ISO 13485 Training Courses and Workshops

Schools providing training courses, certificates, diplomas or degree programs of ISO 13485




Total 21 training courses and degree programs available around the world.

Quality System and ISO 13485 Regulations

Course Format: Online / Virtual Classroom / Webinar
School/Trainer: Colorado State University OnlinePlus
Training Center(s)/Venue(s): Fort Collins, United States
  V

Learn about the FDA’s Quality System Regulations (QSR) as they apply to the requirements and manufacturing quality of nationally and internationally commercialized products with a specific focus on the practice and implementation of a compliant Quality System. These principles are demonstrated using the US FDA Code of Federal Regulations (21 CFR) and International Standard Organization (ISO) documents. Topics include the areas as follows: the quality system requirements, design controls, document and purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product, corrective and preventative action, labeling and packaging controls, handing, storage, distribution, and installation, records, servicing, and statistical techniques. Documentation, record keeping, and how these issues affect medical device product quality and patient safety and the regulatory responsibilities therein will also be addressed. The FDA Quality System Inspectional Technique (QSIT) will also be covered to address the practical applicat... [Read More]

ISO 13485:2003 Internal Auditor

Course Format: Public Course / Instructor-Led / Open Enrollment
School/Trainer: Neville-Clarke (Singapore) Pte Ltd
Training Center(s)/Venue(s): Singapore, Singapore
  V

Objective
This training is designed to give delegates the knowledge and skills needed to undertake an unbiased and constructive Quality System audit in line with the Generic Guidelineslaid down in ISO 19011. Delegates will learn the skills and techniques of Audit and how to effectively communicate the findings so as to increase the effectiveness of Internal Quality Auditing.

Course Content
�An Overview of Internal Audit
- To understand the purpose of the quality audit process and to identify the different types of audit that can conducted
�The requirements of ISO 13485
- A brief overview of the ISO 13485 requirements
�Pre-audit Preparation
- To identify some of the aspects and reasons for preparing prior to conducting an audit
�Conducting the Audit
- To understand internal audit procedure and learn how to conduct effective audit and the dos and don’ts of auditing
�Reporting the Findings & Follow-up
- To understand how findings should be reported and categorized and to identify the process of corrective action and
... [Read More]

ISO 13485 Lead Auditor (Certificate)

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: AQS Management Systems, Inc.
Training Center(s)/Venue(s): Minneapolis, United States
  V

Day One
•Terminology and Definitions
•Background, History and Rationale for Quality Assurance
•Introduction to the ISO Family of Documents
•Analysis of the Contents of ISO 13485
•Audit of Active Medical (Audit #1)

Day Two
•Quality System Requirements
•Analyzing Findings
•Audit of Active Medical to ISO 13485 (Audit #2)
•RABQSA and U.S. Certification System
•Auditor Qualifications
•Roles and Responsibility of Auditors
•Creation of Effective Audit Checklists

Day Three
•Audit of Active Medical - Document Audits (Audit #3)
•Tips for the Professional Auditor
•Audit of Active Medical - Department Audit (Audit #4)
•Compiling Audit Findings
•Documentation in the Quality System
•Planning and Conducting Effective Audits
•Refining Interview and Note-Taking Skills
•Applicability of the Elements to Company Situations
•Prevention vs. Detection

Day Four
•Audit of Active Medical - Department and System Auditing (#5)
•Corrective Action Initiation and Closure
•Refining Audit Interview and Note-Taking ... [Read More]

ISO 13485 Internal Auditor (Certificate)

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: AQS Management Systems, Inc.
Training Center(s)/Venue(s): Minneapolis, United States
  V

Day One
•Terminology and Definitions
•Background, History and Rationale for Quality Assurance
•Introduction to the ISO Family of Documents
•Analysis of the Contents of ISO 13485
•Audit of the Active Medical (Audit #1)
•Quality System Requirements
•Analyzing Audit Findings
•RABQSA and U.S. Certification System
•Auditor Qualifications
•Roles and Responsibility of Auditors

