13485 ISO Training Services

ISO 13485 INTERNAL AUDITOR & LEAD AUDITOR TRAINING

Quality systems are essential for the manufacture of medical devices and to ensure patient safety. To help your company keep up with regulations, APEX provides ISO 13485 Internal Auditor and ISO 13485 Lead Auditor training– a global standard that defines quality management requirements within this industry. ISO 13485 training certification ensures your business meets certain legal and quality management system standards that allow you to become more competitive in the medical device industry and improve your internal processes.

This course is offered in cooperation with DEKRA SERVICES, an Exemplar Global Certified Provider or PROBITAS Authentication Certified course provider.

With relevant insight tailored towards understanding and applying these important standards, APEX Consulting ISO 13485 training allows you to create a dependable framework of proven quality system practices that guarantee superior operating efficiency throughout any organization involved with medical devices.

We offer the following three ISO 13485 certification training courses (Virtual Courses Central Time US):

  • ISO 13485:2016 Foundations Training
  • ISO 13485:2016 Internal Auditor Training
  • ISO 13485:2016 Lead Auditor Training

WHICH ISO 13485 TRAINING COURSE IS RIGHT FOR ME?

ISO 13485 LEAD AUDITOR
ISO 13485 INTERNAL AUDITOR
ISO 13485 FOUNDATIONS
Content
ISO 13485 Lead Auditor training course objectives are geared toward those who are planning to manage audit teams and lead an audit program
ISO 13485 Internal Auditor training course objectives are geared toward those who are planning on scheduling internal audit programs for medical devices
ISO 13485 Foundations training course objectives are geared toward those who are seeking an introduction to medical devices
Work Sessions
18 Activities
16 Activities
12 Activities
Timed Exam
1.5 hours
2 hours
2 hours
Participant Criteria
Participation
Verbal Communication
Written Reports
Achieve Objectives for Course

Content

Course objectives geared towards those who are planning to manage audit teams and lead an audit program

Work Sessions

18 Activities

Timed Exam

1.5 hours

Participant Criteria

Participation

Verbal Communication

Written Reports

Achieve Objectives for Course

Content

Course objectives geared towards those who are planning on scheduling internal audit programs for quality medical devices

Work Sessions

16 Activities

Timed Exam

2 hours

Participant Criteria

Participation

Verbal Communication

Written Reports

Achieve Objectives for Course

Content

Course objectives geared towards those who are seeking an introduction to medical devices 

Work Sessions

12 Activities

Timed Exam

2 hours

Participant Criteria

Participation

Verbal Communication

Written Reports

Achieve Objectives for Course

Establish a working knowledge of regulatory requirements needed to develop and produce medical devices

Gain an in-depth understanding of the ISO 13485:2016 Medical Device Quality Management System standard when you enroll in this instructor-led course. Designed for anyone seeking to learn about quality management requirements for designing, developing, and producing medical devices, this ISO 13485 course distills essential information about the medical device quality management system.

We offer both in-person and virtual learning options, and the two-day ISO 13485 training class concludes with a written competency exam.

Course Details

Length: 2 days
Hours: 8:00 am-6:00 pm (Virtual Courses Cental Time US)
CTUs: 1.6
Competency Unit: MD
Audience: Anyone seeking to understand the requirements of an ISO 13485 Medical Device QMS, including quality assurance professionals, ISO project managers, compliance managers, and regulatory personnel

Online Sessions 💻 – $1245
In-Person Sessions 👨‍🏫 – $1345

Highlighted Topics

Major requirements of the ISO 13485:2016 standard

Types of evidence needed to demonstrate conformity to ISO 13485:2016

Relevant terminology for medical device quality management systems

The relationship between ISO 13485 and applicable regulatory requirements

Learning Objectives

Describe the ISO 13485:2016 QMS standard and its development

Identify medical device QMS terms

Describe the intent and requirements of ISO 13485

Determine the evidence needed to demonstrate conformity to ISO 13485

Apply the process approach and Plan-Do-Check-Act (PDCA) methodology

Describe the relationship between ISO 13485:2016 and applicable regulatory requirements

Prerequisites
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management – Requirements For Regulatory Purposes. Copies will not be provided for you.
Course Format
This is a two-day, instructor-led course available online or in-person. The course will cover ISO 13485:2016 as a standard, with a corresponding competency exam (MD).
This DEKRA SERVICES Exemplar Global Certified/ PROBITAS Authentication Certified course is presented in association with APEX Consulting Group LLC
Certified by Exemplar Global

Learn to plan and schedule an internal audit program for medical device quality management systems

Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).

