This 100+ page step-by-step guide is available free with our ISO 13485 Lead Implementer Course. It is not for sale.
But it is everything you'll need to develop, implement, and maintain a management system to ISO 13485 Certification standard, including sample Procedures and Forms.
If you want to be an MDMS Consultant or if you wish to develop and implement a Medical Device Management System (MDMS), our ISO 13485 Implementer & Auditor Course 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 through to Certification.
- ISO 13485 Consultants & Regulatory Affairs Advisors: Gives you the methodology on how to implement MDMS Projects faster and easier than ever before.
- Experienced Quality Management Professionals and other Executives: Those given the responsibility to maintain their organization's ISO 13485 Certification will gain all the skills and knowledge they need, plus state-of-the-art information on maintaining an MDMS.
ISO 13485 Lead Implementer Course Materials
deGRANDSON's ISO 13485 Lead Implementer Course comes with extensive course materials, including:
- ISO 13485 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
ISO 13485 Lead Implementer Certificate for you
The course itself 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 an Audit Programme Manager, to undertake and manage Internal Audits for your Organisation.
The Course, which is available on-demand and is self-paced, is delivered online in four Modules ...
Module 0: Introduction and background to the Standard and auditing plus introduction to EU, US, and UK Regulations.
Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018
Module 2: Knowledge of the Standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
Module 3: Practice with Scenarios based on actual audits and include advice on dealing with awkward situations and individuals.
On successfully completing the course you will receive an ISO 13485 Lead Implementer Certificate, the qualification of MDMS Consultants.
Our family of Lead Implementer Courses to implement and maintain ISO Management Systems
Available Lead Implementer courses image map. Click on any course you are interested in to learn more about it, including course content, learning materials, etc.
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deGRANDSON Global is an ISO Certified Educational Organization
In October 2021 we secured certification to three education-related ISO Standards. We now have a university-grade management system in place conforming to the requirements of …
We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment. It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.