What does ISO/IEC 17025 cover?
ISO/IEC 17025 addresses laboratory competence, impartiality and consistent operation. Accreditation relates to a defined scope of testing or calibration. Evidence must support technically valid results as well as a functioning management system.
Who it is for
Testing and calibration laboratories, including in-house and commercial laboratories.
Key areas to understand
Start with these areas. Identify which requirements apply to your activities and who is responsible for them.
- 1Use suitable methods and competent personnel.
- 2Control equipment, traceability and result validity.
- 3Protect impartiality and manage nonconforming work.
Evidence to prepare
This list is a starting point. Check the standard for all required documents. For each item, record who is responsible, the activity or site it relates to, and a recent example showing how it works.
- Method verification or validation records
- Staff competence and authorization
- Calibration and metrological traceability records
- Quality-control and proficiency-testing results
- Technical records supporting issued reports
Keep records that explain what was checked, which requirement was used and who checked it. Include any action taken when a requirement was not met. Link each record to the work it supports.
An internal audit example
Suggested checks from 4Auditee
Select one issued result and reconstruct how it was obtained. Identify the method, equipment status, authorized operator and quality checks used on the day. Where applicable, check how measurement uncertainty and decision rules were addressed in the work and report.
Choose a sample that suits your activities and risks. If you find a gap, record the requirement, the evidence and what was missing. Check more examples if the first results suggest a wider problem.
A common problem to check
A calibration certificate on file does not by itself establish fitness for use. Check the range, uncertainty and application against the laboratory’s work.
Prepare for assessment
The assessment type for this guide is laboratory accreditation. Confirm the requirements, what will be assessed and how the assessment will work with the responsible body or customer. These steps help you prepare. You must also follow the scheme’s official rules.
- Define what is covered. List the products, services, activities and sites. Record the standard edition, additional scheme rules and customer requirements.
- Find what is missing. Compare the requirements with current work. Prioritise gaps by risk. Assign someone responsible and a completion date.
- Keep records of everyday work. Check a sample of actual records and speak with the people involved. Make sure they understand their responsibilities.
- Check the results. Complete internal reviews and audits. Check that corrective actions worked before closing problems.
From one site to many
Make it easy to find who is responsible at each site. Keep company policies separate from records of local work. Link each site’s records to its activities, risks and requirements so you can spot gaps at individual sites.
Sites that share a management system do not automatically qualify for one certificate or assessment. Confirm which sites can be included and how they will be checked with the assessment body.
About this guide and its sources
4Auditee wrote this guide using the public source below. The evidence list, audit example and preparation steps are our suggestions. Read the official standard and scheme rules for the full requirements. This guide does not include the standard’s full text or provide certification.
BSI: ISO/IEC 17025 reference information