There is a lot of planning that goes into starting a new lab: personnel, equipment, processes and procedures – and that’s just the tip of the iceberg. That planning becomes even more complicated if your organization intends to pursue accreditation to a standard like ISO/IEC 17025, which governs quality and compliance.
The good news is that there are software solutions out there that can simplify many aspects of this process. The two you’ve probably heard the most about are a Laboratory Information Management System (LIMS) and a Quality Management System (QMS).
As a QMS provider, we get a lot of questions about the differences in these two systems. We are also asked whether or not a lab needs both to be successful. I’ll be perfectly honest with you: the short answer is no. However, if you are planning on pursuing accreditation to an ISO standard like 17025, (which is probably why you’re here) acquiring both is definitely in your best interest. Not only will a good QMS help streamline your accreditation process, but it will significantly reduce the amount of effort and resources required to maintain your accreditation, which is critical to the continued success of your venture.
In this post, I’ll explain the primary differences between the two systems, highlight some red flags to be aware of when you’re evaluating your options, and share some info on a new product offering that we’ve teamed up with our partners at A2LA WorkPlace Training to create: the 17025 QMS Quickstart. Hopefully, you’ll leave here with the information you need to make an informed decision on the best path to success for your organization.
LIMS is an excellent tool to capture your day-to-day test data. LIMS enables you to track casework information as well as report out data and statistics on that casework. It also helps preserve chain-of-custody for a given case or process. For example, a LIMS can tell you who received and prepared a certain sample, the date and time of preparation and testing, and any variables associated with that test: which balance was used for measurement? Which piece of equipment was used for analysis? What was the source of the starting material?
All of these are critical data points that need to be recorded and maintained so you can trace any quality issues or customer complaints back to the source in your internal evaluation. A LIMS can also play a partial role in document management, serving as a repository for Certificates of Analysis (COA) and Safety Data Sheets (SDS). It does have significant limitations in this capacity, however, particularly as it relates to the requirements of ISO 17025.
The question is: how do you document, record and monitor any quality issues and customer complaints that arise? How do you manage and execute your internal evaluations in a manner that is compliant with the requirements of ISO 17025 and help you execute the mission of continuous improvement?
Many people make the mistake of assuming a QMS is simply a glorified document management system. This assumption is forgivable because, depending on your role within an organization, document management may be the only interaction you have with the system.
Document management is absolutely one of the main functions of a QMS, but it’s not the only one. As the name suggests, a QMS actually manages all aspects of quality within an organization. As a document management system, it is used to house everything from work instructions and your organization’s quality manual to individual personnel records. Beyond just documents, however, a QMS holds nearly all the information an assessor will require to administer an audit. When utilized to its full capacity, your QMS is a one-stop-shop for nearly all audit-related material.
This comes as a surprise for many who are new to the regulatory lab environment. We’ve had bewildered customers share that their assessors didn’t care at all about the results coming out of their labs – the assessors were only interested in their documented processes and whether or not they were following them!
Take a moment and let that sink in. If you are seeking accreditation to ISO 17025, your assessors are going to be asking detailed questions about your processes. They’ll want to see detailed work instructions and then verify that you are following the processes you’ve put in place. A QMS can help you with this too.
In addition to document management, a good QMS like Qualtrax will allow you to automate many of the processes that are required by the ISO standard, including risk assessment, equipment maintenance, internal audits, corrective actions and customer complaints, among others.
Qualtrax offers a unique approach to process automation through our workflow builder. The system comes pre-configured with a suite of our Best-in-Class workflows (including the ones listed above) that are ready to deploy right out of the box, but we also give you the ability to construct an unlimited number of workflows specific to processes you follow in your organization.
This unique customization allows you to build workflows that mirror your processes exactly as you have written them. The workflow will then document every action taken, as well as collect any additional data you require at steps throughout the process – it’s all up to you. Not only does this feature help guarantee an audit-ready record, but it also puts guardrails around your processes so employees cannot deviate from the path you have created, which could result in findings in your audit.
