ISO 13485 Training
Unlock your potential with the ISO 13485:2016 Medical Devices Quality Management System (QMS) Lead Auditor Training by BGMC, a globally recognized program that equips professionals with the knowledge and skills to assess, audit, and strengthen quality management systems for medical devices, ensure regulatory compliance, manage risks throughout the product lifecycle, and drive continual improvement across medical device organizations.
ISO 13485 Training
ISO 13485 Foundation
Duration
Online Instructor-led (2 days)
Online Self-paced (16 hours)
exam
ISO 17025 Internal Auditor Exam
ISO 13485 Foundation 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 2 – Normative References
Read MoreLess
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
Who should aattend this ISO 13485 Foundation Course?
The ISO 13485 Foundation Course is designed to provide a fundamental understanding of the ISO 13485 standard, which pertains to Quality Management Systems for medical device manufacturers and suppliers. It benefits a wide range of professionals from this course, including:
- Quality Managers
- Regulatory Affairs Professionals
- Product Managers
- Compliance Officers
- Manufacturing Managers
- Quality Assurance Professionals
- Consultants
- Internal Auditors
- Healthcare Professionals
Prerequisites of the ISO 13485 Foundation Course
There are no formal prerequisites for this ISO 13485 Foundation Course.
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ISO 13485 Foundation Course Overview
ISO 13485 sets the standards for Quality Management Systems that are crucial for organisations supplying medical devices and related services. It ensures compliance with customer and regulatory requirements, making it an essential framework for the medical device industry. This ISO 13485 Foundation Course offers a comprehensive introduction to the vital topic of ISO 13485 and its relevance in the healthcare industry.
Understanding ISO 13485 is of paramount importance for professionals in various roles. Quality Managers, Regulatory Affairs Specialists, Auditors, Manufacturing Supervisors, and individuals involved in the designing, producing, or distributing of medical devices should aim to master ISO 13485. This knowledge empowers them to ensure product quality, safety, and compliance, leading to career advancement and opportunities in the industry.
The Knowledge Academy provides 1-day ISO 13485 Foundation Training that equips delegates with essential knowledge. It covers the requirements of medical devices, the phases of implementation, and the intricacies of conducting an ISO certification audit. Delegates will gain the skills to navigate the complex medical device quality management landscape.
Course Objectives
- To evaluate the expectations and requirements of the customers
- To raise the quality of medical devices manufactured in a company
- To enhance the organisational ability and meet customer requirements
- To promote harmonisation of regulatory requirements for manufacturers
- To improve the credibility and image of a company to represent compliance
Upon completing this course, delegates will benefit from a deep understanding of ISO 13485, enhancing their competence in quality management and compliance within the medical device industry. This knowledge will open doors to career progression and a more substantial contribution to the sector’s growth and safety.
What’s included in this ISO 13485 Foundation Course?
- ISO 13485 Foundation Examination
- World-Class Training Sessions from Experienced Instructors
- ISO 13485 Foundation Certificate
- Digital Delegate Pack
ISO 13485 Foundation Exam Information
To achieve the ISO 13485 Foundation, candidates will need to sit for an examination. The exam format is as follows:Â
- Question Type: Multiple Choice Â
- Total Questions:Â 30Â
- Total Marks:Â 30 MarksÂ
- Pass Mark:Â 50%, or 15/30 MarksÂ
- Duration:Â 40 Minutes Â
- Open Book/ Closed Book:Â Closed Bo
ISO 13485 Lead Implementer
Duration
Online Instructor-led (2 days)
Online Self-paced (16 hours)
exam
ISO 17025 Internal Auditor Exam
ISO 13485 Lead Implementer​ Training ​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 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
Read MoreLess
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
Module 15: ISO 13485 and Quality Management Systems
- ISO 13485
- Quality Management Systems (QMS)
- Exercise
Module 16: Principles of Quality Management System
- Principles of QMS
- Exercise
Module 17: Fundamentals of Quality Management Systems
- Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
- Measurement, Analysis, and Improvement
- General Requirements
- Monitoring and Measurement
- Control of Nonconforming Product
- Performance of QMS
- Analysis of Data
- Improvement
- Corrective Action
- Preventive Action
- Identification of Improvement Opportunities
Module 19: Risk Management
- Risk Management
- Risk Management Principle
- Risk Management Process
- Risk Lifecycle
- Risk Management Tools
- Risk Management Culture
- Assessments and Control of Risk Management
- Exercise
Who should attend this ISO 13485 Lead Implementer Course?
