![]() ![]() Referring to your template as “suggested formatting” will avoid unnecessary nonconformities. The ISO 13485:2016 standard does require a “mandatory” format. Just make sure that your document control procedure allows flexibility to deviate from the template. In addition, using templates ensures a consistent format that makes it easier for everyone to find the information they are looking for. You don’t have to mimic our template, but using a template will accelerate the speed of your writing when you create procedures, and it makes sure you don’t forget any of the essential elements. In 2013 we published a blog about using a procedure template where we described our 12-part procedure template (i.e., TMP-001). Use a standardized template for your procedures ![]() The article was updated and posted as a new blog on Tuesday, March 28, 2023. ![]() During my ride home, however, I thought of a few other ideas that might help anyone writing or re-writing a procedure. Several books related to Lean Manufacturing explain how to use visual communication to replace text (i.e., “a picture says a thousand words”). Give us a call so we can learn more about your needs.Would you like to learn nine ways to improve your quality system procedures? One method is precisely the opposite of our advice from 2011.ĭuring a CAPA course I taught on Friday, January 28, 2011, one of the attendees asked if we teach a course on “How to write better quality system procedures.” Unfortunately, we could only offer material from a course about “Training the trainer.” That “Training the trainer” course focused on visual communication. Our QMS implementation and auditing teams are located in the US, Europe, Asia, and Latin America, so we have the resources to get started right away. There's no time like the present to begin your journey toward ISO 13485 certification. We will solidify the path forward as you prepare for your initial ISO 13485:2016 certification audit. This analysis will uncover opportunities for improvement and reveal how much time and resource effort will be required to merge ISO 13485:2016 requirements with your existing QMS. If you have a quality system that complies with FDA 21 CFR Part 820, we will first conduct a gap analysis to assess your current level of compliance with ISO 13485. Our approach also maximizes your chances of attaining certification during a third-party ISO 13485 audit!Īlready Have a QMS That Complies With FDA Regulations? This approach may require some effort and planning at the outset, but the modest investment of time will pay off with improved organizational performance and tangible ROI. We analyze your processes with the goal of improving them before they are standardized and documented. What distinguishes our approach is our focus on performance and conformance. That's why we take a flexible, staged approach to ISO 13485 implementation, molded around your existing processes, internal resources, and business needs. Experience has taught us that a “one size fits all” approach simply does not work. We have worked with thousands of medical device and IVD companies, from startups to multinationals. Let Our Experienced ISO 13485 Consultants Help You Achieve Certification The QMS we build for you will be ready to expand with you. That’s important, because if your goals include selling outside the US and Europe, ISO 13485 is essential. We deliver a harmonized QMS that meets US FDA, European, and other international requirements, including those of Australia, Brazil, Canada, and Japan. ISO 13485 Certification Opens the Door to Markets Worldwide How much does it cost to get certified to ISO 13485? What’s involved in implementing a new QMS? How do ISO 13485 and FDA regulations overlap? ![]()
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