Day Two
•Creation of Effective Audit Checklists
•Audit of Company Documents (Audit #2)
•Tips for the Internal Auditor
•Audit of Active Medical - Department Audit (Audit #3)
•Compiling Audit Findings
•Documentation in the Quality System
•Planning and Conducting Effective Audits
•Refining Interview and Note-Taking Skill
•Applicability of the Clauses to Company Situations

Day Three
•Audit of Active Medical - Dept and System Auditing (#4)
•Corrective Action Initiation and Closure
•Refining Audit Interview and Note-Taking Skills
•Creation of an Audit Report
•Preparation and Presentation of a Closing Meeting
•Review & EXAM

ISO 13485:2003 For Medical Devices

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Omnex Inc.
Training Center(s)/Venue(s): Ann Arbor, United States
  V

Seminar Goals

Explain the background and goals of ISO 13485:2003 and FDA GMP Compliance Goals for Medical Devices Discussion on Class 1, 2a, 2b and 3/4 medical devices and risk mitigation

Provide an understanding of ISO 13485:2003 requirements
Outline the steps for implementing or updating a quality management system to the ISO 13485:2003 requirements
Provide Best-in-Class quality management system concepts and approaches
Understanding of the US Federal Regulations (detailed) including Canadian, European, and Japanese (summary)

Seminar Outline

Overview of ISO 13485:2003 Family of Standards
ISO 13485:2003 Quality Management System
Explanation of ISO 13485:2003 Requirements
Management Responsibility
Resource Management
Product Realization, Design Control and Risk Mitigation Design Control Guidance - FDA 21 CFR 820.30 and subclause 4.4 of ISO 9001.

Measurement, Analysis and Improvement
US FDA QSR regulation and Good Manufacturing Practices (GMP).
Differences and Additions to ISO 13485
US Medical Devices Regul... [Read More]

ISO 13485:2003 For Medical Devices

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Omnex Canada
Training Center(s)/Venue(s): Aurora, Canada
  V

Seminar Goals

Explain the background and goals of ISO 13485:2003 and FDA GMP Compliance Goals for Medical Devices Discussion on Class 1, 2a, 2b and 3/4 medical devices and risk mitigation

Provide an understanding of ISO 13485:2003 requirements
Outline the steps for implementing or updating a quality management system to the ISO 13485:2003 requirements
Provide Best-in-Class quality management system concepts and approaches
Understanding of the US Federal Regulations (detailed) including Canadian, European, and Japanese (summary)

Seminar Outline

Overview of ISO 13485:2003 Family of Standards
ISO 13485:2003 Quality Management System
Explanation of ISO 13485:2003 Requirements
Management Responsibility
Resource Management
Product Realization, Design Control and Risk Mitigation Design Control Guidance - FDA 21 CFR 820.30 and subclause 4.4 of ISO 9001.

Measurement, Analysis and Improvement
US FDA QSR regulation and Good Manufacturing Practices (GMP).
Differences and Additions to ISO 13485
US Medical Devices Regul... [Read More]

Medical Device Management Systems and ISO 13485 / ISO 14971

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Quality Management International, Inc.
Training Center(s)/Venue(s): Atlanta, Charlotte, Columbus, Houston, Denver, Las Vegas, New York City, Philadelphia, Portland, United States
  V

When medical device nonconformities occur, peoples�lives are often at stake. Consequently, the medical device industry is one of the most heavily regulated, and product and process compliance is a primary objective for all quality management systems for medical devices.

The leading organizations in the medical device industry understand that developing a process-based management system is the best approach to ensuring compliance over time. By understanding their business processes in the context of a management system, these organizations ensure the critical process controls and resources are established sufficiently to ensure the organization complies naturally through its operation. They also ensure they have a key process for identifying and deploying regulatory requirements!

