ISO 13485:2016 Lead Implementer Course Content
If you want to develop and implement a medical device management system (MDMS), this ISO 13485 certification for lead implementers is ideal. It will be especially beneficial to:
- Newcomers to MDMS: You don’t need to be an expert. You’ll be taken on a practical journey from getting started to Certification.
- ISO 13485 Consultants: Gives you the methodology on how to implement MDMS Projects faster and easier than ever before.
- Experienced Medical Device Management Professionals: Understand the impact of the revised Standard, the 130+ instances where documentation may be required, and best practice in maintaining an MDMS.
The course provides you with the Auditing Skills, the Knowledge of the Standard, and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Programme Manager, to undertake and manage Internal Audits for your organization.
Who should enroll in this ISO 13485 Lead Implementer Course?
This ISO 13485 certification course is intended for:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Project managers
- Design engineers
- Software engineers
- Process owners
- Quality engineers
- Quality auditors
- Medical affairs
- Legal Professionals
What will I learn from this ISO 13485 Lead Implementer Course?
And, yes, Auditor Skills are included.
This comprehensive ISO 13485 Certification Course covers all aspects of Internal Auditing and is divided into four Courses:
- Module 1: Introduction and background to the Standard and auditing.
- Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018
- Auditing Skills
- Terms and definitions
- Principles of auditing
- Auditor skills
- Managing an audit programme
- Audit Team Leadership
- Overview of Audit activities
- Audit activities – Step 1
- Audit activities – Step 2
- Audit activities – Step 3 (2 modules)
- Audit activities – Step 4
- Audit activities – Step 5
- Audit Activities – Step 6
- FAQs about Auditing
- Online Course Examination
- Module 2: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Introduction to ISO 13485:2016
- EU, UK, USA Regulations & MDSAP
- Developing & Implementing a QMS
- Terms & Definitions – ISO 13485:2016
- Some Key aspects of QMS Auditing
- Fundamentals of Medical Device Management Systems
- MDMS Implementation and Certification to ISO 13485:2016 – the 33 Steps (3 lessons)
- Initiation
- Planning
- Implementation
- Securing Certification
- Structure & content of ISO 13485:2016
- Parts 1, 2 & 3
- Part 4: Quality Management System Requirements
- Part 5: Management Responsibility
- Part 6: Resources
- Part 7: Product Realisation (3 lessons)
- Part 8: Measurement, Analysis & Improvement (2 lessons)
- Annexes ZA & ZB (Amendment 11 Annexes)
- Advanced aspects of QMS Auditing
- FAQs about the Standard
- Online Course Examination
Module 3:Â Â Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.
- Audit Scenarios – Internal Auditor
- More Audit Scenarios – Lead Implementers
- FAQs about the Auditing Experience
- Online Final Examination
What materials are included in this ISO 13485 Lead Implementer Course?
The ISO 13485 Lead Implementer Certification Course includes course materials invaluable when implementing ISO 13485:2016 like:
- ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
- Diagram: The 33-step Path to ISO 13485:2016 Certification
- Documented Information Requirements of ISO 13485:2016
- Determining the Context of the Organisation
- ISO 13485:2016 and Risk Management
- Risk Assessment Tools and Methodologies (with examples)
- Terms & Definitions
- Typical Process Map
- Sample MDMS Policy Manual
- Sample MDMS Maintained Documentation (procedures), including…
- Sample Procedures
- Sample Records
- Sample Audit Plan
- Sample Audit Work Order
- Sample Nonconformity Report
- Sample Working Document & Checklist
- Sample Management Review Record
- Diagram: Auditor Certification Process
- Diagram: 6-Stage Audit Process
- Sample Code of Ethics
- Management of an Audit Programme
How is this ISO 13485 Lead Implementer Course delivered?
The Program is delivered online from our Learning Management System (LMS) at www.degrandson.inquisiqLMS.com.
All Lessons have a full resume and scaling capabilities. This means, for example, you can…
- Start a Lesson at work on your Work Station running on Windows 10,
- Continue the Lesson on the train home on your iPad running on iOS 11 and,
- Complete the Lesson at home on your Notebook PC running on Windows 8.1
Are there any prequalifications to enroll in this ISO 13485 Lead Implementer Course?
The minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate, or similar National Vocational Qualification) combined with 5 years’ work experience is recommended.
You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.
What is deGRANDSON’s ISO 13485 Implementation Model?
The ISO 13485 Implementation Model was developed by deGRANDSON Global: The 33 Steps to ISO 13485 Implementation is the model we have developed for implementing a medical device management system (MDMS) to meet the requirements of ISO 13485 and to secure accredited Certification.
