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ISO 13485 Lead Implementer Overview
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 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 Realization
- 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 Realization
- 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 Realization
- 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 in the United States 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 Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates
ISO 13485 Lead Implementer Training Course Overview
ISO 13485 Lead Implementer Training in the United States is a course that introduces delegates to the aspects of managing quality in the medical device industry. ISO 13485 Certification is a globally recognized standard that establishes quality management system requirements for organizations that produce medical devices. Understanding its relevance is crucial, as it ensures that organizations 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 in the United States. 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 its ability to enhance an organization's overall performance and mitigate risks associated with medical devices.
The 3-day ISO 13485 Training Course in the United States equips delegates with the necessary knowledge and skills to implement a quality management system for medical devices effectively. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain audit evidence and evaluate it 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 harmonization 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 development consultancy for a respiratory inhaler manufacturer
At the end of this training in the United States, delegates will be able to implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to analyze 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:
- Question Type: Multiple Choice
- Total Questions: 30
- Total Marks: 30 Marks
- Pass Mark: 50%, or 15/30 Marks
- Duration: 40 Minutes
- Open Book/ Closed Book: Closed Book
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ISO 13485 Lead Implementer FAQs
ISO 13485 Lead Implementer is a certification for professionals who aim to establish, implement, and manage a Quality Management System (QMS) based on the ISO 13485 standard, which is specifically designed for the medical device industry.
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates.
Implementing ISO 13485 helps ensure the quality and safety of medical devices, enhances customer trust, improves regulatory compliance, and opens up global market opportunities.
A Quality Management System (QMS) ensures consistent product quality, enhances customer satisfaction, meets regulatory requirements, and supports continuous improvement within an organisation.
The principles of a Quality Management System include customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.
You will learn how to establish, implement, and manage a QMS based on ISO 13485, conduct internal audits, ensure regulatory compliance, and lead a team in implementing these processes.
This training provides you with the skills to effectively implement a QMS, ensures compliance with regulatory standards, enhances your career prospects, and contributes to the overall quality of medical devices.
The certification aims to validate your ability to manage the implementation of a QMS in the medical device industry, ensuring compliance with ISO 13485 standards and improving product quality.
Yes, we offer 24/7 support to assist you with any questions or issues you may encounter during your ISO 13485 Lead Implementer Course.
Yes, we offer a self-paced ISO 13485 Lead Implementer Training Course, allowing you to learn at your convenience and at your own pace.
Holding this certification demonstrates your expertise in implementing and managing a QMS for medical devices, boosting your credibility and career prospects in the medical device industry.
The course includes comprehensive training on ISO 13485 standards, practical case studies, audit techniques, implementation strategies, and guidance on managing a QMS effectively.
The duration of the ISO 13485 Lead Implementer Course is 3 days.
This course is considered intermediate to advanced, requiring a good understanding of quality management principles and some experience in the medical device industry.
With this certification, you can pursue roles such as Quality Manager, Compliance Officer, Regulatory Affairs Specialist, or Lead Auditor in the medical device industry.
Yes, we offer corporate training solutions tailored to meet the specific needs of your organisation for ISO 13485 Lead Implementer Certification.
This certification is essential for professionals involved in quality management, regulatory compliance, and auditing within the medical device industry.
Professionals such as Quality Managers, Regulatory Affairs Specialists, Auditors, and those responsible for implementing and maintaining a QMS should attend this course.
If you encounter any issues accessing the course, please contact our support team for immediate assistance.
Taking this course equips you with the skills to effectively manage a QMS, ensures compliance with industry standards, and enhances your professional credibility in the medical device sector.
After completing the course, you should apply your knowledge by leading the implementation of ISO 13485 in your organisation, conducting audits, and pursuing further professional development in quality management.
While it is not necessary, having prior knowledge or experience with ISO 13485 or other related ISO standards can be advantageous in understanding the course material.
It is not mandatory to have ISO 13485 Certification before this training, but having familiarity with the standard can enhance your learning experience.
The training fees for ISO 13485 Lead Implementerin the United States starts from $2895
The Knowledge Academy is the Leading global training provider for ISO 13485 Lead Implementer.
Please see our ISO 13485 Training courses available in the United States
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"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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