ISO 17025 Certification

Clause 1 outlines the essential requirements of the ISO 17025 standard for the competence, impartiality, and consistent operation of laboratories involved in testing, calibration, and sampling. It applies universally to all laboratories, regardless of size or scope, and encompasses testing, calibration, and sampling activities using standardised, non-standardised, and internally developed methods.

Clause 2 specifies the key documents required for the correct application of ISO 17025. These references provide additional guidelines, rules, or characteristics for various activities or their outcomes, ensuring consistency and adherence to recognised standards. Importantly, the sole normative reference in ISO 17025:2017 is ISO/IEC Guide 99, which is the International Vocabulary of Metrology (VIM) – Basic and general concepts and associated terms

Clause 3 defines specific technical and general terms relevant to the standard, ensuring a consistent understanding among all users. This uniformity is crucial for clear communication and compliance. The clause refers to terms and definitions found in ISO/IEC Guide 99 (VIM) and ISO/IEC 17000.

Clause 4 of the ISO 17025 requirements emphasises the need for impartiality in all laboratory operations, underscoring the importance of delivering unbiased results. It also covers maintaining the confidentiality of customer information, except where disclosure is required by law. Laboratories must be accountable for all their activities, continuously identifying and managing risks to impartiality.

Clause 5 details the organisational structure necessary for effective laboratory operations. Laboratories must clearly define and document the roles and responsibilities of management and key personnel involved in testing and calibration activities. Additionally, laboratories should document their scope of activities, including any conformity assessments they do not perform, and meet specific requirements to ensure independence and impartiality if they are part of a larger organisation.

Clause 6 specifies the requirements for human resources, the physical environment of the laboratory, specialised equipment, and measurement traceability. It also covers the management of products and services provided by external suppliers, ensuring all necessary resources are maintained to support reliable testing and calibration.

Clause 7 outlines the protocols for handling inquiries, requests, and contracts, as well as selecting and validating methods used in testing and calibration. It addresses procedures for sampling, managing test items, and ensuring the quality of laboratory outputs to guarantee reliable and accurate results.

Clause 8 provides laboratories with the option of implementing either a comprehensive management system aligned with ISO 9001 or a simpler system tailored specifically to testing and calibration activities. Regardless of the system chosen, it must effectively support and demonstrate consistent fulfilment of the requirements in Clauses 4 to 7, focusing on continuous improvement and operational efficiency to maintain lab accreditation.