Six steps to ISO 13485:2016 Certification and MDSAP Certification
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- เผยแพร่เมื่อ 15 มิ.ย. 2020
- This webinar explains the six steps to achieve ISO 13485:2016 certification or MDSAP certification:
1. create a quality plan (which you then implement)
2. conduct an internal audit
3. initiate corrective actions
4. conduct a management review
5. Stage 1 certification audit
6. Stage 2 certification audit
The webinar also explains the 9 steps for creating a procedure. This is a process you will repeat for each of the 28 procedures required in ISO 13485:2016. We also explain which procedures you should be implementing first and why. We provide an overview of the design control process and how that integrates with the processes of risk management, usability testing, and software development. There also other links provided in the webinar to additional training resources from Medical Device Academy. - วิทยาศาสตร์และเทคโนโลยี
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thank you for posting this free material in TH-cam. It is helping me getting prepared for a very important job interview for a Software Validation position in a Medical Device american company. I hope I get the job as I will soon be unemployed due to a workforce reduction in the company I have been working for the last 3.5 years
Good luck on your job interview.
Very informative Rob! Will definitely watch all of your webinars! Design Planning, CAPAs, Internal Auditing, Management Reviews, and ISO 13485 Fundamentals!
Thank you for watching.
It is my fist ISO certifications and I am pretty much going through the same journey as you, and I can not express my appreciation for what you do here. Thank you!
Best of luck!
Thank you for this! It is so difficult to equip myself with ISO13485 knowledge due to my company's limited budget. This video has been very helpful in sorting out ISO 13485 into bite sized pieces.
Glad it was helpful! The AAMI Practical guide might be helpful to you as well as a resource.
This is a great video for somebody starting a career in medical device QA/QC field. I look forward to getting empowered by this wonderful youtube production. Thank you.
You are welcome! We are excited to hear that you feel empowered by these videos, and I hope that you can maintain that energy for a long and successful career!
Thank you so much for your videos rob, you are so professional on your job
Thank you for sharing this information. Great presentation. You know the subject well.
Thank you. I have been teaching this since 2005. The video is our #1 most popular video, but it is 3 years old now. Any suggestions for a remake would be greatly appreciated. I'd like to know how to improve it. What's missing?
Rob thank you very much for this video! i am currently in Mexico and i will be taking a lot of training as my job is requesting i take all this training but it's a struggle with the language barrier but I'm slowly tackling that issue. thanks again!
You're very welcome. Good luck with your training.
Thank you Rob. excellent material.
Thank you. Please stay tuned to our channel. We are going to be updating 100% of our procedures in 2024. SYS-029 for FDA Medical Device Reporting is being updated tonight, and our complaint handling procedure (SYS-018) will be next (late December). We are also considering implementation of an eQMS for our turnkey quality system customers. That will make it much faster for people that purchase our turnkey system--even if they don't want the eQMS, because we can use the MS Word Style features to more quickly change logo, company name, etc. We are also going to change all of our procedure revisions to the format used by software revisions (i.e., 0.2 for the second draft, and 1.0 for the initial release). We will do some polls to get feedback on some other preference items (e.g., SYS-xxx vs. SOP-xxx).
Very informative! Thank you! What are other videos you recommend for a biomedical engineer who wants to work in a regulatory affairs specialist role?
Last week I posted a new webinar on software validation on our channel - th-cam.com/video/PV2N73oIAas/w-d-xo.html. Other topics that you should master are: 1) design controls, 2) design changes, 3) risk management, 4) cybersecurity, and 5) human factors.
@@MedicalDeviceAcademy Thank you so much, are these also useful for process engineering? Any tips on how to learn the IQ OQ PQ steps?
First of all thank you for taking the time to make videos like this.
This might be a stupid question but, what is the minimum number of people that you would need for a small shop to become 13485 certified? From what I'm learning I'm thinking its probably 3. Any thoughts on that? Thanks
That's actually a great question. I have seen companies with as few as one person implement a quality system, get MDSAP, 510(k) clearance, and get CE Marked. However, the companies that are that small need to rely upon contract manufacturers heavily and they rely upon our firm to help with independent reviews, internal audits, management reviews, etc.
This is a great presentation and I am using it to prepare for my AQS certified medical certification. One comment about the order of steps 7 and 8- Should you approve your SOP then perform training? Thanks a lot!
What a great question. There are two philosophies and both have merit. Option 1 - train first and then approve. This will ensure that people being trained have an opportunity to give you feedback on things in your revised procedure that are not clear. Option 2 - approve first and train second so people are only training on approved procedures. This also gets the new procedure into effect quicker.
I keep hearing "ISO 1345 Standard". We are talking about ISO 13485, yes?
Yes, specifically the 2016 version.
Great video!
PS: Is 13485 pronounced 1345?
It is common to hear it referred to as "Thirteen Four Eighty Five"
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Hey Rob great video. Can you recommend anybody to develop a 13485. Thank you!!!!
Hi James,
Our company offers a turnkey quality system, but the certification body recommendations depend upon the markets you are interested in. For contract manufacturers and companies only interested in the USA, we have been very happy with Eagle Certification Group: www.eaglecertificationgroup.com/
However, Eagle is not a Notified Body or an MDSAP auditor. Therefore, you would need to select from the NANDO database for Notified Bodies or the Health Canada/FDA list of MDSAP certification bodies.
The UKCA market approval will complicate things further. Currently, only BSI, SGS, and UL are approved bodies in the UK. TUV SUD and DEKRA have applied, but they are not approved yet.
If you only need CE Marking, and you don't need the UKCA, we have been happy with DNV and LNE/GMED for smaller device companies.
@@MedicalDeviceAcademy thank you. If I can email you to provide a bit more information would be great. I have CE support. Development of facility around iso is my interest.
Hi what's the fees?
I assume you are referring to fees for certification. The fees are specific to the certification body. Certification bodies that are not Notified Bodies (NB), such as Eagle Certification Group, are usually the least expensive. We recommend these certification bodies for a contract manufacturer. However, if a contract manufacturer selects a NB for a certification body, then they may also be able to avoid some of the annual supplier audits by NBs. If you are a manufacturer that is interested in Canada as a market, then MDSAP is necessary. This will limit you to 15 possible certification bodies, and only about 11 of them are also NBs. These are generally the most expensive certification bodies and the cost of MDSAP certification is about 2x the cost of a certification body that does not do MDSAP or CE Marking. The cost of initial MDSAP certification is about $30K (and going up all the time). CE Marking is a separate fee on top of your ISO 13485:2016 certification. The ISO 13485:2016 certification will typically be quoted along with your technical file review, and the combined fees can approach $100K.