ISO 9001:2015 - It's Official: Time to Throw Away all the Hard Copy "Controlled Document Books"!4/28/2017  Now ISO 9001:2015 does not disallow the use of printed out, controlled hard copies of procedures, work instructions, and the like. Companies choosing to maintain hard copies of the "approved" documents at point of use or in other controlled locations certainly can keep doing that and your certification won't suffer.
But, this is the 2015 version of the standard. Yes, 2015. It's time to simplify. There are tools out there now that will facilitate compliance with all of the 9001 Documented Information requirements in an electronic environment, and drastically improve the document revision and approval process. Facilitate, as in, make easier. My personal favorite is Microsoft SharePoint. Using Microsoft SharePoint can drastically simplify the way you're currently managing your business documents. Users can simply create a metadata based document library where you can tag documents, search based on keywords and tags, and not worry whether you're accessing a duplicate or latest version of the file. The SharePoint library can simply organize your documents that may be relative to one another ,and share the same security and permissions. Here are some of the features you can use to simplify your workload and management roles: Version control is a distinctive feature for any enterprise-scale document collaboration platform. In SharePoint, the versioning feature automatically saves every version of a document. This allows multiple people to make changes to a document without the fear of overwriting a previous version. An approval workflow feature is also available to simplify organization and sharing task responsibilities. The approval workflow routes items in a SharePoint site to specified people for approval. It manages and tracks all of the human tasks involved with the process and provides a record of the process when it completes. Approval workflows support any business process that requires sending documents or items to colleagues or managers for approval. The check in - check out feature allows you to make changes to a file on a site, and ensures no one else can edit the file. When you have the file checked out, you can edit it online or offline and save it as frequently as needed. You can simply check out, check in, and discard changes you make to files in SharePoint libraries. User permissions can allow users to specify who can view drafts and edit content on any document. This feature allows users to manage and assign documents to specific individuals without having to make all documents public within SharePoint. Don't wait another minute. Start exploring this now. There are so many benefits to moving from a paper based document control system to one that utilizes SharePoint that I would have to post another blog (or 2) to adequately describe them all. Making this leap will save you so much time, and it does not take too long to convert. If you would like a nudge to get started, shoot us an email, or post a comment below. We'd love to help you out!
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If you read the title and had a flashback to the Geico commercial with the camel wandering around the office - I hope it put a smile on your face. If you have no idea what I am talking about - you might want to check it out here.
Hilarious. Ok, so I am not writing about camels or insurance. But I AM writing about "what day it is". Have you ever had a spreadsheet with data that included dates and someone (maybe you) was wondering what day of the week each date corresponded to? As I am sure you know, in healthcare, day of the week matters. There may be different arrival patterns in the ED, there might be different staff scheduled in the birthing unit, There might be...I think you get the idea. Saturdays are not the same as Tuesdays. Excel has a formula to extract the day of the week from a date field that assigns number values to the day of the week depending on which criteria you enter (Monday = 1, Tuesday = 2, and so on). This is helpful, except it leaves people asking, "what day is it?" - as in - "are the 1's Mondays or Sundays?" I've got a simple way to bring the names of the days into your spreadsheet so that no one is left trying to decode your data. i.e. Monday = Monday, Tuesday = Tuesday...easy, right? Check out this video and I'll show you exactly how to do it. :)
A while back I got asked about a way to utilize Excel to compare data from two separate sources or locations - WITHOUT having to painstakingly look through each line manually. If you are manually comparing data across spreadsheets right now, this is especially for you!
In this short video I use a couple of Excel tools to compare two spreadsheets and find what data is missing from one spreadsheet but exists in the other. Here's the setup - one spreadsheet is a list of patients that have been discharged and the other spreadsheet is a list of patients that have been sent bills for their visit. These lists have about 75,000 visits on each one and 1,000 of them have not been billed. DISCLAIMER Before the HIPAA police gets all excited - this is not a list of names, it is a list of randomly generated numbers that I labeled "account number" which represents a patient visit. All made up data. :) END OF DISCLAIMER Ok, where was I? Oh yeah - If I wanted to manually compare both lists to find the "missing 1000" I would likely have at least one birthday before I was done. And I'd probably make a bunch of mistakes. Double yuck. Watch the video, follow the steps and you could do this same comparison yourself in a couple of minutes. Yeah, not a typo - you can find 1000 "needles" in a 75,000 line item "haystack" in a couple minutes!
If you are able to put this quick tip to work, let me know all about it in the comments below!
 The new ISO 9001:2015 has introduced updated management system standards that override the requirements presented in its predecessor, ISO 9001:2008. In particular, the original standards identified in ISO 9001:2008 under 4.2.3 Control of Documents and 4.2.4 Control of records have been overridden by the new standards in the 2015 version under 7.5.3 Control of documented information.
As part of the alignment with other management system standards a common clause on ‘Documented Information’ has been adopted. The terms “documented procedure” and “record” have both been replaced throughout the requirements text by “documented information”. Where ISO 9001:2008 would have referred to documented procedures (e.g. to define, control or support a process) this is now expressed as a requirement to maintain documented information. Where ISO 9001:2008 would have referred to records, this is now expressed as a requirement to retain documented information. To better understand the changes presented in section 7.5.3 over the previous standards outlined in 2008, it is important to identify the difference between Documents and Records:
ISO 9001:2015 outlines the Control of Documented information in section 7.5.3 and is broken down into two separate requirements: 7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure: a) it is available and suitable for use, where and when it is needed; b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). 7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable: a) distribution, access, retrieval and use; b) storage and preservation, including preservation of legibility; c) control of changes (e.g. version control); d) retention and disposition. With the new standard structure in place, don't get confused by this "new requirement" as it really isn't new. We used to have "documents" and "records" and now we "maintain" (i.e document) and "retain" (i.e. record) documented information. |
Thinking of Outsourcing your Internal Audits?
AuthorChristopher M. Spranger, MBA, ASQ MBB Archives
August 2017
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