What are the Minimum Requirements for ISO/IEC 17025?

An assessing, sampling, or calibration laboratory of any kind must complete the process of accreditation to provide testing as a professional service. When it comes to accreditation, the business must demonstrate conformity with the ISO 17025 standard. The profile of the organization is added to the necessary competence and quality thanks to compliance with the ISO 17025 standard. A strong foundation is necessary for the internal organization of managing the testing laboratory. The ISO/IEC 17025 is used by laboratories as a Quality Management System (QMS) to enhance the way they operate and enable more precise diagnostics, effective treatment, and decreased errors in the laboratory process. This is in line with the ultimate objective of laboratory medicine, which is to boost an organization's QMS generally to guarantee patient safety.

Requirements for ISO 17025

Companies must be aware of the numerous ISO/IEC 17025 requirements to create the required compliance protocols that apply to all departments. First off, the 2017 edition differs significantly from the 2005 version in some significant ways. Among them are the following:

• The provisions for General Requirements and Structural Requirements have taken the place of the Management Requirements and Technical Requirements sections that were previously present in the 2005 version.
• The Resource, Process, and Management System Requirements were included in Clauses 6 to 8.

With this, it's important to note that the 2017 version now outlines the fundamental standards needed to direct laboratories in their activities, particularly in assuring their expertise and objectivity.

The following Clauses and Elements Comprise the ISO/IEC 17025 Standard:

1. Discusses the standard's reason, who can use it, and what ISO 17025 for Normative References is.
2. Highlights briefly the references to specific manuals and standards contained in ISO 17025
3. Vocabulary and Definitions - Describes the language used in the standard.
4. The two main requirements of the standard, known as the general requirements, are as follows:
   • Integrity (laboratories won't allow any commercial, financial, or other pushing elements to distort, compromise, or alter the calibers of the test results.
   • Confidentiality (laboratories must guarantee that the findings and other significant data are kept confidential)
5. Outlines the basic organizational framework and elements, processes, and adherence to an effective management system for a laboratory in structural requirements.
6. Requirements of Resource: It includes 6 clauses that specify needy parts in laboratory management have
   • Basic
   • Personnel
   • Equipment
   • Products and services provide externally
7. Process Requirements - Describes the 11 essential procedures for enhancing and putting into practice the requirements of the standard:
   • Examining requests, proposals, and contracts
   • Methods selection, evaluation, and validation
   • Sampling
   • Handling of calibration or test items
   • Technical documents
   • Measuring uncertainty evaluation
   • Ensuring the accuracy of the finding
   • Publishing of findings
   • Complaint
   • Noncompliant work
   • Management of data and information

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