Discover the Perfect Medical Bill Receipt Format for Product Quality

Medical bill receipt format for Product quality

hello everyone when it allows you from easy medical devices calm today I want to make a challenge so the challenge is to create a quality management system within 30 minutes and for that I will use the website called standard dot IO not stand out with the a but with ESO ste and D air d dot IO so I had invited Jason Lim the CEO of standard on my podcast and I asked him if I if it's fine for him if I can access his account and see if within 30 minutes I can create a quality management system so what I will do I will take my clock on my phone so it will be for now zero so we see if we can make it within 30 minutes so if it's fine for for that so let's switch first to the screen so what I have already done is that I have already subscribe to the icons now I have my login and my details and now I can start to create my question management system and we'll see if this is working we'll have also 30 minutes to create and until we finish and then the last step will be just to to download all the documents but not the only 30 minutes because it depends on the on the on the speed of the of the connection and also I will not make this video 30 minutes I will make it shorter we just accelerate when there is only some processing time or some waiting time so I will I will do that so but I will not I will not make any trick with with the clock thing so I will really make it start and finish and we'll see that together so ok I'm here on the environment for standard i/o so what I will do I will I don't know if you see that here so I will click on start so start ok now I have 30 minutes so let's enter inside so first login etc so normally all the information are there okay on the process around here we have to create first the company information and then we will work on the quality manual then the SOPs and then we can get all the documents so let's start so we have the organization name so I will use this medical device or not or Acme medical device I don't know the address the logo so let's put logo so here is my logo registration number I will just put one two three four five six seven eight nine so we start again one two three four five six seven eight nine the premiere address so Main Street France so it's address but so it's fine Save Changes confirmation information yes okay the chains out there so then they are asking us to create the departments and the designation of I think the roles of the people so let's start so add new first departments home as usual quality I mean I will call it Q a RSO quality and regulatory affairs create then add new I will do Department so production [Music] [Applause] [Music] [Applause] [Music] [Applause] okay I think we have in our departments to create our mark weight management symbol if you have more so you have to add that here we'll have weight include some designation so first we have the Co [Music] [Applause] [Music] [Applause] so you see you have really to include all the people that are in your organization I mean mainly this is the people that are that that will be mentioned on your on your procedure so it's important to know which people will be responsible for some procedures so purchasing with a poor chassis okay so let's I think we have enough so I think we are good now so what should I do now yeah okay we go save let's move okay now we have to start work on the quality manuals so I should click here [Music] maybe yes okay now creation of your question manual you have about you are about to quit coach many for finishing this document provides the high-level information so it's really explaining what is required manual so will not read that to you continue so here is the principle so here you have to answer some questions and then they will feel all the documents for you so which is maybe a good principle so let's see that in the course of handling the medical devices which is the following activities is easy organization involved in so and here you have also some explanation about the question so let's look for me for example let's everything the design and development manufacturing and distribution let's say that is your organization also involved in or is managing any installation servicing and authorization activities of the medical device I will say no none of the above is any of the business process activity was host and performed by another organization above behalf of fuels say yes manufacturing is outsourced distribution is outsourced I have no sterilization no installation no servicing I just keep the designer open let's say that is your organization it's only that's three yeah so it's only outpost is your organization the owner of the medical device also known as the product owner yes I am the owner is your organization dealing with general medical devices or in vitro diagnostic devices oh it's great so we can make it go decide oh the distinction or also both so for me let's make it simple so general is this magical I have okay there is new questions that arrives when I answer so select the following medical device type for me it will be [Music] let's keep it simple also [Music] bon pasta so off to paydex there is no automatics I am there is more okay I thought the reason ok auto-pay dick implants are autopoietic implants used in the area of auto body shop edicts ok is this an implantable device yes is this medical device that as an ended software or is a standalone medical device software by itself known of those but yeah why not implant with the media with the software inside why not ok let's continue organization description what is the vision of your company on my vision is easy medical device will be the best medical device provider for all to see all the old orthopedic industry now I know we are very modest that's great we will support patients and healthcare professional that we provide the best in class projects does it remind you some kind of organizational vision what is the mission of the organization my mission easy medical device mission is to save lives by providing products of high quality [Music] okay let's put that only I think as I said you can put really your mission or of your condition and everything probably discution or the medical device and or service that you are additional and okay let's say it's a spine okay is medical device is delivering is manufacturing is the manufacture of spine implants aria it can provide static or dynamic [Music] Risto mobility okay so let me get short have the medical you have the medical devices been approved for sales by any country let's say yes okay no questions so first okay let's say France for example what is the approval number so zero one two three four five six seven eight