Medical Services

ISO 13485 - UL's Medical Quality System Registration Service

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Your quality management system is critical to insure your medical product will be manufactured to your specifications for safe intended use every time. With every product submission, the Regulatory Bodies require proof that your product has been manufactured under a certified quality management system. With UL's ISO 13485 registration service, you will not only have the confidence that your system meets global quality system accreditation requirements, but you will also save time and resources by taking advantage of our local, integrated audits, no matter where in the world your manufacturing, design, packaging, or distribution is done.

ISO 13485 Drivers

Device manufacturers seek registration to ISO 13485 to improve their internal management of medical device quality systems.
Medical industry regulators use the ISO 13485 standard to standardize the evaluation of the quality systems of approved device manufacturers.
Customers of medical device manufacturers such as health care providers have required device manufacturers to seek registration to ISO 13485.
Medical Device component and service providers are also experiencing increasing demand for registration to ISO 13485 from their customers.

UL's ISO 13485 Service Portfolio

Preliminary Evaluation - A practice or mock audit of your site to determine your readiness for a registration audit. You will receive a written report including a list of any nonconformities found.
Registration Audit - Typically scheduled two to four months after your preliminary evaluation. At the conclusion of the registration assessment, your UL audit team will advise you of its recommendation and present a written report before leaving the site.
Continuous Audit - Conducted after registration to measure your continued conformance to the ISO 13485 standard.
Triennial (Recertification) Audit - Recertification assessment to begin a new 3 year cycle of Registration.
Internal Audits and Training - Unless there is a conflict of interest, UL's auditors can conduct your internal audits and staff training. UL also offers ISO 13485 training courses through ULUniversity.

Take Advantage of Global Marketing Requirements with Integrated Audits

You can schedule integrated audits for your management system to take advantage of the similar requirements synergy among your various quality management system needs. Typically, these combined audits require fewer audit days than the audits required for separate systems. For example, in one audit UL can assess conformity to ISO 13485 ISO 9000:2000, Medical Device or In Vitro Diagnostic directives, Canada's CMDCAS, Japan's PAL, Brazil's InMetro certification requirements, and ISO 14971 Risk Management requirements.

Our Credentials

UL's ISO 13485 program is accredited by SCC and UKAS. UL remains current with existing and emerging international standards through its participation in ISO TC 176, ISO TC 207, ISO TC 210, IEC SC62a, GHTF, IASG, Health Canada CMDCAS Registration Body group, European Union Notified Body (MHRA) and IAAR.