ISO/IEC 17025 – Applicability, Use and Summary of Requirements

  • By: Staff Editor
  • Date: September 02, 2011
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The ISO/IEC 17025 applies to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.

ISO/IEC 17025 is applicable to all laboratories regardless of:

  • The number of personnel or
  • The extent of the scope of testing and/or calibration activities.

If a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025, then the clauses pertaining to those activities don’t apply.


To understand the full requirements of the ISO/IEC 17025, get the standard and related manuals and checklists from the ComplianceOnline store:

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This standard, the latest of which was released in 2005 is to be used by laboratories in developing their management system for quality, administrative and technical operations.

Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.

However, the ISO/IEC 17025 is not intended to be used as the basis for certification of laboratories.

This standard doesn’t cover the regulatory and safety requirements for laboratories.


The ISO/IEC 17025 includes the following:

  • Scope
  • Normative references
  • Terms and definitions
  • Management requirements
  • Technical requirements

Management Requirements

The Management Requirements section of the ISO/IEC 17025 standard is divided into 15 chapters:


Organization  Roles and responsibilities of key personnel, laboratory and management should be defined
Management system  Management system should be implemented, maintained and reviewed for improvements
Document control  The management system should be documented – requires documentation control and properly defined processes
Review of requests, tenders and contracts  The requirements of requests, tenders and contracts should be properly defined, reviewed, documented and understood by lab management
Subcontracting of tests and calibrations  Those testing and calibration activities sub-contracted to third parties have to follow the same quality standards and competence requirements
Purchasing services and supplies  Suppliers have to be evaluated to ensure quality is maintained and these processes have to be properly documented
Service to the customer  Customers’ requests, input and feedback have to be handled with a proper system or mechanism and have to be documented
Complaints  Customer complaints should be documented, evaluated and there should be a proper follow-up process
Control of non-conforming testing and/or calibration work  Non-conforming testing and calibration results should be followed up and corrective actions should be performed
Continuous improvement  Lab management improvements should be implemented after analyzing audit reports, data, customer complaints and feedback, corrective and preventive actions and management reviews
Corrective action  The root cause of nonconforming work or deviations from laboratory and management procedures should be identified and appropriate corrective actions applied and monitored.
Preventive action  When potential sources of nonconformities have been identified, preventive actions should be initiated
Control of records  All records in a laboratory need:
  • A unique identification
  • Readily available when needed
  • Secure against unauthorized access
Internal audits  Internal audits have to be carried out to ensure that the laboratory complies with ISO/IEC 17025 requirements
Management reviews  Management reviews have to be carried out to ensure that systems are stable and effective, especially the quality system and testing and calibration procedures

 Technical requirements

The technical requirements clause in this standard includes the following ten chapters:


  • Factors affecting quality of test results should be documented
  • When formulating testing and calibration methods, these factors have to be taken into account
  • Laboratory personnel have to be competent and qualified
  • Regular training programs have to be conducted to improve performance and compliance
Accommodation and environmental conditions  The calibration and test areas should not be affected by an adverse physical environment – optimum conditions have to be maintained at all times
Test and calibration methods and method validation  Test and calibration methods have to be kept up to date and validated in order to achieve the best possible results
Equipment  Equipment has to be properly maintained and performing well in order to get the best and most accurate results
Measurement traceability  All measurements on all equipments have to be ideally traceable to the International System of Units (SI)
Sampling  Statistically relevant, representative samples have to be taken and procedures properly documented
Handling test and calibration items
  • Sample integrity should be maintained during transport, storage, and retention and samples should be disposed of safely
  • Test and calibrations items should have unique identification
Assuring quality of test and calibration results  Quality control samples should be analyzed regularly and checks implemented
Reporting of results  Results should be recorded accurately and clearly, plus conform to the result reporting requirements in the standard


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