I work at a Blood Bank and our CLIA Medical Director is off-site. We separate SOP updates by department so Collections handles donor eligibility/collection and my Laboratory handles their own updates which includes component manufacturing, center testing, transfusion services, and immunohematology reference testing. Luckily for me, our Corporate Office pre-selects which SOPs involve medical and technical policies, processes, and procedures. I can try to outline our process in hopes that it can offer some sort of help. Prior to implementation of any new SOP or any update, CO sends it to our document control contacts so we can train staff on the policies and so we can get CLIA Medical Director approval. Typically, we get updates at least two weeks prior to implementation so we aren't frantically running around trying to get approval and staff members trained. Sometimes we aren't that fortunate but oh well . For any new/updated SOP that involves a CLIA regulated task, we print these for our CLIA Medical Director to review; this includes SOPs involving platelet selection, donor eligibility, irradiating, etc. Even if just a typo was corrected, for example changing "is" to "are," we have our CLIA Medical Director approve the SOPs if it involves a CLIA regulated task. At the end of each SOP, we define which alteration was made for each revision of an SOP. This provides a quick guide so a person reading the SOP can know what change to look for. We also have a highlighting for each SOP revision which makes added or changed text more apparent. I find this helpful because searching for the change can be akin to searching for Waldo. This makes it easier for our Medical Director so he's aware if there was a serious change or just a corrected typo. We have a form where we list each SOP that requires approval at that time and our CLIA Medical Director will sign that after he approves the SOPs.