What Is ISO/IEC 17025? Laboratory Accreditation Requirements
ISO/IEC 17025 is the international standard that specifies general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. The current edition is ISO/IEC 17025:2017, published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
The standard addresses the factors that influence a laboratory’s ability to produce valid results. These include personnel competence, facilities, equipment, metrological traceability, testing and calibration methods, technical records, reporting, and management system controls.
ISO/IEC 17025 applies to the laboratory performing testing or calibration. It does not establish the safety, quality, or performance requirements that a particular product must meet. Those requirements come from applicable regulations, product standards, specifications, and test methods.
For example, a product standard may specify a method for measuring tensile strength, corrosion resistance, coating thickness, or another characteristic. ISO/IEC 17025 establishes requirements relevant to the laboratory’s competence and operation when carrying out that work.
What Is ISO/IEC 17025?
ISO/IEC 17025 specifies requirements that laboratories use to demonstrate competence, impartiality, and consistent operation.
Reliable laboratory testing depends on several connected factors. Personnel need the appropriate competence, equipment must be suitable for its intended use, methods need to be properly selected and implemented, and environmental conditions may need to be controlled. Laboratories also need appropriate technical records and procedures for monitoring the validity of their results.
ISO/IEC 17025 therefore addresses both the technical requirements for laboratory activities and the management system needed to support their consistent operation.
Its requirements cover areas including:
- Impartiality and confidentiality
- Organizational structure and responsibilities
- Personnel competence
- Facilities and environmental conditions
- Equipment
- Metrological traceability
- Externally provided products and services
- Selection and use of methods
- Sampling
- Handling of test and calibration items
- Technical records
- Measurement uncertainty
- Validity of results
- Reporting
- Complaints and nonconforming work
- Management system controls
The standard can be applied across many technical fields without prescribing the individual test methods that a laboratory must use.
Who Does ISO/IEC 17025 Apply To?
ISO/IEC 17025 applies to organizations performing testing, calibration, and sampling associated with subsequent testing or calibration.
It can be used by laboratories regardless of their size or organizational structure, including:
- Independent third-party laboratories
- In-house laboratories
- Calibration laboratories
- Government laboratories
- Research laboratories
- Laboratories operated by manufacturers or other organizations
The standard is also applicable across different technical disciplines. Depending on its activities, a laboratory may test materials, chemicals, consumer products, electrical products, textiles, coatings, packaging, automotive components, or other products and materials.
The requirements that apply in practice depend on the laboratory activities being performed.
What Are the Requirements of ISO/IEC 17025:2017?
The principal requirements of ISO/IEC 17025:2017 are organized into Clauses 4 through 8:
- Clause 4: General Requirements
- Clause 5: Structural Requirements
- Clause 6: Resource Requirements
- Clause 7: Process Requirements
- Clause 8: Management System Requirements
Together, these clauses establish the organizational, technical, and management controls expected of a competent laboratory.
Clause 4: General Requirements
Clause 4 addresses impartiality and confidentiality.
Laboratory activities must be undertaken impartially. The laboratory is required to identify risks to impartiality on an ongoing basis and address those risks where they are identified.
Potential risks can arise from ownership, governance, management, personnel, shared resources, finances, contracts, marketing activities, or other relationships connected with the laboratory.
Confidentiality is also covered under Clause 4. Laboratories are responsible for managing information obtained or created during laboratory activities and protecting confidential information according to applicable commitments and requirements.
These controls help protect the integrity and independence of laboratory activities and results.
Clause 5: Structural Requirements
Clause 5 establishes requirements for the organizational structure and responsibilities of the laboratory.
The laboratory must be a legal entity, or a defined part of a legal entity, that is legally responsible for its laboratory activities.
It must identify the management that has overall responsibility for the laboratory and define its organizational and management structure. This includes the relationships between management, technical operations, and relevant support services.
Responsibilities, authorities, and relationships also need to be defined for personnel involved in managing, performing, or verifying work that can affect laboratory activities.
A clear structure ensures that responsibility for laboratory operations can be identified and maintained.
Clause 6: Resource Requirements
Clause 6 covers the resources necessary to perform laboratory activities competently.
These requirements address personnel, facilities and environmental conditions, equipment, metrological traceability, and externally provided products and services.
