ISO 13485 Auditor Training

C131: DEMO OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATION KIT Price 450 USD

Buy: www.globalmanagergroup.com C131 - CONTENTS OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATIONS TRAINING KIT ISO 13485:2016 Internal Auditor Training Presentation kit (Editable) Sr. No.

The entire PPT presentation kit has 6 main files as below PPT Presentation

Document of Details No. of Slides

1.

Overview of ISO 13485:2016

14

2.

ISO 13485:2016 Principles

10

3.

ISO 13485:2016 Requirements

71

4.

ISO 13485 Documents and Records

13

5.

Risk Management

22

6.

ISO 13485:2016 Quality Management System Internal Audit

50

7.

ISO 13485:2016 Internal audit records

13

8.

Steps for ISO 13485:2016 QMS Installation & Certification

06

1.

Total no. of slides 

199

2.

A trainer's guide and hand outs and editable form to understand ISO 13485:2016 subject well in 8 chapters

Approx. 125 Pages in Ms. word

3.

Workshops and case studies to evaluate effectiveness of training.

02 workshops and 02 case studies

4.

Audit questions

Approx. 800 audit questions

5.

Audit forms

03 file in Ms. word

6.

Sample ISO 13485:2106 system certified Internal Auditor training certificate copy to be given to participant after solving workshops and case studies as per sample

01 file in Ms. word

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C131: DEMO OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATION KIT Price 450 USD

Buy: www.globalmanagergroup.com Topic wise number of slides:Sr. No.

Title of Slides

No of Slide

1.

Overview of ISO 13485:2016

14

2.

ISO 13485:2016 Principles

10

3.

ISO 13485:2016 Requirements

71

4.

ISO 13485 Documents and Records

13

5.

Risk Management

22

6.

ISO 13485:2016 Quality Management System Internal Audit

50

7.

ISO 13485:2016 Internal audit records

13

8.

Steps for ISO 13485:2016 QMS Installation & Certification

06

Total No. of Slides 

199

To get more information about ISO 13485:2016 system training kit Click Here

Part - 1. Presentation: Under this directory further files are made in power point presentation as per the chapter listed below. 

Topic wise power point presentation in 7 modules as listed below.

1. Overview of ISO 13485:2016 food safety management system It covers Overview of ISO 13485:2016, benefits and summary of overall system and change process for ISO 13485:2016 quality management system.

2. ISO 13485:2016 principles It covers 7 principles of quality management system based on ISO 13485:2016 and covers all details how such principles to be considered in making the system.

3. ISO 13485:2016 requirements It covers ISO 13485:2016specifications, requirements, it gives explanation for many new concepts and given in plain English for easy understanding of revised changes given in ISO 13485:2016 and many places clarifications are given.

4. ISO 13485 Documents and Records It covers documented information for ISO 13485:2016.

5. Risk Management It covers techniques to implement the risk based thinking and identify opportunities 6. ISO 13485:2016 Quality Management System Internal Audit It covers internal audit process for ISO 13485:2016 quality management system.

7. ISO 13485:2016 Internal audit records It covers internal audit records for ISO 13485:2016. www.Globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-29795323

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C131: DEMO OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATION KIT Price 450 USD

Buy: www.globalmanagergroup.com 8. Steps for ISO 13485:2016 QMS Installation & Certification It covers steps to carry out quality management system internal audit based on ISO 13485:2016.

Part - 2. A trainer's guide and handouts in editable form to understand ISO 13485:2016 subject well:This topic covers write up for the ready reference to the participant for understanding and reading the subject to get in depth knowledge on the subject It is given in word. You may also use it for further reading and circulations within audience.

Chapter No. 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Section Overview of ISO 13485:2016 ISO 13485:2016 Principles ISO 13485:2016 Requirements Control of Documents and Records Risk Management ISO 13485:2016 Quality Management System Internal Audit ISO 13485:2016 Internal audit records Steps for ISO 13485:2016 QMS Installation & Certification Workshop – 1 & 2 Case Study – 1 & 2

Part –3. Workshops and Case studies to evaluate effectiveness of training 02 workshops and 02 case studies:This topic covers workshops and case study to evaluate effectiveness of training. Each participant needs to solve this workshops and case study after undergoing the training.

