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Manual bill format for Product quality

hi this is rob packard from medical device academy and this is a short video explaining what you get when you purchase our quality manual template a quality manual template is pol-001 that's our first policy the policies are at the top of the quality system in terms of hierarchy and in fact we actually show a diagram of that on i believe it's the second page here where you have policies at the top then system procedures or standard operating procedures as some people call them or sops then you have forms that would be used in work instructions so a list would be a log a form would be a blank form a tmp is a template and a wi as a work instruction and these are all documents that you would have as either empty templates or they would be a very detailed work instruction explaining a process the records are what happens when you fill out a log or a form or a template to make a permanent quality system record but when you purchased our quality system or quality manual template all you get is three of the policy documents and you get a template for generic process interaction diagram which i will show you at the very end of this so you get this template in powerpoint format so you can make edits to it and delete any procedures that would not be applicable change the references to procedure numbers if you want to change the numbers to fit your own quality system or you could even add things in here you could also just completely change the diagram and make it your own rather than having a generic process interaction diagram you could have something specific that's more unique to your company i'm going to go back to the beginning of this procedure and show you some of the things that we've done in here right here we indicate this is compliant with the mdd it's also compliant with the fda's mdr i'm sorry qsr and medical device reporting regulations the eu regulations so we'll delete this line in a couple more weeks here when may 26 comes around and then these other procedures as well here um or sorry regulatory references such as 1345 2016 the md sap companion document so this is compliant with the canadian regulations as well which are shown up here 14971 so it it it's meant to cover all the major three markets the u.s canada and europe another thing that we put in here is we've indicated which clauses are not applicable this is one of the requirements you're only allowed to claim design controls as an exclusion so we have that here we indicate it's not excluded but if your company is only a contract manufacturer and doesn't do design you would change that to be not applicable or sorry excluded and then these are the clauses here that can be not applicable and they're the most common ones you could have any of the ones and subclauses or clauses six seven and eight but we've identified the most common ones and then if you go to each of those sections i'll go to 6.4 because that's the closest we actually provide a draft rationale for why that would be not applicable and so if you if it if it's not applicable for your company then you would delete that section where that non-applicability is and you would change the green font to black font and delete this little part if not applicable if it is applicable to your company then you just delete the green text here and go back to this section here at the very beginning and you would delete 6.4 so that's how you handle areas of non-applicability as you can see throughout the quality manual we've identified references to other procedures like this is the one for supplier quality management if there is a requirement for a procedure we just reference the procedure and all the detailed requirements are in the procedure rather than duplicating it at both places and have the potential for you making a change in one place but not in another so you have inconsistencies if there's no requirement for a procedure then we put the detail in the quality manual itself so that's how our quality manual is structured it's not that long it's 13 pages we went to a lot of effort to try to make it as thin as possible as concise as possible so it often takes a little bit more work to do that um but for those companies that feel that all their employees should read the quality manual at least this makes it a little bit more manageable and you don't have to read quite so much but we try to keep it to the the bare minimums and encourage you to look at the procedures for the detailed requirements wherever there's a procedure that's provided if you have any other questions please let us know but you can also schedule a calendly meeting with us using the calendly app on our contact us page and then we'd be happy to go through this procedure with you or explain how you would implement it for your quality system thank you very much and have a great day you