This guide will walk you through the following: what the international standard ISO 17025 covers, its importance, the specific requirements, and how you can help ensure compliance with this global standard using a digital tool.
ISO/IEC 17025:2017 is the international standard created by the International Organization for Standardization (ISO) together with the International Electrotechnical Commission (IEC). It is comprised of various requirements and guidelines used by laboratory customers, regulation boards, accreditation authorities, and organizations to verify, recognize, and ensure the competency, impartiality, and consistent operation of laboratories in their testing and calibration processes.
The ISO/IEC 17025:2017 serves as a Quality Management System (QMS) for laboratories to improve their process of facilitating more accurate diagnostics, efficient treatment, and reduced errors in the laboratory process. This coincides with the ultimate goal in laboratory medicine which is to improve an organization’s overall QMS toward ensuring patient safety.
ISO 17025 and ISO 9001 are both intended for QMS. But what sets them apart is the scope and the requirements. The requirements for ISO 17025 are specific to testing and calibration laboratories only. Meanwhile, ISO 9001 applies to organizations in all industries.
Across industries, it’s highly encouraged to create a QMS that best fits the needs of an organization. This is to help improve the quality and efficiency of laboratory safety practices, processes, and systems. It goes hand in hand with ISO 15189:2012, the ISO standard for medical-specific laboratories.
The standard’s current version which is the ISO 17025:2017 is key to establishing guidelines and protocols that are aligned with Good Laboratory Practices (GLP). Ultimately, maintaining compliance with ISO 17025 standards can lead to creating replicable testing and calibration processes, thus eliminating the need for retesting.
While ISO 17025 isn’t required, there are numerous benefits to gaining an accreditation or certification. Following internationally recognized standards allows organizations to become at par with what’s considered competent and trusted in the industry. Hence, this helps significantly increase the public’s level of confidence and the trust of peers in the laboratories’ work.
It’s important for organizations to be aware of the various ISO 17025 requirements so that they can establish the necessary compliance protocols across the board. For starters, there have been notable changes introduced in the 2017 version from its previous 2005 version. Some of these include the following:
The Management Requirements and Technical Requirements clauses previously included in the 2005 version were replaced with the clauses for General Requirements and Structural Requirements.
Clauses 6 to 8 detailing the Resource, Process, and Management System Requirements were added.
With these, it’s worth mentioning that the 2017 version now specifies the general requirements needed to guide laboratories in their operations, especially when it comes to ensuring their competence and impartiality.
The ISO 17025 standard is comprised of the following clauses and elements:
Scope – Discusses the objective of the standard, who can use it, and what ISO 17025 is for
Normative References – Highlights brief details on how certain guides and standards are referenced in ISO 17025
Terms and Definitions – Defines the terminology used in the standard
General Requirements – Covers the two main requirements of the standard which are:
Impartiality (laboratories won’t let any commercial, financial, or other pressuring factors manipulate, compromise, or alter the quality of the testing results)
Confidentiality (laboratories are required to ensure that the results and other key information are kept private)
Structural Requirements – Outlines a laboratory’s basic organizational structure and components, its processes, and its adherence to an efficient management system
Resource Requirements – Contains the 6 clauses that specify the necessary components a laboratory must have:
General
Personnel
Facilities and environmental conditions
Equipment
Metrological traceability
Externally provided products and services
Process Requirements – Details the 11 key processes on how to improve and implement the efficiency of the standard’s requirements:
Review of requests, tenders, and contracts
Selection, verification, and validation of methods
Sampling
Handling of test or calibration items
Technical records
Evaluation of measurement uncertainty
Ensuring the validity of results
Reporting of results
Complaints
Nonconforming work
Control of data and information management
Management System Requirements – Emphasizes the two options available for organizations complying with the standard, the differences between the two, and the various activities involved in this section:
Options
Option A – Applies to laboratories that have separate QMS from any other management system
Option B – Applies to laboratories that are part of larger organizations or if they have their own established management systems aligned with ISO 9001:2015
Management system documentation
Control of management system documents
Control of records
Actions to address risks and opportunities
Improvement
Corrective actions
Internal audits
Management reviews
Even if the standards and requirements are released by the ISO and the IEC, third-party enforcement agencies are in charge of implementing and monitoring compliance. They conduct audits on how an organization’s QMS when it comes to laboratory testing and calibration aligns with industry standards set out in the ISO 17025 standard.
Why Get an ISO 17025 Certification
Gaining an ISO 17025 certification merits an organization the following benefits:
Proactive culture of safety
Optimized quality management
Established credibility
Improved customer confidence
To get ISO 17025-certified, follow the practical steps outlined in our checklist guide.
Making sure that your workers, managers, and leaders are well-informed and skilled in laboratory safety and quality practices is key to building a sustainable system of industry-standard processes. Provide ample training programs so that ISO 17025 compliance measures can be improved, strictly enforced, and maintained. Along the way, encourage employees to always practice putting consumer safety and legal obligations in mind and at the heart of what they do.
Mitti (by SafetyCulture) is a powerful, mobile-first operations platform used in digital audits and overall compliance monitoring to help organizations standardize laboratory practices, maintain quality systems, and ensure compliance with the ISO 17025 standard. Beyond using an ISO 17025 checklist, auditors, laboratory supervisors, and leadership teams can maximize Mitti (by SafetyCulture)’s features by doing the following:
Download or customize this ISO 17025:2017 checklist from our Public Library to help you ensure every requirement is accounted for and nothing is overlooked.
Conduct regular internal audits by setting up inspection schedules to monitor all processes involved in maintaining ISO 17025 compliance.
Capture compliance issues during audits and inspections so that the teams and employees responsible can create corrective actions in a timely manner.
Streamline reporting and recordkeeping protocols so that everything is documented and ready for presentation during the third-party audit.
Benchmark performance and determine areas for improvement to ensure continued compliance using analytics.
Organize and store process documentation in Mitti (by SafetyCulture)’s secure cloud storage for easier and efficient retrieval once needed during audits.
Keep Persons-in-Charge (PICs), leaders, workers, ad other stakeholders in the loop of all safe and quality laboratory processes and updates via Heads Up.
