IS0 17025: A Challenge and a Best Practice for Laboratories
For those labs that take a comprehensive approach to ISO 17025 compliance, the benefits are significant
What if ISO 17025 wasn’t a standard, but instead was a technology that automated laboratory best practices? What if following the regulations to the letter — often without even thinking about it — actually led to better overall business performance? In that case, it’s likely every business would aggressively deploy that technology.
“That technology” does indeed exist, and it’s commonly known as LIMS, short for a laboratory information management system, an essential data management and enterprise integration tool for managing laboratory workflow, samples, reporting and compliance requirements. And, while many in the oil and gas industry think of LIMS as a way to manage important data, it is, in fact, much more than that. It is a catalyst that is part technology, part discipline and all-encompassing. In other words, when you think of ISO 17025, don’t think compliance, think higher-quality product.
But certainly conforming to ISO 17025 standards is time-consuming, costly and technologically complex. It covers everything from contract review to method validation and quality assurance. One does not simply check a few boxes to stay in compliance; if it were that easy it wouldn’t be so beneficial in the long run. But getting into compliance — and realizing the benefits of doing so — doesn’t need to be overly costly or time-consuming.
Why a LIMS is Critical to ISO 17025 Compliance
Sections 4 and 5 of ISO 17025 are the primary areas of alignment between regulatory compliance and LIMS functionality. In fact, it is now possible to use a LIMS that is preconfigured for compliance; no additional programming or bolt-on modules are required. For an onsite or third-party laboratory in the oil and gas industry, built-in functionality saves time, money and months of aggravation that can be associated with custom software development.
An integrated data management system, such as Thermo Scientific SampleManager LIMS, is designed to mitigate complexity, easing compliance within oil & gas laboratories and, most important, exposing previously unrecognized opportunities for performance improvement. The LIMS is purpose-built to align with each section of ISO 17025, especially “Management Requirements” and “Technical Requirements.”
- 4.1 Organization and Management
Labs must not only meet standards within their own facilities, they are responsible for compliance at third-party facilities and temporary facilities — such as field-based labs — as well. To manage this level of complexity without disrupting daily activity, a LIMS uses a Web services architecture that is both secure and extensible.
- 4.2 Quality System
ISO 17025 not only calls for documentation of quality systems and procedures, it requires that it “be communicated to, understood by, available to and implemented by” appropriate personnel. The LIMS system can be the conduit for quality system documentation and reinforcement.
- 4.3 Document Control
Document control is an important component of a quality system. The LIMS can store relevant documents in nearly any standard format as an attachment, making compliance with document control a natural extension of routine laboratory work.
- 4.4 Review of Request, Tender or Contract
An oil and gas laboratory must demonstrate that it has the requisite experience, capabilities and resources to meet the requirements of the client. Because the LIMS offers a system-wide view of resources, methods, instrument calibration, etcetera, it plays an important role in the contract review process. SampleManager LIMS, for example, pulls in data from operator loading reports to provide real-time insight into operator workload and possible resource conflicts.
- 4.5 Subcontracting of Tests and Calibrations
ISO17025 requires that laboratories are able to “demonstrate” that any subcontractor is “competent to perform the activities in question,” and that it is also in compliance with the standards. When using a LIMS, all this information is stored within comprehensive “supplier tables” for fast, universal access.
- 4.6 Purchasing Services and Supplies
Laboratories are responsible for the quality of all services and supplies that affect the quality of tests or calibrations. With a LIMS, all supplier statuses, including reagents and other consumables, are easily managed using “supplier management” entry screens that feed into real-time reports and dashboards.
- 4.8 Complaints
ISO 17025 requires that laboratories have policies and procedures in place to resolve complaints. With a LIMS, all this information is easily captured and stored within an incident summary, ensuring compliance and providing an historical record for avoiding such issues in the future.
- 4.11 Preventative Action
ISO 17025 includes provisions for prevention, as well complaint resolution. This is one of places where the regulations align with the LIMS “best practices” capabilities.
- 5.2 Personnel
ISO 17025 requires that laboratory management take full responsibility for the ongoing competency of all staff at all stages of testing and analysis. For this, a LIMS is particularly useful, not only for compliance, but also for ensuring that staff remain properly trained and certified.
- 5.4 Test and Calibration Methods Including Sampling
ISO 17025 requires that labs have easily accessible instructions for operation and handling of instruments and test samples, that all methods are appropriate and compliant/current and that personnel have the requisite experience to use the method. The LIMS stores up-to-date inventory and preparation records, usage and expiry data.
- 5.5 Equipment
ISO 17025 makes it clear that all equipment must meet the required performance parameters for its stated use. To accomplish this, the LIMS maintains comprehensive records for each instrument, as well as each of its components and complete calibration history and status.
- 5.7 – 5.9 Sampling Plan, Handling and Transport, Assuring the Quality of Test and Calibration Results
ISO 17025 requires that labs have defined procedures for sampling plans, handling and transportation of samples, as well as the management of calibration items and for ensuring the quality of results. With LIMS it’s possible to create a sampling plan from a template that automates many of the necessary steps.
- 5.10 Reporting the Results
No laboratory would dispute the ISO 17025 requirement that each test or calibration it carries out should be reported “accurately, clearly, unambiguously and objectively.” A LIMS provides a powerful and flexible reporting tool that generates multiple reports from data stored within the system.
ISO 17025 compliance in the oil and gas industry isn’t easy, especially in labs still using paper-based processes, but for those labs that take a comprehensive approach the benefits are significant. Compliance processes can be part of an integrated program that improves overall multi-facility performance and profitability. Whether an oil and gas laboratory starts with regulation as its impetus or simply wants to improve quality, the end result with LIMS is the same: an integrated system that can deliver the best of both worlds. And, with systems pre-configured for the industry, getting up-and-running on the road to compliance and higher performance is only a log-in screen away.
Colin Thurston is Director of Product Strategy, Process Industries at Thermo Fisher Scientific. He may be reached at editor@ScientificComputing.com.