Personnel
Personnel must have the competence required to perform the laboratory activities for which they are responsible.
The laboratory needs to establish competence requirements for functions that can influence laboratory results. Depending on the role, these may involve education, qualifications, training, technical knowledge, skills, and experience.
Personnel also need appropriate authorization for the laboratory activities they perform.
Facilities and Environmental Conditions
Facilities and environmental conditions must be suitable for laboratory activities and must not adversely affect the validity of results.
Depending on the type of testing or calibration, relevant conditions may include temperature, humidity, dust, vibration, contamination, electrical supply, or electromagnetic interference.
Where environmental conditions can affect results, appropriate requirements need to be documented, monitored, controlled, and recorded.
Equipment
Laboratories must have access to the equipment required for the correct performance of laboratory activities.
This can include measuring instruments, software, measurement standards, reference materials, reagents, apparatus, and other equipment capable of influencing results.
Equipment must be suitable for its intended use and appropriately maintained. Calibration is required where measurement accuracy or measurement uncertainty affects the validity of reported results, or where calibration is necessary to establish metrological traceability.
Metrological Traceability
Where applicable, laboratories need to establish and maintain metrological traceability of measurement results.
This involves a documented, unbroken chain of calibrations, with each calibration contributing to measurement uncertainty, linking measurement results to an appropriate reference.
Where technically possible, metrological traceability is established to the International System of Units (SI).
Externally Provided Products and Services
Laboratories may rely on external products or services that affect laboratory activities.
These can include calibration services, reference materials, equipment maintenance, proficiency testing services, or laboratory activities provided externally.
ISO/IEC 17025 requires appropriate controls for defining requirements and evaluating, selecting, monitoring, and re-evaluating relevant external providers.
Clause 7: Process Requirements
Clause 7 addresses the processes used to accept, perform, evaluate, control, and report laboratory work.
It covers much of the laboratory’s day-to-day technical activity.
Review of Requests, Tenders, and Contracts
Before accepting work, a laboratory needs to confirm that customer requirements are adequately defined and that it has the capability and resources to meet them.
The laboratory also needs to determine that appropriate methods are selected and that any differences between the request and the eventual contract are resolved.
This review establishes the technical requirements of the work before laboratory activities begin.
Selection, Verification, and Validation of Methods
Laboratories must use appropriate methods and procedures for their activities.
Methods can come from international, regional, or national standards, recognized technical organizations, scientific publications, equipment manufacturers, customer requirements, or laboratory-developed procedures.
When introducing a method, the laboratory needs to verify that it can properly perform the method before routine use.
Methods requiring validation must be validated sufficiently for their intended use. This may apply to laboratory-developed methods, methods used outside their intended scope, and standard methods that have been modified.
Sampling
Where a laboratory performs sampling associated with subsequent testing or calibration, it must have an appropriate sampling plan and method.
Relevant sampling information needs to be recorded as part of the laboratory’s technical records.
Handling of Test and Calibration Items
Laboratories need procedures for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test and calibration items.
Items need to be identified appropriately while under the laboratory’s responsibility to prevent confusion and maintain traceability.
Any abnormal conditions or deviations identified when an item is received should also be addressed appropriately.
Technical Records
Technical records must contain sufficient information to support the laboratory activity and, where possible, allow the activity to be repeated under conditions close to the original.
These records may include original observations, data, calculations, dates, personnel involved, and other information relevant to the activity.
Changes to technical records must also remain traceable.
Evaluation of Measurement Uncertainty
Measurement uncertainty is an important consideration in ISO/IEC 17025.
Calibration laboratories are required to evaluate measurement uncertainty for their calibration activities.
Testing laboratories also need to evaluate measurement uncertainty where applicable. The extent of the evaluation depends on the test method and the factors that can influence the result.
Understanding measurement uncertainty helps a laboratory evaluate the confidence associated with measurement results where it is relevant to the activity.
Ensuring the Validity of Results
Laboratories must have procedures for monitoring the validity of their results.
Depending on the laboratory activity, appropriate monitoring can include:
- Reference materials or quality control materials
- Intermediate checks on measuring equipment
- Replicate testing or calibration
- Retesting of retained items
- Review of reported results
- Proficiency testing
- Interlaboratory comparisons
Monitoring data should be recorded and analyzed so that trends or problems can be identified and appropriate action taken where necessary.
