Meeting the ISO/IEC 17025:2017 compliance standards is essential for testing laboratories. Not only does this regulation dictate lab competency, but it also helps demonstrate that your laboratory is performing at par with your internationally accredited peers. In this article, we’ll dive into the significance of ISO/IEC 17025 as well as explore five ways your laboratory can simplify this compliance process. Read on to learn more.
What Does ISO/IEC 17025 Compliance Require?
ISO/IEC 17025:2017 is the international standard that sets the requirements for laboratory competency in testing and calibration. Getting ISO/IEC 17025 certified essentially means that your lab is recognized to be technically proficient in testing and calibration, helping your company facilitate easier acceptance of test results and minimize the need for retesting. When broken down, this ISO standard contains two main sections:
- Management requirements, which are primarily related to the operation and effectiveness of the quality management system within the laboratory
- Technical requirements, which are primarily related to the competence of staff and calibration of equipment
In order to fulfill ISO 17025 requirements, your company needs to prove compliance in both of these categories during an accredited third-party audit. Unfortunately, this process can be convoluted and time consuming. Let’s look at five compliance tips to help get your company audit ready and ensure you pass with flying colors.
How Can Your Company Simplify ISO/IEC 17025 Compliance?1. Document your laboratory and employee competencies
Since ISO 17025 is all about testing and calibration competencies, your auditor is going to ask for concrete proof of your lab’s capabilities in these categories. So, as your company performs its day-to-day activities, be sure to document any procedure that contributes to:
- Consistent processes
- Valid results
- Achievement of overarching lab goals
This can include validation documentation, equipment maintenance, risk assessments, internal audits, safety, etc.
Additionally, to ensure consistent laboratory operation and improvement, monitor and document your employee competence. Set tangible quality goals for each job description under your company umbrella and decide on various key performance indicators (KPIs) to help you track whether your employees are meeting their necessary benchmarks. When facing ISO/IEC 17025 accreditation, having consistent methods and valid lab results is not enough; you need to be able to prove to an auditor that your processes and employees meet the expectations of ISO.
The next piece of the compliance puzzle is your laboratory’s quality documentation. On top of proving your competencies, you’ll also be asked to show that your organization performs work that meets a certain quality standard. These documents often include, but are not limited to, your quality manual, work instructions, and procedures.
The most important of these quality documents that your company should focus on compiling is your quality manual. If structured and written well, this manual provides an efficient way to reference and link policies, systems, documents, and records of your laboratory processes. Essentially, this manual will be the basis of your ISO 17025 audit, pointing your auditor in the right direction to find the information they need to prove compliance. The key to creating a successful quality manual is finding the balance between simplicity and detail so that your auditor can fully grasp your lab’s quality processes without routing through excess documentation.3. Keep your employee training up to date
Under ISO 17025, there are very strict regulations that outline exactly what they expect in terms of employee training. Your employees need to be comprehensively trained on your policies and procedures system and you need to be able to demonstrate that training during your audit. To do so, your training records need to be comprehensive and accessible, and you need to be prepared to prove that each employee has completed their required training activities as well as any necessary follow-up trainings. Relying on department and team leaders to track employee training is never enough, you need centralized record keeping that encompasses your entire organization.4. Perform an internal audit
Internal audits are a great way to prepare for an ISO inspection as well as ensure your company’s processes are meeting your quality standards. The overarching goal of an internal audit is to guarantee that your company’s policies and procedures are followed and to alert you of any holes in policy compliance so that they can be resolved before they cause more serious problems.
In terms of ISO 17025, an internal audit can help your company spot holes in its quality procedures and remedy high-risk areas of your lab processes rather than spending time on areas that are already perfectly compliant. Even beyond just being a helpful tool, accredited auditors are looking for labs to conduct internal audits as part of ISO 17025 Section 4.14:
When planning an ISO 17025 internal audit, these are some of the major criteria you should consider:
- Personnel training and competency (clause 6.2)
- Laboratory facilities and environmental conditions (clause 6.3)
- Sampling and handling of calibration items (clause 7.3 and 7.4)
- Traceability of measurement results (clause 6.4 and 6.5)
- Internal control procedure and acceptability of quality control results (clause 7.7)
- Technical Records (clause 7.5 and 7.11)
The last, and arguably, most important step to guaranteeing ISO 17025 compliance is implementing a strong QMS. In addition to the requirements mentioned above, ISO 17025 outlines strict standards for the way a quality management system operates. When being audited, it is essential that your company can demonstrate how you function within those regulations. With a capable quality management system, employees can assign, track, and verify action items, set up training requirements, and automate workflows to ensure that non-compliance issues are eliminated.
Quality management systems empower decision makers to track who oversees a document, where it is in its lifecycle, who has accessed a document, who has printed it, and who is responsible for maintaining and seeing it to its conclusion. It can also help to guarantee that the highest quality business processes are followed to ensure you are meeting the needs of customers, stakeholders, and ISO requirements. Your entire quality management system can be implemented through the software to quickly and easily prove ISO compliance every step of the way, before an auditor even steps in the door.
However, the wrong QMS software can make meeting ISO 17025 standards more difficult. Picking a system that is either too generic or too robust for your company can greatly hinder your quality process and cause you to fail certification – no matter how prepared you think you are. The right QMS provides value from day one by making it easier for you to meet ISO 17025 requirements: from quality processes to document control, training, and risk management. It is comprehensive enough to meet all the requirements and user-friendly enough that your staff benefits from its services because they understand it.
Monitoring your laboratory’s processes and quality procedures to help you meet ISO 17025 benefits both you and your customers. It offers performance benchmarks, saves your company time by reducing nonconformance, and gives your customers the confidence that they’re working with a capable organization. In order to make this process less confusing, follow the steps we’ve outlined here today: gather your quality documentation, keep employee training up to date, document competencies, perform an internal audit, and implement a strong Quality Management System (QMS).
Check out our other resources on laboratory compliance and meeting ISO standards:
- How to Prepare for a Virtual Laboratory Audit
- The 5 Fastest Ways to Fail an ISO Audit
- How Artificial Intelligence is Predicted to Transform the Lab Industry
- How to Prepare for and Resolve a Pharmaceutical Compliance Crises
- 5 Ways to Prepare For The New UK Medical Device Regulations
Contact DocXellent today to learn about how our Quality Management Software, ENSUR, can make meeting ISO 17025 easier for your laboratory.