Standards / Medical devices and laboratories
ISO/IEC 17025 Testing and calibration laboratories
Competence, impartiality, and consistent operation of testing and calibration labs.
Core documents AMS builds
- Method validation records
- Measurement uncertainty
- Equipment calibration records
- Proficiency testing results
Drafted from your actual processes and systems, then kept under version control with review dates.
The path to ISO/IEC 17025
Six steps from first conversation to ISO/IEC 17025. AMS and our consultants handle each one with you.
- 1Scope
Define which sites, teams, processes and systems ISO/IEC 17025 will cover.
- 2Gap assessment
Compare what you do today with every ISO/IEC 17025 requirement and list what is missing.
- 3Documents
Write the policies, procedures and records ISO/IEC 17025 expects, starting with the method validation records.
- 4Implement and collect evidence
Put the processes into daily work and capture proof that they run, on a schedule.
- 5Internal review
Check readiness with an internal audit or self-assessment, and close the findings.
- 6Certification audit
An accredited certification body runs a stage 1 document review and a stage 2 audit, then issues the certificate. Surveillance audits follow every year.
ISO/IEC 17025 questions
Planning ISO/IEC 17025? Talk to our team
How long does ISO/IEC 17025 implementation take?
Most organizations need about 16–28 weeks, depending on size, number of sites and how much is already in place. A gap assessment gives a firm estimate.
What documents does ISO/IEC 17025 require?
Core documents usually include: method validation records, measurement uncertainty, equipment calibration records, proficiency testing results. AMS drafts them from your actual processes and keeps them under version control.
Can ISO/IEC 17025 be combined with other standards?
Yes. ISO/IEC 17025 is often run together with ISO 13485, ISO 15189. AMS maps shared requirements, so one record can count toward several standards.
How does AMS help with ISO/IEC 17025?
AMS runs the full ISO/IEC 17025 program: scoping, gap assessment, documents, evidence capture, internal audits, corrective actions and the audit pack for your certification body.