GENERAL IDEAS OF ISO/IEC 17025

ISO/IEC 17025 is an international standard that is useful for any organization that performs testing, sampling or calibration and wants reliable results. This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.

By implementing ISO 17025, the accredited laboratories have demonstrated that they are technically competence and able to produce precise and accurate test. It is the international reference for testing laboratories wanting to demonstrate their capacity to deliver reliable results.

ISO/IEC 17025 also enables laboratories to demonstrate that they operate competently and able to generate valid results, thereby promoting confidence in their work both nationally and around the world.

It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

Through the accreditation process, the organizations can demonstrate:

  • The efficiency and validity of their processes
  • The accuracy of their measurements
  • Assurance around innovation
  • Technical competence
  • Impartiality
  • Confidence to customers
  • Commercial advantages
  • International acceptance of results

WHAT ARE THE KEY CHANGES ON 2017 VERSION

ISO/IEC 17025 takes into consideration the new ways of working of laboratories today. The most substantive changes are as follows:

  1. The scope has been revised to cover all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing.
  2. A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.
  3. The process approach now matches that of newer standards, putting the emphasis on the results of a process instead of the detailed description of its tasks and steps.
  4. The standard has a stronger focus on information technologies. In recognition of the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions, it incorporates the use of computer systems, electronic records and the production of electronic results and reports.
  5. A new section has been added introducing the concept of risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management.
  6. The terminology has been updated. Examples include changes to the International Vocabulary of Metrology (VIM) and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.

MAIN CONTENTS OF THE STANDARDS

The 2017 version of ISO/IEC 17025 has modified this structure to be Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements.

General Requirements and Structural Requirements are related to the organization of the laboratory itself.

Structure Requirements cite those issues related to the people, plant, and other organizations used by the laboratory to produce its technically valid results.

Process Requirements are the heart of this version of the standard in describing the activities to ensure that results are based on accepted science and aimed at technical validity.

Management System Requirements are those steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results.

The main clauses as listed below:

  1. General requirements
    • 4.1 Impartiality
    • 4.2 Confidentiality
  2. Structural requirements
    • 5.1 Structural requirements
  3. Resource requirements
    • 6.1 General
    • 6.2 Personnel
    • 6.3 Laboratory facilities and environmental conditions
    • 6.4 Equipment
    • 6.5 Metrological traceability
    • 6.6 Externally provided products and services
  4. Process requirements
    • 7.1 Review of requests, tenders and contracts
    • 7.2 Selection, verification and validation of methods
    • 7.3 Sampling
    • 7.4 Handling of test or calibration items
    • 7.5 Technical records
    • 7.6 Evaluation of measurement uncertainty
    • 7.7 Assuring the quality of results
    • 7.8 Reporting of results
    • 7.9 Complaints
    • 7.10 Management of nonconforming work
    • 7.11 Control of data-information management
  5. Management requirements
    • 8.1 Option
    • 8.2 Management system documentation
    • 8.3 Control of management system documents
    • 8.4 Control of records
    • 8.5 Actions to address risks and opportunities
    • 8.6 Improvement
    • 8.7 Corrective action
    • 8.8 Internal audits
    • 8.9 Management reviews