4/24/2021 0 Comments Iso 13485 Sop Documents
For a better experience, please enable JavaScript in your browser before proceeding.I am the only person in QA, despite my general manager, which is not available as he is on holidays.
13485 Sop Documents Update All TheThey want to get the ISO certification, so I need to update all the quality documentation based on ISO 13485:2016. I have updated almost all documents, but I can see that for this ISO, I will need to create 3 news SOPs: QP716 - Change control; QP811 - Statistical Process Control QP 8212 - Device Risk Management. 13485 Sop Documents Free Or CanThis is my first time creating SOPs, perhaps do you know where I can get these templates for free or can you give me some guidance Many thanks. No doubt youll find some good templates in the posted attachments but will you understand them to the point of adapting them to your company Why do you think a Statistical Process Control SOP is required Im registered to 13485 and dont have one (of course, my circumstances are likely quite different). Do you understand the application of 14971 (risk management) for devices (do you have a copy of 14971). ![]() I am wondering the same, because I believe I should get some support and understand the background better and not just trying to figure out everything by myself. I mentioned this SOPs to my general manager and he said that if they are in the ISO, I need to do them, but I have been looking and I also do not understand why we need the statistical control as we are not manufacturing, but just distributing on behalf of other company. No, I do not have a copy if that, so I guess I should download and read it. As for now, I cannot get any help from someone with more experience, may I ask you what do you recommend me to do Thank you. Address them within the procedures appropriate to your operation. The term statistical techniques is the closest thing used, and it appears in the following: 7.3.6 Design Dev. Design Dev. validation 7.5.6 Validation of processes for production svc provision 8.1 Measurement, analysis, improvement - general 8.4 Analysis of data Since you are a distributor, you probably exclude DD altogether. Likewise, 7.5.6 probably is not applicable to your company. ![]() ISOs favorite vague terms) what statistical techniques will be used, and in 8.4 the requirements is that the procedure will include determination of statistical methods (e.g., our companys Mgmt Team determines the KPIs and metrics to be used, including any statistical methodologies, and those determinations are recorded in. If SPC were an explicit requirement, then you would expect it to appear in 8.2.58.2.6 (monitoring meas. However, the language in those clauses is instead quite general. A lot of people appear to not understand this and think statistical techniques SPC.
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