Internationally, ISO 13485 has been developed and agreed as the quality management system for organizations producing medical devices. ISO 14971 provides the requirements for the application of risk management to medical devices. However, these minimal requirements only establi... [Read More]

QMS Lead Auditor Using ISO 13485

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Quality Management International, Inc.
Training Center(s)/Venue(s): Atlanta, Charlotte, Columbus, Houston, Denver, Las Vegas, New York City, Philadelphia, Portland, United States
  V

You will learn how to:
•Interpret and apply the requirements of ISO 13485
•Apply ISO 14971:2007
•Use the QMS and ISO 13485 to ensure compliance to applicable regulations
•Implement regulatory issues with minimal impact upon operations
•Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
•Relate fiduciary concerns to the performance of the QMS
•Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
•Determine and communicate the resources necessary for the system to work as planned
•Communicate the roles and responsibilities within the QMS to the organization
•Conduct and lead 1st, 2nd and 3rd party audits, particularly on undocumented systems and audit for process effectiveness against measurable objectives
•Relate the capabilities of the organization to the expectations of customers, top management and shareholders
•Use the QMS to work proactively and not reactively
•Use the QMS to manage risk, validate software an... [Read More]

ISO 13485:2003 Internal Auditor Workshop

Course Format: Online / Virtual Classroom / Webinar
School/Trainer: American Society for Quality
Training Center(s)/Venue(s): Milwaukee, United States
  V

Learn to develop and implement an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485. This course will help you prepare for an audit and effectively manage your resources. You’ll understand how to close out an audit and conduct follow-up surveillances.

This training course satisfies the requirement for RABQSA’s QMS Internal Auditor Registration Scheme. Learn the necessary background to develop, implement, and audit an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485. This version of our RABQSA-certified QMS Internal Auditor course includes workshops tailored to meet the medical device industry and discussions of ISO 13485 medical devices�quality management systems requirements for regulatory purposes. Hands-on workshops reinforce the methods and techniques discussed. There is a one-hour exam on the last day.

Learning Objectives
Become familiar with the elements of a sound quality system.
Understand the audit evidence necessary to comply with ISO 13485 requirements.
Using ISO 19011 as... [Read More]

ISO 13485 Lead Auditor Workshop

Course Format: Online / Virtual Classroom / Webinar
School/Trainer: American Society for Quality
Training Center(s)/Venue(s): Milwaukee, United States
  V

Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field.

This training course is an RABQSA-certified course and meets the training requirements for certification of individual QMS auditors, QMS senior auditors, and QMS lead auditors. Successful completion satisfies the training requirements for individual auditor certification by accrediting bodies such as IRCA and RABQSA.

With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. You will discuss a range of topics including ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes, as well as ISO 9001:2000. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, l... [Read More]

ISO 13485 for Senior Management

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: SAI Global (USA)
Training Center(s)/Venue(s): Paramus, United States
  V

SAI Global’s 2-day course is the ideal learning opportunity toward understanding and successfully implementing ISO 13485:2003. The training provides the information and guidance needed to implement and/or understand ISO 13485 requirements. This intense analysis will guide companies toward reviewing current processes and systems, planning for change, and understanding the challenges and benefits of meeting/certifying to ISO 13485.
Who Should Attend?
General managers

Business unit managers

Quality and regulatory professionals

Management representatives

Internal and external auditors

Those who wish to get an understanding of the requirements and how to make them add value to your company

Consultants needing in-depth understanding of the requirements
Key Session Topics
Review of the ISO 13485 requirements

Direct comparison of ISO 13485 to the FDA GMPs/QSR and ISO 9001 standard

How to effectively implement ISO 13485

Regulators’ approach to the ISO 13485 requirements

Risk management (ISO ... [Read More]

ISO 13485/ISO 9001 - FDA Regulated Industries - Internal Auditor Workshop

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: SAI Global (USA)
Training Center(s)/Venue(s): Paramus, United States
  V

This course provides the information and skills needed to effectively perform a comprehensive quality system audit that complies with ISO 13485:2003, ISO 9001:2008 and regulatory requirements. Using interactive workshops, simulated audits, tutorials and case studies, you will develop practical audit skills, improve your evaluation and communication skills, refine your reporting skills and increase your ability to implement corrective action programs.

