Ensuring The Validity Of Results 17025

Transitioning from ISO/IEC to ISO/IEC. Transitioning from the 2005 Version of ISO/IEC 17025. It may well be missed by many, but the standard now defines in the Definitions section and notes in section 7.7.1 (ensuring the validity of results) that not only inter-laboratory comparisons are integral options but intra. Compare ISO Quality Manual Templates. Save time, build confidence, simplify ISO accreditation.

• Ensuring The Validity Of Results 17025 Form

A study conducted by the Laboratory Accreditation Bureau of noncompliances during accreditation assessments to ISO/IEC 17025—“General requirements for the competence of testing and calibration laboratories” found that the most cited clauses were found in section 5.4—“Methods and method validation.” This article attempts to clarify the intent of section 5.4 to help laboratories better select, validate, and manage their methods, procedures, and instructions. We’ll also look at uncertainty of measurement and how it relates to test or calibration measurements and data control.

The majority of noncompliances found by the Laboratory Accreditation Bureau were based on assessment data collected since 2012. The noncompliances were likely due, in part, to confusion caused by the terms “method” and “procedure,” which are used interchangeably in the standard, whereas in practice they are not. What are methods and procedures?According to ISO/IEC 17025, clause 5.4.1, laboratories must “have and use appropriate methods and procedures.” The conjunction “and” infers that methods and procedures are two separate nouns having different meanings; however, ISO/IEC 17025 uses the words interchangeably, which many find confusing. “Procedures” include sampling, handling, storage, transport, and preparation of items to be tested or calibrated.

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Randy Long works as a calibration program manager at the. His duties include assessment team allocation, assessment package review, assessor evaluation, assessor training, laboratory assessment, and participating in the Technical Advisory Group (TAG). Previously, Long worked at Richard J. As a senior calibration technician and laboratory manager. He was instrumental in helping the company achieve ISO/IEC 17025 accreditation by writing a large portion the company’s ISO 9001 and ISO 17025 (Guide 25) quality systems, as well as the majority of the calibration procedures and measurement uncertainties.

ISO/IEC Required documentation.1.Documentation Requirements “ISO/IEC-”3/17/2018 Prepared by: Mohamed SalamaPage 1 of 10 This document authorized to use by SLC company onlyClause DocumentNo. Requirement P R O4 General requirements4.1 Impartiality4.1.4 The laboratory shall identify risks to its impartiality on an on-goingbasis. This shall include those risks that arise from its activities, or fromits relationships, or from the relationships of its personnel. However,such relationships do not necessarily present a laboratory with a risk toimpartiality.☐ ☒ ☒4.1.5 If a risk to impartiality is identified, the laboratory shall be able todemonstrate how it eliminates or minimizes such risk.☐ ☒ ☒4.2 Confidentiality4.2.1 The laboratory shall be responsible, through legally enforceablecommitments, for the management of all information obtained orcreated during the performance of laboratory activities. The laboratoryshall inform the customer in advance, of the information it intends toplace in the public domain.

Ensuring The Validity Of Results 17025 Form

Except for information that the customermakes publicly available, or when agreed between the laboratory and thecustomer (e.g. For the purpose of responding to complaints), all otherinformation is consider proprietary information and shall be regarded asconfidential.☐ ☐ ☒5 Structural requirements5.1 The laboratory shall be a legal entity, or a defined part of a legal entity,that is legally responsible for its laboratory activities.☐ ☐ ☒5.3 The laboratory shall define and document the range of laboratoryactivities for which it conforms with this document.