A Guide To Iso Iec 17025 Standard For Laboratory Accreditation

By Author: Emma
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The International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO) developed the international standard ISO/IEC 17025:2017. Laboratory clients, regulation boards, accreditation agencies, and organizations utilize it to check, acknowledge, and guarantee the competence, impartiality, and consistent operation of laboratories in their testing and calibration procedures. It is made up of several requirements and guidelines.

A Quality Management System (QMS) that helps laboratories enhance their operations by enabling more precise evaluation, effective treatment, and fewer errors in the laboratory process is ISO/IEC 17025:2017. Improving an organization's overall QMS to ensure patient safety is the ultimate goal in laboratory medicine.

What Makes ISO 9001 and ISO 17025 Different From Each Other?
QMS is the focus of both ISO 9001 and ISO 17025. The requirements and scope, however, are what distinguish them. Testing and calibration labs are the only ones subject to ISO 17025 regulations. Meanwhile, businesses across all sectors are subject to ISO 9001.

What Makes ...
... ISO 17025 Important?
Creating a QMS that meets an organization’s needs is strongly advised across all industries. The purpose of this is to enhance the effectiveness and calibre of laboratory safety processes, systems, and practices. It is closely related to ISO 15189, which is the ISO standard for laboratories that specialize in medicine.

The ISO 17025:2017 standard, which is currently in use, is essential for creating policies and procedures that adhere to Good Laboratory Practices (GLP). Retesting may eventually be avoided by developing reproducible testing and calibration procedures as a result of upholding ISO 17025 requirements.

ISO 17025: Is It Required?
Although it is unnecessary to follow ISO 17025, getting certified or certified has several advantages. Organizations can match what is considered knowledgeable and reliable in the market by adhering to globally accepted standards. Therefore, this contributes to a considerable improvement in industry and public confidence in the laboratories' work.

Which Requirements Apply to ISO 17025?
Understanding the different ISO 17025 requirements is crucial for enterprises to set up the required compliance procedures universally. First off, compared to the 2005 edition, the 2017 version has some significant alterations. The following are a few of these:
• In the 2005 edition, the clauses for General Requirements and Structural Requirements were included in place of the Management Requirements and Technical Requirements clauses.
• The requirements for the management system, process, and resources were described in clauses 6 through 8.
It's important to note that, in light of these, the 2017 edition now outlines the general standards that must direct laboratories' operations, particularly about guaranteeing their impartiality and competency.

The following clauses and elements make up the ISO 17025 standard;
• Scope: Explains the purpose of the standard, its applicability, and what ISO 17025 for
• Normative References: Provides a brief explanation of how specific standards guidelines are referenced in ISO 17025.
• Definitions and Terminologies: Provides definitions for the terms used in the standard.
• General Requirements: Covers the standard's two primary requirements, which are:
 Impartiality (labs will not allow for the manipulation, compromise, or alteration of the quality of the test results by commercial, financial, or other pressures)
 Confidentiality (laboratories must guarantee the privacy of the results and other important data)
• Structural Requirements: Outlines the fundamental elements and organizational structure of a laboratory, as well as its processes and compliance with an effective management system.
• Resource Requirements: Includes the six provisions outlining the essential elements that a laboratory has to have:
 The General
 personnel
 Facilities and surroundings
 Equipment
 Traceability of metrology
 Services and Products Offered by Outside Parties
• Process Requirements: Describes the 11 essential steps to enhance and apply the standard's criteria more effectively:
 Examining contracts, tenders, and requests
 Selection, validation, and verification of techniques
 The sampling process
 Managing test or calibration materials
 Technical documents
 An assessment of measurement uncertainty
 Making sure the results are valid
 Outlining the outcomes
 Reported issues
 Unconventional labour
 Management of information and data
• Management System Requirements: Highlights the two substitutes accessible to companies that meet the standard, their differences, and the different tasks that fall under this section:
 Documentation for the management system
 Management system document control
 Record control
 Responses to opportunities and hazards
 Advancement
 Corrective measures
 Internal evaluations
 Reviews of management

The ISO/IEC 17025 accreditation standard is widely accepted for testing and calibration labs. Organizations can use the ISO 17025 audit checklist to help them implement laboratory management systems by verifying certification and accreditation processes. Quick accreditation and adherence to ISO 17025 standards are guaranteed by its more than 200 audit questions for departmental and clause-wise criteria.

Link: ISO 17025 audit checklist