Qualtrax Compliance Software

Maintaining compliance to ISO 17025 is a requirement for your lab, and it's not an easy project to handle manually. There are lots of labs that are using shared network drives to manage documentation, and, in a lot of cases, paper systems to manage accreditation. These types of systems can be hard to manage, navigate, and are very prone to error, lost documentation, and incomplete standards management. Many labs have a very small staff or limited resources, so managing ISO 17025 accreditation consumes at least one full-time resource, especially around audit-time.

Problem: Jana knows that their ISO audit is about to occur, so several weeks in advance she starts putting in extra hours to make sure they have all the documentation they need in order to satisfy the standards. Rachel has to dig through the lab's electronic files to makes sure she's go the most recent versions of documents. When a document is out of date, she has to track down the correct person in the lab to update the documentation and approve its accuracy. Rachel also has to dig through files and binders to make sure all customer complaints are in order and documented correctly. Finally, Rachel has to pull all of this information together for the auditor to have access to.

Solution: Using Qualtrax, the entire lab now works together to make sure all information around compliance is associated to the appropriate part of a standard within the system. Now that all documents for ISO 17025 accreditation are being controlled in Qualtrax, everyone can rest assured that the most recent version of a document is available to everyone at all times. Also, all internal processes are now being tracked in Qualtrax, so it takes a matter of minutes to pull up past customer complaints, nonconformance reports, calibration reports, and more when it's audit time. Jana can run a quick report to see where gaps in compliance documentation exist, and fix those issues before the auditor ever arrives! When that auditor comes to the lab, Jana just gives the auditor access to Qualtrax and the auditor can easily see the documentation needed to complete the audit—documentation that doesn't pertain to an audit can be given a permission setting so only lab personnel can see it. This lab has full control over the audit and successful compliance to any standard!

Your lab has a tremendous amount of documentation to keep up with to maintain ISO 17025 accreditation. In a paper environment, document retention takes up an enormous amount of space - even if you're using a network drive to store your documents electronically, there are so many revisions to store that it's easy for that drive to get ugly and unmanageable, fast! When you're retaining documents for 25 years to a lifetime, this quickly adds up. Tracking the history of all of these documents is a big task to wrap your arms around but is a requirement for your lab.

Problem: Jamie is looking through files on her lab's network to try to find the most recent revision of her lab's Standard Operating Procedures (SOPs). There are several versions of the SOPs, and she needs to make sure that she pulls the most recent version for the auditor to review. If it's this hard for her to locate, imagine how it must be for every other employee of the lab!

Solution: Using Qualtrax the SOPs are searchable and easy to navigate to through the browse tree. Jamie can also see all of the past revisions of the document in the event that she needs to go back through and see when the document was last updated, who it was updated by, and what changes were made. This is true of every document in the system!

You handle a lot of very sensitive information that lab visitors and auditors don't need to see, but that you definitely need to have record of in your system. Every single document you put in Qualtrax can be given specific view and edit permissions. This allows your lab complete control over who can see and edit your documentation. This also eliminates the need to have confidential information sitting on a shared drive or in a binder/filing cabinet.

Problem: Brad is a lab manager who wants to make sure that certain documents are only viewable by a specific group of employees in the lab. In a paper system this means that a handful of employees are given security privileges to certain paper documents, and in an electronic environment these employees need to have access to certain folders on the network. Now, the trick is making sure that these sensitive documents only appear in these limited locations. In addition, as employees come and go at the lab, Brad has to keep these permissions current.

Solution: Using Qualtrax, Brad can set up groups in the system and give them specific permissions to view and edit specific documents. This guarantees that only employees with certain security permissions can access sensitive documents. As users are added or deleted from the system and put into groups in Qualtrax, these permissions will automatically be granted to the appropriate employees. Brad can rest easy knowing that sensitive documents have the security they need. Using Qualtrax permission settings is also a great way to ensure that all employees see documents that pertain to their job function, and this helps you limit what "view-only" guests (such as auditors) are able to access when they visit your lab.

Every business (labs included) has several processes that require paper passing. Equipment calibration, purchasing requests, paid time off requests, chemical tracking, customer complaints, and others are all processes that can get lost on someone's desk or email inbox. It's a waste of everyone's time to try to track down the next person in line to ensure a process is pushed through to completion, and it can be very time intensive to determine status of a process. Processes are a reality for every business, and handling them isn't always easy.

Problem: Kelly is trying to put in a vacation request for her summer trip. She's filled out the paper form with plenty of time to spare and given it to her manager. Kelly's manager has taken the vacation request and signed off that it's been approved. This request now needs to be sent to the lab manager, but the vacation request gets lost on Kelly's manager's desk once things in the lab pick up and more strain is put on the manager's time. The vacation request finally turns up, but only after Kelly checked in with her manager to make sure everything was in order for her to leave town the next week.

Solution: Kelly logs in to Qualtrax and submits her vacation request using a Qualtrax workflow. This request will route directly to Kelly's manager where she'll get an electronic notification that approval is needed. Once Kelly's manager has approved, the vacation request will be sent to the lab manager who will give final approval. At that time, Kelly will get an electronic notification saying that her vacation has been approved and she's good to go! In some cases, customers will have approvals put a notification on a company-wide calendar, and alert Kelly's close employees that she'll be out. While this process is going on, Kelly can log in to Qualtrax at any time and see where her request is in the approval process. This gives everyone visibility of what is going on and peace of mind that things are going as they should.

All labs are audited, and let's face it, audit preparation is inconvenient. Here you are trying to handle your casework, and now you have to stop to make sure all of your paperwork is in order for your auditor. Your ISO 17025 accreditation is the glue that holds your lab together, so why should an audit be so painful? With all of your documents, training records, and processes being stored in one location, you can stay audit-ready at all times and get back to your casework!

Problem: Kristen has been told that a re-certification audit for ISO 17025 accreditation will be taking place in a month. Kristen has started to work longer hours to make sure all paperwork is in order and that all standards are satisfied. Kristen also pulls all employee training records to make sure they are up to date. Finally, Kristen starts pulling all calibration, chemical tracking, purchasing request, and customer complaint records for the auditor to have at hand. She's juggling her normal responsibilities with audit preparation.

Solution: Now that the lab is using Qualtrax, audits are no big deal. Kristen ran a gap analysis report to see where there were documentation gaps in their compliance requirements. Kristen also ran a training report to make sure all trainings were current. All workflows are searchable in Qualtrax, so there's no need to pull past process documentation. In short, Kristen's lab stays audit-ready.

Trainings and certifications (and re-certifications, for that matter) are some of those things that somehow take up more time than we'd all like them to. In a paper-system, pulling files is a long, hard way to make sure your whole lab is up to date on trainings, and it's easy to overlook re-certification and training deadlines. Qualtrax will help you keep everything in line by notifying managers when trainings have expired, and when re-certifications are in order. All trainings can easily be reported on so that you can see where gaps in training requirements might exist.

Problem: Chris knows that he has met his standard training requirements but isn't sure when one of his re-certification trainings is due. He goes to the lab director to ask them to pull his training records so he can plan his training accordingly. The lab director gets to it as soon as he can. Finally, they pull his record only to find that he has two incomplete trainings that should have been completed the month prior.

Solution: Using the Qualtrax training matrix, Chris logs in to Qualtrax and pulls up his training history. He can see all of the trainings that are available to him and whether or not they are required or optional. From here Chris can also see which trainings have been completed and which trainings still need to be satisfied. Using document management, Chris can also see when his certifications expire. The lab manager can also use the training management piece of Qualtrax to quickly run a report to see who has completed lab trainings and where employees still need some training.