nine I'm sorry zero one zero one two three four five six seven eight nine zero provide the organization name of the local representative organization name [Music] maybe it's the European affairs identity I suppose I have to check that with me here we should have here you should have maybe a sentence what does it mean exactly so let's keep eating mythical device which is local open the TV select the department that are based within your primary address so everything let's say QA Ray market team for chasing training engineering and administration as we said we transform production it's not us but it is do you have any second right side no in your organization who is the owner and share of this document I want to make the CEO the owner because for me it's cyclist yeah let's make me see you all the owner of this which department does this document belongs to okay that's the QA array ok I think we are good it's back good so let's click let's check the clock we are at 12 minutes when we have just finished the quality manual so let's keep moving so now we will do the SOPs SOPs so SOPs we have I think we have solution so we have over here that are incomplete I think that is other SOPs that we'll work on and here are all the documents that are attached to it and here some remaining documents okay so let's work on the SOP here SOP control of document SOP continue so in your organization who is the owner and share of the document so control dock is QA Quality Manager okay QA manager which department to this belongs to tote we arranged this nice you know for viewer for everyone so see the 1/4 - CEO as this is the most important document that determines the chemistry in the oven society's recommended to have someone within the measurement to approve okay create era director I think here what you should have done is also true as we already created some levels for the organization to put a drop down button and rest to selecting so I will mention that to him level two so okay let's again caf-co production manager no that's it QA manager so every manager level three so let's say quality system list and manager okay let's see that finish you P we have done our first recipe so the second is the control of record of records continue in the organization with the owners so same I think control focus which department you are a I'm dead not applicable after the records are exported from standard and signed on the art copies with your organization prefer to scan and safe keep them in your organization so that obeys instead of maintaining them in our copy so yes how many how frequent days do you perform backup of your documents estado okay so as its everyday what method are you using to backup your document so let's see what other options local storage server how many years are the return prod for recall so as this is implants it's fifteen years okay so finish good document practices so same we are here in terms of question first so this is a QA manager again and Siskiyou area and control of non-conforming projects quick okay okay cue the actor it's a belongs to Kiara no I'm dead software you see this part goes quick for some of them because just to know who is the owner so corrective and preventive actions or QA manager cue array from the date that the CAPA is raised how many weeks is given to the Institute investigator to investigate identify the root cause and propose the Kappa so let's say 60 days I know weeks I mean you eat so sorry so 60 days means 4/8 okay forward from the date that the cap is proposed how many weeks is given to the investigator to implement the next direction okay 60 days 60 days then let's say 300 to implement auto increment action so 365 days so one year when the proposed CAPA is implemented what is the timeline in month given to my towed effectiveness its six-month okay so here you can apparently provide your KPIs so that you can say what are the limits and how you have what other otherwise for you to deploy that so we'll check that on the corrective and preventive action Kappa will look at the at its Pacific Lee and see if those in things are implemented inside okay next one is the internal and external audit SOP so for this one continue internal and external so it's a manager this time it's [Music] [Applause] [Music] [Applause] [Music] [Applause] [Music] [Applause] [Music] [Applause] [Music] [Applause] [Music] [Applause] [Applause] [Music] [Applause] [Music] [Applause] [Music] production controls or production is production let's put production manager here Department production is any of the document processor yes it's fine oh great so we are already here with our SOPs and the forms are those need to be modified so this is the form normal forms until the end so so what are our options here can we check that let's check first one I know here we have we should go back we go back just to reinsert I know it's Vanya so it's to edit the answer so no so preview and export so then so we can have here we can see on the the ISO that we have all the things are already here so and here you can review so let's check now where we are let me open again my phone Oh 24:11 so less than 30 minutes in less than 30 minutes all the procedures are created so now let's check let's check those procedures and see exactly what is inside so you have quite which one we said first let's start with the question manual ok so we have now the question manual here it is and we have the details my logo nice ok so we have all the information that we mentioned if there is an exclusion the vision that I decided the mission the product description the different registration of my product and for example in France it's this medical device with the representative that maybe in other countries it's other people representative here all the listed if concerned let's ask at the primary side were the address and what are the partners there ok it looks really great for now or so what is outsourced the question so this is basically seen only the pyramid for documentation all the information regarding medical device files regarding nothing I think it's it looks pretty complete some looks pretty pretty good let's move move move just to see we all think so what is missing is ayat we can do that just check again what is missing is let's go back to watch manual for example I think if you click here you can also put ok here you can put the the document number so here I will call that qsm 0 0 1 for example which is quite system or quite manual qm let's say watch menu qm 0 0 1 which she is then the quite a manual number 1 but I don't think there will be a second one but it's just to put the document number and think we can do that for all the documentation so here or document number so I can also go there and create so SOP you should have that