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Free Design Control Procedures Templates for a Quality Management System

| 20 Comments

One of the most time consuming aspects of developing and maintaining a quality system is creating procedures. I think it’s no secret that teams tend to look for procedure templates to get a baseline of what the procedure should look like and what it should contain. With proof-reading, formatting and routing for signatures, developing┬áprocedures always take longer than expected. There are a lot of templates out there and most of them are either too rudimentary or too expensive. This is outrageous. Companies should have easy access to the resources needed to sufficiently comply with FDA and ISO standards. So, in an attempt to push the industry in the right direction, here is the first (of what I hope to be many) procedure template that I am releasing. It is a Design Control Procedure template that is geared for medical device companies under the FDA CFR 820 regulations and ISO 13485 standards. You will need to add company-specific information to it, but it should help smaller companies jump start their Quality System. It is saved as a Microsoft 2010 Word Document.

Download it here:
Design Control SOP

If you need a different Microsoft Word version or would like to request a different procedure template, let me know in the comments. Thanks and good luck!

Also, If you like these templates, consider donating to help me pay for server costs and keep me motivated to continue putting these free templates out. Have a good day!





Author: Alvin

This is a blog about entrepreneurship, travelling, business and life from the mind of Alvin Tai.

20 Comments

  1. Hi Alvin. Kudos on this effort. I think it’s terrific and greatly appreciated. I have a question about this design controls SOP. I noticed in the scope that it excludes investigational devices yet the clinical IDE regulations exempt us from GMPs generally, but do require compliance to design controls. How would this SOP be different for IDE devices? Many thanks for your thoughts.

  2. Dr. Easton, I apologize for the scope confusion. The statement in the scope “This document does not apply to investigational research and development prior to project funding and approval.” is meant to allow research teams to develop an initial proof of concept without going through formal design controls. This is during very early stages of the project. Formal design controls still apply to IDEs; it will also make your life much easier when you reach PMA/510k submissions.

    You could include an additional section for clinical trials in this procedure. It would most likely be a part of your validation stage. Hope that helps!

    Check the Good Clinical Practices section on the FDA site:
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm

  3. I could use your help……please…..I am trying to develop a qa management system for medical device….I built a qa management system for anhydrous ammonia but this is so different please help

  4. Thank you. Your efforts in this arena are much appreciated. I am a design engineer, currently in the initial design phase of a medical device and would appreciate guidance on creating simple design procedure templates for input/output and FMEA. In my experience, these templates have become too complicated and I feel it could be more simplistic. I have been designing dental implants for years but I now am in a position to lead on the documentation. I’d be happy to pay a consultation and development fee for helpful advice. If you can, if appreciate an email. Thank you, again.

  5. Alvin, I’m looking for someone that can assist in putting in place a quality management system for a medical device. Please contact me to discuss. Thanks.

  6. Hello Alvin,

    Thanks for your expertise, SOP templates and all the comments. I’m working with a company that’s a supplier to several industries, including life sciences/healthcare. Currently, they haven’t setup a QMS yet. I’m trying to help them and am writing SOPs and policy documents. In addition to your SOP template suite, could also provide one or two other resources for various regulated industry templates.
    One other thing, I started my own consulting company (LLC) last year (2015) but haven’t done any business through it yet: I still need to get a website developed. My biggest question right now however is how do I find the appropriate HR or business contact person to be considered for contract to bid on? Thanks again.
    Regards,
    FJ

  7. Hi Alvin, Thanks for the template. I was wondering if you had any examples or templates of the following sections?
    4.1 SOP-XXX, Document Controls
    4.2 SOP-XXX, Purchasing Controls
    4.3 WI-XXX, Engineering Change Order Work Instruction
    4.4 WI-XXX, Verification and Validation Work Instruction

    Thanks

  8. Hi Alvin, I’m from the Philippines and I’m part of the secretariat team of the Philippine Biomedical Device Innovation Consortium (PBDIC). We are helping the consortium members, mostly Universities, bring their medical device idea to the market. A design control document template would be a great help in the consortium. Looking forward to your template. Thank you so much

  9. Hello. I am with a small startup and am in the process of developing our QMS. The Design Control SOP has been extremely helpful so thank you. I am in need of templates (Design Plan, Design Input, Design Output, ect.) Do you have anything to share or could you recommend a site? Thank you for your time.

  10. Pingback: Free Complaint Handling Procedure Templates for a Quality Management System - Read Me.

  11. Hi Alvin,

    I think that you need to update the reference to the standard to be used for software design. It has been a typo there.. ISO 62304 I guess it should be.

  12. Your 2 SOP templates have been very helpful. I am looking forward to seeing more of your templates.

  13. Dear Avin,
    i would highly appreciate if you can share design control forms to fulfill the designe control requirements,

  14. Dear Alvin,

    Your template looks great !

    What Sections in the Template should I customize for my company? and what type of information should I include?

    I know that the Plan Section has to tailored for my company.

    Thanks,
    Bob C.

  15. Thank you. Your efforts in this arena are much appreciated.
    Please let me know if template for the form to be used during Medical design control are available.
    Please send me the link.
    I have dowloaded your SOP but need example of the form to be used.
    Thank you in advance
    Chris

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