This course includes ISO 13485:2003 as well as all of the ISO 9001 information from SAI Global’s standard internal auditor course, with the additional benefit of showing how the audit process fits with regulatory issues related to FDA-regulated industries (food, drug, cosmetic, medical device, healthcare, and their suppliers).

Through lectures, practical and interactive workshops and simulated audits, attendees will practice and refine auditing techniques.
Who Should Attend?
Internal auditors

Quality professionals

Management representatives

RA/QA managers/engineers

R&D manage... [Read More]

ISO 13485:2003 & The Medical Devices Directives Workshop

Course Format: Public Course / Instructor-Led / Open Enrollment
School/Trainer: SQT Training Ltd.
Training Center(s)/Venue(s): Limerick, Ireland
  V

ISO 13485:2003 is the European Harmonised Standard used by medical device manufacturers. Notified Bodies will use this standard when assessing whether companies have a QMS, which meets European Directive requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark.

This means that companies must be conversant with:

ISO 13485:2003
The significant aspects of the directives
The documentation requirements of ISO 13485:2003 & the directives
The role of relevant guidance standards

This course will enable CE marking to be obtained more quickly and efficiently.

COURSE OBJECTIVES

On completing this course the participant will:

Appreciate the main elements of ISO 13485:2003
Look at the main requirements of the medical devices Directives �90/385/EEC, 93/42/EEC & 98/79/EC
Understand the additional FDA QSR requirements
Be able to classify devices according to the MDD �93/42/EEC
Be aware of the Guidance documents available
Understand the requirements for post marketing surveillance

... [Read More]

IRCA Certified ISO 9001 & ISO 13485 Lead Auditor

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Kelmac Group Limited
Training Center(s)/Venue(s): Dublin, Cork, Limerick, Waterford, Galway, Ireland
  V

This course is registered by the Governing Board of the CQI - International Register of Certified Auditors (IRCA) and meets part of the requirements of those seeking registration as a QMS Auditor/Lead Auditor under that scheme (IRCA/2245)

Who should attend?
Management representatives
Quality directors
Managers, engineers, and consultants
Auditors of medical device manufacturing firms (internal and external)

Benefits to Your Business
The knowledge and skills to effectively audit your management system
To conduct a risk assessment of the effectiveness and maturity of your management system
The ability to conduct second party and third party audits of your supply chain.

ISO 13485:2003 Implementation (Certificate)

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Kelmac Group Limited
Training Center(s)/Venue(s): Dublin, Cork, Limerick, Waterford, Galway, Ireland
  V

This course has been designed by leading experts to provide high quality training to professionals seeking to effectively implement a Medical Devices Quality Management System based on ISO 13485:2003.

Who should attend?
Quality Managers
Quality Control Professionals
Healthcare Consultants
Medical Device Consultants
Enforcement Officers
Regulatory Personnel
Certification Bodies/Registrars
Implementation Team Members
Professionals in the Medical Device Industry & Supply Chain

Benefits to Your Business
Do you want to design and implementing a Management System with minimal external assistance and at the lowest cost?
Do you want to achieve registration at the first attempt?
Do you want free access to winning documentation templates?
Do you want to gain top management and employee buy-in?
Do you want to want to select quality Certification Bodies/Registrars?
Do you want to keep maintenance costs to a minimum?

ISO 13485:2003 Internal QMS Auditor (Certificate)

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Kelmac Group Limited
Training Center(s)/Venue(s): Dublin, Cork, Limerick, Waterford, Galway, Ireland
  V

This course has been designed by leading experts to provide high quality training to professionals seeking to effectively audit a Medical Devices Quality Management System based on ISO 13485:2003.