The ISO 13485 Lead Implementer Course gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course:
- Quality Managers
- Regulatory Affairs Professionals
- Product Managers
- Compliance Officers
- Manufacturing Managers
- Quality Assurance Professionals
- Internal Auditors
Prerequisites of the ISO 13485 Lead Implementer Course
There are no formal prerequisites for this ISO 13485 Lead Implementer. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates.
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ISO 13485 Lead Implementer Training Course Overview
ISO 13485 Lead Implementer Training is a course that introduces delegates to managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes Quality Management System requirements for medical device organisations. Understanding its relevance is crucial to ensuring that organisations consistently meet customer and regulatory requirements in the medical device field.
Mastering ISO 13485 is essential for anyone responsible for implementing and managing Quality Management Systems in the medical device industry. It provides a valuable credential for individuals dedicated to quality assurance and regulatory compliance, opening opportunities for high-profile jobs and enhanced earnings. Its importance lies in improving an organisation’s overall performance and mitigating risks associated with medical devices.
The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the knowledge and skills to effectively implement a Quality Management System for medical devices. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain and evaluate audit evidence objectively. They will also learn how to control nonconforming products identified during the inspection process.
Course Objectives
- To evaluate the expectations and requirements of the customers
- To improve the quality of medical devices manufactured by a company
- To promote harmonisation of regulatory requirements for manufacturers
- To enhance the credibility and image of a company to represent compliance
- To engage management actively and undertake management system activities
- To design and develop consultancy for a respiratory inhaler manufacturer
At the end of this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to analyse the data and implement identified opportunities for improvement.
What’s included in this ISO 13485 Lead Implementer Course?
- ISO 13485 Lead Implementer Examination
- World-Class Training Sessions from Experienced Instructors
- ISO 13485 Lead Implementer Certificate
- Digital Delegate Pack
ISO 13485 Lead Implementer Exam Information
To achieve the ISO 13485 Lead Implementer, candidates will need to sit for an examination. The exam format is as follows:Â
- Question Type: Multiple Choice Â
- Total Questions:Â 30Â
- Total Marks:Â 30 MarksÂ
- Pass Mark:Â 50%, or 15/30 MarksÂ
- Duration:Â 40 Minutes Â
- Open Book/ Closed Book:Â Closed Book
ISO 13485 Internal Auditor
Duration
Online Instructor-led (2 days)
Online Self-paced (16 hours)
exam
ISO 17025 Internal Auditor Exam
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 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
Read MoreLess
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.
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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
ISO 13485 Lead Auditor
Duration
Online Instructor-led (2 days)
Online Self-paced (16 hours)
exam
ISO 17025 Internal Auditor Exam
ISO 13485 Lead Auditor Training 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 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
Read MoreLess
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
Module 15: ISO 13485 and Quality Management Systems
- ISO 13485
- Quality Management Systems (QMS)
- Exercise
Module 16: Principles of Quality Management System
- Principles of QMS
- Exercise
Module 17: Fundamentals of Quality Management Systems
- Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
- Measurement, Analysis, and Improvement
- General Requirements
- Monitoring and Measurement
- Control of Nonconforming Product
- Performance of QMS
- Analysis of Data
- Improvement
- Corrective Action
- Preventive Action
- Identification of Improvement Opportunities
Module 19: Risk Management
- Risk Management
- Risk Management Principle
- Risk Management Process
- Risk Lifecycle
- Risk Management Tools
- Risk Management Culture
- Assessments and Control of Risk Management
- Exercise
Module 20: Key Terms and Definitions of Lead Auditor
- Key Terms Definitions
Module 21: Lead Auditor Responsibilities
- Lead Auditor Responsibilities
- Auditing Organisation
- Auditees
Module 22: Team Leader Skills
- Team Leader Skills
- Exercise
Module 23: Structure and Intent of ISO 13485
- Structure and Intent
- Clause 5 – Management Responsibility
- Clause 6 – Resource Management
- Clause 7 – Product Realisation
- Clause 8 – Measurement, Analysis, and Improvement
Module 24: Medical Devices, Quality, and Auditing Terminology
- Medical Devices
- Quality Management System
- Auditing Terminology
- Exercise
- Module 25: Processes, Procedures, and Records
- Processes
- Procedure
- Records
Module 26: Checklist Development
- Purpose
- Completed Checklist Provides
- Process Based Audits
- Checklist
- Process Checklist
Module 27: Planning, Preparation, and Management of Audits
- Planning
- Preparation
- Management of Audits
- Exercise
Module 28: Interviewing Skills
- Key Interviewing Skills
- Star Technique
Module 29: Corrective Action and Verification
- Overview
- Corrective Action
- Documented Procedure
- Process
Module 30: Preventative Action
- Preventive Action: Process
- Exercise and Questions
Who should attend this ISO 13485 Lead Auditor Course?
