ISO/IEC 17025:2017 Standard Overview

ISO/IEC 17025:2017 Standard

• This standard outlines general requirements for the competence of testing and calibration laboratories.
• The standard is applicable to all organizations performing laboratory activities, irrespective of staff size.
• Laboratories are evaluated on their competence, impartiality, and consistency of operations.
• Customers, regulatory bodies, and accreditation organizations use this standard to assess laboratory competence.

General Requirements

• Impartiality: Laboratories must operate without bias and structured to maintain impartiality.

• Management commitment is crucial to maintaining impartiality.

• Laboratories are responsible for safeguarding their impartiality from commercial, financial, or other pressures.

• Laboratories must identify and address any potential threats to impartiality.

• Confidentiality: Laboratories are responsible for managing all information obtained during testing and calibration activities.

• Confidentiality is secured by legally enforceable commitments.

• Customers are informed about public disclosure of their details beforehand.

Structural Requirements

• Laboratories must be legally distinct (a legal entity).
• Management structure must be identified with overall responsibility for the lab.
• A detailed outline of the lab's intended activities must be documented.
• Lab activities must conform to the standard's demands even when conducted off-site.

Resource Requirements

• Laboratories need sufficient personnel, facilities, equipment and support systems for operation.
• Staff competence, including education, training, and experience, must be documented.
• Procedures must exist for determining employee competence and ensuring appropriate personnel training.
• Laboratories need calibration protocols and labelled equipment to maintain traceability to the International Systems of Units (SI).
• Appropriate equipment must be in place for testing and calibration operations.

Process Requirements

• Procedures are required for reviewing requests, tenders, and contracts to ensure adequacy of resources, and suitability of the methods used.
• Laboratories must validate and document methods employed in testing and calibration processes.
• Procedures related to selecting personnel, training employees, supervising their performance, and authorizing personnel for specific lab tasks need to be documented.
• Procedures for handling test or calibration items must be established to ensure integrity, protection from damage or contamination, and clear identification methods.
• Procedures for evaluating measurement uncertainty are necessary for the validity of the lab's results.

Reporting of Results

• Results must be reviewed and authorized before release, presenting them accurately and clearly.
• Reports should include necessary details like the method used, date of sampling, unique identifiers, etc.
• Detailed reporting requirements are stipulated based on the type of report (e.g., test report, calibration certificate).
• Conformity with established specifications or standards must be reported.
• Reports must document any opinions or interpretations explicitly.