Who should attend?
Quality managers
RA managers
Auditors of medical device manufacturing firms (internal and external)
Cross functional team members implementing the standard

Benefits to Your Business
The knowledge and skills to effectively internally audit your management system
To conduct a risk assessment of the effectiveness and maturity of your management system

ISO 13485:2003 Understanding (Certificate)

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: Kelmac Group Limited
Training Center(s)/Venue(s): Dublin, Cork, Limerick, Waterford, Galway, Ireland
  V

This course has been designed by leading experts to provide high quality training to professionals seeking to effectively understand a Medical Devices Quality Management System based on ISO 13485:2003.

Who should attend?
Quality managers
RA managers
Auditors of medical device manufacturing firms (internal and external)
Those individuals working in an ISO 13485 complaint environment or in the Medical Devices Industry
Cross functional team members implementing the standard

Benefits to Your Business
The knowledge and skills to effectively understand your management system and legislation applicable.

Understanding an ISO 13485 Quality Management System

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: STAT-A-MATRIX
Training Center(s)/Venue(s): Edison, United States
  V

Get the information you need to understand the ISO 13485:2003 and ISO 9001 standards and how they impact your organization. Dynamic group discussions focus on when compliance or registration is required or desirable, how to document and design an effective quality management system, what the revised requirements mean for the worldwide medical device industry, and what auditors are looking for and finding. Also covered are the steps and potential benefits of registration, such as increased productivity, cost effectiveness, higher perceived quality, enhanced internal and external communication, and competitive advantage.

For a complete week of FDA regulatory training, combine this two-day interactive program with our Understanding FDA’s Medical Device Quality System Regulation (2 days), FDA Quality System Inspectional Techniques (QSIT) (1 day), .

ISO 13485 Training Objectives

Understand and describe the purpose, benefits and objectives of ISO 13485:2003.
Explain the similarities and differences between ISO 9001 and ISO 13485:2003.
Discuss th... [Read More]

Internal Auditor Training for ISO 13485 Workshop

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: STAT-A-MATRIX
Training Center(s)/Venue(s): Edison, United States
  V

Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485:2003 and ISO 9001:2008. Get your training from the industry leaders-STAT-A-MATRIX has been training auditors longer than any other training organization in the world. This version of our RABQSA-certified internal auditor course includes workshops tailored to the changing medical device industry and discussions of ISO 9001:2000 and ISO 13485:2003.

Objectives

Understand how to prepare, conduct, and follow-up on internal audits for ISO 9001:2000 and ISO 13485:2003.

Introduction to Internal Quality Systems Assessment-An introduction to the elements comprising a quality system, interpretation of the requirements of ISO 9001:2000 and ISO 13485:2003, and a discussion of what third-party assessment agencies look for.
The Three Audit Phases-Planning, execution, and follow-up are examined closely using concepts detailed in ISO 19011.
Planning and Auditing-How to prepare for an audit and manage your resources eff... [Read More]

Auditor/Lead Auditor Training for ISO 13485 Workshop

Course Format: On-Site / In-House / Private Tutoring
School/Trainer: STAT-A-MATRIX
Training Center(s)/Venue(s): Edison, United States
  V

Learn how to assess compliance with ISO 9001 and ISO 13485:2003 from the industry experts. Based on our ISO 9001 RABQSA-certified QMS lead auditor training course, this interactive course covers the ISO 13485:2003 and ISO 9001 requirements for quality management systems.

Get your lead auditor training from the seminar experts-STAT-A-MATRIX has been training lead auditors longer than any other training organization.

Objectives

During five rigorous days, you will cover background of the ISO 9000 and ISO 13485 standards, and go through every phase of the audit-from planning to conduct to follow-up so you will be able to lead your own audits efficiently and effectively.
QA System Assessment-A proactive approach to quality assurance in the medical device industry. Covers elements that comprise a total quality system, including policy, manual, procedures, and instructions.
Understanding the Requirements-Discuss the requirements of ISO 9001, as well as those of ISO 13485:2003 and their relationship to ISO 9001; includes discussion of applicable indu... [Read More]

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