ISO Management System Certification

ISO 13485:2016 - Medical Devices Quality Management Systems

ISO 13485:2016 specifies QMS requirements for organizations involved in medical device design, production, installation, and servicing, emphasizing risk management and regulatory compliance.

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Standard ISO 13485:2016
Certified worldwide 31,215
Certificate validity 3 years
Surveillance Annual

Overview

What ISO 13485:2016 is — and why it matters

ISO 13485:2016 specifies QMS requirements for organizations involved in medical device design, production, installation, and servicing, emphasizing risk management and regulatory compliance.

It covers the full device lifecycle, including post-market surveillance.

The Standard

What the standard requires

Built on the common ISO “Annex SL” structure, the requirements map to these clauses:

Clause 4

General – QMS scope.

Clause 5

Management responsibility – Policy, reviews.

Clause 6

Resource management – Infrastructure, work environment.

Clause 7

Product realization – Design, purchasing, production, validation.

Clause 8

Measurement – Monitoring, audits, improvement.

Getting Ready

What you’ll need to get certified

  • Design history files (DHF); risk management per ISO 14971; validation records for processes.
  • Supplier controls and traceability; post-market vigilance reports; CAPA for complaints.
  • Cleanroom/sterility controls; regulatory submission evidence.

The Audit

How ACS-GP certifies your management system

Our audits follow ISO/IEC 17021-1 (requirements for certification bodies) and ISO 19011 (guidelines for auditing management systems).

  1. Per ISO/IEC 17021-1 and ISO 19011, with MDD/MDR alignment.

  2. Stage 1: Technical file review; Stage 2: Cleanroom audits; surveillance on complaints.

Value Addition Auditing. We assess both efficiency and effectiveness — so your management system becomes a genuine business asset, not just a certificate on the wall — while upholding impartiality, competence and evidence-based findings.

The Payoff

The benefits of certification

What the standard delivers

  • Accelerates regulatory approvals (FDA, EU MDR), enabling faster market entry.
  • Ensures device safety, reducing liability and recalls.
  • Enhances supply chain reliability for medtech globals.

Why certify with ACS-GP

  • IASCB for Notified Body equivalence.
  • Bundled with ISO 14971 risk training.

Questions

ISO 13485:2016 certification — FAQs

Who should get ISO 13485:2016 certified?
Any organisation that wants independent proof its management system meets the standard — to win and reassure customers, satisfy regulators, reduce risk and improve day-to-day performance. It suits businesses of any size, in any sector.
How long does certification take?
It depends on how ready your management system is. Once your documented system is implemented and running, we complete a two-stage initial audit (readiness review, then the certification audit). We’ll give you a clear timeline after understanding your scope and sites.
How long is the certificate valid?
The certificate is valid for three years. Each year we carry out a surveillance audit to confirm your system stays effective, and in year three a recertification audit renews the cycle.
How much does ISO 13485:2016 certification cost?
Audit time — and therefore cost — depends on your organisation’s size, the number of sites, and the complexity and risk of your processes. Request a quote and we’ll prepare a clear, no-obligation proposal.

Ready to certify to ISO 13485:2016?

Talk to ACS-GP about certifying your organisation — or explore the other standards we certify against.

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