Rob Packard knows the answer.

Fran Gillen Feel free to I mail. I have many years experience in this . Together we can simplify.

Nicole Baldridge This is a big task and a super question. I suggest you take a look at where the standard changed the most (risk) and attack those places first in your QMS. I personally think that management review, internal audit and CAPA are some of the strongest procedures in the QMS.

Kris Kelly Hi Dinarie - I think we can help you - please shoot me a message so we can discuss. Kris G. Kelly

I don’t know if your company has financial bandwidth for training or consultants on this topic but, if so, I can recommend Oriel Stat-A-Matrix. Their 13485 transition training is very helpful.

With a small company it might be best to do a complete reboot of the QMS. Don’t change it, replace it with one streamlined and appropriate to your product, regulatory environment and business needs

Dinarie Correa, MBA connect with me, happy to offer my 2cents and assistance where I can be of value add!

Robyn Scopis With a small company, it's about streamlining. Start with the daily procedures like document control. Big systems get in the way and hurt more than they hurt. I can talk strategy free of charge if you DM me!

Robyn Scopis Start with document control. From there quality manual, complaints, and CAPA . These are used on a daily basis. From there is a case of what you do. If you are in manufacturing, manufacturing. If you are in design mode, design. Lastly I would finish up with regulatory procedures like adverse events, recalls. If you have questions, free of charge, contact me.

Courtland Imel Dinarie,
I agree with Joe (Robert is a great guy) and Nicole. Start with an overview plan for your QMS (map it out on a white board - allow yourself to change as needed). Work on Management responsibilities first, and then move into CA and PA. You can find lots of great information on line. I will also suggest attending the AFDO event under CASA (your local group) and the main AFDO event in Vermont this year - since you will be close (AFDO is FDA teaching state inspectors and we get to listen). You can hear directly from FDA or ex FDA staffers. For training help, I'll suggest joining GMP TEA (free group, made up of the trainers at large firms, helping each other). If I can help in any other way, let me know. We assist many small firms obtain and remain in compliance in many different ways. Good luck on your journey. Thanks, courtland

1) You have to review and strengthening the supplier control processes
2) You have to review the production processes...If the processes cannot be verified 100%, then you have to validate them. You will need the procedure.
3) You have to review your design and transfer activities...es. Cpk/Ppk

Eckhard Jokisch 1.) I would recommend starting with chapter 5: Management Responsibilities.
This would put you in the position to gain attention, budget and other support.
2.) Take the chance to get rid of all the documents as most probably you don't need the documents but the information pieces (AKA documentation). Sometimes an eQMS helps but be careful to choose the tool. There are cheap or even free solutions that do the trick and don't cost a fortune.

James Shore Start with a simple flowchart and map out the current process. Then identify the required iso elements. After that, identify the procedures that can be used and purge the rest of them.
I'm going through the same situation at three other companies right now and it has been very helpful.

Alberto Paduanelli That's what consultants are for 😉

Develop a new QMS. Let the old one run its course and design a new one on the background. First build your tree on a macro level and determine the new rules of the game. Keep It Simple 😄

Hi - the ITL Group offers regulatory consultancy - from simply teaching about things like 13485 right the way through setting up someone's QMS from scratch will all associated documentation, procedures etc using a modified version of our "off the peg" system.

If your requirements stretch as far as some consultancy I'd be happy to help. It's a big job, but do-able once you break it down into chunks.

More importantly because we run to 13485 our systems by their nature have to be streamlined and efficient whilst still being effective - we can't afford to be bogged down with a heavyweight QMS that isn't fit for purpose so we can pass that experience on.

Marcelo Antunes Have you though about revising everything to make them hem more simple while still complying eith requirements? I’ve performed several full simplification with several small clients over the uears, and everytime it was a hugh success. Think, for example, about using mainly flowcharts and only write only what is strictly necessary.

I brought up the same question to our auditor. He said just stay with ISO 9001-2015, but we don't make a finished product or design from concept to production. It looks like you do.
Our auditor is Richard Cornick 858-263-2888.
Super nice guy call him. In the future please consider us for out sourcing you parts. Best Regards.

Ivan Liljegren I suggest to start with the quality manual and make sure that you cover all requirements with a minimum set of SOPs. Any remaining SOPs not referenced from the quality manual, are targets for invalidation.

Annika Fahlén I would strongly advice you to start at the top i.e. with the Quality Policy including objectives. Then management responsibility and review. Work in the same direction as the steering (should) come from. Based on the classification of the device the rest could differ. Therefore I would suggest to perform/apply risk management for the QMS and its processes. That will give you help to understand the next steps.

Dan Brown I understand that you're too small to hire a consultant for the whole project, but you might want to consider strategic use of one to assist key portions to stretch your resources. Next, the standard requires that you address risk throughout your system. Meet with the team and consider your risks. Then build out your revised QMS beginning with the highest risks and only as complex as is required to reduce the risk while complying with the standard and regulations.

Some procedures may have started simpler and became more complex with their application to the nuances of the product. What you need to assess is not "overly complex for small company" but what was the intent of the procedure? What was the requirement it was bridging to the nature or particulars of the product? Then, is there opportunity for it to be streamlined to its barest essentials and still address/comply with the standard and/or requirement?

Go for critical sop first

Start by doing a risk assessment versus the regulations - once completed you should start with the top level docs and work down eg. Quality Manual, Policy then SOPs and associated docs - It's sometimes easier to start from scratch and let the old system run its course - make sure you document the changes in an overriding document - Good Luck 😀

Overhaul quality policy first then cascade down to critical SOPs, very quickly you should be able to identify redundancies while amalgamating critical process and procedure. Start with the mindset that's Its all out the window and start fresh taking the key relevant parts to create new docs. Good luck !!!

Dave Gaisser Getting thrown into a major re-write can be overwhelming. A previous employer spun out a satellite business and I had the same task – create a new quality system from the old outdated one, which took forever. If you are going to change the existing QMS, start with document control to properly record subsequent changes. Then do a gap analysis to see areas where your Quality Manual needs updating to ISO 13485:2016. Revise in order of priorities, starting with Management, Risk Assessment, and critical procedures. As you proceed, you may see where you can eliminate or trim excess documents to simplify your system.

As others note, it may be easier to replace your entire system. One client licensed an existing technology along with its overly-complex quality system. After trying to figure how to revise it, we just scrapped it and put in a more streamlined version for their 4-person company, updated to match their needs. This saved a significant amount of time and money (and pain.)