The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:
- Lead Auditors
- Quality Control Managers
- Regulatory Affairs Managers
- Compliance Officers
- Manufacturing Managers
- Quality Assurance Professionals
- Internal Auditors
Prerequisites of the ISO 13485 Lead Auditor Course
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of Quality Management Systems, auditing techniques, regulatory requirements, and practical experience in medical device manufacturing would significantly benefit the delegates.
Read MoreLess
ISO 13485 Lead Auditor Training Course Overview
ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations must consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required to implement a Quality Management System for medical devices and conduct audits to ensure organisational performance. Acquiring knowledge from this training benefits organisations by streamlining processes and lowering operational challenges. Delegates pursuing this training can improve their expertise and capabilities, opening new career opportunities and potential income growth. Professionals responsible for Quality Management Systems will find mastering ISO 13485 Lead Auditor Training highly advantageous.
The Knowledge Academy provides a 5-day ISO 13485 Lead Auditor Training Course that offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning to map identified risks and monitor continuous improvement.
Course Objectives
- To improve the quality of medical devices manufactured by a company
- To promote harmonisation of regulatory requirements for manufacturers
- To provide access and evidence in accordance with regulatory requirements
- To engage management actively and undertake management system activities
- To protect the confidentiality of all documents and information obtained in the audit
- To obtain quality objectives from the manufacturer and pass them to the organisation
After completing this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities.
What’s included in this ISO 13485 Lead Auditor Course?
- ISO 13485 Lead Auditor Examination
- World-Class Training Sessions from Experienced Instructors
- ISO 13485 Lead Auditor Certificate
- Digital Delegate Pack
ISO 13485 Lead Auditor Exam Information
To achieve the ISO 13485 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows:Â
- Question Type:Â Multiple ChoiceÂ
- Total Questions:Â 30Â
- Total Marks:Â 30 MarksÂ
- Pass Mark:Â 50%, or 15/30 MarksÂ
- Duration:Â 40 Minutes Â
- Open Book/ Closed Book:Â Closed Book
Maximize Your Investment with ISO 13485 Medical Devices Quality Management Training Bundles
Our training experts have curated a comprehensive range of ISO 13485 Medical Devices Quality Management System (QMS) course bundles designed to strengthen your professional competence and enhance product quality, regulatory compliance, and risk management across medical device organizations.
PHYSICAL CLASSES
- Instructor-led ISO 50001 training
- EnMS clause requirements
- Energy audit case workshops
- Lead Auditor certification support
Online Classes
- Live virtual EnMS sessions
- Interactive audit discussions
- Digital learning materials
- Digital certificate support
Enterprise Solutions
Contact For Price
- Organization-wide EnMS programs
- Customized ISO 50001 training
- Learning progress tracking
- Cost-effective enterprise solutions
E-LEARNING
- Self-paced ISO 50001 learning
- Full course access
- Practical audit exercises
- Certificate upon completion
PHYSICAL CLASSES
- Instructor-led ISO 50001 training
- EnMS clause requirements
- Energy audit case workshops
- Lead Auditor certification support
Online Classes
- Live virtual EnMS sessions
- Interactive audit discussions
- Digital learning materials
- Digital certificate support
E-learning
- Self-paced ISO 50001 learning
- Full course access
- Practical audit exercises
- Certificate upon completion
Enterprise Solutions
Contact For Price
- Organization-wide EnMS programs
- Customized ISO 50001 training
- Learning progress tracking
- Cost-effective enterprise solutions
Not Sure Which Course is Right for You?
