That would be difficult to provide, becasue each quality manual really should be targeted at how that specific company runs. But, if you are looking for a checklist of items to include in your quality manual, here is a cool document: Check out page 9 and 10, it is a clear table of contents. I don't have my manual set up the same way, but it includes a lot of the components. Include flowcharts of key procceses and c ommittees in your company, and don't forget to clearly call out your exclusions from section 7. Similar Discussion Threads Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote gunilletta 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10 28th October 2016 05:08 PM rdesmond ISO - Medical Device Quality Management Systems 9 19th April 2013 11:35 AM dkcmc Document Control Systems, Procedures, Forms and Templates 5 21st April 2011 06:44 AM WisdomseekerSC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 9th December 2009 12:30 AM S3Support ISO - Medical Device Quality Management Systems 12 26th November 2007 12:37 PM.

1. Iso 13485 Quality Policy

How does expert support work?. Our ISO 13485 expert will meet with you regularly – he will tell you where to start, what the next steps are, and how to resolve any issues you may face. You can meet via Skype, over the telephone, or through any other means at your convenience.

Reach out to us at any time during your implementation project with unlimited email support, and have your questions answered within 24 hours by our experts. Once you complete your documents, let our experts review them – they’ll provide you with feedback and indicate what needs to be improved. All the support you need ISO 13485 certification is much more than just documentation. The implementation of the standard needs to be appropriate to your company, and you need to deal with your employees, your management, and your existing processes in an appropriate way. This is why our experts are on hand with live online support to answer any difficult questions – we can set up a call via Skype, over the telephone, or through any other method convenient for you; or, we can answer your questions via email – whatever suits you best. We’ve done most of the work for you – documents are 90% complete We have already filled in about 90% of the information for you.

For most documents, you’ll just need to enter the particulars for your organization: business name, responsible parties, and any other information unique to your company. Each document guides you through the process, including comments on which elements are required, and which are optional.

We take the guesswork out of ISO 13485 documentation, so you can rest assured you’ve completed everything accurately and with the utmost efficiency. About 13485Academy 13485Academy is one of the Academies of.

Advisera specializes in helping organizations implement top international standards and frameworks such as, and. Over the years, Advisera has become a global leader in the provision of web-based training and (information security management) and ISO 22301 (business continuity management).

Iso 13485 Quality Policy

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