What are the basic criteria for ISO/IEC 17025 Accreditation?

There are a number of basic criteria or requirements that a lab must meet and fulfil in order to achieve ISO/IEC 17025 accreditation. Presentation of supporting documentation of the way the requirements have been satisfied is an essential part of the review process a lab must go through to prove their compliance.

ISO/IEC 17025 is broken down into five basic requirements:

General Requirements

• Impartiality – the lab must prove that all work is completed with safeguarding impartiality in mind, that the lab is committed to impartiality and any risks to impartiality are identified.
• Confidentiality – the lab must show that customer information is kept confidential.

Structural Requirements

• There must be evidence of a person that has overall management responsibility for the laboratory
• There must be documentation of the lab’s procedures within the Quality Management System. This is typically accomplished with the use of a Quality Manual but is not required if it is documented somewhere.
• The lab must also define the range of activities and document it’s procedures. A lab may be accredited for only 3 tests out of 10 that it performs so it is important to clarify which tests the lab is accredited for.

Resource Requirements

• Personnel – The lab must document competence requirements such as education and work experience of their staff. All staff must also be trained, and proficiency is evaluated at the time of training and on an on-going basis. Records of their training and on-going evaluations must be maintained for review.
• Facilities – the lab facilities and environmental conditions must be suitable for the laboratory activities being performed.
• Equipment – The lab must provide proof that all equipment is validated and checked before use (i.e. testing customer samples)
• Measurement Traceability – Traceability allows you to establish the accuracy of a measurement. It is defined as the “property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement of uncertainty”.  The lab must show that calibration results are documented, calibration procedures are followed, and a calibration certificate is available.

Process Requirements

• Contract Review – Review of requests, tenders and contracts must have a procedure. A lab must inform the customer if they think a requested test is inappropriate.
• Method Validation – Methods are validated before use using known reference materials where available to ensure the chosen methods are fit for intended purpose.
• Sampling – a laboratory may or may not be responsible for sampling. In the tribology industry typically, the customer is responsible for sampling, but this may not be the case in other labs where chain of custody is incredibly important.
• Technical Records – Records must be maintained with sufficient information to produce an audit for an assessment cycle. Assessment cycles are typically 2 years, but it depends on the industry and governing bodies.
• Uncertainty – Scientific uncertainty means that there is a range of possible values within which the true value of the measurement lies.  Uncertainty calculations of the method must be available to the customer.
• Ensuring validity of results on an on-going basis – the lab must show that method validations and equipment are be checked periodically.
• Proficiency Testing – This can be done externally or internally. For external PT, test samples of unknown concentrations are sent to all Fluid Life laboratories. These samples are then analyzed, and the results are provided to an independent evaluation body, who then provides a report, indicating how Fluid Life performed compared to other laboratories across North America. The results are given as z-score. Alternatively, a lab may employ interlab PT if the analytes (chemical substances that are the subject of chemical analysis) are not available from an appropriate PT provider.
• Reporting – There are numerous requirements for reporting. This section is about 3 pages long, however a lab can offer abbreviated reporting if the customer agrees to the format. This is typically discussed in the requests or contracts process. One item that is required is to identify a test result that may have been amended due to a work recall.
• Complaints and non-conforming work – The lab must have a procedure for handling complaints and non-conformances. Examples of non-conformances include if services fail to satisfy customer obligations, serious and valid customer complaints, or if a documented procedure isn’t followed. By documenting and resolving non-conformances, the lab can identify opportunities for improvement.
• Control of Data – Most laboratories have some sort of Laboratory Information Management System (LIMS). This system must be protected and in the event of a failure, backups are required to provide an audit trail.

Management Requirements (Option A: 9001 requirements)

• Document control, approval, issue
• Control of records
• Risk identification, consideration, and address
• Continuous improvement and preventative action
• Corrective actions
• Internal audits
• Management reviews / quality management meetings conducted annually

Fluid Life works hard to ensure that all lab facilities are ISO/IEC 17025:2017 accredited.