Queries about ISO 13485

1. What is the basis of this business and the key point?

If your question considers the business of producing medical devices, the key point is to ensure the safety and performance of the medical device. The ISO 13485:2016 specifies requirements for a quality management system for organizations involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g.technical support).

2. How to start easiest and how can we understand 13485

First of all, you need to educate yourself about this standard. You can find some courses about it, find a consultant, and educate yourself with online articles. We recommend that the best start is to read our articles in the ISO 13485 Knowledge database which you can find on the following link: https://advisera.com/13485academy/knowledgebase/ 

Here I can specify the following articles:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

Furthermore, you can find useful articles on our ISO 13485 Blog: https://advisera.com/13485academy/blog/

Among all articles on that blog, for starters I can recommend the following articles:

• ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/
• How to define roles and responsibilities within an ISO 13485-based QMS https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/
• Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

3. and how can we apply it completely easiest?

This depends on how much time and resources you have. You can hire a consultant or you can buy a predefined documentation toolkit where all requirements are already described and your job is to and it is your job to adapt them to your processes, products, people, and more.

Here is the link to our ISO 13485 Documentation Toolkit: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

Depending on which package you buy, you can get different levels of expert help.

Here are some more useful articles:

• How to choose a consultant for ISO 13485 implementation https://advisera.com/13485academy/blog/2019/04/04/how-to-choose-a-consultant-for-iso-13485-implementation/
• Implementing ISO 13485:2016 with a consultant vs. DIY approach https://info.advisera.com/13485academy/free-download/implementing-iso-13485-2016-with-a-consultant-vs-diy-approach