contents of Audit Plan 19.Step no. 2- Developing Checklists 20.Step no. 3- Conducting Opening Meeting 21.Step no. 4- Conducting the Audit 22.Interview and questioning techniques 23.Collecting Evidences of Compliance 24.Objective Evidences 25.Step no. 5- Recording Audit Findings 26.Identifying Non-compliances 27.Categorizing Non-Compliances 28.Nonconformity Report 29.Nonconformity Reporting 30.Step no. 6 - Conducting the Closing Meeting 31.Step no. 7 - Preparing the Audit Report 32.Contents of Audit Report 33.Conducting Audit Follow-up 34.Auditor’s Qualities 35.Auditor's Personal Behavior 36.Auditor’s Conduct 37.The Audited Persons’ Conduct 38.Overview of the Process of Collecting and Verifying Information 39.Management System Internal Audit Process 40.Reference For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 5 of 10

  6. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Session - 6 : In this session, participants will learn about ISO 13485:2016 Internal Audit Records. It covers total 9 slides on below topics: 1.Session - 6 : ISO 13485:2016 Internal Audit Records 2.Internal Quality Management System Audit Records 3.Internal Quality Management System Audit Records 4.Internal OH&S System Audit Records (continued...) 5.Form No. 1 - Internal Quality System Audit Plan 6.Internal Quality System Audit Records (continued…) 7.Form No. 2 - QMS Internal Audit Nonconformity Report 8.Internal Quality System Audit Records (continued…) 9.Form No. 3 - ISO 13485:2016 QMS Clause-wise audit review report Session - 7 : In this session, participants will learn Steps for ISO 13485:2016 Risk Management. It covers total 6 slides on below topics: 1.Session - 8 : Steps for ISO 13485:2016 QMS Installation & Certification 2.Requirements to establish ISO 13485:2016 Quality Management System 3.Steps for installation of ISO 13485:2016 Quality Management System 4.List of some commonly found Nonconformities during Audit 5.Steps for ISO 13485 Quality Management System Certification 6.ISO 13485 is not for those Session - 8 : In this session, participants will learn Steps for ISO 13485:2016 Installation & Certification. It covers total 6 slides on below topics: 1.Session - 8 : Steps for ISO 13485:2016 QMS Installation & Certification 2.Requirements to establish ISO 13485:2016 Quality Management System 3.Steps for installation of ISO 13485:2016 Quality Management System 4.List of some commonly found Nonconformities during Audit 5.Steps for ISO 13485:2016 Quality Management System Certification 6.ISO 13485:2016 is not for those For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 6 of 10

  7. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Part – 2 Hand-outs: For each lecture, hand-out is given in PDF format. The participant can download or print any documents to read it later to get detailed knowledge of all the six topics. Sr. No 1 2 3 4 5 6 Name of Literature Total Pages 12 6 23 13 38 9 37 Session - 1 : Overview of ISO 13485:2016 Session - 2 : ISO 13485:2016 Principles Session - 3 : ISO 13485:2016 Requirements Session - 4 : Documented Information Session - 5 : ISO 13485:2016 System Internal Audit Session - 6 : ISO 13485:2016 Internal Audit Records A.ISO 13485:2016 Internal Audit Records B.ISO 13485:2016 Clause Wise and Department Wise Audit Checklist Session - 7 : Risk Management 7 11 Part – 3 Exams: Each session contains session exam, Participants have to pass the exam after completion of each session. After passing all session exams there is one final exam, participant must have to pass exam with minimum 80% marks. User can reappear and clears each exam to complete the course and get download/print their ISO 13485:2016 internal auditor training certificate. Part – 4 Audit Checklists: The Audit checklists with more than 400 quality management system audit questions as below: 1.ISO 13485:2016 requirement wise questions 2.Department wise audit questions Part – 5 Training Certificate: After passing the exam the colorful training certificate is generated and user can download it or print it. Any one globally can cross verify the training certificate through our LMS platform. For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 7 of 10

