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