ISO/IEC 17025:2017 Checklist - Clause 4 & 5

Title Page

Laboratory/Site
Conducted on
Prepared by
Location

Internal Assessment

4. General Requirements

4.1 Impatiality

4.1.1 Laboratory activities • shall be undertaken impartially and structured and safeguarded to ensure impartiality
4.1.2 Laboratory management • shall be committed to impartiality
4.1.3 Laboratory responsibility • commercial, financial or other pressures must not compromise impartiality with regard to laboratory activities
4.1.4 Risk identification the laboratory to undertake this on an on-going basis and include those arising from: • its activities • its relationships • relationships of personnel
4.1.5 Risk mitigation • the laboratory shall demonstrate how risk to impartiality is eliminated or minimized

4.2 Confidentiality

4.2.1 Laboratory responsibility • through legally enforceable commitments, manage all information obtained or created during the performance of laboratory activities • inform the customer in advance of the information it intends to place in the public domain • maintain all customer information as confidential, except for that information the customer makes public or that agreed to be made public
4.2.2 Release of customer information • must not occur unless - when required by law - authorized by contractual arrangements • customer to be notified of information provided (unless prohibited by law)
4.2.3 Customer information from other sources • shall be confidential between the customer and laboratory • the source of this information shall remain confidential to the laboratory
4.2.4 Confidentiality obligations of personnel • shall keep confidential all information obtained or created during the performance of laboratory activities, except as required by law

5. Structural Requirements

5.1 Legal status • the laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible for its laboratory activities
5.2 Laboratory management • identify management that has overall responsibility for the laboratory
5.3 Scope of laboratory activities • the laboratory to define and document the range of activities which it claims conformity to the Standard • cannot include laboratory activities which are provided externally on an ongoing basis
5.4 Conduct of laboratory activities and premises • to be performed to meet the requirements of - the ISO 17025:2017 standard - customer requirements - regulatory authorities • activities include those conducted at - permanent facilities - sites away from permanent facilities - temporary or mobile facilities - customer premises
5.5 Structure, personnel and documentation a) define the laboratory’s place in any parent organisation, the relationship between management, technical operations and support services b) specify the responsibilities, authorities and interrelationships of those who manage, perform or verify work affecting the results of laboratory activities c) document procedures to the extent necessary to ensure consistent conduct of laboratory activities and the validity of results
5.6 Personnel authorities and resources a) available to implement, maintain and improve the management system b) able to identify deviations in the management system or laboratory activity procedures c) able to initiate actions to prevent or minimize deviations d) report to laboratory management the performance of the management system and needs for improvement e) ensure the effectiveness of laboratory activities
5.7 Laboratory management responsibilities a) ensure communication on the effectiveness of the management system and meeting customers’ and other requirements b) ensure integrity of the management system is maintained when changes are planned and implemented