Frequently Asked Questions (FAQs)

• ISO 9000 QUALITY MANAGEMENT SYSTEM
  
• ISO 14000 ENVIRONMENTAL MANAGEMENT SYSTEM
  
• FOOD SAFETY MANAGEMENT SYSTEM
  
• METROLOGICAL MEASUREMENT SYSTEM
  
• ISO/IEC 17025 - COMPETENCE OF TESTING AND CALIBRATION LABS
  
• INTEGRATED PERFORMANCE MANAGEMENT SYSTEM
  
• STATISTICAL PROCESS CONTROL (SPC)
  

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What is ISO/IEC 17025?

ISO/IEC 17025 is an International Standard (published by the International Organization for Standardization) that specifies the general requirements for the competence to carry out tests and/or calibrations. There are 15 management requirements and 10 technical requirements. These requirements outline what a laboratory must do to become accredited.
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. It contained all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results.
The first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses have been amended or added only when considered necessary in the light of ISO 9001:2000. The latest edition of ISO 9001:2008 has been published by ISO on 15 Nov 2008 and an introductory and support guidance package issued by ISO TC 176/SC2 is freely available for download - PDF, 160KB

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What does ISO/IEC 17025 apply to?

ISO/IEC 17025 applies to all organizations performing tests and/or calibrations. It applies to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities covered by this International Standard.

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How does a laboratory get accredited to ISO/IEC 17025?

A laboratory must document a quality management system. A documented quality manual is a basic requirement on the road to laboratory accreditation. In addition, quality management procedures must be established for how the system is maintained. Once the system is documented it must be implemented in the laboratory. It will also accompany the laboratory’s application for accreditation. The implementation period will require several months to establish the records that an accreditation body will review at an accreditation audit.
Finally, the laboratory undergoes the ISO/IEC 17025 assessment by an accreditation body that is competent to perform laboratory accreditation.

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ISO/IEC 17025:2005 and ISO 9001:2008

Accreditation bodies that recognize the competence of testing and calibration laboratories should use this International Standard as the basis for their accreditation. Clause 4 specifies the requirements for sound management. Clause 5 specifies the requirements for technical competence for the type of tests and/or calibrations the laboratory undertakes.
Growth in the use of management systems generally has increased the need to ensure that laboratories which form part of larger organizations or offer other services can operate to a quality management system that is seen as compliant with ISO 9001 as well as with this International Standard. Care has been taken, therefore, to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory's management system.
Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001.
Conformity of the quality management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. Nor does demonstrated conformity to ISO/IEC 17025 Standard imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001.

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Certification vs. Accreditation

Certification

• Means compliance with a standard or specification (e.g. systems or product standards).
• Is assessed by management systems auditors who are certified by an independent body as meeting internationally agreed criteria.
• Can cover more than the sections or tests that have been accredited through laboratory accreditation.
• May be general in the scope of recognition.
• Considers the total business including strategy and planning.

• Is the recognition of specific technical competence.
• The scope of accreditation is normally highly specific.
• Evaluates people, skills and knowledge.
• Is formal recognition that a testing laboratory is competent to carry out specific tests or specific types of tests.
• Uses technical assessors who are recognised experts in their field.
• Also evaluates management systems compliance.

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For more information, please contact Tadesse Solomon, I-QUAS Contact at: iquas@ethionet.et or (251-11) 662 3846 or (251-91) 161 3073, Addis Ababa, Ethiopia.

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