Risk management as set out in in Section 3 of Annex I Ĭlinical evaluation in accordance with Article 61 and Annex XIV, including PMCF Resource management, including selection and control of suppliers and sub-contractors Identification of applicable general safety and performance requirements and exploration of options to address those requirements The quality management system shall address at least the following aspects:Ī strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system Usually, you’ll get the same auditor for 3 years so he will be able to see the progress.īelow is a case study explaining to you the workflow of an audit. Remember, this process is a journey so you will have many years to improve and show a better system year after year. But don’t argue against them if they are valid. What I hope is that this will be minor issues.
In the end, you can still have some small issues and then get some non-conformance. Your job during this time will be to provide them with all the evidence to prove that you are compliant to the concerned standards. As they will stay a few days, they will not be able to review everything. You can read this article to get some idea.īasically, the auditors will come and sample your system to review your documents.
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But, you also need to understand how to behave during an audit as there are some rules to respect. If you followed Step 1 to Step 4 you should be in good shape to get certified.
This step is critical as if you don’t succeed on it, you’ll not be able to manufacture and sell your Medical Devices.
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The coupon code is “EASY10” for a 10% discount.Īnd to be more specific to the EU MDR 2017/745 and IVDR 2017/746 requirements, I also released an episode with Stefan Bolleininger on “Creation of a QMS compliant to MDR”.Ĭheck both episodes to help you build your QMS. If you prefer to see the interview check the video below.ĭon’t miss also the offer provided by Jason in case you are interested in his solution. He accepted to get interviewed on my Podcast and I tried to summaries the discussion on this blog post. To define what is the best process to create a Quality Management System, I asked Jason Lim from Stendard.io to help us. The answer is NO and we will help you understand that. “As soon as the documents are ready, then we can get certified” The Medical Device industry is highly regulated and having the right system is important to be sure that we provide the right product to the customers.īut one issue that always happens is the fact that companies think that it’s only a question of documentation. The creation of a Quality Management System is always a challenge for companies that want to sell medical devices.