ISO 17025 checklist for your laboratory

An ISO 17025 checklist helps you check whether your laboratory is ready for an application or an assessment. The checklist below is our own guide, not an official list from the Dutch Accreditation Council (RvA) . The documents the RvA asks for with an application are listed in annex A of ASR105 . The checklist is grouped by what the auditor does: they choose a method, a measuring instrument or a job, and follow it through the whole system. Use the checklist alongside your scope of accreditation and your quality system. If you do not yet know whether ISO 17025 applies to you, start with the explanation of the standard.

The checklist asks yes or no questions, but the real work lies in the evidence behind the answer. A “yes” without a record does not count with an auditor.

How do you use this checklist?

1. Go through the questions in each block with a colleague who does the work.
2. Note for each question where the evidence is: a document, a record or a conversation.
3. Mark every “no” or “don’t know” and turn it into an action.
4. Repeat the check every quarter, or before each audit.

Block 1: scope and organisation

• Do you know which activities fall under your accreditation, with the method and range?
• Is the organisation of your laboratory described, including who is responsible for what?
• Is the impartiality of your work safeguarded, and is that recorded?
• Are there agreements on the confidentiality of client information?

An example of what an auditor asks: “Which methods do you perform under your accreditation, and which do you not?” A laboratory that cannot answer that question directly has a scope problem.

Block 2: staff and competence

• Is it recorded for each staff member which tasks they may carry out?
• Are education and experience recorded, with evidence?
• Is competence checked regularly, for example by observation or a test?
• Does everyone know who has the final authority over a result?

Evidence: a competence matrix with the date of the last assessment. The overview of documents is on quality system and documents.

Block 3: equipment and measuring instruments

• Is every measuring instrument on a list with its identification, location and status?
• Does each measuring instrument that significantly affects the result have a calibration or check interval, with justification? The RvA requires calibration only for such equipment (INF002, 6.4.6).
• Can you demonstrate the traceability of your reference standards?
• Are defective devices marked and taken out of use?

Block 4: methods and validation

• Does every accredited method have a work instruction with a version number?
• Is the method validated, or is the validation for this application justified?
• Has measurement uncertainty been determined and documented? See the page on measurement uncertainty.
• Is the method checked regularly with a reference or control sample?

Block 5: samples and jobs

• Is each request reviewed before the work starts?
• Is each sample or test item uniquely identified and recorded on receipt?
• Is sample storage described and monitored?
• Can you trace a report back to the sample and the measurement data?

Block 6: results and reporting

• Does each report state the method and the uncertainty, or state that the uncertainty is available on request? For results close to a specification limit, the uncertainty belongs in the report (INF002, 7.8.3.1).
• Is a statement of conformity supported by a decision rule? See declaration of conformity.
• Are changes to a report logged, with the reason and authorisation?
• Are proficiency tests used to check the quality of your results? See proficiency testing.

Block 7: quality control and improvement

• Is internal quality control set up for each method?
• Are complaints recorded and followed up?
• Are nonconformities analysed for cause, not only corrected, and is the measure assessed for effect? See nonconformities.
• Has an internal audit covering the whole scope taken place, and has the result been discussed? For a first application, the RvA requires this (INF002, 8.8).
• Has management reviewed the system, and did that lead to actions?

Fictional example: the checklist in one morning

A fictional food safety laboratory works through the checklist with two staff members. They find four points.

None of these findings is serious on its own. Together they show where the system is weak. That is exactly the purpose of the check.

Common mistakes

• Having only the quality manager complete the checklist. The people who do the work often know better where things go wrong.
• Ticking “yes” from memory. Always ask for the evidence.
• Doing it once. A checklist completed once loses its value within six months.
• Not closing actions. An open point without an owner and a date comes back at the next check.

Frequently asked questions

Is this checklist enough to pass an assessment? No. The checklist helps you prepare. The RvA determines the assessment, based on the standard and your own evidence.

Must I share the checklist with the RvA? No, the RvA does not ask for it in the document list of ASR105. It is an internal tool. You must, however, be able to show evidence for the points during the audit.

How often should I work through the checklist? At least for every application and every audit, and in addition periodically as part of your own internal audit.

Is a part missing? That can happen. Adapt the checklist to your own scope and methods. Add points where your laboratory has specific risks.

Sources

• RvA: testing laboratories 
• RvA: calibration laboratories 
• RvA: explanation of NEN-EN-ISO/IEC 17025 (INF002)