ISO 13485 Training | ISO 13485 Internal Auditor Training in Gurgaon

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ISO 13485 Training

ISO 13485 Internal Auditor

Gurgaon

Attain in-depth knowledge of quality management system requirements under ISO 13485.
Understand the quality auditing that assures the medical devices conform to the commitment
Learn the roles and responsibilities of an internal auditor while managing the quality. &n

Dates & Prices Dates & Prices

Course information

ISO 13485 Internal Auditor Course Outline

Module 1: Introduction to ISO 13485:2016

Introduction
What is ISO 13485:2016?
Benefits of Implementing ISO 13485
Applications of ISO 13485
First Steps to ISO 13485:2016 Compliance
What is a Medical Device?
Purpose of a Quality Management System
Importance of ISO 13485
Basic Principles of ISO 13485
Exercise

Module 2: ISO 13485 Clauses 1 and 2

Clause 1 – Scope
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 2 - Normative References

Module 3: ISO 13485 Clauses 3 and 4

Clause 3 - Terms and Definitions
Clause 4 - Quality Management System
Clause 4.1 General Requirements
Clause 4.2 Document Requirements
Exercise

Module 4: Requirements and Quality Systems

Requirements and Quality Systems
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 7 - Product Realization
Clause 8 - Measurement, Analysis, and Improvement
Exercise

Module 5: Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation Requirements
Management Responsibility
Resources
Product Realization
Infrastructure
Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

Stages to Implementation
Gap Analysis
Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

Certification Audits
Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards

Module 9: Internal Auditing

Internal Auditing
Internal Audit Objectives
Auditing Skills
Steps in Internal Auditing
Planning, Preparation, and Management of Audits
Internal Audit – PDCA Cycle
Types of Audits
Audit Techniques
Exercise

Module 10: Internal Audit Plan

Audit Plan
Criteria

Module 11: Audit Process

Audit Process
Conducting Process Audits
Scope
Criteria
Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

Internal Audit Evidence and Findings
Classification
Closing Report
Nonconformities
Documented Procedure
Exercise

Module 13: Roles and Responsibilities

Internal Auditor Responsibilities
Closing Meetings

Module 14: Resource Management and Product Realization

Provision of Resources
Infrastructure
Planning and Development of Products

Who should attend this ISO 13485 Internal Auditor Course?

The ISO 13485 Internal Auditor Course in Gurgaon is a programme that allows professionals to conduct ISO 13485-based medical device Quality Management System (QMS) Internal Audits. This course can be beneficial for professionals, including:

Quality Managers
Engineers
Technicians
Regulatory Affairs Professionals
Manufacturing Managers
Compliance Officers
Medical Device Consultants

Prerequisites of the ISO 13485 Internal Auditor Course

There are no formal prerequisites for this ISO 13485 Internal Auditor Course.

ISO 13485 Internal Auditor Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organization must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It comprises an independent and systematic process audit to determine QMS's conformity or nonconformity.

This training session equips learners with the auditing techniques of quality management systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will get higher designations and expand their professional networks within a short period. Professionals in roles such as quality managers, regulatory affairs specialists, quality control officers, and individuals involved in internal quality audits in the medical device industry should aim to master the ISO 13485 Internal Auditor Training Course in Gurgaon.

In this 2-day ISO 13485 Internal Auditor Training course in Gurgaon, delegates will gain comprehensive knowledge of quality management systems and how to conduct internal auditing. During this training, delegates will learn about the management's responsibilities for making policy and financial decisions to support QMS. They will also learn how to plan a medical device and quality process audit and the documentation requirements.

Course Objectives:

To carry out activities in order to achieve audit objectives
To provide products and services to medical device organizations
To enhance the organizational ability and meet customer requirements
To identify the context of a company as well as internal and external issues
To create a culture of continual improvement and improve decision-making
To maintain records and implement quality processes within an organization

After attending this training in Gurgaon, delegates will be able to promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the quality management system and document each test during processing.

What’s included in this ISO 13485 Internal Auditor Course?

ISO 13485 Internal Auditor Examination
World-Class Training Sessions from Experienced Instructors
ISO 13485 Internal Auditor Certificate
Digital Delegate Pack

Why choose us

Our Gurgaon venue

Includes..

Free Wi-Fi

To make sure you’re always connected we offer completely free and easy to access wi-fi.

Air conditioned

To keep you comfortable during your course we offer a fully air conditioned environment.

Full IT support

IT support is on hand to sort out any unforseen issues that may arise.

Video equipment

This location has full video conferencing equipment.

Gurgaon is situated within Haryana in the National Capital Region. As the city is otherwise known by its historical name Guru Gram which means Village of the Guru, it is now home to more than 240 Fortune 500 companies. There is currently around 876,820 people living within Gurgaon, with the English language becoming more and more important within India, most of the schools within Gurgaon are now teaching instruction through Hindu and English. Schools with Gurgaon will be either public or private. Most of the schools are run by the Haryana Board of School Education, Central Board of Secondary Education and the Indian Certificate Secondary Education. English medium schools include the Delhi Public School, Morning Bell School and the Dronacharya Public School. Universities and colleges within Gurgaon include the Ansal Institute of Technology, National Brain Research Centre, KR Mangalam University, ITM University and the Amity University all of which are located within Gurgaon or are commutable to. Not all of the institutions are main campuses but branch or satellite campuses. Depending on the university or college which is chosen there is a range of different degrees such as GCE, A levels, O levels, undergraduate courses and graduate courses, within a number of different subject such as neuroscience, nursing, dental science, engineering, Business, law, technology, languages and many more.

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Unlock your potential with The Knowledge Academy's ISO 13485 Training | ISO 13485 Internal Auditor Training in Gurgaon, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Training | ISO 13485 Internal Auditor Training in Gurgaon. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 13485 Training | ISO 13485 Internal Auditor Training in Gurgaon sessions.

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Small class sizes

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What our customers are saying

The trainer was excellent. She was very knowledgeable, made the course content interesting (as it could have come across as death by PowerPoint) and very approachable,

Andrea Blowers

I would like to provide positive feedback regarding the Lead Audit Certification ISO training, specifically highlighting the exceptional skills and expertise of the trainer, John. The training program was truly enlightening and informative. John's ability to convey complex concepts in a clear and concise manner was commendable. He demonstrated a deep understanding of ISO standards and effectively guided us through the entire auditing process. John's patience and willingness to answer all our questions made the training experience even more valuable. His interactive teaching style kept us engaged throughout the sessions, making it easier for us to grasp the practical application of the ISO standards. Furthermore, John's extensive industry experience was apparent in the real-life examples and case studies he shared, adding relevance and context to the topics discussed. His ability to relate to our specific industry challenges was highly appreciated.

Misa Milosevic

Very interactive session

Vijaykumar Putchakayala

ISO 13485 Training | ISO 13485 Internal Auditor Training in Gurgaon FAQs

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The training fees for certification in Gurgaon starts from INR34995

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Resources are included for a comprehensive learning experience.

"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water

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ISO 13485 Training | ISO 13485 Internal Auditor Training in Gurgaon

Course information

ISO 13485 Internal Auditor Course Outline

Who should attend this ISO 13485 Internal Auditor Course?

Prerequisites of the ISO 13485 Internal Auditor Course

ISO 13485 Internal Auditor Course Overview

What’s included in this ISO 13485 Internal Auditor Course?