ISO 13485 is the harmonized quality system standard for medical device manufacturers, their suppliers, and other third parties that provide products or product components, including QMS-related services for the company. ISO 13485 is based on ISO 9001 and supplemented with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions.

Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that a quality system is implemented and maintained.

Oriel STAT A MATRIX offers a full range of ISO 13485 consulting and training solutions for companies of all sizes.

Whether you are looking to obtain first-time conformance or transition/upgrade an existing QMS to ISO 13485:2016, our experienced consultants can help. Contact us to learn more.

Frequently Asked Questions About ISO 13485 Certification

Who needs to be certified to ISO 13485?

Certification to the ISO 13485 standard is often a prerequisite if you want to sell your medical device and/or IVD outside of the United States. Although being registered does not fulfill the requirements of the various industry regulators – such as US Food and Drug Administration (FDA) – ISO 13485 is commonly used as the basis for regulatory requirements. As such, implementation of the ISO 13485 standard is an essential consideration, not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their medical device products are manufactured to the highest quality.

A revised ISO 13485 was published on February 25, 2016 – the first revision in over a decade. As of March 2019, certifications issued to ISO 13485:2003 will no longer be valid.

Key updates to ISO 13485:2016 include:

• A broader focus on risk throughout the standard’s clauses, requiring more senior management involvement in the quality management system
• Greater supplier controls, including risk-based controls
• Additional management review requirements
• The integration of competency with training requirements
• A focus on requirements for software
• Validation using preclinical and clinical evaluations
• Validation of packaging and distribution requirements
• A feedback section, including a new complaint-handling section and other guidance for customer communications
• Additional improvement measures: adding the use of postmarket surveillance, risk-based decisions, and timelines

What is the difference between FDA’s QSR outlined in 21 CFR 820 and ISO 13485?

In the US, FDA requires compliance to Quality System Regulation (QSR) – as outlined in 21 CFR 820 – for all medical device manufacturers distributing products via interstate commerce. Conformance to ISO 13485 is voluntary.

However, in the EU and many other countries, conformance to ISO 13485 is often seen as the first step in achieving compliance with those countries’ regulatory requirements.

Will MDSAP require conformity to ISO 13485?

The MDSAP audit model includes ISO 13485 requirements. Note, however, that conformance to ISO 13485:2016 is just one element of meeting the requirements of MDSAP. Learn more about MDSAP.

Will the new EU Medical Device Regulations require EN ISO 13485:2016 certification?

Fundamentally, yes. Although the regulations do not require certification to a specific EN ISO standard, medical device companies must establish and implement a quality system that meets a number of compliance requirements outlined in the new Medical Device Regulation and In Vitro Diagnostic (IVD) Regulation.

The easiest way to achieve this compliance is to establish, implement, and attain EN ISO 13485 certification for the manufacturer’s quality management system. EN ISO 13485:2012 is the current harmonized standard for quality systems, as published in the Official Journal. We anticipate that, in a short time, the EN ISO 13485:2016 standard will become the harmonized standard for quality systems, as the presumed conformity for EN ISO certification will need upgrading to the 2016 version by March 2019.

Why Choose Oriel STAT A MATRIX for Your ISO 13485 Training and Consulting?

Since 1968, organizations have relied on Oriel STAT A MATRIX for management systems training and consulting. We have trained more than 130,000 auditors and helped thousands of organizations attain certification to ISO 9000 and related management standards, including ISO 13485.
Oriel STAT A MATRIX was:

• The first US-based consultancy to provide ISO 9000 certification consulting (1988).
• The first US-based trainer to be registered by the Institute of Quality Assurance (IQA, the predecessor to IRCA) to train ISO 9000 lead auditors (1990).
• The first training provider certified by the Registrar Accreditation Board (RAB, the predecessor to RABQSA and Exemplar Global) to offer lead auditor and internal auditor training (1992).