ISO 13485 Training | ISO 13485 Internal Auditor Training in San José

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ISO 13485 Training

ISO 13485 Internal Auditor

San José

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

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 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 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 San José 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.

San Jose is the capital of Costa Rica and the nation’s largest city. The population of San Jose is around 334,000 people and the urban and metro area combined houses around 3,500,000 people. The Universidad Cristiana Del Sur is a university in San Jose. The university was established in 1997 and offers courses taught in Spanish and English. The university offers students study in associate, bachelor and licentiate degrees. The university is accredited by the Costa Rica Ministry of Education and the Adult Council on Higher Education Private Universities to award Bachelor Awards. Another university in San Jose is the Universidad Hispanoamerica which is a private university which is dedicated to medical studies.

Address

San Jose Plaza Roble Las Terrazas
Centro Corporativo Plaza Roble,
Edificio 5,
San Jose,
Costa Rica

T: + 1-866 272 8822

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 San José. 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.

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Unlock your potential with The Knowledge Academy's ISO 13485 Training | ISO 13485 Internal Auditor Training in San José, 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 San José. 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 San José sessions.

Highly experienced trainers

Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience

State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible

Small class sizes

Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment

Great value for money

Achieve certification without breaking the bank. Find a lower price elsewhere? We'll match it to guarantee you the best value

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Streamline large-scale training requirements with The Knowledge Academy's In-house/Onsite at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

Tailored learning experience

Leverage benefits offered from a certification that fits your unique business or project needs

Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.

Team building opportunity

Our offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings

Monitor employees progress

The course know-how will help you track and evaluate your employees' progression and performance with relative ease

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What our customers are saying

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ISO 13485 Training | ISO 13485 Internal Auditor Training in San José FAQs

What is ISO 13485?

ISO 13485 defines the quality management system requirements for organisations that must demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements consistently.

Who should attend this course?

This course is intended for everyone who wants to enhance their knowledge of quality management systems for medical devices and auditing techniques to meet the ISO requirements.

What is the importance of a Quality Management System (QMS)?

A Quality Management System (QMS) is important for understanding and meeting objectives, collecting process performance outcomes, and improving processes based on objective assessment.

What is internal auditing?

Internal auditing is an impartial and independent assessment of the internal controls of an organisation in order to manage risk effectively across an organisation’s risk appetite.

What are the reasons for implementing ISO 13485 in a company?

ISO 13485 is essential for a company to improve its credibility, create a culture of continual improvement, improve decision-making, improve employee engagement, and improve customer satisfaction.

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

In this ISO 13485 Internal Auditor Training course, you will learn about how to conduct an audit, maintain continuous improvement, meets the standard requirements, Plan the sequence of interviews, and other essential topics.

What is the cost/training fees for ISO 13485 Internal Auditor in San José?

The training fees for ISO 13485 Internal Auditorin San José starts from $2295

Which is the best training institute/provider of ISO 13485 Internal Auditor in San José?

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

What are the best ISO 13485 Training courses in San José?

Please see our ISO 13485 Training courses available in San José

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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