I've been doing some work on a very young QMS for a medical device manufacturer. Right now the goal is strictly 21 CFR 820 compliance, but ISO 13485 certification is part of the small company's future aspirations. We are doing our first 510(k) and filing away the validation reports. I have a controlled validation report form from a template package that we are using. We are summarizing the reports, intended use, conclusions, etc. on the form and filing it in the DHR, but should I also control this document with some record number? Is it enough to title it and file it in the DHR, or do these types of records have to be controlled with document numbers and such?