already ready so it's not something that that is important now it's just to be ready so SOP 0 1 SOP 0 2 you it's a p03 etc so you have just to go each of them and write the reference of your document if you know that and we said that you will check one which is the corrective and preventive action because we were putting some specific details and also we am not on the right one preview an export kappa here kappa okay so we are now on the kappa procedure we have all the information regarding what is capa then the procedure with the overall flow for the creation of kappa and the corrective action what is the preventive action details in the kappa and here we have the information regarding the eight weeks for the creation of for the investigation if I can say 365 hour weeks it was days I thought this is a mistake so it should be then 52 weeks to create to put in package there all the actions and then what about the effectiveness monitoring six calendar month here for the 15s motoring okay so this means that yes it's customizing really related to the information I'm providing to - I'm answering at the first step of the of the of the device okay so here now we have all our procedures so what are we doing with that what we can do is export all so we can export all so if I click what happens okay you can export everything on dokic's format so if you want to use them to update them or you can use them use directly the PDF format if you want to send that to somebody and - yeah to display it or to ask him for his review etc so it's two different formats so what do I do i click on the doc is from okay I received the package it's about four mega right we'll take ten seconds six seconds five seconds five seconds to download and we can look at it then okay so we reserved this package here with the information about quality manual standard operating procedures forms and all those so if you look at kata manual so many this is the document I showed you previously okay coach manual so qm 0 0 1 and this is mainly the document and it's update can update it you know if i need to enable for editing and then i can change for example here whatever ok so then i can edit that what is also great is I think if I remember at the end at the end there is all the history so that you have the version so you have to add a new version if needed so this year will be 1 2 3 4 and the version will be 0 2 and the author will be get a QA director implementation date so here you have to fill it and so on so update of I don't know let's make it like that and then when you will release you have to change version to be here ok same for standard operating procedures you have all the documents available here let's pick again 150 collective action for example okay you have your procedure with your information so then as I said you have read to take them to read them and to see I this is matching your organization then you have the forms let's take for example the cup pies there kappa kappa form okay let's look at the kappa form okay patent case request oded background description I think this is great for a company that is just starting to get all this and then to be able to use the system which is easy to use as you have seen and will avoid you to have a lot of costs for your the creation of your documentation and here we have a work institution template if you have to include new procedures and then here are the checklist for the ISO 13485 let's look quickly how it looks like okay you have yeah all the requirements and here if it's completely out so it's like a checklist for you to to use okay this looks really great so um as I have said so within 30 minutes I build this quality management system then you have just to customize it a bit to reflect reality but mainly I think this this solution is really great as an intermediary solution between somebody that really wants to create his is quite a management system from scratch to a person that is hiring hiring a consultant this is a guided solution means that you will have just to fill some of the details and within 30 minutes you have all the information minimal information required and then you have to customize it for your organization so as you can see a challenge was was good so I respect the timeline so within less than 30 minutes I created a quite management system and we saw it live then how it is working what is exactly included inside and the changes that we we made when doing the question were implemented inside the document so I think this is really a good solution to help you create your quality management system quickly but then also to give you time to make your customization because what is important is that what your organization is doing is reflected on your procedures you am what I'm saying is right what you do and do what you write so it's many what you will have to to execute as as you reserved your documents to read them and to see if this is really matching what you are doing in your organization so if you have not already looked at that I would put that also on the on the on the hand screen of this video the podcast episode with Jason Lim with the CEO of standard i/o and the one that provided me here the full access of his solution so I can test it independently and I would provide him all my feedback related to to the experience today and think that maybe he can improve but Jason is really a great guy and is really here to help the organization and I'm sure that his software will will expand and will improve by itself in a few and few months so if you want to purchase this software the solution Jason also provided a coupon code he said that you can use the coupon code easy ten so easy for easy medical device and ten for for the percentage so it would be 10% off 10% discount so if you want to to purchase this solution and the next step for standard i/o is the creation of a cloud-based workflow where they will provide the solution for p4 organization for manufacturers to be able to have a workflow of approval for their documents for any document change they will provide this solution so that each people that will be logged on the system can approve the documents and then you the release will be more controlled so yeah so if you have any feedback from your side if you want to also test the free version of the software go to this link here on the at the bottom or on the show notes and then make a test by yourself you know you not have fully disclose of all the features but this is I think a good start and then don't forget also to provide your feedback to Jason so that you can also make some improvements Fiza office solution I think it would be a great solution at the end so thank you then for your support and waiting for your feedback so thank you and have a good day