HomeInternational certificationISO 13485/488

ISO 13485/488:2016 · Medical devices — quality management

ISO 13485/488MD QMS

The quality system regulators expect from manufacturers, distributors and service providers of medical devices — the base for CE marking and market registration.

Apply for ISO 13485/488 →What it gives you

SCHEME CARD · QUALITY & INDUSTRY

ISO 13485/488Medical devices — quality management · 2016

Who it's for: Device manufacturers, contract manufacturers and more
Audit model: Stage 1 + Stage 2 + surveillance
Certificate validity: 3 years
Typical timeline: 8–12 weeks

Listed in public registerCombines with ISO 9001

3 yrscertificate validity, with annual surveillance audits

2audit stages — documentation review, then on-site assessment

8–12weeks from application to certificate, typical timeline

1business day to a fixed offer after your application

Why companies certify

Who needs ISO 13485/488— and when

ISO 13485 adds regulatory rigour to a quality system: design controls, risk management per ISO 14971, traceability, complaint handling and post-market surveillance. Certification is the first step to market access in the EU and beyond.

Required for CE marking under MDR/IVDR, for registration in many national markets and by hospital procurement.

INDUSTRIES WE CERTIFY TO ISO 13485/488

Device manufacturersContract manufacturersDistributors & importersSterilisation servicesSoftware as medical deviceLaboratories

Not sure whether ISO 13485/488 fits? Our auditors run a short diagnostic review and suggest the scheme — or a combination of two or three — that answers your customers' requirements.

Inside the standard

What the audit examines

01Design & development

Controlled inputs, outputs, verification and validation.

02Risk management

ISO 14971 applied through the life cycle.

03Traceability

Device history records and UDI readiness.

04Complaint & vigilance

Reporting to authorities and post-market surveillance.

05Supplier control

Critical suppliers qualified and monitored.

06Sterile & clean processes

Validated special processes.

What the audit covers

Requirements,clause by clause

ISO 13485/488 is audited against these requirement areas. Open each one to see what auditors look for in your company.

Clause 4Quality management system+

Documentation, medical device file, control of records.

Clause 5Management responsibility+

Policy, planning, responsibility, management review.

Clause 6Resource management+

Competence, infrastructure, work environment and contamination control.

Clause 7Product realisation+

Planning, design and development, purchasing, production and servicing.

Clause 8Measurement, analysis, improvement+

Feedback, complaints, reporting to authorities, internal audit, CAPA.

Benefits

What ISO 13485/488certification gives you

Foundation for CE marking and national registrations
Acceptance by hospital and distributor procurement
Controlled design, production and post-market processes
Reduced regulatory findings and recalls
Qualified supplier status for OEMs
Combined audit with ISO 9001

Integrated audit

Hold more than one standard? One audit.

ISO 13485/488 shares its structure with ISO 9001. We audit them together — one team, one visit, one report.

−25%audit days on average

1lead auditor for all standards

The path to certificate

Five steps from application to ISO 13485/488

Scroll the steps — the bar shows where you are in the process. Every step has a named coordinator and a fixed timeline.

STEP 1 / 5 · Application & offer

STEP 11 business day

Application & offer

You send a short application; a coordinator sizes the audit and sends a fixed offer.

→ Offer with audit plan

STEP 21–2 days

Stage 1 audit

Documentation review and readiness check — remote or on site. Gaps are listed, not penalised.

→ Readiness report

STEP 3By calculation

Stage 2 audit

On-site assessment of implementation and effectiveness with a team that knows your sector.

→ Audit report

STEP 45–10 days

Decision & certificate

Independent certification decision; the certificate is issued and entered into the public register.

→ ISO 13485/488 certificate

STEP 5Annual

Surveillance & renewal

Annual surveillance keeps the certificate in force; re-certification in year three.

→ Certificate maintained

Readiness check

Are you readyfor Stage 1?

Tick what you already have. You do not need a perfect system to apply — you need a working one.

Medical device file and classification documentedDesign control and risk management files availableValidation of special processes completedComplaint handling and vigilance procedure in placeSupplier evaluation records availableInternal audit and management review completed

Your readiness

Based on the items ticked on the left. Indicative — the Stage 1 audit gives the formal picture.

Apply for ISO 13485/488 →

FAQ · ISO 13485/488

Questions companiesask before certifying

Did not find yours? Call us — a coordinator answers within the same business day.

+38 (044) 332-30-76

Is ISO 13485 the same as CE marking?+

No. CE marking is a conformity assessment under MDR/IVDR; ISO 13485 is the quality system most notified bodies expect to see behind it.

We only distribute devices — do we need it?+

Distributors and importers increasingly certify to satisfy manufacturers and regulators; the scope is then limited to storage, distribution and traceability.

What about ISO 13488?+

ISO 13488 was withdrawn; today the single standard is ISO 13485:2016.

Related schemes

Often certifiedtogether

Get certifiedto ISO 13485/488

Send an application — we define scope and audit duration, and issue a fixed offer within one business day.

Auditors with experience in your industry
Fixed price — no surprises after Stage 1
Certificate listed in the public register