ISO 17025 (also sometimes labeled as ISO/IEC 17025) is an international standard that establishes requirements “for the competence of testing and calibration laboratories.” The standard was first published in 1999 by the International Organization of Standardization (ISO), with the goal of bringing product testing labs around the world into step with one another.
The Origins of ISO 17025
To help organizations better understand the ISO 17025 standard, the United Nations Industrial Development Organization (UNIDO) compiled Complying with ISO 17025, a “practical guidebook” concerning the laboratory testing and compliance standard. In the document, UNIDO noted that the standard was implemented, in part, to help developing nations to compete with the rest of the world in product development and testing. Specifically, developing nations faced issues “in that their measurements and product certificates [were] often not accepted in other countries.”
How It Works
To help developing nations enter a range of different product development marks, the International Laboratory Accreditation Cooperation developed “a global conformity assessment system for testing laboratories.” To have their work accepted by other countries, laboratories can become accredited based on the ISO 17025 standard.
This accreditation process is carried out by “nationally recognized laboratory accreditation bodies,” which in turn have agreements with other similar bodies in other countries. The result is a system that essentially breaks down international borders between testing and calibration laboratories.
The ISO 17025 laboratory testing and compliance standard includes a range of different requirements, split into 5 different categories. These categories include Scope, Normative Resources, Terms and Definitions, Management Requirements, and Technical Requirements. These different categories lay forth a variety of different rules and standards for testing and calibration laboratories—including testing and calibration standards, staff competence, equipment standards, quality management, and more.
The ISO 17025 Laboratory Document Control Process
One of the key laboratory standards laid forth by ISO 17025 concerns document control and management. The ISO 17025 document management requirements relate to both paper and electronic files and call upon laboratories to establish procedures for the control and security of those documents.
The following types of documents should be a part of the ISO 17025 document control standard:
- Documents that “give work instructions so that staff have a source of reference to enable them to conduct their work properly and consistently.” These documents may include instruction manuals, files highlighting lab standards and policies, or otherwise instructive documents.
- Documents used by laboratory personnel to record data and other findings. These files may include reports and other similar test-related files.
ISO 17025 doesn’t just highlight the types of documents that must be controlled in a lab setting. On the contrary, the ISO laboratory document control standard also stipulates a clear-cut process for document access, revision, accessibility, review, approval, deletion, and storage.
Here are most of the key document control requirements in the ISO 17025 standard:
- Review: ISO 17025 requires that all documents be reviewed and approved by “defined management personnel” at the laboratory.
- Revision: Files must be flagged and organized based on revision and completion status. All revisions or amendments must also be reviewed and approved by top personnel. When amendments are made, they must be clearly highlighted (tracking of changes) and applied to every copy of a report or file. Mistakes in old documents, meanwhile, should not be deleted, but instead crossed out so that readers can see them, but know they are inaccurate.
- Organization: A document control system compliant with ISO 17025 document management requirements must include a range of organization data for each file—including publication or filing date, revision dates, page numbering, and more.
- Accessibility: Documents should be easily available and accessible wherever they are needed. In most laboratories, this rule just means that staff can access documents from the same place where they are carrying out experiments, testing, calibration, and other operations.
- Document deletion or storage: Files that are inaccurate or otherwise irrelevant should be immediately deleted. Other documents should be archived and backed up in a secure fashion, where they are safe from prying eyes but still retrievable by authorized personnel.
Using eFileCabinet to Achieve ISO 17025 Compliance
The benefits of becoming ISO 17025 accredited are obvious for laboratories that specialize in product testing or calibration. By matching up with international standards, a laboratory will be able to lock down more clients and customers and do business on an international scale.
Before a laboratory can become ISO 17025 accredited, however, it must first ensure that it is compliant with the regulations laid forth by the international standard. Reaching ISO 17025 compliance is a complicated process that involves a wide variety of considerations and laboratory policy changes. However, when it comes to ISO 17025 document management requirements, eFileCabinet can help testing and calibration laboratories bring their document control systems into step with the standard.
Indeed, with the eFileCabinet document management system, your lab can easily meet each of the document control requirements stipulated by ISO 17025. Here are just a few of the features that eFileCabinet can bring to the table for a testing or calibration laboratory:
- Easy Cloud or desktop storage of reports, forms, test files, instruction manuals, policies, relevant legislation, and other key documents
- Role-based security permissions, to help simplify the document review and approval process
- File sync, to ensure that revisions are applied to all copies of a document
- Secure file storage and encryption, both in transit and at rest (File storage redundancy guarantees that documents are never lost.)
- Desktop and mobile access, so that documents are always accessible—no matter where lab personnel are carrying out operations
- Intuitive folder library systems and text search, so that files are always easy to find
Looking to ensure ISO 17025 compliance at your laboratory? Get eFileCabinet today to ensure compliance with the standard’s document management requirements. You can learn more about the product, view our different pricing plans, or get in touch with us directly by filling out the form on this page for a 15-minute demo.