Speak to a training expert for advice if you are unsure of what course is right for you. Give us a call onÂ
Why Choose BGMC ISO 13485 Medical Devices Quality Management System – Refresher Training
Globally Recognized:
BGMC’s ISO 13485 Refresher Training aligns with internationally accepted medical device quality management and regulatory standards, ensuring your knowledge remains current and compliant with global medical device regulatory requirements.
Comprehensive Learning:
Covers the latest updates to ISO 13485:2016, including quality management system requirements for medical devices, risk management throughout the product lifecycle, design and development controls, supplier management, validation and verification, post-market activities, and continual improvement.
Career Boost:
Enhance your professional credibility in medical device quality and regulatory compliance with refreshed certification, supporting your role as a quality auditor, lead implementer, quality manager, regulatory affairs professional, or medical device QMS specialist.
Hands-On Application:
Apply real-world medical device quality principles through updated case studies, risk management exercises, design control scenarios, internal audit simulations, nonconformity handling, CAPA implementation, and regulatory compliance practices.
Progression Path:
A strong foundation for advancing into specialized roles such as ISO 13485 Lead Auditor, Lead Implementer, Medical Device Quality Manager, Regulatory Affairs Manager, or Integrated Management System (IMS) Expert.
ISO 13485 Training FAQs
What does ISO 13485 mean, and why is it important?
ISO 13485 is an international standard for quality management systems in medical devices. It ensures organisations meet regulatory requirements, provide safe and effective products, enhance customer trust, and improve overall operational efficiency.
Is ISO 13485 only for medical devices?
While primarily focused on medical devices, ISO 13485 applies to any organisation involved in designing, producing, or supplying healthcare-related products, ensuring quality and compliance with regulatory requirements in the medical field.
What is the difference between ISO 13485 and GMP?
ISO 13485 is a standard for quality management systems, whereas GMP (Good Manufacturing Practice) focuses on manufacturing processes. ISO 13485 ensures compliance, while GMP emphasises consistent product quality and safety.
What is the difficulty level for these ISO 13485 Courses?
The course is designed to be accessible to all levels, making it suitable for both beginners and experienced professionals. It covers foundational concepts while offering in-depth insights into personal and organisational growth strategies.
What are the benefits of this ISO 13485 Training?
ISO 13485 Training ensures improved compliance with global regulations, enhances organisational efficiency, reduces risks, and boosts professional credentials for individuals working within the medical device and healthcare industry.
What does this ISO 13485 Certification aim to achieve?
ISO 13485 Certification aims to establish robust quality management systems, ensuring organisations deliver safe, high-quality medical devices that comply with international regulations and build stakeholder trust.
Which individuals or roles require this ISO 13485 Medical Devices Course?
Quality managers, Regulatory Professionals, Auditors, and Personnel involved in designing, manufacturing, or distributing medical devices benefit greatly from ISO 13485 Medical Devices Training.
Are there any prerequisites to attending this ISO 13485 Course?
The prerequisites for this course are based on the course specifications and the target group of professionals it serves. Check the respective course page of the course that you are planning to take to know about its prerequisites.
What is the significance of holding this ISO 13485 Certification?
Holding ISO 13485 Certification demonstrates expertise in medical device quality management, enhances professional credibility, improves career opportunities, and ensures compliance with international regulatory standards.
What are the steps for implementing ISO 13485?
Key steps include understanding requirements, conducting a gap analysis, developing a quality management system, implementing procedures, training employees, and undergoing an audit to achieve certification.
What is included in this ISO 13485 Online 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.
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