Every workflow is searchable and reportable, so you can call up all records with a few clicks of the mouse, making audit prep a breeze. Process automation also reduces the time it takes to manage these tasks manually, and every step is automatically documented for you.
The last major function that Qualtrax offers that sets it apart from a LIMS is a testing and training tool that allows you to automatically track and document the competency and training of your personnel, which is required by ISO 17025. The tool can be used for everything from documenting the simple acknowledgement of reading the company quality manual to setting up multiple choice and true/false questions, proving proficiency on a deeper level. These tests can also incorporate external materials to read, as well as videos to watch. Some organizations also include a step that requires a physical task to be observed and then signed off on by the trainer. The depth and detail of your tests, as well as the percentage of correct answers required to pass a certain assessment are completely up to you. Qualtrax also allows each employee to access his or her own training record – another requirement of the 17025 standard.
The system automatically scores each test, updates and maintains the personnel file for you. You are also able to schedule recurring evaluations, which can relieve the pressure of manually keeping track of when your employees are due to retake a certain test or assessment. Just one more thing that Qualtrax can take off your plate, allowing you to focus on continuous improvement.
We realize that many labs in the startup phase are facing challenges greater than simply managing their accreditation. They need help getting accredited in the first place! To that end, Qualtrax has teamed up with A2LA WorkPlace Training to offer a product aimed specifically at new labs that are trying to get up and running quickly: the 17025 QMS Quickstart.
Introducing the 17025 QMS Quickstart
For labs looking for the fastest path to accreditation, the 17025 QMS Quickstart is an extremely attractive option. We are working hand-in-hand with A2LA WorkPlace Training to bring you a sleek, streamlined quality management platform to get up and running as quickly as possible.
This package includes templates for all of the documentation you will need to meet your accreditation requirements, pre-loaded into the Qualtrax platform. You will still need to write your processes and procedures, but the fill-in-the-blank-style templates (your Quality Manual for example) will ensure you have all the requisite documentation in place, greatly reducing the amount of time you need to spend preparing for your audit and accelerating your path to accreditation. While no quality management system is 100% turn-key, this is as close as it gets!
Not only will you be receiving a package that was designed and vetted by accreditation professionals, you’ll also get a fully functional quality management system with simplified workflows to handle essential tasks like corrective actions, internal audits, risk assessments and more. These workflows are designed to capture the information that your accrediting body will ask for to demonstrate that you are meeting your accreditation requirements.
The other benefit to using the 17025 QMS Quickstart and instituting a quality management system early on is the significant reduction in maintenance requirements. For start-up labs who can’t afford a full-time quality manager, this package includes all the automation necessary to ensure you don’t have to worry about maintaining your compliance as long as you are actively using the processes built into Qualtrax.
Our goal with the 17025 QMS Quickstart product is to help you establish a foundation that you can build on as your processes and your business grow and evolve. It is designed to give start-up labs the minimum requirements necessary to move successfully down the path to accreditation. As your organization grows, Qualtrax will grow with you. The platform you receive with this package is our full-service solution that also includes our more advanced Best-in-Class workflows that will be ready to deploy when the need arises. You will not have to buy additional modules or functionality as your business expands.
Both LIMS and QMS software can be valuable additions to your regulatory tool kit. For labs pursuing or maintaining ISO/IEC 17025 accreditation, Qualtrax can add an invaluable layer of security, while minimizing or eliminating many of the tedious aspects of maintaining your compliance and accreditation.
Many labs have recognized the value, but struggle to find the capital to acquire both systems at the outset. Others are lured in by the promise of a system that can do both. If you come across a vendor like this as you research your options, make sure you’re asking the critical questions: how will this system demonstrate that you’re following the processes and procedures you’ve put in place?
Remember, document management is only a fraction of the information an auditor will be looking for when it comes to your accreditation. Look for a system that can track every step of your process, prevent deviation, document it and make it easily reportable. The more you can automate, the faster and cleaner your audits will be and the less time you will need to spend preparing for them – time you could be using to run samples.