ISO 13485 Training | ISO 13485 Internal Auditor Training in Hong Kong

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ISO 13485 Training

ISO 13485 Internal Auditor

Hong Kong

Aquire knowledge of quality management system requirements in ISO 13485 Internal Auditor
Understand the quality auditing that assures the medical devices conform to the commitment
Acquire skills with our comprehensive ISO 13485 Internal Auditor Training

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 Realisation
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 Realisation
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 Audit
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 Realisation

Provision of Resources
Infrastructure
Planning and Development of Products

Who should attend this ISO 13485 Internal Auditor Course?

The ISO 13485 Internal Auditor Course 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 course.

ISO 13485 Internal Auditor Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation 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 includes an independent and systematic process audit to determine QMS's conformity or nonconformity.

This training session will provide delegates with auditing techniques for Quality Management Systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will quickly get higher designations and expand their professional networks. 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 this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of Quality Management Systems and how to conduct internal auditing. They will also learn about management's responsibilities for making policy and financial decisions to support QMS, how to plan a medical device, quality process audit, and documentation requirements.

Course Objectives

To carry out activities in order to achieve audit objectives
To provide products and services to medical device organisations
To enhance the organisational 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 organisation

After attending this training, delegates can 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 Hong Kong 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.

Hong Kong is an autonomous territory of the People’s Republic of China and can be located on the southern coast of China. Hong Kong has a population of around 7 million people. The education system in Hong Kong is mostly based around the English system and it is overseen by the Education Bureau and the Social Welfare Department. One of the earliest schools in Hong Kong was Li Ying College established in 1075. The education level begins with preschool education that is payable education, paid by pupil’s parents. The primary and secondary education is mandatory for every child in Hong Kong to attend from the age of 6 to 18. Higher education remains exclusive in Hong Kong and adult education is a growing sector in Hong Kong, with two non-profit school running evening courses. The University of Hong Kong was founded in 1911 and is the oldest tertiary (higher education) institution in Hong Kong and is organised into 10 academic faculties with English as the main language of instruction. The Education Bureau in Hong Kong also provides educational services for immigrant children from mainland China and other countries. Hong Kong also has 175 internal schools.

Address

62/F & 66/F
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99 Queens Road
Central
Hong Kong

T: +852 2592 5349

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Training | ISO 13485 Internal Auditor Training in Hong Kong. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

Learn more in our FAQs

Unlock your potential with The Knowledge Academy's ISO 13485 Training | ISO 13485 Internal Auditor Training in Hong Kong, 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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ISO 13485 Training | ISO 13485 Internal Auditor Training in Hong Kong FAQs

What is the ISO 13485 Internal Auditor Training?

ISO 13485 Internal Auditor Training equips delegates with skills to audit medical device quality management systems, ensuring compliance with ISO 13485 standards. It focuses on auditing techniques, process improvement, and regulatory requirements for the medical device industry.

Who should attend this course?

This course is ideal for Quality Managers, Internal Auditors, Regulatory Compliance Professionals, and anyone involved in implementing or auditing ISO 13485 systems within medical device organisations.

Are there any prerequisites for this course?

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

What is included in this ISO 13485 Internal Auditor Training?

In this training course, delegates will have intensive training with our experienced instructors, a digital delegate pack consisting of important notes related to this course, and a certificate after course completion, ensuring you gain practical experience and in-depth knowledge.

What is the duration of this course?

This course takes 2-day to complete during which delegates participate in intensive learning sessions that cover various course topics.

What are the benefits of this course?

Delegates gain expertise in auditing ISO 13485 systems, improve organisational compliance, enhance product quality, and boost career opportunities in the medical device industry.

Do you offer 24/7 support for the ISO 13485 Internal Auditor Training?

Yes, The Knowledge Academy offers 24/7 support via phone & email before attending, during, and after the course. Our customer support team is available to assist and promptly resolve any issues you may encounter.

Do you provide self-paced ISO 13485 Internal Auditor Course?

The Knowledge Academy provides flexible self-paced training for this course. Self-paced training is beneficial for individuals who have an independent learning style and wish to study at their own pace and convenience.

What is the scope of the ISO 13485 Internal Auditor Certification?

The certification validates your ability to conduct ISO 13485 audits, ensuring regulatory compliance and supporting global market access for medical devices.

Do you provide exam for this course?

No, there is no formal exam at the end of this course. However, delegates are assessed through practical exercises and activities throughout the training to ensure they understand and can apply the concepts effectively.

What are the topics covered in the ISO 13485 Internal Auditor Training?

Key topics include ISO 13485 requirements, audit planning, conducting and reporting audits, risk management, and process improvement in medical device quality systems.

What skills are gained from the ISO 13485 Internal Auditor Training Course?

Delegates develop skills in auditing techniques, non-conformance reporting, risk assessment, and ensuring compliance with ISO 13485 standards for medical device quality management systems.

What career opportunities can I avail myself from this ISO 13485 Internal Auditor Certification?

Completing the ISO 13485 Internal Auditor Certification can lead to roles such as Internal Auditor, Quality Assurance Specialist, Compliance Officer, and Regulatory Affairs Specialist in industries like medical devices, healthcare, and pharmaceuticals, ensuring adherence to quality management standards.

What will I learn in this ISO 13485 Internal Auditor Training Course?

You will learn to interpret ISO 13485 standards, plan and execute audits, identify risks, and recommend improvements to enhance quality management systems.

Will I receive a certification after completing this ISO 13485 Internal Auditor Training?

Yes, after completing this course you will receive a certificate of completion to validate your achievement and demonstrate your proficiency in the course material.

Why choose The Knowledge Academy in Hong Kong over others?

The Knowledge Academy in Hong Kong stands out as a prestigious training provider known for its extensive course offerings, expert instructors, adaptable learning formats, and industry recognition. It's a dependable option for those seeking this course.

What is the cost/training fees for ISO 13485 Internal Auditor in Hong Kong?

The training fees for ISO 13485 Internal Auditorin Hong Kong starts from HKD11995

Which is the best training institute/provider of ISO 13485 Internal Auditor in Hong Kong?

The Knowledge Academy is the Leading global training provider for ISO 13485 Internal Auditor.

What are the best ISO 13485 Training courses in Hong Kong?

Please see our ISO 13485 Training courses available in Hong Kong

Why choose us

Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.

Many delivery methods

Flexible delivery methods are available depending on your learning style.

High quality resources

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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