ISO/IEC 17025:2017

General requirements for the competence of testing and calibration laboratories

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.

ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.

The customers of laboratories (which could be regulatory authorities), organizations (which could be peer-assessment schemes or accreditation bodies) and others can take advantage of ISO/IEC 17025:2017 when it comes to confirming or recognising the competency of laboratories.

The ISO/IEC 17025 is a benchmark in the quality management system requirements in regards to being able to properly certify against. This standard can easily be focused in on in order for your company to see what new areas may be needed regarding improving your product’s level of performance.

Requirements for ISO/IEC 17025:2017

 

  • General Requirements (Clause 4)

Laboratory plan and implementation actions about risk and opportunities. Eliminate or minimize the risk related to impartiality, on an on-going basis.

The confidentially requirement is also extended to laboratory personnel, including any committee members, contractors, personnel of external bodies or individual acting on the laboratory behalf.

 

  • Structural requirements (Clause 5)

This includes Legal status of the laboratory, organization and

The structure of Management, identification of management, range of laboratory activities, documenting its procedures, availability of personnel responsible for the implementation and maintaining the integrity of the management system.

 

  • Resource requirements (Clause 6)

Resources required for the activity shall be gathered in addition to what is naturally available just in case. This may include people, facilities, equipment, systems and even supplementary services. It’s expected that everyone will act fairly in order to do their best work.

Transport, storage, use and planned maintenance of equipment must be in well-defined procedure. It’s expected that the equipment used for measurement should achieve its required measurement accuracy.

 

  • Process requirements (Clause 7)
  • Review of requests, tenders and contracts
  • Selection, verification and validation of methods
  • Sampling
  • Handling of test or calibration items
  • Technical records
  • Evaluation of measurement uncertainty
  • Assuring the validity of results
  • Reporting of results
  • Complaints
  • Nonconforming work
  • Control of data – Information management

 

  • Management System requirements (Clause 8)

Laboratories to establish and maintain a management system as per the requirements of ISO 9001.