ISO 17025:2005, the international standard for laboratory quality systems. Compliance with this standard provides a globally accepted basis for laboratory accreditation. The standard specifies the Management and technical requirements to be met by testing and calibration laboratories in both their organisation and their Management of quality. Complying with ISO 17025 will enable laboratories to identify where their current operations meet the requirements of ISO 17025 and, in those areas where they do not, it will guide them in developing systems to achieve such compliance.
ISO 17025 standard includes clauses as follows:
Introduction of ISO 17025
The first edition (1999) of this International standard was produced as the result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001,both of which it replaced.
* Scope of ISO 17025
This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
* Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of
* Terms and definitions
The purpose of this document is to give relevant terms and definitions in ISO/IEC 17000.
* Organization requirements
The laboratory or the organization of which it is part shall be an entity that can be held legally responsible.
* Management system
The laboratory shall establish, implement and maintain a Management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programs, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.
* Document control
The laboratory shall establish and maintain procedures to control all documents that form part of its Management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.
* Review of requests, tenders and contracts
The laboratory shall establish and maintain procedures for the review of requests, tenders and contracts. The policies and procedures for these reviews leading to a contract for testing and/or calibration.
* Subcontracting of tests and calibrations
When a laboratory subcontracts work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor.
* Purchasing services and supplies
The laboratory shall have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests.
* Service to the customer
The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer's request and in monitoring the laboratory's performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers.
The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).
* Control of nonconforming testing and/or calibration work
The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer.
The laboratory shall continually improve the effectiveness of its Management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and Management review.
* Corrective action
The laboratory shall establish a policy and a procedure and shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the Management system or technical operations have been identified.
* Preventive action
Needed improvements and potential sources of non conformities, either technical or concerning the Management system, shall be identified. When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored.
* Control of records
The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality records shall include reports from internal audits and Management reviews as well as records of corrective and preventive actions.
* Internal audits
The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the Management system and this International Standard. The internal audit program shall address all elements of the QMS.
* Management reviews
In accordance with a predetermined schedule and procedure, the laboratory's top Management shall periodically conduct a review of the laboratory's Management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness, and to introduce necessary changes or improvements.
* General technical requirements
Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory.
* Personnel requirements
The laboratory Management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. When using staff who are undergoing training, appropriate supervision shall be provided.
* Accommodation and environmental conditions
Laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests and/or calibrations.
* General test and calibration methods and method validation
The laboratory shall use appropriate methods and procedures for all tests and/or calibrations within its scope. These include sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical analysis.
* Selection of methods
The laboratory shall use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes. Methods published in international, regional or national standards shall preferably be used.
* Laboratory-developed methods
The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources.
* Non-standard methods
When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer's requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use.
* Validation of methods
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.
* Estimation of uncertainty of measurement
A calibration laboratory, or a testing laboratory performing its own calibrations, shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations and types of calibrations.
* Control of data
Calculations and data transfers shall be subject to appropriate checks in a systematic manner.
* Equipment requirements
The laboratory shall be furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data).
* Measurement traceability
* Sampling requirements
The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling plan as well as the sampling procedure shall be available at the location where sampling is undertaken.
* Handling of test and calibration items
The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer.
* Assuring the quality of test and calibration results
The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied
* General reporting the results
The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.
* Test reports and calibration certificates
Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so
* Test reports
In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results
* Calibration certificates
In addition to the requirements listed in 5.10.2, calibration certificates shall include the requirements as defined in the standard
* Opinions and interpretations
When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and interpretations have been made. Opinions and interpretations shall be clearly marked as such in a test report.
* Testing and calibration results obtained from subcontractors
Testing and calibration results obtained from subcontractors of ISO 17025
* Electronic transmission of results
In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met (see also 5.4.7).
* Format of reports and certificates
The format shall be designed to accommodate each type of test or calibration carried out and to minimize the possibility of misunderstanding or misuse.
* Amendments to test reports and calibration certificates
Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement: "Supplement to Test Report [or Calibration Certificate], serial number… [or as otherwise identified]", or an equivalent