After successful completion of workshop and case studies the ISO 13485:2016.

Part - 4. Quality management system audit questions:The ready to use ISO 13485:2016 audit questions as below.

1. ISO 13485:2016 Clause wise questions 2. ISO 13485:2016 Department wise audit questions

Part - 5. ISO 13485:2016 management system audit forms:This topic covers audit forms to carry our internal audit of ISO 13485:2016 and 3 forms are given.

Part - 6. Sample Copy of ISO 13485:2016 Internal Auditor Certificate:Sample ISO 13485:2016 Internal Auditor training certificate copy. This sample certificate helps to create training certificate for participants after completing the ISO 13485:2016 Internal Auditor training using our training kit. www.Globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-29795323

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C131: DEMO OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATION KIT Price 450 USD

Buy: www.globalmanagergroup.com Chapter-2.0 ABOUT COMPANY Global manager group is a progressive company promoted by a group of qualified engineers and management graduates having rich experience of over 25 years in ISO consultancy and management areas. The company serves the global customers through on-site and off-site modes of service delivery systems. We offer a full range of consulting services geared towards helping all types of organizations to achieve competitiveness, certification and compliance to international standards and regulations. So far, we have more than 2700 clients in more than 36 countries.

Our readymade training kit and editable documentation kit help the clients in making their documents with ease and complying with the related ISO standard faster.

1. Our promoters and engineers have rich experience of providing management training and ISO series consultancy for more than 2700 companies globally. We have clients in more than 36 countries.

2. We are a highly qualified team of 80 members (M.B.A., Degree Engineers). Our Director has rich professional experience in this field (since 1991).

3. We have 100% success rate in ISO series certification for our clients from reputed certifying bodies. We possess a branded image and are a leading name in the global market.

4. We suggest continual improvement and cost reduction measures as well as provide highly informative training presentations and other products that give you payback within 2 months against our cost.

5. So far, we have trained more than 50000 employees in ISO series certification.

6. We have spent more than 60000 man-days (170 man-years) in the preparation of ISO documents and training slides.

Global Manager Group is committed for: 1. Personal involvement and commitment from the day one 2. Optimum charges 3. Professional approach and globally helped many companies for this standard 4. Hard work and update the knowledge of team members 5. Strengthening clients by system establishment and providing best training materials in any areas of management to make their house in proper manner 6. Establishing strong internal control with the help of system and use of the latest management techniques.

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C131: DEMO OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATION KIT Price 450 USD

Buy: www.globalmanagergroup.com Chapter-3.0 USER FUNCTION 3.1 Hardware and Software Requirements A. Hardware:

Our document kit can be better performed with the help of P4 and above computers with a minimum 10 GB hard disk space.



For better visual impact of the power point document you may keep the setting of colour image at high end.

B. Software used in Document kit



Hand-outs written in MS-Office 2007 and window XP programs. You are, therefore, required to have MS-Office 2007 or higher versions with Windows XP. 3.2 Features of PPT Training kit:-



This kit will save much time in typing and preparing your presentation at your own.



The documents and presentation are written in easy to understand English language.



Easily customized by you to add audio clips in the local language etc. to prepare presentation for any other groups and user can easily customize it for own use.



Good guide for training of all the group members for ISO 13485:2016 internal auditor training.



The kit is user-friendly to adopt and easy to learn.



The contents of this kit are developed under the guidance of experienced experts.



The kit provides a model of the management system that is simple and free from excessive paperwork.

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GMG

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1

Schematic Representation of Process Approach Process Approach Diagram

Top Management Processes

Customers / Interested parties

Inputs

A

B

C

Outputs

Customers / Interested parties

Internal Processes Support Processes As shown in the diagram, input is received from customer as enquiry or order, and it is processed by various internal processes to deliver the final output as product or service delivery to customer.

•

Top management processes include, for example, planning, allocation of resources, management review, etc.