Reporting of Results
Results must be reviewed and authorized before release.
Laboratory reports must present results accurately, clearly, unambiguously, and objectively. They also need to contain the information required by the applicable method and any information agreed with the customer.
Specific reporting requirements vary depending on whether the laboratory activity involves testing, calibration, or sampling.
Complaints and Nonconforming Work
ISO/IEC 17025 requires laboratories to maintain a documented process for receiving, evaluating, and making decisions on complaints.
Laboratories also need procedures for dealing with nonconforming work.
When laboratory activities or results do not conform to established procedures or agreed requirements, the laboratory must evaluate the significance of the issue and determine the appropriate action.
Clause 8: Management System Requirements
Clause 8 addresses the management system that supports consistent laboratory operation.
Its requirements cover:
- Management system documentation
- Control of documents
- Control of records
- Actions addressing risks and opportunities
- Improvement
- Corrective actions
- Internal audits
- Management reviews
The laboratory needs to maintain the documentation and records necessary to support consistent implementation of its activities.
When a nonconformity occurs, corrective action may involve controlling and correcting the problem, determining its cause, considering whether similar problems could occur elsewhere, implementing appropriate action, and reviewing its effectiveness.
Internal audits are used to determine whether the management system conforms to the laboratory’s own requirements and the requirements of ISO/IEC 17025.
Management reviews evaluate the continuing suitability, adequacy, and effectiveness of the management system and laboratory activities.
What Is ISO/IEC 17025 Accreditation?
ISO/IEC 17025 accreditation is formal recognition by an accreditation body that a laboratory has demonstrated competence to perform specified testing or calibration activities.
During accreditation, an accreditation body assesses the laboratory against ISO/IEC 17025 together with any applicable accreditation requirements.
The assessment can cover areas such as:
- Personnel competence
- Testing or calibration methods
- Equipment and facilities
- Metrological traceability
- Technical records
- Monitoring of result validity
- Reporting
- Management system implementation
The resulting scope of accreditation identifies the laboratory activities for which competence has been formally recognized.
A laboratory may perform other activities outside its accredited scope, so accreditation should not be interpreted as automatically covering every service offered by the laboratory.
ISO 17025 Certification vs Accreditation
ISO 17025 certification is a commonly used search term, but accreditation is the established form of third-party recognition used to demonstrate a laboratory’s competence under ISO/IEC 17025.
ISO/IEC 17025 contains requirements specific to laboratory activities, including personnel competence, equipment, methods, metrological traceability, measurement uncertainty, and the validity of results.
During accreditation, an accreditation body assesses whether the laboratory meets the applicable ISO/IEC 17025 requirements for the laboratory activities concerned.
When a regulation, certification scheme, customer, or other program requires testing by an ISO/IEC 17025-accredited laboratory, the applicable accreditation requirements should be checked before testing is arranged.
Who Accredits ISO/IEC 17025 Laboratories?
ISO and IEC develop and publish ISO/IEC 17025. They do not accredit laboratories.
Laboratory accreditation is carried out by accreditation bodies that assess laboratories against ISO/IEC 17025 and applicable accreditation requirements.
In China, laboratory accreditation is provided by CNAS (China National Accreditation Service for Conformity Assessment).
Why ISO/IEC 17025 Matters in Laboratory Testing
Laboratory results are often used to support decisions about product performance, material properties, certification, and regulatory compliance.
ISO/IEC 17025 addresses key factors that affect the validity of these results, including personnel competence, equipment, testing conditions, methods, technical records, and quality controls.
Depending on the product and market, testing by an ISO/IEC 17025-accredited laboratory may be required by regulations, certification schemes, buyers, retailers, or contractual requirements.
ISO/IEC 17025 accreditation demonstrates laboratory competence for specified activities. Product compliance is determined separately against the applicable regulations, standards, testing, documentation, and certification requirements.
ISO/IEC 17025 defines the competence, technical, and management requirements that support valid testing and calibration results. Its requirements provide a structured basis for evaluating how laboratories control the people, equipment, methods, records, and processes involved in their work.
Before arranging product testing, identify the applicable test standard and laboratory requirements for the intended use of the results. This helps ensure that the selected laboratory and testing arrangement are appropriate for the product, market, and compliance objective.
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