It is the foundation on which our ISO 13485 courses are built.
So, where does it come from?
The International Standards Organisation (ISO) has published two standards that focus on developing and implementing an organization’s QMS:
- The quality management system standard: ISO 9001:2015. This standard is the specification for a QMS. It specifies the requirements of a quality management system for organizations seeking to establish, implement and maintain a framework to consistently meet and exceed customer expectations.
- The Regulations of UK MHRA, EU EMA. US FDA, Other MDSAP Adopters, and WHO for the rest of the World.  Cognizance of this ever-changing mass of regulation and associated Guidelines has been taken in interpreting the Standard’s implementation in compliance with the regulations as applicable.
To help make sense of it all from an MDMS Implementer/Project Manager’s viewpoint, we have developed this ISO 13485 Implementation Handbook, which you’ll find embedded below. Alternatively, you can also get a copy of it by downloading the PDF file below.
Free ISO 13485 Implementation Handbook
This instruction manual is free with our ISO 13485 Lead Implementer Course. It is not for sale.
It goes over everything you’ll need to develop, implement, and maintain a management system that can achieve ISO 13485 Certification. This includes learning how to:
- Obtain Top Management Support (ISO 13485 Clause 0.1)
- Assemble MDMS Project Team
- Undertake a Gap Analysis of current QMS against ISO 13485 requirements and prepare Project Plan
- Identify the strategic purpose of the MDMS to the Organization (ISO 13485 Clause 0.1)
- Identify Regulatory and (for EU Market) the Annex requirements. ISO 13485 Clauses 4.1 and 5.2)
- Identify Regulator, Certification Body, Notified Body needs
- Establish MDMS and define Operational Processes (ISO 13485 Clause 4.1)
- Define Documentation including the Medical Device File (ISO 13485 Clauses 4.2.1 and 4.2.3)
- Prepare a Quality Policy (ISO 13485 Clauses 4.2.2 and 5.3)
- Define key Roles and Responsibilities (ISO 13485 Clause 5.5)
- Determine actions to address Risks (ISO 13485 Clauses 4.1.2, 4.1.5, 4.1.6, 6.2, 7.1, 7.3.3, 7.4.1,7.5.6, 7.6, and 8.2.1)
- Establish MDMS objectives and plans to achieve them (ISO 13485 Clause 5.4.1)
- Establish Design & Development Processes (ISO 13485 Clause 7.3)
- Determine Operational Planning and Controls (ISO 13485 Clause 7.1)
- Decide monitoring measurement and calibration needs (ISO 13485 Clause 7.6)
- Establish Operational Controls and Monitoring (ISO 13485 Clauses 8.1 and 8.2.5)
- Establish Feedback and Complaints Procedures (ISO 13485 Clause 9.1.2)
- Develop Mandatory and other Procedures (ISO 13485 Clause 4.2.4)
- Develop Mandatory and other Records (ISO 13485 Clause 4.2.5)
- Determine and secure required Resources (ISO 13485 Clauses 6.1, 6.3, and 6.4)
- Establish Procedure in provision (purchasing) (ISO 13485 Clause 7.4)
- Establish Internal and External Communications (ISO 13485 Clause 7.2.3)
- Develop general Staff Awareness (ISO 13485 Clause 5.5.2)
- Implement Operational Plans and issue documents (ISO 13485 Clauses 7.1 and 7.5)
- Complete Job-Specific Training (ISO 13485 Clause 6.2)
- Go Live! Implement Procedures (ISO 13485 Clause 7.5)
- Determine and review Customers’ requirements (ISO 13485 Clause 7.2)
- Manage Production and Service Provision including Non-conforming Product (ISO 13485 Clauses 7.5 and 8.3 )
- Establish Product & Service Release (ISO 13485 Clause 8.2.6)
- Conduct Internal Audits (ISO 13485 Clause 8.2.4)
- Conduct MDMS Performance Analysis & Evaluation (ISO 13485 Clause 8.4)
- Conduct Management Reviews (ISO 13485 Clause 5.6)
- Implement Improvement including CAPA (ISO 13485 Clause 8.5)
Not sure this is the best ISO 13485 Course for you?
See our full suite of ISO 13485 Training courses for comparison or check out our answers to frequently asked questions about ISO 13485 certification.
Related Courses
ISO 13485 Internal Auditor Course – to conduct effective internal audits
ISO 13485 Transition Course – to migrate your MDMS to the 2016 Standard
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Lead Implementer Courses: Overview
