Standards / Medical devices and laboratories
ISO 15189 Medical laboratories
Quality and competence for medical and clinical laboratories.
Core documents AMS builds
- Pre-examination procedures
- Examination validation
- Quality control records
- Result reporting procedure
Drafted from your actual processes and systems, then kept under version control with review dates.
The path to ISO 15189
Six steps from first conversation to ISO 15189. AMS and our consultants handle each one with you.
- 1Scope
Define which sites, teams, processes and systems ISO 15189 will cover.
- 2Gap assessment
Compare what you do today with every ISO 15189 requirement and list what is missing.
- 3Documents
Write the policies, procedures and records ISO 15189 expects, starting with the pre-examination procedures.
- 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 15189 questions
Planning ISO 15189? Talk to our team
How long does ISO 15189 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 15189 require?
Core documents usually include: pre-examination procedures, examination validation, quality control records, result reporting procedure. AMS drafts them from your actual processes and keeps them under version control.
Can ISO 15189 be combined with other standards?
Yes. ISO 15189 is often run together with ISO 13485, ISO/IEC 17025. AMS maps shared requirements, so one record can count toward several standards.
How does AMS help with ISO 15189?
AMS runs the full ISO 15189 program: scoping, gap assessment, documents, evidence capture, internal audits, corrective actions and the audit pack for your certification body.