•

Internal processes include, for example, customer related processes, design and development, production and service provision , etc.

•

Support processes include, for example, training, maintenance, etc.

GMG

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2

ISO 13485 Quality Management Principles This standard is based on seven universally accepted quality management principles which are a synthesis of the philosophies of quality experts. These seven quality management principles have been developed and updated by international experts of ISO/TC 176 and given in ISO 9000 standard, which serve as the framework of new set of standards on quality management.

The seven principles are: • 1.

2.

3.

4.

5.

6.

7.

GMG

Customer focus Leadership Engagement of people Process approach Improvement Evidence-based decision making Relationship management

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3

Overview of the ISO 13485 Standard The contents of this international standard include: 0 1 2 3 4 5 6 7 8

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Introduction Scope Normative references Terms and definitions Quality management system(QMS) Management responsibility Resource management Product realization Measurement, analysis and improvement

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4

4-tier Documentation Structure for ISO 13485 Quality Management System

Quality Manual

First Tier

Quality Management System Procedures

Second Tier

Work Instructions / SOPs / Exhibits

Third Tier

Fourth Tier

Formats / Registers / Records HR & Admin

GMG

Sales & Marketing

Purchase

Production

QC & QA

R&D

Stores

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5

Phase 2: Risk Evaluation Decision Table –Take risk acceptability decision Severity (S) Probability (P)

1

2

3

4

5

5 4

3 2 1 Red

:

Risk reduction is essential

Yellow

:

Risk can be retained at current level

Green

:

Risk is acceptable

Risk ranking number = S x P

Risk threshold values decided up to 10 is green; between 10 to 15 is yellow; and above 15 is red , i.e. take actions.

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6

Seven Steps of Implementation of Audit Program 1. Audit Planning 2. Develop Checklists 3. Conduct Opening Meeting

4. Conduct Audit 5. Record Findings 6. Conduct Closing Meeting 7. Prepare Audit report

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7

Requirements to Establish ISO 13485 Quality Management System ISO 13485 Quality Management System for Medical devices has to be earned by real hard work and total transformation at all levels in an organization. The requirements for installing Quality Management System are :

1. Strong commitment of CEO

9. Customer focus, external and internal

2. Ability to allocate resources

10. Utilization of intellect of workers and supervisors



Manpower



Managerial time, including CEO’s



Finance for expert’s assistance

3. Good labor relations 4. Patience

11. Reduced supervision and promotion of self-inspection 12. Planned continuous improvement 13. Environment of trust and team work

6. Standardization of activities

14. Promoting use of risk-based thinking to determine risk and opportunities and plan actions

7. Decentralization of quality functions

15. Institutionalized audit.

5. Company’s quality policy

8. Training of personnel and building competence

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8

C131: DEMO OF ISO 13485:2016 INTERNAL AUDITOR TRAINING PPT PRESENTATION KIT Price 450 USD

Buy: www.globalmanagergroup.com Chapter- 4.0 BENEFITS OF USING OUR PRESENTATION KIT 1. By using these slides, you can save a lot of your precious time while preparing the ISO 13485:2016 internal auditor training course materials for in-house training programs.

2. To provide you with the presentation materials and hand-outs that you need for an effective presentation on ISO 13485:2016 internal auditor training, what it is, and what it requires.

3. Present the basics of ISO 13485:2016 internal auditor training to management or other groups. It also helps to create the internal team of auditors and provide them training.

4. It will save much cost in document preparation.

5. To deliver ISO 13485:2016 internal auditor training in a group, using a PowerPoint presentation.

6. Take care for all the section and sub sections of ISO 13485:2016 internal auditor training and give better understanding at all the levels during training implementation and sharpen the awareness of QMS training requirements for all employees within organization.

7. The entire kit is prepared by a globally proven team of leading ISO consultants.

Chapter- 5.0 METHOD OF ONLINE DELIVERY On completion of the secured purchase, we provide a username and password to download the product from our FTP server. We provide instant online delivery of the kit to the users by sending an e-mail of username and password.

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