Course Details

Length: 3 days (M-W)
Hours: 8:00am-6:00pm (Virtual Courses Cental Time US)
CTUs: 2.4
Competency Units: MD, AU
Audience: Anyone responsible for planning and scheduling an internal audit program for ISO 13485:2016, including quality assurance managers, ISO project managers, ISO project team members, compliance managers, and regulatory personnel

Online Sessions 💻 – $1595
In-Person Sessions 👨‍🏫 – $1695

Highlighted Topics

Requirements of the ISO 13485:2016 standard

Terminology for medical device quality management systems

Principles, processes, and methods of auditing

The Plan-Do-Check-Act (PDCA) methodology

Learning Objectives

Fully understand and successfully interpret the ISO 13485 requirements

Identify medical device QMS terms

Understand how to audit using the process approach

Ask audit questions that get results

Describe the relationship between ISO 13485:2016 and applicable regulatory requirements

Prerequisites
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management System – Requirements For Regulatory Purposes. Copies will not be provided for you.
Course Format
This is a three-day, instructor-led course available online or in-person. There are written tests on each of the competency units on days 2 and 3. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.
This DEKRA SERVICES Exemplar Global Certified/ PROBITAS Authentication Certified course is presented in association with APEX Consulting Group LLC
Certified by Exemplar Global

Learn how to lead an audit program for medical device quality management systems

Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops.

Participants will learn how to lead the audit process and to complete reporting. Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification.

Course Details

Length: 4 days (M-Th)
Hours: 8:00am-6:00pm (Virtual Courses Cental Time US)
CTUs: 3.6
Competency Units: QM, AU, TL
Audience: Anyone responsible for leading an audit program for ISO 13485, including quality assurance managers, quality assurance professionals, ISO project managers, ISO project team members, compliance managers, or regulatory personnel

Online Sessions 💻 – $2195
In-Person Sessions 👨‍🏫 – $2395

Highlighted Topics

Requirements of ISO 13485, ISO 9001, and 21 CFR 820

How to apply the standards in the medical device sector

Methods for planning and conducting an audit

Audit skills and behaviors necessary for an effective, efficient management system audit

Learning Objectives

Fully understand and interpret the requirements of ISO 13485

Understand 21 CFR 820 requirements and be able to compare these to ISO 13485 requirements

Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements

Understand how to apply ISO 9001 and ISO 13485 standards during in-class practical audit exercises

Understand terminology of ISO 9001 and ISO 13485 and application in a medical device environment

Develop an ISO 9001/ISO 13485 auditing system based on the ISO 19011 auditing requirements

Learn how to ask audit questions that get results and to construct effective audit checklists

Learn how to conduct opening and closing meetings that have impact

Learn how to generate effective corrective actions

Prerequisites
All attendees are required to bring their own copy of the ISO 13485:2016 Quality Management Systems – Requirements for Regulatory Purposes. Copies will not be provided for you.
Course Format
This is a four-day, instructor-led course. There are written tests on each of the competency units on days 2, 3, and 4. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
This DEKRA SERVICES Exemplar Global Certified/ PROBITAS Authentication Certified course is presented in association with APEX Consulting Group LLC

Ready to Obtain your ISO 13485 Certification?

If you are ready to take the next step towards becoming ISO 13485 certified, we offer both internal auditor and lead auditor training courses that will prepare you for real-life auditing situations. Our courses cover all necessary topics and provide hands-on workshops and competency exams to ensure your understanding and competency.

Our instructors are experienced in the medical device industry, providing valuable insights and practical tips for successful audits. Additionally, our courses are available both online and in-person, making it convenient for individuals or companies to obtain their certification.

Don’t hesitate any longer – register now for one of our upcoming ISO 13485 training courses and become a certified auditor in the medical device sector!  We look forward to helping you on your journey towards ISO 13485 certification.

ADDITIONAL RESOURCES

In addition to our ISO 13485 training courses, we also offer consulting services to help companies achieve and maintain their ISO 13485 certification. Our team of experts can assist with gap analysis, documentation review, and implementation of quality management systems tailored to your organization’s specific needs.

We also offer customized on-site training for companies that prefer a more personalized approach. This allows you to train multiple employees at once and address any specific concerns or challenges within your organization.

We provide ongoing support and updates to ensure that your company remains compliant with the latest industry standards and regulations. With our comprehensive resources and expertise in the medical device sector, we are confident in our ability to help you achieve success in obtaining and maintaining your ISO 13485 certification.

FREQUENTLY ASKED QUESTIONS ABOUT ISO 13485 TRAINING

The ISO 13485 certification applies specifically to medical, which includes organizations that produce and manufacture medical devices.
Yes, our ISO 13485 Lead Auditor and Internal Auditor training package includes the certification exam.
The medical device industry is highly regulated and must meet a certain standard of quality for the devices to be used in the medical industry.

Testimonials

The level of knowledge, including experience, of the instructor was excellent!
Course Participant
The instructor was really good at helping and answering all questions.
Course Participant
The class was great. instruction was perfect. It was very challenging.
Course Participant

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