  8. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Upon Completion of this course, participants will be able to: Chapter - 2: COURSE OBJECTIVES Familiarize yourself with ISO 13485:2016 quality management system requirements clauses and sub clauses Get an overview of ISO 13485:2016 quality management system (QMS) and the benefits to implement it. Familiarize yourself with the high level structure and the framework of QMS. Understand General and structural requirements of ISO 13485:2016 standard. Know about the resource requirements and process requirements for QMS. Know about the management system requirements. Understand documentation and list of procedures and records to be maintained and to check them as internal auditor. Get the knowledge of internal auditing and use of audit checklist. Understand the processes involved in auditing. Know about the types of auditing and questioning techniques. Understand how to prepare and maintain internal audit records. Get the ready-to-use internal audit checklist with clause-wise questions to perform an effective audit. Understand the new concepts of impartiality, risk management and risk evaluation techniques, decision rule, and process approach. Make a team of internal auditors to establish quick and effective system for 13485:2016 accreditations. For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 8 of 10

  9. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com This course is developed and brought to you by Punyam Academy; an ISO/IEC 17024 accredited training provider company, which offers various e-learning as well as classroom training courses for working professionals, college students, and other individuals for enhancing their career to new heights. Our e-learning courses help them to succeed in today's competitive environment, to renew licenses, and to update, strengthen and add quality to their existing knowledge and skills. Our courses are also useful for those who want to get certification, or start a new profession. Compatibility and Requirements for smoothly running our course 1.Bandwidth: Internet bandwidth must me 1 MBPS or higher. 2.Operating System: Microsoft Windows XP and higher versions, iOS, Android. 3.Browser: Best viewable in Mozilla Firefox, Google Chrome. Also supports Internet Explorer. 4.Screen Resolution: To view slides properly, you must have a screen resolution of 1024 x 768 or higher. 5.Cookies: You must have browser cookies enabled, so that we can maintain your current session as you navigate through the application. 6.JavaScript: You must have enabled JavaScript, so that application runs smoothly. 7.Adobe Acrobat Reader: Some documents in our application are in pdf format, so you must have installed adobe acrobat reader in your computer to be able to read such documents that you download. 8.Pop-up Enable: In your browser setting, check Pop-up blocker off, or enable Pop-up window. 9.Speaker: You must have speakers or a headphone attached to your computer, so that you can listen to the course lecture while learning. Clickto Purchase this Course. Chapter - 3: WHO SHOULD ATTEND THIS COURSE? Chapter - 4: USER MANUAL ENROL For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322 Page 9 of 10

  10. PAS129: ISO 13485:2016 Certified Internal Auditor Training E-learning Course Duration: 14 Hours Website: www.Punyamacademy.com Punyam Academy is an ISO/IEC 17024 certified training provider company, which offers various ISO Training Courses and conducts webinars for online certification as well as classroom training. We are a leading name in E-learning, training and certification on ISO standards and all other types of management system standards. Punyam Academy specializes in a complete range of courses on awareness, auditor and lead auditor courses on ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, OHSAS 18001, ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, FSSC 22000, ISO 27001, ISO 50001, ISO 13485, ISO 20000, ISO/IEC 17024, ISO 17034, Sedex, ISO 22301, NABH, Certified Calibration Engineer and other management system training courses. We provide E-learning courses on all of these topics through effective, enjoyable and time-saving online training sessions and webinars. We have conducted more than 300 public training programs as well as online corporate training sessions in more than 45 countries. To review how our LMS works, Visit Our Website for more E-learning Courses and PPT Packages: Chapter - 5: ABOUT COMPANY Click Here https://www.punyamacademy.com/eshop For more information about ISO 13485:2016 Certified Internal Auditor Training Click Here Page 10 of 10 www.punyamacademy.com E mail: sales@punyamacademy.com Tele: +91-79-2979 5322

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